Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Approved 03.29.2018
Policy for Interactions
with Industry and
Other Outside Entities
I
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Table of Content
Approved 03.29.2018
Table of Contents
Preface, Purpose, and Administration ..................................................................... 1
P.1. Purpose of the Policy .......................................................................................................................................... 1
P.1.1 Importance of Collaboration with Industry ..................................................................... 1
P.1.2 Definition Of Conflict Of Interest ................................................................................... 2
P.1.3 Purpose ............................................................................................................................ 2
P.2. Administration of the Policy .............................................................................................................................. 3
P.2.1 Committee Structure ....................................................................................................... 3
P.2.2 COA Responsibilities ...................................................................................................... 3
P.2.3 ERB Responsibilities ...................................................................................................... 4
P.2.4 OII Responsibilities ........................................................................................................ 4
P.2.5 Definition of MGB Individuals ....................................................................................... 5
P.2.6 Responsibilities of MGB Individuals .............................................................................. 5
P.2.7 Compliance Responsibility ............................................................................................. 6
P.2.8 Policy Review and Amendment ...................................................................................... 6
Researchers’ Financial Interests and Outside Activities Related to Research and
Financial Conflicts of Interest ................................................................................. 7
1.1. Policy Overview ................................................................................................................................................. 7
1.1.1 Policy ............................................................................................................................... 7
1.1.2 Researcher Responsibilities............................................................................................. 8
1.1.3 To Whom this Policy Section Applies ............................................................................ 8
1.2. Policy Requirements for Interactions Related to Research ................................................................................. 9
1.2.1 Required Reporting to MGB ........................................................................................... 9
1.2.2 Reportable Interests ....................................................................................................... 10
1.2.3 Impermissible Conflicts of Interest ............................................................................... 10
1.2.4 Interests and Activities That May Be Allowed ............................................................. 15
1.3. Oversight of Interactions Related to Research .................................................................................................. 16
1.3.1 MGB Authority and Responsibilities Relating to Financial Interests and Outside
Activities of Researchers ........................................................................................................ 16
1.3.2 Required Disclosure in Publications and Presentations ................................................ 17
1.3.3 Required Disclosure to Subjects in Human Subjects Research .................................... 17
1.3.4 Additional Disclosure and Accountability Measures .................................................... 17
1.3.5 Management of Financial Conflicts of Interest ............................................................. 18
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Table of Content
Approved 03.29.2018
1.3.6 Special OII Responsibilities with Respect to Public Health Service Funding .............. 18
Clinical Care and Interactions with Industry ........................................................20
2.1. Policy Overview ............................................................................................................................................... 20
2.1.1 Policy ............................................................................................................................. 20
2.1.2 Definition of Clinical Conflict of Interest ..................................................................... 20
2.1.3 Ancillary Equipment ..................................................................................................... 21
2.1.4 To Whom the Policy Applies ........................................................................................ 21
2.2. Policy Requirements ......................................................................................................................................... 22
2.2.1 Evaluation of Clinical Conflicts of Interest................................................................... 22
2.2.2 Reporting of Clinical Conflicts of Interest .................................................................... 22
2.2.3 Additional Policy Requirements Related to Clinical Care and Interactions with Industry
................................................................................................................................................ 22
2.3. Oversight of Clinical Conflicts of Interest ........................................................................................................ 23
2.3.1 COA’s Authority for Evaluating and Managing Clinical Conflicts of Interest ............ 23
2.3.2 Management of Clinical Conflicts of Interest ............................................................... 23
2.3.3 Disclosure to Patients .................................................................................................... 23
2.3.4 Clinical Care and Royalties Through the Institution ..................................................... 23
Industry Support Related to Education ..................................................................24
3.1 Policy Overview ................................................................................................................................................ 24
3.1.1 Rationale and Policy Statement..................................................................................... 24
3.1.2 Description of Industry Support of Education .............................................................. 24
3.1.3 Types of MGB Educational Activities .......................................................................... 25
3.1.4 OII Review of Industry Support .................................................................................... 25
3.2. Oversight of Industry Support Related to Education ........................................................................................ 26
3.2.1 ERB Authority to Implement, Monitor, and Enforce Policy ........................................ 26
3.2.2 Requirements for ERB Review and Approval .............................................................. 26
3.2.3 ERB Review of MGB Educational Activities ............................................................... 26
3.2.4 ERB Oversight for Industry Support for Trainee Travel .............................................. 27
3.2.5 Educational Services Arrangements.............................................................................. 27
3.2.6 Exception for Merit-Based Fellowship Awards ............................................................ 27
3.3. Policy Requirements for Industry Support of MGB Educational Activities ............................................. 28
3.3.1 Overview ....................................................................................................................... 28
3.3.2 Compliance with Continuing Medical or Other Healthcare Professional Education
Standards ................................................................................................................................ 28
3.3.3 Control of Content ......................................................................................................... 28
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Table of Content
Approved 03.29.2018
3.3.4 Multiple Sources of Monetary Support Required ......................................................... 28
3.3.5 Review and Resolution of Financial Interests ............................................................... 28
3.3.6 Disclosure of Support .................................................................................................... 29
3.3.7 Support to Institution, not Individuals .......................................................................... 29
3.3.8 Selection of Participants ................................................................................................ 29
3.3.9 Naming of Activity/ Specific Training Position ........................................................... 29
3.3.10 Reports to Industry ...................................................................................................... 29
3.3.11 Commercial Promotion at MGB Educational Events ................................................. 29
3.3.12 Documentation ............................................................................................................ 30
3.3.13 Budget Review ............................................................................................................ 30
3.4. Policy Requirement for Industry Support to Presidents’ Funds for Medical Education .......................... 31
3.4.1 Requirements for Industry Contributions to Presidents’ Funds .................................... 31
Consulting and Other Outside Activities ................................................................32
4.1. Policy Overview ............................................................................................................................................... 32
4.1.1 Policy ............................................................................................................................. 32
4.1.2 To Whom Does this Section 4 Apply? .......................................................................... 33
4.2. Policy Requirements for Outside Activities ..................................................................................................... 34
4.2.1 Requirements for Outside Activities ............................................................................. 34
4.2.2 Time Limitations for Outside Activities ....................................................................... 35
4.2.3 Prohibited Outside Activities ........................................................................................ 36
4.2.4 Fiduciary Positions Require COA Review and Approval ............................................. 37
4.2.5 Compensation for Outside Activities ............................................................................ 38
4.2.6 Restriction on Use of MGB Name ................................................................................ 38
4.2.7 Competition with MGB ................................................................................................. 39
4.2.8 When Written Agreements Are Required ..................................................................... 39
4.2.9 Institutional Review of Outside Activities .................................................................... 40
4.3. Policy Requirements for Outside Activities of Institutional Officials ...................................................... 41
4.3.1 Prohibition on Certain Executive Positions .................................................................. 41
4.3.2 Restrictions on Outside Activities ................................................................................. 41
4.3.3 Required PICC Approvals ............................................................................................. 41
4.4.1 OII Review and Approval Required.............................................................................. 42
4.4. Oversight of Agreements for Outside Activities of Medical/Professional Staff and Research Staff
Members .................................................................................................................................................................. 42
4.4.2 Outside Activities That Do Not Require OII Review, but May Require Supervisor
Review .................................................................................................................................... 43
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Table of Content
Approved 03.29.2018
4.4.3 Outside Activities That Require Supervisor Review and Approval ............................. 44
4.5. Oversight of Agreements for Outside Activities of Employee Members ................................................ 45
4.5.1 OII Review and Approval Required.............................................................................. 45
4.5.2 Time Limitations for Outside Activities ....................................................................... 45
4.5.3 Outside Activities That Do Not Require OII Review, but May Require Supervisor
Review .................................................................................................................................... 45
4.5.4 Outside Activities That Require Supervisor Review and Approval ............................. 46
4.6. Authority of Supervisors................................................................................................................................... 48
4.6.1 Independent Supervisor Review and Authority ............................................................ 48
4.6.2 Considerations for Supervisor Review .......................................................................... 48
4.6.3 Supervisor Conflict of Interest ...................................................................................... 48
4.6.4 COA Authority for Unresolved Issues .......................................................................... 48
4.7. Standard Requirements for a Written Agreement ............................................................................................. 49
4.7.1 Time .............................................................................................................................. 49
4.7.2 Restriction on Use of MGB Name ................................................................................ 49
4.7.3 Scope and Field of Services .......................................................................................... 49
4.7.4 Overlap with Field of Research ..................................................................................... 49
4.7.5 Restriction on Intellectual Property............................................................................... 50
4.7.6 Disclosure of Unpublished Research ............................................................................ 50
4.7.7 Confidentiality ............................................................................................................... 50
4.7.8 Exclusivity or Non-Compete Provisions ....................................................................... 50
Institutional Conflicts of Interest ...........................................................................51
5.1. Policy Overview ............................................................................................................................................... 51
5.1.1 Policy Statement ............................................................................................................ 51
5.1.2 To Whom Does Section 5 Apply?................................................................................. 51
5.2. Policy Requirements for Certain Institutional Financial Interests ........................................................... 52
5.2.1 Institutional Equity Acquired Outside Treasury Investments ....................................... 52
5.2.2 License Payments and Research ................................................................................... 54
5.2.3 Oversight of Major Gifts and Research......................................................................... 55
5.2.4 Royalties and Clinical Care ........................................................................................... 55
5.3. Policy Requirements for Financial Interests and Outside Activities of Institutional Officials ................ 56
5.3.1 New Outside Activities Require COA review ............................................................. 56
5.3.2 New Human Subjects Research .................................................................................... 56
5.4. Policy Requirements for Financial Interests and Outside Activities of Direct Supervisors of Research . 57
5.4.1 Conflicts of Interest for Direct Supervisors .................................................................. 57
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Table of Content
Approved 03.29.2018
5.5. Policy Requirements for Institutional Purchasing and Comparable Transactions ................................... 58
5.5.1 Conflicts of Interest in Institutional Purchasing and Comparable Transactions ........... 58
5.5.2 Interested Individuals .................................................................................................... 58
5.5.3 Recusal Requirement for Interested Individuals ........................................................... 58
5.5.4 Procedures for Certain Purchasing Transactions .......................................................... 59
5.5.5 Procedures for Other Transactions ................................................................................ 60
5.6. COA Oversight of Institutional Conflicts of Interest ........................................................................................ 61
5.6.1 COA Oversight of Institutional Conflicts of Interest .................................................... 61
Gifts From MGB Vendors and Potential Vendors .................................................62
6.1. Policy Overview ............................................................................................................................................... 62
6.1.1 Policy on Gifts to MGB ................................................................................................ 62
6.1.2 Policy on Gifts from Vendors or Potential Vendors to a MGB Individual or to MGB for
the Use or Benefit of a MGB Individual ................................................................................ 62
6.1.3 To Whom Section 6.1.2 Applies ................................................................................... 63
6.1.4 Scope of Policy.............................................................................................................. 63
6.1.5 MGB Code of Conduct ................................................................................................. 63
Glossary and Terms .................................................................................................64
Acting in a MGB Capacity ..................................................................................................... 64
Affiliated Institution ............................................................................................................... 64
Business .................................................................................................................................. 65
Clinical Conflict of Interest .................................................................................................... 65
Clinical Research.................................................................................................................... 65
COA ....................................................................................................................................... 65
Company ................................................................................................................................ 65
Covered Individuals ............................................................................................................... 65
ERB ........................................................................................................................................ 65
Employee Members................................................................................................................ 66
Executive Position .................................................................................................................. 66
Faculty .................................................................................................................................... 66
Family..................................................................................................................................... 66
Fiduciary Position .................................................................................................................. 66
Financial Conflict of Interest.................................................................................................. 66
Financial Interest .................................................................................................................... 67
HMS Conflicts Policy ............................................................................................................ 67
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Table of Content
Approved 03.29.2018
HMS Standing Committee ..................................................................................................... 67
Industry................................................................................................................................... 67
Institutional Officials.............................................................................................................. 67
Institutional Responsibilities .................................................................................................. 68
Interested Individual ............................................................................................................... 68
Medical/ Professional Staff Members .................................................................................... 68
MGB ....................................................................................................................................... 68
MGB Educational Activity..................................................................................................... 69
MGB Individual ..................................................................................................................... 69
Nominal Risk Clinical Research ............................................................................................ 70
OII .......................................................................................................................................... 70
Outside Activities ................................................................................................................... 71
Outside Entity ......................................................................................................................... 71
Participate ............................................................................................................................... 71
Participate in Clinical Research ............................................................................................. 72
Policy ...................................................................................................................................... 72
PICC ....................................................................................................................................... 72
Research ................................................................................................................................. 72
Research Staff Members ........................................................................................................ 73
Researchers............................................................................................................................. 73
Reviewable Purchasing Transaction ...................................................................................... 73
Significant Financial Interest ................................................................................................. 74
Special Equity ........................................................................................................................ 75
Sponsored Research ............................................................................................................... 76
Technology ............................................................................................................................. 77
Transaction ............................................................................................................................. 77
Written Agreement ................................................................................................................. 77
1
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Preface, Purpose, and Administration
Approved 03.29.2018
Preface, Purpose, and Administration
P.1. Purpose of the Policy
P.1.1
Importance of
Collaboration
with Industry
Mass General Brigham (“MGB”), its Affiliated Institutions, their leadership,
and their individuals have a long history of supporting collaborations with
Industry and other Outside Entities. Preserving these relationships is essential
because they advance MGB’s mission of providing, promoting, and
supporting high quality and leading edge patient care, research, and medical
education.
At the same time, MGB recognizes that conflicts of interest, and the
appearance of conflict of interest, may arise from these interactions. These
conflicts create a risk that integrity, independence, leadership, exercise of
professional judgment, or the reputation of MGB may be compromised.
However, in most cases these risks are manageable and the relationships are
encouraged and allowed because of their importance to the advancement of
MGB’s mission.
Interactions with Industry and other Outside Entities also have the potential to
create conflicts of commitment, in that Outside Activities or Financial
Interests may deter individuals from devoting an appropriate amount of time,
energy, creativity, or other personal resources to their MGB responsibilities.
Here too, these risks are generally manageable and do not prevent
relationships from going forward.
To assure that these relationships are reviewed consistently with these values,
MGB has adopted this Mass General Brigham Policy for Interactions with
Industry and Other Outside Entities to evaluate and appropriately address
these relationships.
Note: The term “MGB” refers to Mass General Brigham Incorporated and/or
one or more of its Affiliated Institutions. Except for Section 1.2.3, terms in
this Policy that have initial capital letters shall have the meaning specified in
the Glossary. Italicized terms in Section 1.2.3 shall have the meaning
specified in the HMS Conflicts Policy.
To Table of Content
2
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Preface, Purpose, and Administration
Approved 03.29.2018
P.1. Purpose of the Policy, Continued
P.1.2
Definition
Of Conflict
Of Interest
For purposes of this Policy, a “conflict of interest” refers in general to “a set
of circumstances that creates a risk that professional judgment or actions
regarding a primary interest will be unduly influenced by a secondary
interest” (Institute of Medicine, 2009).
These circumstances include, but are not limited to, the following:
• Those where outside financial or other interests may inappropriately
influence the way the individual carries out his or her MGB
responsibilities, or
• Those where an individual’s outside interests may be adverse to MGB
,
or
• Those where an individual has the opportunity to use his or her MGB
position for personal financial gain.
The determination of the existence of a conflict of interest, according to the
standards specified above, is based on an evaluation of relevant facts and
circumstances by the decision-making entity designated in this Policy for that
particular context, as may be more specifically detailed in this Policy.
P.1.3
Purpose
The purpose of the Mass General Brigham Policy for Interactions with
Industry and Other Outside Entities is to
• Maintain the highest standards of integrity and professionalism in all
MGB activities and affairs
• Support principled relationships with Industry and other Outside Entities
that advance patient care, research, and medical education consistent with
these standards, and
• Preserve public confidence that these standards are and will be
maintained.
To Table of Content
3
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Preface, Purpose, and Administration
Approved 03.29.2018
P.2. Administration of the Policy
P.2.1
Committee
Structure
The MGB Board of Directors has established the Professional and
Institutional Conduct Committee (PICC), and the Chief Executive Officer of
MGB has established the Committee on Outside Activities (COA), the
Educational Review Board (ERB), and the Office for Interactions with
Industry (OII). In accordance with their charges, these committees and OII
are responsible for overseeing, implementing, monitoring, and enforcing the
Mass General Brigham Policy for Interactions with Industry and Other
Outside Entities and for resolving individual cases. In carrying out their
responsibilities, these committees and OII may delegate specific
responsibilities to other institutional committees, offices, or individuals.
P.2.2
COA
Responsibilities
Subject to certain reserved authorities of PICC, COA handles matters that
arise in connection with the Outside Activities and interests of MGB and
MGB Individuals that present issues under this MGB Policy, including
conflicts of interest. COA reviews and resolves matters that present potential
conflicts of interest by applying, interpreting, and articulating conflict-related
policy, except for matters that are the responsibility of the ERB.
In performing its functions, COA has the authority to develop, adopt, and
oversee implementation of policy within existing policy framework; to
address issues of academic and institutional integrity that arise in matters
involving conflicts; to develop, adopt and oversee implementation of
appropriate resolution of such matters, including approval of plans to manage
conflicts, and where appropriate, to prohibit certain activities or actions; to
develop, adopt, and oversee implementation of such policies as are necessary
for compliance with applicable laws pertaining to individual and institutional
conflicts of interest; to refer any case or issue to PICC; and to take whatever
actions are necessary to implement this Policy or are consistent with its
formal
charge or other authority delegated to it.
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Preface, Purpose, and Administration
Approved 03.29.2018
P.2. Administration of the Policy, Continued
P.2.3
ERB
Responsibilities
Subject to certain reserved authorities of PICC, ERB oversees industry
support for MGB educational activities. ERB reviews and approves all
industry-support for MGB
educational activities by applying, interpreting, and
articulating policies related to industry-supported education.
In performing its functions, ERB has the authority to develop, adopt, and
oversee implementation of details of policies for review of industry support
for educational activities; to review and act on industry support proposals; to
ensure compliance with applicable internal and external policy requirements;
to ensure the appropriate level of content review for industry-supported
educational activities; to review relevant financial relationships of individuals
providing content for such programs or soliciting/spending gifts to support
such programs; to establish monitoring programs and work with COA and
relevant officials on appropriate sanctions of policies; to develop, adopt, and
oversee implementation of such policies as are necessary for compliance with
applicable laws; to refer any case or issue to PICC; and to take whatever
actions are necessary to implement this Policy or are consistent with its
formal
charge or other authority delegated to it.
P.2.4
OII
Responsibilities
OII assists PICC, COA, ERB, and their delegates with the administration of
this Policy.
• OII has the authority to refer matters to COA
or ERB, as appropriate, or to
their respective delegates for assessment and action required by this
Policy.
• OII has the authority to develop procedures, guidelines, forms, and tools it
considers necessary and appropriate to fulfill its responsibilities under this
Policy.
• OII has the authority to take appropriate actions to address personal
Financial Interests and Outside Activities consistent with the authority
delegated to it.
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5
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Preface, Purpose, and Administration
Approved 03.29.2018
P.2. Administration of the Policy, Continued
P.2.5
Definition of
MGB
Individuals
MGB Individuals are responsible for complying with this Policy. MGB
Individuals include specifically
• Any trustee, director, officer, executive, full- or part-time
Medical/Professional Staff Member, Research Staff Member, or
Employee Member of a MGB Affiliated Institution (other than MGB CP);
• Any member of a MGB committee;
• Any consultant, independent contractor, student, trainee, sponsored staff,
researcher, or other individual Acting in a MGB Capacity;
• The following people affiliated with MGB CP
o MGB CP Trustees, officers, executives, and members of MGB CP
committees with board-delegated powers
o Physicians and non-physicians employed by MGB CP
o Physicians who have an appointment to the professional staff of a
hospital owned or controlled by MGB
o Other physicians and non-physicians, who, in the judgment of the
Chief Executive Officer of MGB CP, have significant MGB CP-
related management responsibilities.
P.2.6
Responsibilities
of MGB
Individuals
MGB Individuals are required to:
• Conduct their MGB activities and obligations, as well as their Outside
Activities, in strict compliance with this Policy at all times;
• Remain impartial in exercising professional judgment and leadership and
in advancing MGB’s best interests;
• Provide such information as is required by MGB in connection with the
implementation of this Policy on or through any applicable MGB
disclosure process. Such information shall be shared with those
responsible for the administration and enforcement of this Policy.
MGB Individuals must also fully comply with
• The MGB Code of Conduct
• All other applicable MGB policies, and
• All applicable laws and regulations.
MGB Individuals who have faculty appointments at Harvard Medical School
(HMS) must also fully comply with all applicable HMS policies.
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6
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Preface, Purpose, and Administration
Approved 03.29.2018
P.2. Administration of the Policy, Continued
P.2.7
Compliance
Responsibility
Failure to comply with MGB policy or to fully, accurately, and according to
prescribed timetables disclose required information, including making
incomplete, erroneous or misleading disclosures, and failure to comply with
disclosure and accountability requirements and management plans constitute
violations of this Policy and will be addressed and adjudicated within
applicable disciplinary policies and procedures of MGB and its Affiliated
Institutions.
P.2.8
Policy Review
and
Amendment
PICC shall review this Mass General Brigham Policy for Interactions with
Industry and Other Outside Entities periodically in light of changes in
policies of governmental entities, other c
omparable academic medical centers,
and other relevant circumstances, and may revise, supplement, or otherwise
amend this Policy from time to time. The Mass General Brigham Policy for
Interactions with Industry and Other Outside Entities may also be amended
by the MGB Board of Directors.
To Table of Content
7
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
Section 1
Researchers’ Financial Interests and Outside Activities
Related to Research and Financial Conflicts of Interest
1.1. Policy Overview
1.1.1
Policy
Collaborations between MGB and its Researchers and Industry and other
Outside Entities are critical to the success of the MGB research mission
and to
advancing science and patient care. However, such relationships must be
carefully managed to ensure that they do not affect the design, conduct, or
reporting of MGB research, or raise issues of transparency or other concerns
that should be addressed.
Note: The term “MGB” refers to Mass General Brigham Incorporated and/or
one or more of its Affiliated Institutions. Except for Section 1.2.3, terms in
this Section 1 that have initial capital letters shall have the meaning specified
in the Glossary.
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8
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.1. Policy Overview, Continued
1.1.2
Researcher
Responsibilities
All MGB Researchers must
• Comply with this Section 1;
• Report Financial Interests and Outside Activities, including Significant
Financial Interests that reasonably appear to be related to their
Institutional Responsibilities, defined as research, clinical care,
education, administration, and other MGB activities, as required by
MGB;
• Comply with MGB and, as applicable, HMS prohibitions on situations
determined to be impermissible in the research context;
• Comply with MGB and, as applicable, HMS requirements imposed to
otherwise manage Financial Conflicts of Interest;
• Comply with any applicable training requirements; and
• Comply with any other requirements determined to be needed by MGB
and, as applicable, HMS to assure transparency or to address other
issues relating to Financial Interests and Outside Activities as they
pertain to MGB research activities.
Important: MGB Researchers may be subject to additional requirements,
including those of the
• MGB Human Research Committee (including MGB or other applicable
IRBs);
• Embryonic Stem Cell Research Oversight Committee;
• Animal Care and Use Committees;
• Institutional Biosafety Committee; and
• Other required reviews and approvals.
1.1.3
To Whom this
Policy Section
Applies
This Section 1 applies ONLY to MGB Researchers.
Researchers are MGB Individuals who are project directors or principal
investigators of any MGB research activity, and any other person, regardless
of title or position, who is responsible for the design, conduct, or reporting of
MGB research activities, including collaborators or consultants. The term
“Researchers” is not limited to principal investigators.
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.2. Policy Requirements for Interactions Related to Research
To Table of Content
1.2.1
Required
Reporting to
MGB
Researchers are required to disclose their Financial Interests, including but
not limited to Significant Financial Interests, and other Outside Activities
with Industry or other Outside Entities that reasonably appear to be related
to their Institutional Responsibilities, including reporting in the following
ways:
• Researchers are required to complete the annual MGB disclosure
statement when requested.
• In addition, in forms and formats at different times as specified by
MGB, researchers are also required to disclose requested information,
including Significant Financial Interests. Examples include but are not
limited to submission of human subjects research protocols,
submissions for research funding from any source, or new consulting or
other Outside Activities.
• Researchers applying for and conducting research funded by the Public
Health Service are required to update their disclosures within 30 days of
discovering or acquiring a new Significant Financial Interest.
• Researchers applying for and conducting research funded by the Public
Health Service must disclose the occurrence of reimbursed or sponsored
travel as required by MGB, including but not limited to the purpose of
the travel, the identity of the sponsor/organizer, the destination, and the
duration.
• Researchers applying for and conducting research funded by
foundations or other entities that require that MGB apply Public Health
Service standards to that research must also follow those standards.
Note: Institutional Responsibilities include research, clinical care,
education, administration, and other MGB activities.
10
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.2. Policy Requirements for Interactions Related to Research,
Continued
1.2.2
Reportable
Interests
Reportable Interests
Interests that are disclosable under this section 1.2.2 include, but are not
limited to, Significant Financial Interests as defined in federal regulations 42
CFR Part 50 and 42 CFR Part 54, 60 FR 35811 (and as they may be
subsequently modified) that would reasonably appear to be related to the
researcher’s Institutional Responsibilities with respect to
• any research supported by U.S. Public Health Service, and
• any other research as designated by COA.
1.2.3
Impermissible
Conflicts of
Interest
MGB and HMS policies state that the following activities are impermissible.
Note: This section (1.2.3) is intended to conform to the current HMS Policy
on Conflicts of Interest and Commitment (HMS Conflicts Policy), except that
Sections 1.2.3. A1, A2, and A3 extend these HMS Conflicts Policy
requirements to all Researchers, regardless of whether they have an HMS
appointment, and Section 1.2.3.B extends the HMS requirements to
Researchers who are also Institutional Officials, regardless of whether they
have an HMS appointment. Any changes in the HMS Conflicts Policy
automatically apply to HMS faculty who are subject to the HMS Conflicts
Policy. COA shall decide whether to extend any such change in the HMS
Conflicts Policy to MGB Individuals who are not otherwise covered by the
HMS Conflicts Policy.
Note: Sections 1.2.3. A1, A2, and A3 apply to research conducted at MGB
and to all other research in which MGB is considered to be “engaged,” as
determined by the MGB IRB.
Continued on Next Page
To Table of Content
1.2. Policy Requirements for Interactions Related to Research,
11
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
Continued
1.2.3
Impermissible
Financial
Conflicts of
Interest
Continued
To Whom It
Applies
Policy Requirements
All MGB
Researchers
A1. Clinical Research Rule (The “I(a) Rule”):
It is presumed that Researchers who Participate in Clinical Research
may not have a Financial Interest (Equity or Income) exceeding the de
minimis thresholds in a Business whose Technology is being
investigated. The presumption may be overcome when, in the
judgment of the HMS Standing Committee on Conflicts of Interest
and Commitment (Standing Committee) or its designee, individuals
holding presumptively prohibited
Financial Interests present
demonstrable, compelling justification - consistent with the rights and
welfare of
Clinical Research subjects - for being permitted to
simultaneously hold the Financial Interest and Participate in the
Clinical Research.
De Minimis Thresholds: Researchers
may receive $25,000 or less
annually
1
from a Business in the form of Income (e.g., consulting fees or
other remuneration for services) and still Participate in Clinical Research
on the Business's Technology. Furthermore, Researchers may have an
Equity Financial Interest of $50,000 or less in a publicly held Business
and continue to Participate in Clinical Research on the Business’s
Technology so long as the equity was not given in connection with the
Clinical Research at issue. Holding any equity in a privately held
Company is presumed to be prohibited.
Duration of Restriction: A Researcher must be free of all Financial
Interests above the de minimis thresholds from a relevant Business prior to
commencing the Clinical Research. Participation in Clinical Research
shall apply for the entire duration of the Clinical Research and the rule
continues to apply even should the Researcher elect to terminate Clinical
Research activities.
2
The rule shall apply until the date that is the later of (i) six (6) months
following the last day that a human study participant completes the
Clinical Research
(e.g., data lock plus 6 months), or (ii) the first
Publication of data derived from the Clinical Research, or a decision not to
publish the data derived from Clinical Research.
Continued on Next Page
To Table of Content
1
The payments may be considered to be accrued by the Researcher on the date of service or on the date of receipt of
the payments so long as the Researcher is consistent in the treatment of such payments.
2
A Researcher may petition for relief from the application of the Clinical Research Rule to the entire period set
forth here. If granted, however, the expectation is that Participation has been surrendered for the duration of the
Clinical Research.
12
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.2. Policy Requirements for Interactions Related to Research,
Continued
1.2.3
Impermissible
Financial
Conflicts of
Interest
Continued
Policy Requirements
Researchers,
continued
Dual-Career Family Exception: Upon petition to the Standing Committee, a
Researcher may overcome the presumption that s/he may not Participate in
Clinical Research or receive Research support if (i) the conflict arises
solely by virtue of the career pursuits of the Researcher’s spouse or
domestic partner, (ii) the Standing Committee determines, in its discretion,
that strict application of one or both of the rules under the circumstances
would unduly inhibit scientific progress, and (iii) any potential conflict of
interest is one that the Standing Committee finds, in its discretion, can be
managed adequately through a formal management plan.
Institutional License/Royalty Sharing Agreement Exception: Upon petition
to the Standing Committee, a Researcher
may overcome the presumption
that s/he may not Participate in Clinical Research or receive Research
support if (i) the conflict arises solely because of income received through
an institutional license or royalty sharing agreement, (ii) the Standing
Committee determines, in its discretion, that strict application of the rule
under the circumstances presented is unduly restrictive after weighing the
merits of allowing the
Research to go forward and the risks of the potential
conflict of interest, and (iii) the potential conflict arising by reason of the
income received through the institutional agreement can be managed
through a formal management plan.
All MGB
Researchers
A2. Research Support Rule (The “I(b) Rule”):
It is presumed that Researchers who have an Equity Financial Interest
above the de minimis threshold in a Business may not receive
Sponsored Research support from that Business for Research. The
presumption may be overcome when, in the judgment of the Standing
Committee or its designee, individuals holding presumptively
prohibited Equity
Financial Interests present sufficient countervailing
circumstances (the benefits of the proposed Research must outweigh
the risks, and the Financial Interest must be able to be appropriately
managed) for being permitted to simultaneously hold the Equity
Financial Interest and receive Sponsored Research support.
De minimis Threshold for Researcher’s Equity Financial Interest in
Publicly Traded Business: A Researcher may have an Equity
Financial
Interest of one percent or less in a publicly traded Business and
Participate in Research using Sponsored Research support from the
Business so long as (a) the Business was not founded by the Researcher, or
(b) the equity was not acquired in connection with the Research at issue.
Any interest exceeding 1% of the publicly traded Business’s value would
require an exception from the Standing Committee or its designee. Holding
any equity in a privately held Business is presumed to be prohibited.
Continued on Next Page
To Table of Content
13
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.2. Policy Requirements for Interactions Related to Research,
Continued
1.2.3
Impermissible
Financial
Conflicts of
Interest
Continued
To Whom It
Applies
Policy Requirements
All MGB
Researchers,
continued
Review of Faculty Equity Financial Interest in a Privately Held Business:
Any Equity Financial Interest in a privately held Business will require an
exception from the Standing Committee or its Designee to Participate in
Research using Sponsored Research support from the Business. The de
minimis threshold does not apply to privately held Businesses.
Duration of Restriction: A Researcher must be free of all Equity
Financial
Interests above the de minimis threshold from a relevant Business prior to
commencing the Sponsored Research. Participation in the Sponsored
Research shall apply for the entire duration of the Sponsored Research and
rule continues to apply even should one elect to terminate Sponsored
Research activities.
3
The rule shall apply until the date that is the later of (i) six (6) months
following the last day that data is collected (e.g., data lock plus 6 months),
or (ii) the first Publication of data derived from the Sponsored Research
,
or a decision not to publish the data derived from the Sponsored Research.
SBIR/STTR Exception: If the anticipated Sponsored Research support that
will violate the Research Support Rule will be through a subgrant under
the Small Business Innovation Research (SBIR) Program or the Small
Business Technology Transfer (STTR) Program
4
, the involved Researcher
may conduct the Research notwithstanding the Equity Financial Interest if
the institution that will be responsible for administering the SBIR/STTR
subgrant determines that any potential conflict of interest held by the
Researcher, given his or her equity interest in the small Business, may be
managed effectively with an institutional management plan. This
exception does not apply to
Clinical Research. This exception is subject to
additional restriction and/or prohibition based on applicable federal law
and institutional policy.
Continued on Next Page
To Table of Content
3
A Researcher may petition for relief from the application of the Research Support Rule to the entire period set
forth there. If granted, however, the expectation is that Participation has been surrendered for the duration of the
Sponsored Research.
4
The Standing Committee on Conflicts of Interest and Commitment or an affiliate COI Committee may determine
that other grant programs of a similar structure and aim to the SBIR/STTR programs warrant consideration under
this exception and may grant these exceptions following review.
14
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.2. Policy Requirements for Interactions Related to Research,
Continued
1.2.3
Impermissible
Financial
Conflicts of
Interest
Continued
Policy Requirements
Researchers,
continued
Dual-Career Family Exception: Upon petition to the Standing Committee, a
Researcher may overcome the presumption that s/he may not Participate in
Clinical Research or receive Research support if (i) the conflict arises
solely by virtue of the career pursuits of the Researcher’s spouse or
domestic partner, (ii) the Standing Committee determines, in its discretion,
that strict application of one or both of the rules under the circumstances
would unduly inhibit scientific progress, and (iii) any potential conflict of
interest is one that the Standing Committee finds, in its discretion, can be
managed adequately through a formal management plan.
Researchers
A3. External Activity Rule (The “I(d) Rule”):
Researchers who serve in a fiduciary role
5
to a for-profit Business may
not Participate in Clinical Research on the Business's Technology nor
receive Sponsored Research support from the Business.
SBIR/STTR Exception: If the anticipated Sponsored Research support
that will violate the External Activity Rule will be through a subgrant under
the Small Business Innovation Research (SBIR) Program or the Small
Business Technology Transfer (STTR) Program
6
,
the involved Researcher
may conduct the basic Research notwithstanding the Financial Interest if
the institution that will be responsible for administering the SBIR/STTR
subgrant determines that any potential conflict of interest held by the
Researcher, given his or her equity interest in the small Business, may be
managed effectively with an institutional management plan. This exception
does not apply to
Clinical Research. This exception is subject to additional
restriction and/or prohibition based on applicable federal law and
institutional policy.
Continued on Next Page
To Table of Content
5
A fiduciary role includes but is not limited to members of the fiduciary board of directors, managers of or members
of a member-managed limited liability company, and partners in a partnership or limited liability partnership.
6
The HMS Standing Committee or an affiliate COI Committee may determine that other grant programs of a similar
structure and aim to the SBIR/STTR programs warrant consideration under this exception and may grant these
exceptions following review.
15
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.2. Policy Requirements for Interactions Related to Research,
Continued
1.2.3
Impermissible
Financial
Conflicts of
Interest,
Continued
To Whom It
Applies
Policy Requirements
1. ONLY MGB
Researchers who
are ALSO
Full-Time
Faculty at
Harvard
Medical School,
AND
2. MGB
Researchers who
are also MGB
Institutional
Officials
B. Executive Position Rule (the “I(c) Rule”)
Researchers who are also Full-Time Faculty at Harvard Medical School
and Researchers who are also MGB Institutional Officials may not hold
an Executive Position in a for-profit Business engaged in commercial or
Research activities of a biomedical nature. Researchers with part-time
appointments may hold approved Executive Positions at for-profit
Businesses but may not Participate in Clinical Research on the
Business’s Technology nor receive Sponsored Research support from the
Business.
1.2.4
Interests and
Activities
That May Be
Allowed
All other Financial Interests and Outside Activities will be reviewed and may
be determined by MGB to be allowable subject, where appropriate, to MGB
requirements for transparency or accountability, and in the case of a
determination of Financial Conflict of Interest, a management plan.
To Table of Content
16
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.3. Oversight of Interactions Related to Research
1.3.1
MGB
Authority and
Responsibilities
Relating to
Financial
Interests and
Outside
Activities of
Researchers
MGB, acting through its designated officials and Committees, has the
authority to and is responsible for:
• Reviewing reported Significant Financial Interests that reasonably
appear to be related to Researchers’ Institutional Responsibilities;
• Determining whether any reported Significant Financial Interests are
related to any of a Researchers’ research;
• Determining whether any reported related Significant Financial
Interests constitute Financial Conflicts of Interest; a Financial
Conflict of Interest exists where MGB reasonably determines that a
disclosed Financial Interest could directly and significantly affect the
design, conduct, or reporting of the research;
• Evaluating and resolving identified Financial Conflicts of Interest in
research, including how identified Financial C
onflicts of Interest must
be managed, reduced, or eliminated;
• Providing appropriate oversight of identified Financial Conflicts of
Interest and any related management plans, with other MGB officials
and offices as circumstances require;
• Taking any other appropriate actions to address Significant Financial
Interests and Outside Activities to the extent in their judgment
necessary; and
• Evaluating Financial Interests and Outside Activities that do not
constitute Significant Financial Interests and/or do not constitute
Financial Conflicts of Interest and taking such actions as determined
to be needed by MGB to achieve transparency, to assure
accountability, or to address other issues relating to those Interests
and Activities insofar as they pertain to MGB research activities.
To Table of Content
17
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.3. Oversight of Interactions Related to Research, Continued
1.3.2
Required
Disclosure in
Publications
and
Presentations
Obligation of Researchers to Disclose Certain Financial Interests
In addition to any disclosure requirement of the publisher, a Researcher who is
publishing, formally presenting research results, or providing expert
commentary on a subject must simultaneously disclose any Financial Interest
in an Outside Entity that owns or has a contractual right to the technology
being reported or discussed or that sponsors the research being reported or
discussed.
1.3.3
Required
Disclosure
to Subjects in
Human
Subjects
Research
Disclosure to Subjects in Human Subjects Research
The existence of all material financial interests of institutions and researchers
in a human research study that are related to the research being performed shall
be disclosed to the subjects in the study. Standards for "material" and "related"
shall be established by the COA, guided by the Public Health Service
regulations.
The precise wording of disclosure in the consent form should be determined by
the IRB, but should include an explanation of the fact that the financial interest
in question has been reviewed and the research allowed to go forward by the
IRB.
At a minimum, the document or statement by which disclosure is made must
include a clear reference to the presence of the financial interest, an indication
that additional information is available regarding the details of the financial
interest and how it is being addressed, and how that information can be readily
obtained by those to whom the disclosure is made.
1.3.4
Additional
Disclosure and
Accountability
Measures
Required Additional Measures
For any research, MGB may require researchers to disclose certain information
regarding interests in connection with a research study to assure transparency
and may require other actions as necessary to assure accountability and
integrity.
To Table of Content
18
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.3. Oversight of Interactions Related to Research, Continued
1.3.5
Management of
Financial
Conflicts of
Interest
When a Financial Conflict of Interest is determined to exist, MGB shall
develop and implement a management plan that specifies actions that have
been taken and/or will be taken to manage the Financial Conflict of Interest.
In addition to the actions specified in Sections 1.3.2, 1.3.3, and 1.3.4,
examples of actions that may be taken to manage an identified Financial
Conflict of Interest include but are not limited to the following:
• Public disclosure of the Financial Conflict of Interest
• Disclosure to the research team
• Modification of the research plan
• Independent oversight of the research, including appointment of an
independent monitor
• Change of personnel or personnel responsibilities
• Disqualification from participation in the research
• Reduction or elimination of the Financial Conflict of Interest, or
severance of the relationship that creates the Financial Conflict of
Interest.
1.3.6
Special OII
Responsibilities
with Respect
to Public
Health Service
Funding
Prior to the expenditure of any Public Health Service funding to support
research at MGB, MGB, acting through its designated Institutional Officials,
Committees, and Offices, shall:
• Ensure that any impermissible conflicts are eliminated;
• Ensure that any other identified Financial Conflicts of Interest are
managed, as determined by MGB’s designated Institutional Officials,
Committees, and offices;
• With respect to funds from the Public Health Service, notify the Public
Health Service of the existence of any Financial Conflict of Interest and
ensure that a management plan has been implemented; and
• Comply in all other respects with applicable requirements for Public
Health Service-funded research.
Continued on Next Page
To Table of Content
19
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Approved 03.29.2018
1.3. Oversight of Interactions Related to Research, Continued
To Table of Content
1.3.6
Special OII
Responsibilities
with Respect to
Public Health
Service
Funding
Continued
For any Financial Conflict of Interest that MGB identifies after Public Health
Service funding for the research at MGB has commenced, OII shall, within
sixty days of the identification:
• Ensure that any impermissible Financial Conflicts of Interest are
eliminated;
• With respect to any other identified Financial Conflicts of Interest, ensure
that a management plan has been implemented,
at least on an interim basis,
and take any additional interim measures deemed necessary;
• Notify the Public Health Service regarding the Financial Conflict of
Interest;
• In addition, with respect to failure by a Researcher to disclose in a timely
manner a Significant Financial Interest that is determined by MGB to
constitute a Financial Conflict of Interest, or failure by MGB to review or
manage in a timely manner such a Financial Conflict of Interest, or failure
by a Researcher to comply with a Financial Conflict of Interest
management plan, complete a retrospective review and, to the extent
required by federal regulation, submit a mitigation report to the Public
Health Service; and
• Comply in all other respects with applicable requirements for Public
Health Service-funded research
20
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Clinical Care and Interactions with Industry
Approved 03.29.2018
Section 2
Clinical Care and Interactions with Industry
2.1. Policy Overview
2.1.1
Policy
Collaborations between MGB Individuals providing patient care and Industry
present unique opportunities to improve and advance patient care. However,
these collaborations must be carefully managed to avoid improper influence
and inducements in clinical care. MGB encourages such collaborations,
subject to the requirements of this Section 2.
MGB
Individuals subject to this Section 2 are responsible for compliance with
this Section.
Note: The term “MGB” refers to Mass General Brigham Incorporated and/or
one or more of its Affiliated Institutions. Other terms in this Section 2 that
have initial capital letters shall have the meaning specified in the Glossary.
2.1.2
Definition of
Clinical
Conflict of
Interest
A clinical conflict of interest may exist when a MGB Individual covered by
this Section 2 has a personal Financial Interest or Outside Activity with a
manufacturer of a drug, device, or other products for use in patient care,
according to thresholds that may be established from time to time by COA,
which could influence or be perceived as influencing his/her clinical decision-
making or interactions with his/her patients.
A clinical conflict of interest may arise when MGB receives royalties derived
from the sales of a particular drug, device, or other technology and, under
institutional royalty-sharing policies, a MGB
Individual subject to this Section
2 shares in those royalties according to thresholds that may be established
from time to time by COA and uses the drug, device, or other technology in
his/her clinical practice at MGB.
To Table of Content
21
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Clinical Care and Interactions with Industry
Approved 03.29.2018
2.1. Policy Overview, Continued
2.1.3
Ancillary
Equipment
Conflicts of interest that may arise in connection with the purchase of
ancillary equipment (e.g., equipment whose use does not require active
selection by a MGB Individual as part of a specific clinical procedure, such as
standard hospital equipment like scissors, sutures, and skin staples) for use at
MGB patient care facilities are addressed in Section 5 of this Policy.
Accordingly, this Section 2 does not address the use of ancillary equipment,
even though the equipment may be utilized during a patient’s medical
treatment.
2.1.4
To Whom the
Policy Applies
Section 2 applies to any MGB Individual who is a licensed caregiver and who,
in the course and scope of his/her MGB responsibilities, provides to patients
the care for which he/she is licensed.
To Table of Content
22
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Clinical Care and Interactions with Industry
Approved 03.29.2018
2.2. Policy Requirements
2.2.1
Evaluation of
Clinical
Conflicts of
Interest
Financial Interests or other Outside Activities in a manufacturer of a drug,
device, or other products for use in patient care of MGB
Individuals subject to
this Section 2 that exceed thresholds established by COA may constitute
clinical conflicts of interest and will be evaluated as provided in Section 2.3.
2.2.2
Reporting of
Clinical
Conflicts of
Interest
MGB Individuals covered by this Section 2 are required to report their
Financial Interests and Outside Activities, as required by MGB, including
completing the MGB disclosure statement
and such other disclosure processes
when requested.
2.2.3
Additional
Policy
Requirements
Related to
Clinical Care
and
Interactions
with
Industry
In addition to the provisions of Section 2, MGB Individuals covered by this
Section 2 must abide by all other applicable provisions in the Mass General
Brigham Policy for Interactions with Industry and Other Outside Entities,
including specifically the provisions in Section 4 on Consulting and Other
Outside Activities, the provisions in Section 5 on Institutional Purchasing and
Comparable Transactions, and the provisions in Section 6 on Gifts from MGB
Vendors and Potential Vendors, as well as provisions of policies of Affiliated
Institutions regarding Vendor Access and Pharmaceutical Samples.
To Table of Content
23
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Clinical Care and Interactions with Industry
Approved 03.29.2018
2.3. Oversight of Clinical Conflicts of Interest
2.3.1
COA’s
Authority for
Evaluating and
Managing
Clinical
Conflicts of
Interest
COA shall review and, where appropriate, manage those Financial Interests
and Outside Activities that are deemed clinical conflicts of interest, according
to thresholds established by COA.
2.3.2
Management
of Clinical
Conflicts of
Interest
Because of the special circumstances associated with the physician-patient
relationships and the exigencies of clinical care situations, management of any
clinical conflict of interest shall be tailored to fit individual circumstances.
Possible management mechanisms for clinical conflicts of interest shall be
determined by COA. They may include but are not limited to one or more of
the following:
• Disclosure
of the interest or activity, in accordance with the provisions
of Section 2.3.3;
• Corroboration through a disinterested process of any prescription
involving a product or device of a Company in which the clinical
conflict of interest exists;
• Review of practice patterns;
• Reduction or elimination of the conflict; and
• Transfer of clinical care to an alternate clinician.
2.3.3
Disclosure to
Patients
COA may determine in particular cases that clinical conflicts of interest,
according to thresholds established by COA, warrant individualized patient
disclosure before a MGB Individual covered by this Section 2 prescribes or
uses that Company’s medical device, pharmaceutical, or medical care-related
product in connection with the care of his/her individual patients.
2.3.4
Clinical Care
and Royalties
Through the
Institution
License agreements under which MGB technology is licensed to a Company
must state, as an exception to any requirement that the Company pay royalties
to MGB, that the Company will not pay royalties derived from the sales of a
particular drug or device to MGB, unless COA approves an arrangement
under which all such royalties will be donated to a specific non-MGB
charitable organization.
To Table of Content
24
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Industry Support Related to Education
Approved 03.29.2018
Section 3
Industry Support Related to Education
3.1 Policy Overview
3.1.1
Rationale and
Policy
Statement
Industry support for MGB Educational Activities helps to further MGB ability
to carry out its educational mission. However, these situations need to be
carefully managed to ensure that such support does not introduce bias into the
content of MGB Educational Activities. MGB encourages such support,
subject to the requirements of this Section 3.
All MGB Educational Activities supported by Industry must comply with the
policy requirements imposed by the Education Review Board (ERB), as
described in more detail in this Section 3.
Note: The term “MGB” refers to Mass General Brigham Incorporated and/or
one or more of its Affiliated Institutions. Other terms in this Section 3 that
have initial capital letters shall have the meaning specified in the Glossary.
Note: These policy requirements do not cover the participation of MGB
Individuals in Industry-funded external educational activities not put on or
sponsored by MGB. Such activities are covered by Section 4 Consulting and
Other Outside Activities, and Section 6 Gifts, below.
3.1.2
Description of
Industry
Support of
Education
Industry support may be provided through:
• Monetary support, or
• In-kind support.
These two types of support may be directed to a specific MGB Educational
Activity so long as such support is accepted in compliance with Section 3.3.
Additionally, monetary support may be directed to a President’s Fund for
Medical Education so long as such support is accepted in compliance with
Section 3.4.
To Table of Content
25
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Industry Support Related to Education
Approved 03.29.2018
3.1. Policy Overview, Continued
3.1.3
Types of
MGB
Educational
Activities
MGB Educational Activities include:
• Clinical training programs, such as residencies and fellowship
programs that involve a significant component consisting of direct
patient care;
• Educational events, including continuing medical education
programs or other professional health care education programs that
involve conferences or lectures or other forms of verbal
presentations, regardless of whether the participants receive credit;
• Educational tools and resources, including MGB newsletters and web
sites designed to distribute educational information to healthcare
practitioners, patients, and the public, even if such information
pertains to research;
• Educational service arrangements, whereby an Industry entity seeks
to have a MGB hospital provide a training or educational program
for its employees or other physicians with a specified focus or
content (these may include observerships, preceptorships, and other
similar arrangements); and
• Other educational programs that are put on, or sponsored, by any
MGB entity.
3.1.4
OII Review of
Industry
Support
All Industry support for MGB Educational Activities must be reviewed by
the MGB Office for Interactions with Industry (OII).
OII works with the ERB, as appropriate, to ensure compliance with MGB
policies and procedures.
To Table of Conten
t
26
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Industry Support Related to Education
Approved 03.29.2018
3.2. Oversight of Industry Support Related to Education
3.2.1
ERB
Authority to
Implement,
Monitor, and
Enforce Policy
Subject to the reserved authority of PICC as referenced in Section P.2.3, the
Education Review Board (ERB) has the authority to implement and enforce
the MGB policy requirements for this section of the Mass General Brigham
Policy for Interactions with Industry and Other Outside Entities, including
the authority to:
• Review and approve any Industry support, whether made directly or
indirectly through intermediaries;
Determine appropriate conditions for Industry support;
Monitor and enforce compliance pertaining to Industry support of
MGB Educational Activities; and
• Make exceptions both in particular cases and to general policy
requirements.
The ERB may delegate specific responsibilities to other institutional
committees, offices, or individuals.
3.2.2
Requirements
for ERB
Review and
Approval
The ERB must review and approve all support from Industry for any MGB
Educational Activity.
The ERB has the authority to determine the conditions or restrictions for
receipt of in-kind Support.
If other institutional approval is required, such approval is required prior to
the ERB’s review. For example, all clinical fellowships must be approved
by the MGB Education Committee (PEC) prior to ERB review.
3.2.3
ERB Review
of MGB
Educational
Activities
In addition to the requirements the ERB sets for Industry support of MGB
Educational Activities, the ERB reviews the contractual documentation,
budget, and Financial Interests related to all MGB Educational Activities
supported by Industry. Additionally, the ERB may review the content of any
MGB Educational Activity supported by Industry.
To Table of Content
27
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Industry Support Related to Education
Approved 03.29.2018
3.2. Oversight of Industry Support Related to Education, Continued
To Table of Content
3.2.4
ERB Oversight
for Industry
Support for
Trainee Travel
The ERB has the authority to determine the terms under which Industry
support for trainee travel to attend professional meetings, conferences, or
other training programs is acceptable.
3.2.5
Educational
Services
Arrangements
In recognition that educational services arrangements present special factors,
the ERB shall have the authority to implement special criteria for them,
including permitting such arrangements to be funded by a single Industry
entity under certain, limited circumstances as defined by the ERB.
3.2.6
Exception for
Merit-Based
Fellowship
Awards
ERB review and approval is not required for merit-based fellowship awards
funded by Industry where awardees are selected by a nationally-recognized
professional or scientific association through a selection committee composed
predominantly of members who do not represent an Industry entity.
28
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Industry Support Related to Education
Approved 03.29.2018
3.3. Policy Requirements for Industry Support of MGB
Educational Activities
3.3.1
Overview
All MGB Educational Activities with Industry support are subject to the
following requirements as well as any additional requirements as deemed
appropriate by the Education Review Board (ERB).
3.3.2
Compliance
with
Continuing
Medical or
Other
Healthcare
Professional
Education
Standards
All MGB Educational Activities with Industry support for which medical or
other healthcare professional educational credit is offered through an
accredited provider (whether CME or other credit) must comply with the
standards for accreditation in the respective professional field.
All MGB Educational Activities with Industry support for which professional
medical or other healthcare education credit is not offered must still meet the
Industry-support standards for accreditation in the respective professional
field (e.g., a program designed for physicians must meet ACCME Standards
for Commercial Support, a program designed for nurses must meet the
American Nurses Credentialing Center’s Commission on Accreditation
standards). For programs in fields for which there are no such standards,
standards will apply as established by the ERB.
3.3.3
Control of
Content
Industry may not control the selection of speakers or content of the MGB
Educational Activity.
3.3.4
Multiple
Sources of
Monetary
Support
Required
Industry support for a specific MGB Educational Activity must come from
more than one Industry entity, in accordance with conditions imposed by the
ERB and subject to exceptions granted by the ERB. Generally, no one
Industry entity can provide more than 70% of the total commercial support.
3.3.5
Review and
Resolution of
Financial
Interests
All program/course directors, speakers, moderators, panelists, others as
determined by the ERB must report their Financial Interests and Outside
Activities that are related to the MGB Educational Activity, as required on
any applicable forms or other disclosure processes, and must be resolved by
ERB prior to the educational activity start date.
To Table of Content
29
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Industry Support Related to Education
Approved 03.29.2018
3.3. Policy Requirements for Industry Support of MGB
Educational Activities,
Continued
3.3.6
Disclosure of
Support
Industry support for a MGB Educational Activity must be disclosed to
participants. For educational events, disclosure must be made prior to the
beginning of the event.
3.3.7
Support to
Institution, not
Individuals
Industry support must be directed to an administrative unit of a MGB
Affiliated Institution, not to a MGB Individual.
3.3.8
Selection of
Participants
The supporting Industry entity cannot be involved in reviewing or selecting
participants in the supported activity. Industry representatives may attend a
MGB educational event so long as such attendance is compliant with
guidance issued by the ERB.
3.3.9
Naming of
Activity/
Specific
Training
Position
A MGB Educational Activity may not be named after the Industry entity
supporting the activity. In the case of a training program, the specific training
position in that program may not be designated as Industry-supported training
position in the program.
3.3.10
Reports to
Industry
No identifying information about participants in Industry-supported MGB
Educational Activities may be disclosed to the supporting Industry entities
without ERB approval.
3.3.11
Commercial
Promotion at
MGB
Educational
Events
Commercial exhibits, advertisements, and other promotional opportunities
associated with MGB Educational Activities must comply with the ACCME
Standards for Commercial Support and any other guidance issued
by the ERB.
Exhibits at MGB Educational Events may not be located in the same room as
the educational activity, nor in an obligate path to the room.
To Table of Content
30
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Industry Support Related to Education
Approved 03.29.2018
3.3. Policy Requirements for Industry Support of MGB
Educational Activities,
Continued
3.3.12
Documentation
Any agreement (or other appropriate documentation as determined by ERB)
for Industry support of a MGB Educational Activity must be in writing, and
specify the terms, conditions, and purposes of the Industry support. As stated
in Section 3.1.4, all agreements for Industry support of a MGB Educational
Activity shall be processed through OII.
Additionally, agreements for educational events and/or educational tools and
resources must be signed prior to commencement of the event or publication
of the tool/resource. Agreements for clinical training programs must be
signed prior to the completion of the program.
No Industry funds may be spent until there is a signed agreement (or other
appropriate documentation as determined by the ERB), and the MGB
Educational Activity has secured funding from a second commercial
supporter.
3.3.13
Budget Review
The program/course director must submit a budget to the Office for
Interactions with Industry (OII) and obtain ERB approval for the proposed
Industry-supported MGB Educational Activity.
To Table of Content
31
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Industry Support Related to Education
Approved 03.29.2018
3.4. Policy Requirement for Industry Support to Presidents’ Funds
for Medical Education
3.4.1
Requirements
for Industry
Contributions
to Presidents’
Funds
Industry entities may contribute to the support of the MGB’ educational
mission through the President’s Fund(s) for Medical Education at each of the
MGB hospitals. These funds are used to support the healthcare educational
mission and activities of MGB. The requirements listed below apply to
Industry contributions to a President’s Fund(s) for Medical Education.
• A company’s contributions to any President’s Fund(s) for Medical
Education must not be targeted or directed to any specific MGB
Educational Activity.
• MGB may not identify any activity supported by the President’s Fund
as being supported by a specific Industry entity. MGB may separately
acknowledge all Industry supporters who have contributed to the
President’s Fund.
• The President of each hospital has sole discretion to distribute the
President’s Fund(s) for Medical Education for that hospital to any of
its MGB Educational Activities.
• To the extent the President’s Fund(s) for Medical Education in any
hospital is distributed to a clinical training program, the program must
be reviewed and approved by the MGB Education Committee (PEC)
prior to receiving funds from the President’s Fund for Medical
Education to support the program.
To Table of Content
32
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
Section 4
Consulting and Other Outside Activities
4.1. Policy Overview
4.1.1
Policy
Consulting and other Outside Activities between MGB Individuals and
Industry and other Outside Entities provide opportunities for productive
collaboration, and foster the exchange of knowledge and information that
leads to advances in science and patient care. However, these collaborations
must be overseen to ensure that they do not affect the way in which MGB
Individuals conduct their MGB responsibilities and do not result in a misuse
of MGB assets. Therefore, MGB
encourages such relationships, subject to the
requirements of this Section 4.
All MGB Individuals subject to this Section 4 are responsible for compliance
with this Section 4.
Subject to the reserved authority of PICC as referenced in Section P.2.2, COA
has the authority to implement and enforce the MGB Policy requirements for
this Section 4 of the Mass General Brigham Policy for Interactions with
Industry and Other Outside Entities, including the authority to:
• Monitor and enforce compliance pertaining to Outside Activities; and
• Make exceptions both in particular cases and to general Policy
requirements.
Note: The term “MGB” refers to Mass General Brigham Incorporated and/or
one or more of its Affiliated Institutions. Other terms in this Section 4 that
have initial capital letters shall have the meaning specified in the Glossary.
To Table of Content
33
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.1. Policy Overview, Continued
4.1.2
To Whom
Does this
Section 4
Apply?
Section 4, Consulting and Other Outside Activities, applies to Covered
Individuals including Medical/Professional Staff Members, Research Staff
Members, and Employee Members, all as reflected in the chart below. In
addition, Sections 4.2.1, 4.2.3, 4.2.5, 4.2.6, and 4.2.7 also apply to all MGB
Individuals while Acting in a MGB Capacity (except outside Trustees,
Directors, and committee members).
Covered
Individuals
Description
Medical/
Professional
Staff Members
Individuals who are members of the medical or professional staffs of any
MGB hospital and who
• have full-time or part-time faculty appointments at Harvard Medical
School, or
• are Service/Department Chiefs/Chairs at MGB or an Affiliated
Institution, or
• are employed full- or part-time by MGB or an Affiliated Institution.
Exceptions:
The following individuals are considered Medical/Professional Staff
Members only when they are at a MGB site or otherwise Acting in a MGB
Capacity:
• individuals who are members of the medical or professional staff of
any MGB hospital and who have an HMS faculty appointment, but
• are neither employed by MGB or an Affiliated Institution, nor are
Service/Department Chiefs/Chairs, and
• who have a medical/professional staff appointment at a non-MGB but
HMS affiliated hospital, which is their primary job location.
Research Staff
Members
Individuals who have full-time or part-time non-faculty appointments at
Harvard Medical School and
• who are not Medical/Professional Staff Members, and
• who are participating in research activity under the administrative
authority of MGB or an Affiliated Institution
Exception:
Individuals who meet the criteria for Research Staff Members above, but
whose primary affiliation is at a non-MGB but HMS affiliated hospital, are
considered Research Staff Members only when they are at a MGB site or
otherwise Acting in a MGB Capacity.
Employee
Members
Administrative staff, nurses, support personnel, and other full-time or part-
time employees of MGB or a MGB-Affiliated Institution who are not
Medical/Professional Staff Members or Research Staff Members.
To Table of Content
34
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.2. Policy Requirements for Outside Activities
4.2.1
Requirements
for
Outside
Activities
Outside Activities of Covered Individuals, whether full-time or part-time, and
any other MGB Individual while Acting in a MGB Capacity (except outside
Trustees, Directors, and committee members) must meet all of the
requirements listed below.
• They must not involve the performance of services that, in the judgment of
the supervisor, compete or overlap inappropriately with the individual’s
obligations to MGB.
• They must be performed outside the individual’s regular service period at
MGB, and must be within allowable time limits for Outside Activities as
specified in Section 4.2.2.
• They must not involve use of MGB or HMS students or trainees.
They must not involve the use of institutional funds or substantial use of
institutional personnel, premises, equipment, or facilities. Minimal use of
office resources is not considered a substantial use.
• They must not result in the individual’s engaging in promotional activity
for the Outside Entity.
• They must be conducted so that the time and creative energy devoted to the
Outside Activity does not, in the judgment of the appropriate supervisor,
compromise or interfere with the Individual’s responsibilities at MGB.
To Table of Content
35
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.2. Policy Requirements for Outside Activities, Continued
4.2.2
Time
Limitations
for Outside
Activities
The table below describes the time limits that different groups of full-time
Covered Individuals can spend on Outside Activities.
Full-Time Covered
Individuals
Time Limits
• Full-time
Medical/Professional
Staff Members with
Harvard Medical
School Faculty
Appointments
Maximum allowable amount of time that may be spent on
Outside Activities is 20 percent of the member’s professional
effort, not to exceed the equivalent of one working day per
seven-day week. Supervisors may further limit the allowable
amount of time.
• Full-time
Medical/Professional
Staff Members without
Harvard Medical
School Faculty
Appointments
• Full-time Research
Staff Members
Individuals in this category may spend such time on Outside
Activities as is permissible by the policies of their institutions
and as approved by their supervisors.
• Full-time Employee
Members
Individuals in this category are generally expected to devote their
full professional time, energy, loyalty, and commitment to MGB
.
A limited amount of time for outside research, teaching, and
other activities may be allowable as determined by their
supervisors.
To Table of Content
36
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.2. Policy Requirements for Outside Activities, Continued
4.2.3
Prohibited
Outside
Activities
Consulting and other Outside Activities undertaken by MGB Individuals are
encouraged and in most cases allowable according to the provisions of this
Section 4. These provisions establish oversight requirements and minimize
the possibility of inappropriate considerations affecting the exercise of MGB
responsibilities. However, for a limited variety of Outside Activities, the
potential for negative impact on the integrity of MGB missions is high, and
accordingly, certain Outside Activities are prohibited.
A. Certain Company or Other Outside Entity Speaking and Training
Engagements
Many speaking and training engagements for Companies or Other Outside
Entities are encouraged, including CME presentations sponsored by
accredited CME providers. However, other engagements may compromise
the independence and the reputation of the speaker and of MGB to such an
extent that they are not allowed. These engagements are described below.
Neither a Covered Individual, nor any other MGB Individual who is Acting in
a MGB Capacity (except outside Trustees, Directors, and committee
members), may participate in:
• Any arrangement or speaking engagement that is termed a “Speakers
Bureau”; or
• Any speaking engagement for which a Company or Other Outside Entity
has the contractual right to control what the individual says or otherwise
has the final right of approval for content and edits of the individual’s
presentation materials; or
• Any arrangement between an individual and a Company or Other Outside
Entity
o under which an agreement indicates that the speaker’s name will be
on a list of speakers or potential speakers; or
o under which the individual will be engaged in promotional activity
for the Company or Other Outside Entity; or
• Any other exceptional circumstances as determined by the Committee on
Conflicts of Interest (COA), including but not limited to excessive
frequency of, or excessive compensation for, speaking engagements.
Continued on Next Page
To Table of Content
37
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.2. Policy Requirements for Outside Activities, Continued
4.2.3
Prohibited
Outside
Activities
continued
Note: This section is not intended to prohibit a MGB Individual from
entering into an agreement with a Company or Other Outside Entity, other
than a pharmaceutical, device, or biomedical Company, that acts as an agent
or broker to fill national and internationally-based requests for speaking
services for prominent figures in government, foreign service, education,
science, medicine, and the like, provided the arrangement has the approval of
OII and does not violate the intent of this Section 4.2.3.A.
B. Ghostwriting
A Covered Individual, or any other MGB Individual who is Acting in a MGB
Capacity, may not be listed as an author on an article written by Industry
representatives or others unless:
• The individual has met all standards for academic authorship as defined in
the HMS Authorship Guidelines, and
• All others who contributed to the work such that their contribution merits
authorship (to the knowledge of the individual) are also listed as authors.
C. Executive Positions
A Medical/Professional Staff Member with a full-time faculty appointment at
Harvard Medical School is prohibited under the HMS Conflicts Policy from
holding an Executive Position in a for-profit Business engaged in commercial
or research activities of a biomedical nature.
An Institutional Official is prohibited from holding an Executive Position in a
for-profit Business engaged in commercial or research activities of a
biomedical nature. COA may grant exceptions to this prohibition for
Institutional Officials who do not hold full-time HMS appointments.
Note: Individuals who are researchers are subject to additional categories of
impermissible activities. See Section 1,
Researchers’ Financial Interests and
Outside Activities with Industry Related to Research.
4.2.4
Fiduciary
Positions
Require COA
Review and
Approval
A full-time Medical/Professional Staff Member, Research Staff Member, or
Employee Member may not accept a new position on a Board of Directors or
any other position with a fiduciary responsibility in a biomedical Company
without prior review and approval by the COA.
To Table of Content
38
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.2. Policy Requirements for Outside Activities, Continued
4.2.5
Compensation
for Outside
Activities
A. Fair Market Value
Compensation received by a Covered Individual for consulting or other
Outside Activities may not exceed fair market value for the services provided
by the Covered Individual. In the event that a question concerning fair market
value arises, the Committee on Outside Activities (COA) has the authority to
resolve the issue.
B. Set In Advance
The aggregate compensation or the compensation methodology for consulting
or other Outside Activities must be set in advance.
C. Arms Length
All agreements must be negotiated at “arms-length” and must not take into
account the volume or value of referrals or other business generated between
or among MGB, the Covered Individual and the Outside Entity.
4.2.6
Restriction on
Use of
MGB
Name
A Covered Individual and any other MGB Individual while Acting in a MGB
Capacity must conduct his or her Outside Activities so as to prevent any
Outside Entity from using, without the prior written approval of the MGB
entity involved, the name or logo of any MGB entity in any:
• Advertising,
• Promotional, or
• Other public or printed material.
An individual subject to this Section is responsible for informing the Outside
Entity of this restriction.
Allowed Usage of MGB Entity Name
An Individual subject to this Section may use the name of a MGB entity to
identify the Individual’s position or title at MGB, so long as the use does not
imply MGB endorsement or responsibility for the Outside Activity, the
Outside Entity, or the Outside Entity’s product or services.
COA may further restrict the use of the name of a MGB entity under
appropriate circumstances.
To Table of Content
39
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.2. Policy Requirements for Outside Activities, Continued
4.2.7
Competition
with MGB
Neither a Covered Individual nor any other MGB Individual while Acting in a
MGB Capacity may engage in competition with MGB. Exceptions may be
made by the Covered Individual’s supervisor provided that the activity is
unlikely to and in fact does not adversely affect the interests of MGB or the
ability of the Covered Individual to carry out his or her MGB responsibilities,
and is otherwise acceptable. The supervisor may impose restrictions or
limitations as deemed appropriate in his or her judgment.
This Section 4.2.7 is not intended to apply to consulting or other Outside
Activities or to research collaborations with other health care providers
entered into by MGB and that involve Researchers, provided they comply
with this Section 4 and other applicable institutional policies. COA may
provide for additional exceptions to this Section 4.2.7.
4.2.8
When Written
Agreements
Are Required
A Written Agreement is required when an Outside Activity is with a
pharmaceutical, medical device, or biotechnology Company or other
Company that provides, has provided, or is likely to provide goods or services
to MGB.
Examples: Examples of entities that may provide goods or services to MGB
include:
• Companies that sell or distribute medical or pharmaceutical equipment,
supplies or services, and/or
• Companies that provide non-medical goods and services, including
clerical supplies, computer hardware and software, kitchen supplies,
office
equipment, as well as legal, financial, accounting, advertising, consulting,
or real estate brokerage services.
Notes:
• Written Agreements must conform to the standard requirements for
Written Agreements, as described in Section 4.7.
• Covered Individuals are strongly encouraged to enter into Written
Agreements for all Outside Activities in order to protect their own
interests, including private liability considerations, and to avoid disputes.
However, Written Agreements are only required in the circumstances
described in this Section 4.2.8.
Continued on Next Page
To Table of Content
40
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.2. Policy Requirements for Outside Activities, Continued
To Table of Content
4.2.8
When Written
Agreements
Are Required
Continued
Special rules for certain speaking and training agreements: A speaking or
training engagement with any Company that provides, has provided, or is
likely to provide goods or services to MGB requires a Written Agreement,
unless: CME credit is given and the engagement is hosted by an ACCME-
accredited provider, or comparable entity as determined by COA.
No Written Agreement is required if the engagement is paid for and hosted by
an academic institution or professional or scientific organization.
Note: Expert witness agreements: No Written Agreement is required for
expert witness services, but supervisor review is required pursuant to Sections
4.4.3 and 4.5.4.
4.2.9
Institutional
Review of
Outside
Activities
Institutional reviews of certain Outside Activities are required to ensure that
institutional interests are adequately addressed when Covered Individuals
engage in Outside Activities.
This review is not conducted on behalf of Covered Individuals; they are
encouraged to have their private attorneys or other advisors review all
agreements on their personal behalf.
41
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.3. Policy Requirements for Outside Activities of Institutional
Officials
4.3.1
Prohibition on
Certain
Executive
Positions
An Institutional Official is prohibited from holding an Executive Position in a
for-profit Business engaged in commercial or research activities of a
biomedical nature. COA may grant an exception to this prohibition for
Institutional Officials who do not have full-time HMS appointments.
4.3.2
Restrictions on
Outside
Activities
Institutional officials may not accept any new Outside Activities (whether
fiduciary or not) with any biomedical Company, or any other Company that
does (or is reasonably likely to do) significant business with any MGB entity,
without prior review and approval by COA.
4.3.3
Required
PICC
Approvals
Certain consulting and other Outside Activities of Institutional Officials
require final approval by PICC.
To Table of Content
42
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.4. Oversight of Agreements for Outside Activities of
Medical/Professional Staff and Research Staff Members
To Table of Content
4.4.1
OII Review
and Approval
Required
Every Medical/Professional Staff member and Research Staff Member is
required to submit to the Office for Interactions with Industry (OII) every
proposed Written Agreement for an Outside Activity; to obtain OII’s review
and approval of such Agreement; and to ensure that the Written Agreement
complies with OII’s requirements prior to being signed or accepted. This
requirement to obtain OII’s review and approval applies even if the Outside
Activity was not required to have a Written Agreement.
Exceptions to OII review:
The following agreements do not require OII review:
• Written Agreements described in Section 4.4.2 (supervisor review and
approval may be required);
• Non-disclosure Written Agreements in which no intellectual property is
transferred and which protect only confidential information of the
disclosing party with no obligations other than to keep such information
confidential;
• Written Agreements for expert witness services (supervisor review is
required);
• Written Agreements for non-research personal consulting for a
governmental entity (supervisor review is required);
• Written Agreements for speaking engagements if
• CME credit is given and the engagement is hosted by an ACCME-
accredited provider, or comparable entity, as determined by COA, or
• The engagement is paid for and hosted by an academic institution or
professional or scientific organization.
43
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.4. Oversight of Agreements for Outside Activities of
Medical/Professional Staff and Research Staff Members,
Continued
4.4.2
Outside
Activities That
Do Not
Require OII
Review, but
May Require
Supervisor
Review
Outside Activities described in the table below do not need to be submitted to
OII for review and approval even if they involve a Written Agreement.
However, Medical/Professional Staff Members and Research Staff Members
are required to obtain their supervisors’ review and approval for the Outside
Activities described below. Supervisors shall have the authority to decide
that such review is not necessary for any of the Outside Activities described
in the table below, except for those that exceed the compensation threshold in
Section 4.4.3, which Outside Activities must be reviewed by the applicable
supervisor.
Additionally, Medical/Professional Staff Members and Research Staff
Members are required to obtain their supervisor’s approval for any Outside
Activity that the supervisor determines that he/she wishes to review. A
supervisor has the prerogative to refer any matter to COA.
Activity Type
Description
Academic Publication
Activity
Outside Activity relating to authorship/editing of academic media,
such as:
• Textbooks
• Editorships
“Moonlighting”
Activity
Outside Activity relating to clinical work within the institution or
another healthcare institution that is:
• Optional
• Not part of a Medical/Professional Staff Member’s or
Research Staff Member’s institutional duties, and
• Separately paid.
Medical Malpractice
Review Activity
Outside Activity relating to medical malpractice review
Certain Activity
involving a
governmental entity
Outside Activity for non-research personal consulting for a
governmental entity
To Table of Content
44
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.4 Oversight of Agreements for Outside Activities of
Medical/Professional Staff and Research Staff Members,
Continued
4.4.3
Outside
Activities That
Require
Supervisor
Review and
Approval
In addition to the Outside Activities listed in Section 4.4.2 that require
supervisor review unless waived by the supervisor, the following Outside
Activities must be reviewed and approved by the supervisor in advance of
undertaking the activity. This supervisor review and approval is in addition to
OII review and approval where that is required.
The table below describes those situations where supervisor review is
required.
Factor
Description
High
Compensation
Any Outside Activity that contains substantial monetary or equity
compensation
Thresholds
Relevant thresholds are:
• Cash compensation that exceeds $30,000 per year, or
• Equity compensation valued at more than $30,000 per year or
consists of more than 1% of the equity in a Company.
COA may revise these thresholds from time to time. Supervisors have the
authority to set lower thresholds for supervisor review of agreements for
Covered Individuals reporting to them.
Fiduciary
Obligation or
Scientific
Advisory Board
(Committee)
Service
Any Outside Activity that contains a fiduciary obligation to the Outside
Entity or that calls for membership on the Outside Entity’s Scientific
Advisory Board or Scientific Advisory Committee. Such agreements
may also require COA review.
Expert Witness
Activity
Any Outside Activity relating to serving as an expert witness in a legal or
administrative proceeding
Online Medical
Opinion Activity
Any Outside Activity involving the delivery of medical opinions or
advice online to patients/consumers.
Other
Circumstances
Any other unusual provisions or circumstances relating to an Outside
Activity (including, without limitation, multiple agreements or substantial
time commitments), as determined by OII or COA, may also be
considered to require supervisor review.
To Table of Content
45
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.5. Oversight of Agreements for Outside Activities of Employee
Members
4.5.1
OII Review
and
Approval
Required
The following Written Agreements for Outside Activities of an Employee
Member must be submitted to Office for Interactions with Industry (OII) for
prior review and approval:
• Written Agreements that purport to involve performance of research
activities, or
• Written Agreements that purport to involve a grant or transfer of
intellectual property rights to the Outside Entity.
4.5.2
Time
Limitations for
Outside
Activities
Full-time Employee Members are generally expected to devote their full
professional time, energy, loyalty, and commitment to MGB. A limited
amount of time for outside research, teaching, and other activities may be
allowable as determined by their supervisors.
4.5.3
Outside
Activities That
Do Not
Require OII
Review, but
May Require
Supervisor
Review
Employee Members who have been designated to complete a MGB
Disclosure Statement must obtain their supervisors’ review and approval in
advance of undertaking any Outside Activity that is with or for a
pharmaceutical, medical, device, or biotechnology Company or other
Company that provides, has provided, or is likely to provide goods or
services to MGB. Supervisors shall have the authority to decide that such
review is not necessary for any such Outside Activities except for those that
are described in Section 4.5.4, which Outside Activities must be reviewed
and approved by the applicable supervisor.
Additionally, Employee Members are required to obtain their supervisor’s
approval for any Outside Activity the supervisor determines that he/she
wishes to review.
A supervisor has the prerogative to refer any matter to the COA.
To Table of Content
46
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.5. Oversight of Agreements for Outside Activities of Employee
Members,
Continued
4.5.4
Outside
Activities That
Require
Supervisor
Review and
Approval
In addition to the Outside Activities described in Section 4.5.3 that require
supervisor review unless waived by the supervisor, the following Outside
Activities must be reviewed and approved by the supervisor in advance of
undertaking the activity. This supervisor review and approval is in addition
to OII review and approval where that is required.
The table that follows describes those situations where supervisor review is
required.
Factor Description
High
Compensation
An Outside Activity that contains substantial monetary or equity
compensation
Thresholds
Relevant thresholds are
• cash compensation that exceeds $30,000 per year, or
• equity compensation valued at more than $30,000 per year or consists
of more than 1% of the equity in a Company.
COA may revise these thresholds from time to time. Supervisors have the
authority to set lower thresholds for supervisor review of agreements for
Covered Individuals reporting to them.
Fiduciary
Obligation or
Scientific
Advisory Board
(Committee)
Service
Any Outside Activity that contains a fiduciary obligation to the Outside
Entity or that calls for membership on the Outside Entity’s Scientific
Advisory Board or Scientific Advisory Committee. Such agreements may
also require COA review.
Financial
Consulting
(including
“Expert
Networks”)
Any Outside Activity with an Outside Entity or individual
• involved in the investment or financial services industries, or
• where the consulting involves providing analysis or advice for
investment or similar purpose (including consulting through “expert
networks”)
Expert Witness
Activity
Any Outside Activity relating to serving as an expert witness in a legal or
administrative proceeding.
Online Medical
Opinion
Activity
Any Outside Activity involving the delivery of medical opinions or advice
online to patients/consumers.
Continued on Next Page
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47
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.5. Oversight of Agreements for Outside Activities of Employee
Members,
Continued
4.5.4
Outside
Activities That
Require
Supervisor
Review and
Approval
Continued
Other
Circumstances
Any other unusual provisions or circumstances relating to an Outside
Activity (including, without limitation, multiple agreements or substantial
time commitments), as determined by OII or COA, may also be considered
to require supervisor review.
To Table of Content
48
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.6. Authority of Supervisors
4.6.1
Independent
Supervisor
Review and
Authority
Supervisors have the right to review any and all Outside Activities, whether
or not covered by a Written Agreement, of Covered Individuals who report to
them.
Supervisors have the right and authority to disapprove any Outside Activity
if, in the supervisor’s judgment, the amount of time, compensation, or other
factors would interfere with the Covered Individual’s MGB responsibilities.
4.6.2
Considerations
for Supervisor
Review
In reviewing and deciding whether to approve an Outside Activity,
supervisors may take into account any relevant factors, including the Covered
Individual’s:
• Level of seniority
• Authority, and
• Administrative responsibilities.
For example, supervisors may limit the amount of time devoted to Outside
Activities or the amount of compensation received.
4.6.3
Supervisor
Conflict of
Interest
If a supervisor has a personal Financial Interest above thresholds established
by COA in a matter for which he or she has supervisory responsibility
pursuant to this Section 4, the supervisor must recuse himself or herself from
acting on the matter and shall refer the matter to his or her supervisor.
4.6.4
COA
Authority for
Unresolved
Issues
If any issue reviewed by a supervisor is not resolved in the normal course of
business, the COA has the authority to resolve the issue.
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49
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.7. Standard Requirements for a Written Agreement
4.7.1
Time
Each Written Agreement must contain sufficient evidence that the committed
time will be within allowable limits, preferably by specifying the maximum
number of days committed through that Written Agreement.
4.7.2
Restriction on
Use of
MGB
Name
Except for minimal risk circumstances approved by the OII, every Written
Agreement must state that Outside Entities do not have the right to use the
logo or name of any MGB entity in any form in any advertising, promotional
or other public material without the prior written approval of the MGB entity
involved.
• A Covered Individual may use the name of a MGB entity (in connection
with an Outside Activity) to identify the Individual’s position or title at
MGB, so long as the use, in the judgment of COA, does not imply MGB
endorsement or responsibility for the Outside Activity, the Outside Entity,
or the Outside Entity’s product or services, unless otherwise restricted by
COA.
4.7.3
Scope and Field
of Services
Written Agreements:
• Should clearly specify all of the services, including scope and field of
those services, to be provided by the Covered Individual, and
• M
ust not provide for services that compete or overlap inappropriately with
the individual’s obligations to MGB.
4.7.4
Overlap with
Field of
Research
If the field of activity in any Outside Activity overlaps with the field of
research conducted by the Covered Individual at or through MGB, then the
following additional requirements apply.
• If the Covered Individual’s research at MGB is sponsored by the Outside
Entity with which the Covered Individual is entering into the Written
Agreement, the intellectual property provisions of the Written Agreement
for the Outside Activity must not be so broad as to purport to grant to the
Outside Entity ownership of or other rights in any intellectual property
that may arise from, or relate to, the sponsored research agreement
between the Outside Entity and MGB.
Continued on Next Page
To Table of Content
50
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Consulting and Other Outside Activities
Approved 03.29.2018
4.7. Standard Requirements for a Written Agreement, Continued
4.7.4
Overlap with
Field of
Research
Continued
•
OII may determine that it is acceptable in the Written Agreement to grant
the Outside Entity a more limited scope of rights to intellectual property
arising so
lely out of consulting activities. These consulting activities must
be specifically and clearly distinguishable from the MGB-based research
conducted under the sponsored research agreement.
4.7.5
Restriction on
Intellectual
Property
Written Agreements must not purport to grant to any Outside Entity the rights
to intellectual property that are assigned or assignable to MGB under its
Intellectual Property Policy, except as MGB determines appropriate,
consistent with its Intellectual Property Policy.
4.7.6
Disclosure of
Unpublished
Research
Written Agreements must not give an Outside Entity any priority or advantage
in gaining access to any unpublished MGB research information or any
intellectual property that arises from activities performed by the Covered
Individual or others at or through MGB.
4.7.7
Confidentiality
•
Written Agreements must not limit or restrict a Covered Individual’s
ability to use or publish the results of research, education, patient care or
other activities performed at or through MGB.
• Written Agreements may impose confidentiality obligations on:
o Information, data, and other results generated by the Covered
Individual under the Written Agreement, and
o Information provided to the Covered Individual by the Outside Entity,
provided that the language must not cover any information created or
acquired in connection with the individual’s MGB responsibilities and
that there is a pre-defined period of confidentiality.
4.7.8
Exclusivity or
Non-Compete
Provisions
The requirements listed below apply to exclusivity or non-compete
provisions.
• Written Agreements must not restrict the ability of the Covered Individual
to conduct research, education, patient care, or administrative activities at
or through MGB.
• A Covered Individual is free to accept restrictions limiting his or her right
to undertake other activities for another Outside Entity. It must be clear
that those restrictions do not apply to activities supported by that Outside
Entity or any other Outside Entity at or through MGB.
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51
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
Section 5
Institutional Conflicts of Interest
5.1. Policy Overview
5.1.1
Policy
Statement
Collaborations among MGB, MGB Individuals, and Industry provide
opportunities for productive collaboration and foster the exchange of
knowledge and information that leads to advances in science and patient care.
However, MGB Financial Interests in Industry, including Financial Interests
of Institutional Officials and other supervisory personnel, may result in
inappropriate influence, or the appearance of inappropriate influence, on
MGB charitable activities. MGB requires that these Interests receive special
review and oversight, as described in this Section 5.
Note: The term “MGB” refers to Mass General Brigham Incorporated and/or
one or more of its Affiliated Institutions. Other terms in this Section 5 that
have initial capital letters shall have the meaning specified in the Glossary.
5.1.2
To Whom Does
Section 5
Apply?
The various policy requirements of this Section 5 Institutional Conflicts of
Interest apply to different MGB groups.
5.2. Policy Requirements for Certain Institutional Financial Interests apply
to Mass General Brigham Incorporated and MGB Affiliated Institutions.
5.3. Policy Requirements for Financial Interests and Outside Activities of
Institutional Officials apply to Institutional Officials.
5.4. Policy Requirements for Financial Interests and Outside Activities of
Supervisors Whose Direct Reports Engage in Research apply to such
supervisors.
5.5. Policy Requirements for Institutional Purchasing and Comparable
Transactions apply to certain MGB Individuals, including outside directors
and trustees, involved in institutional transactions.
To Table of Content
52
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.2. Policy Requirements for Certain Institutional Financial
Interests
5.2.1
Institutional
Equity
Acquired
Outside
Treasury
Investments
Sometimes MGB acquires equity (stock, stock options, or similar ownership
interests) outside the normal Treasury investment and Development Office
acquisition processes. In most cases this happens as a result of a license of
institutional technology or investments relating to technology or start-up
Company activities. Such equity is referred to here as “Special Equity.”
Institutional Conflicts of Interest may arise when MGB holds Special Equity
in a Company and conducts Clinical Research on or clinical validation of
technology of that Company.
Accordingly, MGB adopts a rebuttable presumption that a MGB Affiliated
Institution may not conduct Clinical Research on the technology of a
Company, or validate or test on patients the unvalidated technology of a
Company, (collectively referred to in this Section 5.2.1 as Clinical
Research/Validation) if it or any other MGB Affiliated Institution
simultaneously holds Special Equity in the Company.
The presumption may be overcome only if:
(a) COA determines that there are demonstrable, compelling circumstances,
consistent with the rights and welfare of clinical research subjects, for the
MGB Affiliated Institution conducting the Clinical Research/Validation
while it or any other MGB institution holds special equity; OR
(b) COA determines that the Clinical Research/Validation will be conducted
at a different MGB Affiliated Institution from the one that owns or stands
to benefit financially from the equity, and that individuals at the Affiliated
Institution that owns or stands to benefit from the equity have no
significant supervisory or other authority over the Researchers in the
Clinical Research/Validation; OR
(c) COA determines that the benefits of the MGB Affiliated Institution
conducting the Clinical Research/Validation outweigh the risks, and the
Clinical Research/Validation has been determined by the IRB to present
no more than minimal risk to the subjects participating in it.
Continued on Next Page
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53
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.2. Policy Requirements for Certain Institutional Financial
Interests,
Continued
5.2.1
Institutional
Equity
Acquired
Outside
Treasury
Investments
Continued
If the presumption is overcome under (a), (b), or (c), the Clinical
Research/Validation may proceed only if COA determines that the equity
holding can be appropriately managed, pursuant to a COA-approved
management plan directed at protection of the integrity of the Clinical
Research/Validation and the human subjects participating in it. PICC shall
have the authority to review any decision by COA pursuant to this
Section5.2.1 that has significant financial implications for MGB.
For purposes of this section 5.2.1, Clinical Research/ Validation shall not
include research that is determined by the Institutional Review Board and/ or
COA to be Nominal Risk Clinical Research. Such Nominal Risk Clinical
Research/ Validation is not subject to the rebuttable presumption above, but
may proceed only pursuant to a management plan approved by COA, which
authority is delegable by COA to OII.
Factors that may be relevant to the analysis of whether compelling
circumstances exist for the Clinical Research/Validation include, but are not
limited to, the following:
• The nature of the science involved;
• A description of the institutional financial interest and how closely it is
linked to the Clinical Research/Validation;
• The degree to which the interest may be affected by the Clinical
Research/Validation;
• The magnitude of the potential risks to subjects or integrity inherent in the
Clinical Research/Validation;
• How those risks could be affected as a result of the institutional financial
interest;
• Whether the MGB Affiliated Institution is uniquely qualified, by virtue of
its attributes (e.g. special facilities or equipment, unique patient
population) and its researchers, to conduct the Clinical
Research/Validation; or
• The degree to which the institutional conflict of interest can be effectively
managed.
Continued on Next Page
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54
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.2. Policy Requirements for Certain Institutional Financial
Interests,
Continued
To Table of Content
5.2.1
Institutional
Equity
Acquired
Outside
Treasury
Investments
Continued
Possible elements of associated management plans may include, but are not
limited to, the following:
• Special oversight of human subjects involved in the Clinical
Research/Validation, for example, through additional internal monitoring
mechanisms or through an external IRB or DSMB;
•
Increasing or establishing firewalls or other conflicts management systems
to separate financial decision-making from decision-making about the
Clinical Research/Validation;
• Independent data monitoring to ensure validity, through an objective
individual or individuals outside the MGB Affiliated Institution with no
ties to the Clinical Research/Validation or to the outside entity;
• Disclosure of institutional conflicts as defined in this Section 5 in all
relevant settings, including to human subjects involved in the Clinical
Research/Validation; or
• Modification or restriction of the MGB Affiliated Institution’s financial
interest, through lock-up provisions, divestiture, or the like.
5.2.2
License
Payments and
Research
Institutional Conflicts of Interest may arise when a MGB Affiliated Institution
receives or has the potential to receive significant license payments from the
sale of technology that is the subject of Clinical Research conducted at that
Institution. These license payments include, but are not limited to:
• Upfront payments
• Milestone payments, and
• Royalties.
Requirement for COA Review and Approval
When OII determines that a MGB Affiliated Institution proposes to conduct
Clinical Research on the technology of a Company that is subject to a license
or option to license from that Institution and that Institution is receiving
license payments, above a threshold established by COA, from the sale of that
technology, the proposed research must be reviewed and approved by COA
before the research begins at that Institution. In performing its analysis, COA
may take into account any factors that it deems relevant to the analysis.
55
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.2. Policy Requirements for Certain Institutional Financial
Interests,
Continued
To Table of Content
5.2.3
Oversight of
Major Gifts
and Research
Institutional Conflicts of Interest may arise when a MGB Affiliated Institution
receives substantial gifts from a Company:
• That sponsors Clinical Research at that Institution or
• Whose technology is proposed to be studied or tested in Clinical Research
at that Institution.
Requirement for COA Review and Approval
When OII determines that a MGB Affiliated Institution proposes to conduct
Clinical Research sponsored by, or on the technology of, a Company from
which that Institution has received substantial gifts above thresholds
established by the COA, including gifts in kind, the proposed research must
be reviewed and approved by COA before the research begins at that
Institution. In performing this analysis, COA may take into account any
factors it deems relevant to the analysis.
5.2.4
Royalties and
Clinical Care
Institutional Conflicts of Interest may arise when MGB receives royalties
derived from the sales of particular drugs or devices to MGB.
License agreements under which MGB technology is licensed by MGB to a
Company must state that the Company will not pay royalties derived from the
sales of a particular drug or device to MGB, unless the COA approves an
arrangement under which all such royalties will be donated to a specific non-
MGB charitable organization.
56
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.3. Policy Requirements for Financial Interests and Outside
Activities of Institutional Officials
5.3.1
New Outside
Activities
Require COA
review
Institutional Officials may not accept any new Outside Activities (whether
fiduciary or not) with any biomedical Company, or any other Company that
does (or is reasonably likely to do) significant business with any MGB
Affiliated Institution, without prior review and approval by the COA.
5.3.2
New Human
Subjects
Research
Institutional Conflicts of Interest may arise when MGB conducts Clinical
Research sponsored by, or on the technology of, a Company in which an
Institutional Official has a Financial Interest or Outside Activity.
Requirement for COA Review and Approval
When OII determines that MGB proposes to conduct Clinical Research
sponsored by, or on the technology of, a Company, and that research is
within the scope of the responsibilities of an Institutional Official who holds
one of the following relationships or interests in the Company, the proposed
research must be reviewed and approved by COA before the research begins
at MGB:
• A fiduciary position in the Company; or
• Annual compensation or other income from the Company above a
threshold established by COA; or
• Equity or other ownership interest in the Company, including stock
options, above a threshold established by COA;
In performing its analysis, COA may take into account any factors it deems
relevant to the analysis.
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57
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.4. Policy Requirements for Financial Interests and Outside
Activities of Direct Supervisors of Research
5.4.1
Conflicts of
Interest for
Direct
Supervisors
A conflict of interest may arise any time that a supervisor whose direct reports
participate in research has Financial Interests or Outside Activities, based on
thresholds established by the COA, in a Company:
• That sponsors research (or that is proposing to sponsor research)
conducted by the supervisor’s direct reports, or
• Whose technology is (or is proposed to be) the subject of research
conducted by the supervisor’s direct reports.
COA may impose restrictions on and implement management mechanisms
for
the supervisor with respect to oversight of such research.
• Note: A MGB Individual participating in research may request COA’s
review of a potential conflict of interest, as defined in this section, of his
or her direct supervisor with respect to that research. COA shall have the
prerogative to decide whether the relationship merits management.
• Direct supervisors of research may request OII or COA review of any
potential conflict.
• COA can review other situations where appropriate.
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58
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.5. Policy Requirements for Institutional Purchasing and
Comparable Transactions
5.5.1
Conflicts of
Interest in
Institutional
Purchasing and
Comparable
Transactions
Institutional Conflicts of Interest may arise when MGB enters or considers
entering a transaction with any of the following:
• A MGB Individual
• A person who is a member of a MGB Individual’s Family; or
• An Outside Entity in which a MGB Individual or a member of his/her
Family has a Financial Interest or relationship.
The requirements in this Section 5.5 are intended to ensure the integrity of
decision-making in institutional transactions.
5.5.2
Interested
Individuals
A MGB Individual, including an outside director or trustee, is deemed to be
an Interested Individual for a particular transaction if he/she is a party to or
aware that MGB is entering (or considering entering) into a transaction with:
• A person who is a member of the MGB Individual’s Family, or
• An Outside Entity in which that MGB Individual or a member of his/her
Family has either a Financial Interest or relationship that exceeds
thresholds established by COA.
5.5.3
Recusal
Requirement
for Interested
Individuals
Except as stated below, a MGB Individual must not participate in discussions
on or recommendations regarding, act upon, or otherwise participate in the
decision-making regarding the transaction in which he/she is an Interested
Individual.
Limited Allowable Participation
The Interested Individual may participate in discussions and/or
recommendations about a transaction, but not in the final decision-making,
provided that:
• The person with authority for final decision-making or the chairperson of
a committee determines that involvement of the Interested Individual is
appropriate, and
Continued on Next Page
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59
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.5. Policy Requirements for Institutional Purchasing and
Comparable Transactions,
Continued
To Table of Content
5.5.3
Recusal
Requirement
for Interested
Individuals
Continued
• Others involved in the discussion and/or recommendation are aware of the
Financial Interest or relationship held by the Interested Individual, whether
by disclosure by the Interested Individual or otherwise; and
• The Interested Individual possesses particular expertise or knowledge that
would be beneficial to the final decision.
Note:
COA may determine additional exceptions to the recusal requirement of
Section 5.5.3.
5.5.4
Procedures for
Certain
Purchasing
Transactions
For any transaction that involves a contract to purchase Goods or Services
exceeding thresholds established by COA (referred to in this section as a
“Reviewable Purchasing Transaction”), the following procedures must be
completed prior to entering into the transaction.
When informed of a Reviewable Purchasing Transaction, OII shall determine
from submitted MGB Annual Disclosure Statements whether a MGB
Individual or member of his or her Family has a Financial Interest in or
relationship with the Outside Entity involved in the transaction that exceeds
thresholds established by COA.
• If OII finds there is no such Financial Interest or relationship, this finding
shall be documented in writing, and the transaction may be entered into.
• If OII finds there is one or more such Financial Interests or relationships,
the person responsible for the transaction must make a written
determination that, notwithstanding the apparent conflict, the transaction is
fair and reasonable to MGB and is in the best interest of MGB. The basis
for this determination must include but is not limited to:
The consideration of at least two alternative disinterested competitive
proposals, or
• A determination that two such competitive proposals do not exist or that it
would be impractical to solicit them, along with an explanation for why it
was determined appropriate to enter into the transaction without
considering such competitive proposals.
60
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.5. Policy Requirements for Institutional Purchasing and
Comparable Transactions,
Continued
To Table of Content
5.5.5
Procedures for
Other
Transactions
The determination described in the fourth paragraph of section 5.5.4 must be
made under either of the following circumstances:
• For a Transaction that involves the purchase of Goods or Services falling
below the threshold for a Reviewable Purchasing Transaction in Section
5.5.4, and
• For any transaction other than a purchasing transaction.
But only if:
• The Transaction is with a MGB Individual or a Family Member of a MGB
Individual; or
• The person responsible for the transaction is aware that a MGB Individual
or a member of his or her Family:
o Has a Financial Interest in or relationship with the Outside Entity
involved in the transaction that exceeds the thresholds for Individuals
established by COA (as described in Section 5.5.4), and
o Meets one of the following descriptions:
is actually involved in the Transaction, or
is an Institutional Official or
is an outside director or trustee, or
has his/her MGB affiliation with the entity entering into the
transaction or with a parent of that entity and the transaction is
within the scope of his or her responsibilities.
The requirements of this Section 5.5.5 do not apply to transactions involving
ordinary and routine research or technology transfer matters that are processed
through the appropriate research and/or technology transfer office in the
ordinary course of business.
61
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Institutional Conflicts of Interest
Approved 03.29.2018
5.6. COA Oversight of Institutional Conflicts of Interest
To Table of Content
5.6.1
COA Oversight
of Institutional
Conflicts of
Interest
Subject to the reserved authority of PICC as referenced in Section P.2.2, COA
shall have overall authority and responsibility for overseeing Institutional
Conflicts of Interest. COA shall review and manage or otherwise resolve all
cases of potential Institutional Conflicts of Interest as described in Sections
5.2.1, 5.2.2, 5.2.3, 5.3.1, 5.3.2, and 5.4.1.
62
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Gifts From MGB Vendors and Potential Vendors
Approved 03.29.2018
Section 6
Gifts From MGB Vendors and Potential Vendors
6.1. Policy Overview
6.1.1
Policy on Gifts
to MGB
Gifts to MGB or its Affiliated Institutions from pharmaceutical Companies,
medical device Co
mpanies, and other vendors may provide valuable resources
that help MGB to carry out its charitable activities. However, such gifts may
raise concerns about inappropriate influence on MGB charitable missions.
Therefore, they must be overseen by appropriate MGB officials.
Gifts to MGB from pharmaceutical Companies, medical device Companies,
and other vendors and potential vendors for the support of MGB Educational
Activities sh
all be handled by OII in accordance with Section 3 of this Policy.
All other gifts are the responsibility of the relevant Institution’s Development
Office.
Note: The term “MGB” refers to Mass General Brigham Incorporated and/or
one or more of its Affiliated Institutions. Other terms in this Section 6 that
have initial capital letters shall have the meaning specified in the Glossary.
6.1.2
Policy on Gifts
from Vendors
or Potential
Vendors to a
MGB
Individual or to
MGB for the
Use or Benefit
of a MGB
Individual
When gifts are made to or for the benefit of MGB Individuals, they have the
potential to influence or create the appearance of influencing the behavior of
MGB Individuals in carrying out their MGB responsibilities.
MGB Individuals may not accep
t any gifts (including meals and entertainment
or funding for meals and entertainment), regardless of value, from
pharmaceutical Companies, medical device Companies, or other vendors or
potential vendors of MGB.
MGB and its Affiliated Institutions may not accept any gifts for the personal
use or benefit of staff members (including meals and entertainment or funding
for meals and entertainment), regardless of value, from pharmaceutical
Companies, medical device Companies, or other vendors or potential vendors
of MGB.
Continued on Next Page
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63
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Gifts From MGB Vendors and Potential Vendors
Approved 03.29.2018
6.1. Policy Overview, Continued
6.1.2
Policy on Gifts
from Vendors
or Potential
Vendors to a
MGB
Individual or to
MGB for the
Use or Benefit
of a MGB
Individual
Continued
Special rule for certain gifts offered to MGB Individuals: If a MGB
Individual is offered a non-cash gift or gratuity prohibited under this Policy
and believes that it would be contrary to the best interests of MGB to decline
the gift or gratuity, the MGB individual may accept the gift or gratuity and
must report the matter to OII. OII, after consultation with COA and the MGB
Individual’s supervisor, will direct the MGB Individual to take appropriate
action, which may include keeping the gift or gratuity, returning it, or
donating it to an appropriate MGB entity or department.
6.1.3
To Whom
Section 6.1.2
Applies
Section 6.1.2 applies to:
• All full-time Covered Individuals;
• All other MGB Individuals while Acting in a MGB Capacity.
The provisions of this Section 6.1.2 apply to gifts, whether provided at a
MGB site or off site.
6.1.4
Scope of
Policy
The following are not considered gifts (but generally require Written
Agreements or other documentation as determined by OII):
• Reasonable compensation for providing services; and
• Reimbursement of reasonable costs incurred by an individual in the
performance of providing services to the entity providing the
reimbursement;
• Circumstances where MGB or an individual to whom this Section 6
applies provides fair market value for the item;
• Other situations as determined by COA.
6.1.5
MGB Code of
Conduct
Additional policies on gifts and outside remuneration are found in the MGB
Code of Conduct policy on Gifts, Gratuities, and Outside Remuneration.
To Table of Content
64
Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Glossary and Terms
Note: Any Term in this Glossary that is referred to as an “HMS definition” shall have the
definition provided in the HMS Conflicts Policy (and as it may be subsequently modified).
Term
Definition
Acting in a
MGB Capacity
Acting in a MGB capacity means an individual is:
• Engaged in an activity that constitutes or is part of his/her MGB role (for
example, serving on a committee or seeing patients as a part-time member
of the medical staff of a MGB hospital); or
• Acting at the direction of a MGB supervisor to carry out an activity that
constitutes the individual's MGB role (for example, attending an off-site
meeting at the supervisor's direction); or
• Engaging in any activity in which the individual identifies him/herself as
associated with MGB in such a manner that a reasonable person would
believe that the individual is acting on behalf of MGB or in a MGB
capacity. For further explanation, see here (link only accessible to MGB
Employees)
Affiliated
Institution
Any of the following institutions:
• The Brigham and Women’s/Faulkner Hospitals, Inc., and all affiliates
• The Massachusetts General Hospital, and all affiliates
• The North Shore Medical Center, Inc., and all affiliates
• Newton-Wellesley Hospital, and all affiliates
• Mass General Brigham Community Physicians (“MGB CP”)
• Spaulding Rehabilitation, Inc. and all affiliates
• Partners Harvard Medical International, Inc.
• Partners International Medical Services, Inc.,
• AllWays Health Partners, Inc. and
• other institutions and entities designated in the future as Affiliated
Institutions
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Business
(HMS definition)
Any legal entity organized for profit or non-profit purposes.
• This term includes, but is not limited to: corporations, partnerships, sole
proprietorships, associations, organizations, holding companies, and
business or real estate trusts.
• A Business is considered to be “non-profit” if it is legally organized for
charitable purposes (e.g., 501(c)(3) and equivalents), unless it is
principally organized, funded, and/or managed by one or more for-profit
entities engaged in commercial or Research activities of a biomedical
nature.
• Not included in this term are Harvard University, including Harvard
Medical School, and the institutions formally affiliated with Harvard
Medical School (for example, the Harvard teaching hospitals).
→ A1 Clinical Research Rule
→ A2 Research Support Rule
→ A3 External Activity Rule
→ B Executive Position Rule
Clinical
Conflict of
Interest
A clinical conflict of interest may exist when a MGB Individual covered by
Section 2 of this Policy has a personal Financial Interest or Outside Activity
with a manufacturer of a drug, device, or other products for use in patient care,
according to thresholds that may be established from time to time by COA,
which could influence or be perceived as influencing his/her clinical decision-
making or interactions with his/her patients.
Clinical
Research
(HMS definition) Any Research that is subject to IRB approval (excluding
those studies determined to be Nominal Risk Clinical Research by an IRB
and/or COI Committee). Also see definition of “Participate in Clinical
Research.”
→A1 Clinical Research Rule
→ A2 Research Support Rule
→ A3 External Activity Rule
COA
Committee on Outside Activities
Company
A for-profit outside entity
Covered
Individuals
Medical/Professional Staff Members, Research Staff Members, and Employee
Members
ERB
Education Review Board
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Employee
Members
Administrative staff, nurses, support personnel, and other full- or part-time
employees of MGB or a MGB-affiliated Corporation who are not
Medical/Professional Staff Members or Research Staff Members.
Executive
Position
(HMS definition) Any position that is responsible for a material part of the
operation or management of a Business.
This term specifically includes, but is not limited to, the following positions:
Chief Executive Officer, Chief Operations Officer, Chief Scientific Officer,
Chief Medical Officer, Scientific Director, and Medical Director.
→ B Executive Position Rule
Faculty
(HMS definition) Any person possessing an academic appointment in the
Faculty of Medicine [of Harvard Medical School]. Full-time Faculty on
sabbatical or other paid leave are considered full-time for the purposes of the
Policy. Full-time Faculty on approved unpaid leave are not considered full-
time for these purposes. Faculty who, alone or together with one or more
members of their Family, exercise a controlling interest in any trust,
organization, or enterprise other than the [Harvard] University or any Harvard
affiliated institution, will be evaluated under this policy based on any income
or equity held by the entity in which the controlling interest is held. Such
entities are viewed, for purposes of this policy, as extensions of the term
“Faculty”.
→ B Executive Position Rule
Family
Spouse, domestic partner, and dependent children
Fiduciary
Position
A fiduciary position is a position in which one has a legal responsibility of
care for the assets or rights of another entity or person. Members of a Board of
Directors of a company have fiduciary positions. Other types of fiduciary
positions include serving as an officer or executive of a company, such as the
CEO or COO, which positions require high-level responsibility for the day-to-
day management of the business.
Financial
Conflict of
Interest
A Significant Financial Interest that could directly and significantly affect the
design, conduct, or reporting or PHS-funded research.
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Financial
Interest
(HMS definition) Any equity interest in a Business (“Equity Financial
Interest”) or the receipt of, or the right or expectation to receive (except rights
to future income under institutional royalty sharing agreements), any income
from a Business (“Income Financial Interest”) held by the Faculty member
and/or his/her Family.
• Equity Financial Interests may include any type of ownership interest, such
as owning stock or stock options, but excludes equity that arises solely by
reason of investment in a Business by a mutual, pension, or other
institutional investment fund over which the Faculty member and/or
his/her Family does not exercise control.
• Income Financial Interests may take the form of various types of
compensation and may be paid either by the Business or by an agent or
other representative of the Business on its behalf. Examples of income
that might be paid or owed by a Business to a Faculty member and/or
his/her Family include, but are not limited to, consulting fees, salary, or
other payments for various services, interests in real or personal property,
dividend payments, payments derived from the licensing of Technology,
and forgiveness of debt. The term explicitly excludes, however,
Postmarket Royalties.
→ A1 Clinical Research Rule
→ A2 Research Support Rule
→ A3 External Activity Rule
→ 1.2.4
HMS Conflicts
Policy
The formal Conflicts of Interest policy document of the Harvard Medical
School, as it may be revised from time to time. As of the date of this version
of the MGB Policy, the formal Harvard Medical School document is the
Harvard University Faculty of Medicine Policy on Conflicts of Interest and
Commitment, available at http://ari.hms.harvard.edu/files/integrity-academic-
medicine/files/final_hms_coi_policy_10.11.2016_0.pdf
HMS Standing
Committee
The HMS Standing Committee on Conflicts of Interest and Commitment
Industry
A for-profit Outside Entity
Institutional
Officials
• Presidents and Chief Executive officers
• Officers and executives at and above the Vice President level
• Service/Department Chiefs/Chairs
• Other senior officials designated by the President/CEO of MGB and each
Affiliated Corporation
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Institutional
Responsibilities
Institutional Responsibilities include research, clinical care, education,
administrative, and other MGB activities.
Interested
Individual
A MGB Individual, including an outside director or trustee, is deemed to be an
Interested Individual for a particular transaction if he/she is a party to or aware
that MGB is entering (or considering entering) into a transaction with:
• that MGB Individual,
• a person who is a member of the MGB Individual’s Family, or an Outside
Entity in which that MGB Individual or a member of his/her Family has
either a Financial Interest or relationship that exceeds thresholds
established by COA.
Medical/
Professional
Staff Members
Individuals who are members of the medical or professional staffs of any
MGB hospital AND who:
• Have full-time or part-time faculty appointments at Harvard Medical
School, OR
• Are Service/Department Chiefs/Chairs at MGB or an Affiliated Institution,
OR
• Are employed full-time or part-time by MGB or an Affiliated Institution
Exceptions
The following are considered Medical/Professional Staff Members only when
they are at a MGB site or otherwise Acting in a MGB Capacity:
• Individuals who are members of the medical or professional staff of any
MGB hospital and who have an HMS faculty appointment, but
• are neither employed by MGB or an Affiliated Institution, nor are Service/
Department Chiefs/Chairs, AND
• who have a medical/professional staff appointment at a non-MGB but
HMS affiliated hospital, which is their primary job location.
MGB
Mass General Brigham and/or one or more of the Affiliated Institutions
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
MGB
Educational
Activity
All MGB educational endeavors designed to provide educational information
to healthcare practitioners (including physicians, nurses, residents, and
fellows), non-physicians, non-professional staff, patients, and/or the public,
regardless of whether the participants receive credit for their participation
(e.g., accredited CME, CNE, and other such accredited programs, as well as
unaccredited educational courses).
MGB Educational Activities include the following:
• Clinical training programs, such as residencies and fellowship programs
that involve a significant component consisting of direct patient care;
• Educational events, including continuing medical education programs or
other professional health care education programs that involve conferences
or lectures or other forms of verbal presentations, regardless of whether the
participants receive credit;
• Educational tools and resources, including MGB newsletters and web sites
designed to distribute educational information to healthcare practitioners,
patients, and the public, even if such information pertains to research; and
• Other educational programs that are put on, or sponsored, by any MGB
entity
MGB
Individual
Any trustee, director, officer, executive, full- or part-time
Medical/Professional Staff Member, Research Staff Member, or Employee
Member of a MGB Affiliated Institution (other than MGB CP)
Any member of a MGB committee
Any consultants, independent contractors, students, trainees, sponsored staff,
researcher, collaborator, or other individuals acting in a MGB capacity
The following people affiliated with MGB CP:
• MGB CP Trustees, officers, executives, and members of MGB CP
committees with board-delegated powers
• Physicians and non-physicians employed by MGB CP
• Physicians who have an appointment to the professional staff of a hospital
owned or controlled by MGB
• Other physicians and non-physicians, who, in the judgment of the Chief
Executive Officer of MGB CP, have significant MGB CP-related
management responsibilities.
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Nominal Risk
Clinical
Research
(HMS definition) Clinical Research that is determined by the Institutional
Review Board and/or the HMS or an affiliate institution’s Conflict of Interest
Committee as both:
i. minimal risk (as that term is defined in 45 CFR Part 46 and
ii. falls within one or more of the following categories
(i) Use of bodily fluids, secretions, or other biospecimens,
(excluding such materials obtained for clinical care purposes,
which are covered in b. below) that are obtained through non-
invasive, routine, and established collection procedures from a
healthy, non-pregnant individual who is not a member of a
vulnerable population (as defined in 45 CFR part 46) and
provided that the samples cannot be linked to any individually
identifiable person by any Faculty member who Participates in
the Nominal Risk Research;
(ii) Use of excess bodily fluids, secretions, or other biospecimens,
which may be linked by a Faculty member who Participates in
the Nominal Risk Clinical Research to an individually
identifiable patient, where the samples are otherwise obtained
during the course of clinical care by an individual who (1) does
not Participate in the Nominal Risk Clinical Research; (2) is not
under the direction or control of any individual who
Participates in the Nominal Risk Clinical Research; and (3) is
not supervising any individual who Participates in the Nominal
Clinical Risk Research;
(iii) Medical records review, including collection of coded
identifiable data, provided, however, that the protocol ensures
that, after collection of the data, any Faculty who Participate in
the Nominal Risk Research cannot link it to an individually
identifiable patient;
(iv) Non-sensitive survey Research on individuals or group
characteristics or behavior, provided that if the subjects are
considered members of a vulnerable population as defined by
45 CFR Part 46, the institution’s conflicts of interest committee
and/or Institutional Review Board may, on a case by case basis,
conclude that the Research is not Nominal Risk Clinical
Research; or
(v) Such other categories of Research activities as may from time
to time be designated by the Faculty of Medicine Standing
Committee on Conflicts of Interest.
OII
Office for Interactions with Industry
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Outside
Activities
Any activity that is not performed as part of an individual’s MGB
responsibilities and either:
• Draws on his or her expertise relating to his or her responsibilities at
MGB, or
• Is with an Outside Entity, the primary business activities of which relate to
his or her responsibilities at MGB, or
• Is with an Outside Entity that is a biomedical company or other vendor
that
does or is likely to do business with MGB, or
• Is with an Outside Entity that provides health care related goods or
services.
Outside Entity
Any for profit or non-profit corporation, foundation or other entity or
organization, including any governmental entity that is not a MGB Affiliated
Institution.
Participate
(HMS definition) To be responsible for the design, conduct, or reporting of
Research, regardless of title or position.
• This term assumes that the individual may have the opportunity to
influence or impact the results. It is not intended to apply to individuals
who provide primarily technical support to a Research study or who act in
a purely advisory capacity with no direct access to the study data, unless
such individuals are nonetheless in a position to influence or impact the
study’s results or have privileged information as to its outcome.
• If a Faculty Member Participates in Research pursuant to this definition,
such participation shall be considered to be for the entire duration of the
study even should the Faculty member elect to terminate the Research
activities.
→ A1 Clinical Research Rule
→ A2 Research Support Rule
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Participate in
Clinical
Research
Faculty who Participate in Clinical Research either:
1. are responsible for the design, conduct, or reporting of an IRB-
approved study
and, as part of that IRB-approved study:
a. have access to information about living individuals by intervening or
interacting with them for Research purposes; and/or
b. have access to identifiable private information about living individuals for
Research purposes; and/or
c. obtain the voluntary informed consent of individuals to be subjects in
Research; and/or
d. study, interpret, or analyze identifiable private information or identifiable
data for Research purposes; and/or
e. have access to the study treatment assignment made through, for example,
a randomization process; or
2. serve as the Primary Author, or one of the primary authors, of a
Publication reporting the results of an IRB-approved study. A primary author
of a publication is the individual who, in compliance with HMS Authorship
Guidelines [http://ari.hms.harvard.edu/files/integrity-academic-
medicine/files/authorship_guidelines.pdf] and ICMJE Authorship Guidelines
[http://www.icmje.org/icmje-recommendations.pdf], takes primary
responsibility for the integrity of the work as a whole even if he or she does
not have an in-depth understanding of every part of the work.
→ A1 Clinical Research Rule
→ A2 Research Support Rule
→ A3 External Activity Rule
→B Executive Position Rule
Policy
The Mass General Brigham Policy on Interactions With Industry and Other
Outside Entities
PICC
Professional and Institutional Conduct Committee
Research
(HMS definition) Systematic investigation designed to develop or contribute to
generalizable knowledge relating broadly to public health, including
behavioral and social sciences research. The term encompasses basic,
Sponsored, and Clinical Research, including applied Research and product
development.
→ A1 Clinical Research Rule
→ A2 Research Support Rule
→ A3 External Activity Rule
→ B Executive Position Rule
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Research Staff
Members
Individuals who have full-time or part-time non-faculty appointments at
Harvard Medical School and:
• who are not Medical/Professional Staff Members, and
• who are participating in research activity under the administrative
authority of MGB or an Affiliated Institution
Exception: Individuals who meet the criteria for Research Staff Members,
above, but whose primary affiliation is at a non-MGB but HMS affiliated
hospital, are considered Research Staff Members only when they are at a
MGB site or otherwise Acting in a MGB Capacity.
Researchers
MGB Individuals who are project directors or principal investigators of a
MGB research activity, and any other person, regardless of title or position,
who is responsible for the design, conduct, or reporting of, MGB research
activities, including collaborators or consultants. The term “Researchers” is
not limited to principal investigators.
→ A1 Clinical Research Rule
→ A2 Research Support Rule
→ A3 External Activity Rule
→ B Executive Position Rule
Reviewable
Purchasing
Transaction
Any transaction that involves a contract to purchase goods or services
exceeding thresholds established by COA.
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Significant
Financial
Interest
(1) A financial interest consisting of one or more of the following interests of
the Researcher (and those of the Investigator’s spouse and dependent children)
that reasonably appears to be related to the Researcher’s Institutional
Responsibilities:
(i) With regard to any publicly traded entity, a significant financial
interest exists if the value of any remuneration received from the
entity in the twelve months preceding the disclosure and the value
of any equity interest in the entity as of the date of disclosure, when
aggregated, exceeds $5,000. For purposes of this definition,
remuneration includes salary and any payment for services not
otherwise identified as salary (e.g., consulting fees, honoraria, paid
authorship); equity interest includes any stock, stock option, or
other ownership interest, as determined through reference to public
prices or other reasonable measures of fair market value;
(ii) With regard to any non-publicly traded entity, a significant
financial interest exists if the value of any remuneration received
from the entity in the twelve months preceding the disclosure,
when aggregated, exceeds $5,000, or when the Researcher (or the
Researcher’s spouse or dependent children) holds any equity
interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights),
upon receipt of income related to such rights and interests.
(2) The occurrence of any reimbursed or sponsored travel (i.e., that which is
paid on behalf of the Researcher and not reimbursed to the Researcher so that
the exact monetary value may not be readily available), related to their
Institutional Responsibilities; provided, however, that this definition does not
apply to travel that is reimbursed or sponsored by a Federal, state, or local
government agency, an Institution of higher education as defined at 20 U.S.C.
1001(a) or a research institute that is affiliated with an institution of higher
education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, or a
medical center.
Continued on Next Page
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Significant
Financial
Interest,
Continued
The term significant financial interest does not include the following types of
financial interests: salary, royalties, or other remuneration paid by the
Institution to the Researcher if the Researcher is currently employed or
otherwise appointed by the Institution, including intellectual property rights
assigned to the Institution and agreements to share in royalties related to such
rights; any ownership interest in the Institution held by the Researcher, if the
Institution is a commercial or for-profit organization; income from investment
vehicles, such as mutual funds and retirement accounts, as long as the
Researcher does not directly control the investment decisions made in these
vehicles; income from seminars, lectures, or teaching engagements sponsored
by a Federal, state, or local government agency, an Institution of higher
education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a
medical center, or a research institute that is affiliated with an Institution of
higher education; or income from service on advisory committees or review
panels for a Federal, state, or local government agency, an Institution of higher
education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a
medical center, or a research institute that is affiliated with an Institution of
higher education.
Special Equity
Equity or other ownership interests received by MGB outside normal Treasury
or Development Office stock acquisitions, for example, as a consequence of a
license of institutional technology or other involvement in a start-up Company.
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Sponsored
Research
(HMS definition) Research, training and instructional projects involving funds,
personnel, certain proprietary materials, or Technology, or other compensation
from outside sources under an agreement that (i) the institution classifies as a
sponsored award in accordance with institutional policy or (ii) gives the donor,
or an identifiable third party designated by the donor, preferred access to or
ownership rights over the Research or the products of the Research, e.g. raw
data, scientific developments, or intellectual property. Provision of periodic
general reports and copies of publications shall not be considered preferred
access.
• Notwithstanding the forgoing, Sponsored Research shall not
incorporate the following agreements:
1. Gifts: Agreements that an institution classifies as a gift in accordance with
institutional policy except as specifically set forth below:
a. Faculty members who hold equity in the donor company are
prohibited from receiving gifts that are made solely for the support of
the Faculty member’s Research or that of the Faculty member’s
laboratory.
2. Certain Material Transfer Agreements: Agreements that provide for the
provision of tangible materials, including equipment, from an outside source
pursuant to a material transfer or other agreement provided each of the
following factors are met:
a. The proposed protocol does not consist of Research on the material
in question, either directly or indirectly (e.g., the primary usefulness of
the material in the proposed protocol is as a research tool to achieve
scientific aims distinct from the donor company’s business aims and
not as a potential product or integral component of such product);
b. The proposed agreement does not grant to the Business any rights to
intellectual or tangible property created in or resulting from the use of
the material in the proposed Research, except:
1. Options to negotiate (even if such options are exclusive) a
license to intellectual property made in, and derived directly
from the use of the material in, the Research; or
2. A non-exclusive license for Research purposes to intellectual
property made in, and derived directly from the use of the
material in, the Research.
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Mass General Brigham Policy for Interactions with Industry And Other Outside Entities
Glossary and Terms
Approved 03.29.2018
Sponsored
Research,
Continued
3. The agreement otherwise meets with the approval of
designated University/Hospital institutional officials who may
impose additional prohibitions and/or restrictions in view of
potential conflicts, as deemed warranted.
→ A2 Research Support Rule
→ A3 External Activity Rule
→ B Executive Position Rule
Technology
(HMS definition) Any compound, drug, device, diagnostic, medical or surgical
procedure intended for use in health care or health care delivery.
• A Technology "belongs" to a Business in a way that would implicate the
Clinical Research Rule if the Business (i) manufactures the Technology (or
contracts with another entity to manufacture the Technology under its
direction) or (ii) owns or has licensing rights to the Technology. An exception
to this general rule, however, may be granted if the Conflict of Interest
Committee at the Institution approving the IRB Protocol determines, after a
review of the specific facts, that a Technology is (i) off-patent and
manufactured as a generic, (ii) non-exclusively licensed to multiple
companies, or (iii) manufactured by multiple companies; and, as a result, there
is a sufficiently dilutive market for the Technology to conclude that the
Technology does not belong to any one Business.
→ A1 Clinical Research Rule
→ A3 External Activity Rule
→ B Executive Position Rule
Transaction
Any contract, agreement, transaction or act of MGB
Written
Agreement
A written agreement between a Covered Individual and an Outside Entity
setting forth the terms of an arrangement relating to an Outside Activity