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Office for Human Research Protections (OHRP)
Department of Health and Human Services (HHS)
Considerations in Transferring a
Previously-Approved Research Project to a
New IRB or Research Institution
This guidance, when finalized, will represent OHRP’s current thinking on this topic and should
be viewed as recommendations unless specific regulatory requirements are cited. The use of the
word must in OHRP guidance means that something is required under HHS regulations at 45
CFR part 46. The use of the word should in OHRP guidance means that something is
recommended or suggested, but not required. An institution may use an alternative approach if
the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is
available to discuss alternative approaches at 240-453-6900 or 866-447-4777.
Date: May 23, 2012 (DRAFT)
Scope: This guidance presents common scenarios for transfer of a previously-approved
research project to another institutional review board (IRB) or to a new engaged research
institution, and outlines the administrative actions to be considered by IRBs, engaged
institution(s), and investigators. This document applies to non-exempt human subjects
research conducted or supported by HHS.
The guidance addresses the following questions:
1. What is the regulatory background for research project transfer?
2. What actions may apply when the research project remains at the same institution,
but responsibility for IRB review is transferred either from an internal to an
external IRB, or from an external IRB to another external IRB ?
3. What actions may apply when the research project remains at the same institution,
but responsibility for IRB review is transferred from one internal to another
internal IRB?
4. What actions may apply when the research project is transferred to a new engaged
institution?
To enhance human subject protections and reduce regulatory burden, OHRP and Food
and Drug Administration (FDA) have been actively working to harmonize the agencies'
regulatory requirements and guidance for human subjects research. This draft guidance
document was developed as a part of these efforts. FDA has also issued draft guidance
entitled, “Considerations When Transferring Clinical Investigation Oversight to Another
IRB.” See http://www.fda.gov/RegulatoryInformation/Guidances/ucm307757.htm
FDA and OHRP recognize that the two documents may appear somewhat different as
there are minor variations in formatting and some necessary variations due to differences
in the regulated entities under FDA’s and OHRP’s jurisdiction. The agencies wish to
stress, however, that our intent was to provide harmonized guidance to IRBs, sponsors,
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institutions, investigators, and other entities involved in the study oversight transfer
process. FDA and OHRP will continue to work closely in the development of final
guidance and appreciate comments from interested parties.
Target Audience: IRBs, institutions, and investigators that are responsible for the
review, oversight, or conduct of human subjects research conducted or supported by
HHS.
Regulatory Background:
The following represents key regulatory information that is pertinent to this guidance:
(1) An institution must designate on its Federalwide Assurance (FWA) one or more
IRBs to review and approve human subjects research (45 CFR 46.103(b)(2)), and
must certify to HHS that non-exempt human subjects research has been reviewed
and approved by its designated IRB (45 CFR 46.103(b)).
(2) Institutions must have written procedures which the IRB will follow for ensuring
prompt reporting to the IRB of proposed changes in a research activity, and for
ensuring that such changes in approved research, during the period for which IRB
approval has already been given, may not be initiated without IRB review and
approval except when necessary to eliminate apparent immediate hazards to the
human subjects (45 CFR 46.103(b)(4), 46.108(a), and 46.115(a)(6)).
(3) The IRB must review proposed protocol changes at a convened meeting (45 CFR
46.108(b)), except where expedited review is appropriate under HHS regulations
at 45 CFR 46.110(b)(2).
(4) An IRB must conduct continuing review of research at intervals appropriate to the
degree of risk, but not less than once per year (45 CFR 46.109(e)).
(5) An institution must have and follow written procedures for ensuring prompt
reporting to the IRB, appropriate institutional officials, and the department or
agency head (or designee) of (i) any unanticipated problem involving risks to
subjects or others or any serious or continuing noncompliance with 45 CFR part
46 or the requirements or determinations of the IRB; and (ii) any suspension or
termination of IRB approval (45 CFR 46.103(b)(5) and 46.113). Such reports
also must be submitted to OHRP (45 CFR 46.103(a)).
(6) An institution, or when appropriate an IRB, must prepare and maintain adequate
documentation of IRB activities, including the following (45 CFR 46.115):
• Copies of all research proposals reviewed, scientific evaluations, if any, that
accompany the proposals, approved sample consent documents, progress
reports submitted by investigators, and reports of injuries to subjects;
• Minutes of IRB meetings which shall be in sufficient detail to show
attendance at the meetings; actions taken by the IRB; the vote on these actions
including the number of members voting for, against, and abstaining; the basis
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for requiring changes in or disapproving research; and a written summary of
the discussion of controverted issues and their resolution;
• Records of continuing review activities;
• Copies of all correspondence between the IRB and the investigators;
• Written procedures for the IRB in the same detail as required in 45 CFR
46.103(b)(4) and (5); and
• Statements of significant new findings provided to subjects, as required by 45
CFR 46.116(b)(5) (45 CFR 46.115(a)).
(7) Documentation of IRB activities, and records relating to research which is
conducted, must be retained for at least 3 years after completion of the research. (45
CFR 46.115(b)).
Guidance:
Introduction
Research projects that were previously approved by an IRB sometimes are transferred to
another IRB or to another institution. These transfers occur for a variety of reasons, and
give rise to a number of regulatory, administrative, and logistical questions.
Transfer of review responsibility for a research project from one IRB to another should
be accomplished in a way that assures continuous IRB oversight with no lapse in either
IRB approval or the protection of human subjects, and with minimal disruption of
research activities. Therefore, we recommend that the original IRB work closely with the
investigator, the sponsor, if any, and the receiving IRB, as appropriate, throughout the
transfer process to ensure an orderly transition and continued protection of human
subjects. Effective communication among the IRBs, investigators, and others (e.g.
institutional representatives, Data Safety Monitoring Board, Clinical Research
Organization) throughout the process is critical to ensuring a smooth transition to another
IRB. In some situations, a transfer may disrupt study enrollment or other aspects of a
research project, whether because of unforeseen difficulties in the transfer process or
because of concerns arising from the study. OHRP believes that serious disruptions will
be rare and hopes that providing this guidance will minimize disruptions.
This document reviews the possible actions to consider when responsibility for IRB
review of an ongoing IRB-approved research project is transferred from one IRB to
another, or when a research project that was previously approved by an IRB is transferred
to another engaged institution. Institutional officials and IRB administrators will want to
take into account not only the regulatory requirements, but also a variety of legal,
administrative, and logistical considerations in establishing their own policies for such
transfers. Of note, the HHS regulations at 45 CFR part 46 do not explicitly address the
issue of research project transfer.
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The IRB transfer process is expected to vary, depending on the reasons for the transfer,
the parties involved, and the number and risk of the studies being transferred. OHRP
recognizes that some transfers may be relatively simple and quick to achieve, whereas
others may be more complicated and involve additional legal, regulatory, administrative,
and logistical considerations. For example, transfer of IRB oversight due to purely
administrative reasons such as consolidating IRB workload may be straight-forward,
whereas a transfer of oversight due to the original IRB’s non-compliance would be
anticipated to be more lengthy and involved. In general, the type of IRBs involved (e.g.,
academic, hospital-based, independent) would not affect the actions to consider when
transferring oversight.
The key entities involved in a research project transfer are:
(1) The transferring IRB (also referred to in this document as the original IRB);
(2) The receiving IRB (also referred to in this document as the new IRB);
(3) The institution(s) engaged in the research; and
(4) The investigator.
When transferring IRB review and oversight of research projects from one IRB to
another IRB, OHRP recommends that the transfer process be documented in a written
agreement between the original and receiving IRBs, if appropriate. [Note: OHRP
recognizes that for transfers of oversight between IRBs at the same institution, a written
agreement may not be necessary as the process may be addressed by the institution’s
established procedures (assuming all appropriate steps as identified below are covered).]
The agreement should address the following eight actions, as appropriate. We describe
each of these actions in more detail below. [Note: The following list is not meant to be
exhaustive. Additional actions may be necessary and/or appropriate.]
(1) Identifying those studies for which IRB oversight is being transferred;
(2) Ensuring the availability and retention of pertinent records;
(3) Establishing an effective date for transfer of oversight, including records, for the
research project(s);
(4) Conducting a review of the study(ies) by the receiving IRB, where appropriate,
before it accepts responsibility for the study(ies);
(5) Confirming or establishing the date for the next continuing review;
(6) Determining whether the consent form needs to be revised;
(7) Notifying the key parties; and
(8) Addressing IRB regulatory issues.
Common Transfer Scenarios
Transfer of responsibility for IRB review can occur under a number of possible scenarios.
These are the most common:
Scenario 1: Conduct of the research project remains at the same engaged institution:
Transfer from an internal IRB to an external IRB, or transfer from an external IRB to
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another external IRB. An “internal IRB” refers to an IRB that is operated by the
institution; an “external IRB” refers to an IRB operated by another institution, or to a
commercial or independent IRB.
Scenario 2: Conduct of the research project remains at the same engaged institution:
Transfer from one internal IRB to another internal IRB.
Scenario 3
(a) Transfer to a new internal or external IRB designated by the new
institution; or
: Research project is transferred to a new engaged institution:
(b) Continued reliance on the original IRB.
These three scenarios and the possible actions to consider for each are discussed in the
following sections.
Scenario 1. Same Engaged Institution: Transfer from an Internal IRB to an
External IRB, or Transfer from an External IRB to Another External IRB
Research projects can be transferred from an internal IRB to an external IRB that is
independent or operated by another research institution, or transferred from an external
IRB to another external IRB. Such transfers occur for a number of reasons, such as:
• A medical school decides to transfer a category of its studies (e.g., drug clinical
trials) to an external IRB that possesses relevant expertise.
• A hospital’s IRB realizes it has an excessive workload, but the institution does not
want to establish an additional internal IRB.
• A small college has an insufficient number of studies to justify maintaining its
own internal IRB.
• A group of independent institutions establish a new central IRB to review
research projects conducted jointly by these institutions.
• A fire, flood, or other disaster temporarily precludes an institution’s internal IRB
from fulfilling its review responsibilities.
• An institution decides to transfer its studies to another external IRB because the
external IRB that it has been relying upon will be closing.
Such a transfer from an internal IRB to an external IRB, or an external IRB to another
external IRB, may involve the following eight actions for consideration:
(1) Identifying those studies for which IRB oversight is being transferred
One of the first actions in the transfer process is determining for which studies IRB
oversight is being transferred. OHRP recommends that the original and receiving IRBs
have a clear understanding of this as it will help to bring certainty and continuity to the
process and to allow for effective planning. The number of research projects, the risk
posed by them, and the circumstances leading to the transfer as discussed below, will
influence subsequent actions in the transfer process, e.g., whether records are obtained
from the original IRB or the investigator, how the transfer date is established, and
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whether the receiving IRB decides to conduct a review before accepting responsibility for
the research.
(2) Ensuring the availability and retention of pertinent records.
Before the receiving IRB accepts oversight of the transferred research project, it should
obtain copies of pertinent records (e.g., research protocol, grant proposal, sample consent
form, investigator’s brochure, minutes of IRB meetings at which the research was
reviewed, etc.) to allow it to meet its ongoing review and oversight responsibilities for the
research once transferred.
(a) Availability of pertinent records.
With concurrence of the research institution or sponsor, if relevant, the original
IRB should make pertinent records available to the receiving IRB. [Note: In some
cases, institutions or sponsors may not agree to the transfer of records to a
proposed IRB. If that is the case, the transfer of study oversight to that IRB
should not take place. The institution, sponsor, and/or investigator should work
expeditiously to arrange for oversight by another IRB.] This can be accomplished
by providing the receiving IRB with paper or electronic copies of the pertinent
records. Alternatively, the receiving IRB may decide to obtain the records
directly from the investigator. If records are obtained in this manner, the
receiving IRB should also obtain meeting minutes from the original IRB as this
information may be critical to the receiving IRB’s assessment of the adequacy of
the previous review (e.g., discussion of controverted issues, quorum, etc). The
receiving IRB may choose to obtain records directly from the investigator, for
example, when a transfer occurs as a result of non-compliance actions of the
original IRB.
Both the original IRB and the receiving IRB should maintain adequate records
regarding the research projects affected by the transfer. Such records should
include any written agreement between the original and receiving IRBs, the title
of the protocols being transferred, the research sites affected, the names of the
associated investigators, the identities of the original IRB and the receiving IRB,
and the date(s) on which the receiving IRB accepts responsibility for oversight of
the research projects. In addition, the original and receiving IRBs should keep
adequate records of all communications to all affected investigators.
Under some circumstances, e.g., if the original and transferring IRBs are located
at the same institution, OHRP recognizes that the records regarding the research
projects affected by the transfer may be stored in a mutually accessible location.
Duplication of research project records would not be necessary.
(b) Retention of IRB records.
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An engaged institution must be able to access documentation of IRB activities and
records relating to the research project for at least 3 years after completion of the
research at the engaged institution (45 CFR 46.115(b)). In addition, the records
must be accessible for inspection and copying by OHRP at reasonable times and
in a reasonable manner. The storage of the records (whether in paper or
electronic form) can be accomplished by the internal IRB, by the external IRB, by
a separate office of the institution (e.g., the vice president for research), by an
external organization, or by a combination of these.
As a general matter, the original and receiving IRBs have the flexibility to work
out any suitable arrangement for handling the transfer and maintenance of the
records as long as the records remain accessible for inspection and copying by
authorized representatives of OHRP at reasonable times and in a reasonable
manner. For example, the original IRB could transfer to the receiving IRB the
records related to the research projects that are still active and retain the records
for “closed” research projects.
There may be circumstances where the original IRB reaches an agreement with
the receiving IRB to retain some of the documentation for the transferred research
projects, yet may not be able to commit to retaining the documents for at least 3
years after the completion of the research. This situation may arise, for example,
where an IRB ceases operations yet retains responsibility for some records for
projects that are still ongoing, either by physically maintaining these records or by
reaching a storage arrangement with a responsible third party. Factors to consider
in selecting an appropriate record retention arrangement may include the reasons
for the transfer, as well as the nature of the research projects and the records.
(3) Establishing an effective date for transfer of oversight, including records, for the
research project(s)
Human subjects research that is not exempt must have ongoing oversight by an IRB in
order to meet several regulatory requirements, including requesting proposed changes in
research, reporting unanticipated problems involving risks to subjects or others, and
exercising the authority to suspend or terminate research at any time (45 CFR 46.103 and
45 CFR 46.113). Therefore, to avoid any interruption in the conduct of human subjects
research when IRB oversight is being transferred to another IRB, OHRP recommends
establishing a transfer date for each research project, including records, for which
oversight is being transferred. Although there is no regulatory requirement to establish a
transfer date, such an action promotes continuity, helps prevent a lapse in IRB coverage,
and minimizes confusion regarding which IRB is responsible for review and action if, for
example, an unanticipated problem should arise or research needs to be quickly
suspended or terminated. If oversight is being transferred because of the closure of an
IRB, the original IRB should inform all investigators and institutions, as appropriate, of
the pending closure date. If oversight by a new IRB cannot be obtained by the closure
date, the non-exempt human subjects research that had been overseen by the now closed
IRB must stop (45 CFR 46.103).
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Depending on the circumstances of the transfer, the transfer date may be established
using one of a variety of methods, such as the following:
• In the written agreement, the exact date is specified in advance between the
original IRB and the receiving IRB; or
• In the written agreement, the date is made contingent upon the review and
acceptance of the research project by the receiving IRB. For example, if the
receiving IRB decides to perform an initial review of the research project, the
transfer may take effect on the date the receiving IRB makes its decision to
approve, require modification in (to secure approval), or disapprove the research
project. In this situation, the receiving IRB should notify the original IRB and
other involved parties of the date of its approval and acceptance of oversight
responsibilities
Note that if both the original and receiving IRBs are located within the same institution or
IRB organization, the transfer date may be determined according to the established
procedures of that institution or IRB organization.
When a large number of research projects are being transferred, it may be preferable to
phase-in the transfer over a period of weeks or months to facilitate a smooth transition.
If oversight is being transferred because of the closure of an IRB, the original IRB should
inform all investigators and/institutions, as appropriate, of the pending closure date.
(4) Conducting a review of the study(s) by the receiving IRB, where appropriate, before it
accepts responsibility for the study(ies)
When the research project is transferred from an internal to external IRB, or an external
IRB to another external IRB, and the research institution remains the same, 45 CFR part
46 does not require the receiving IRB to review the project prior to the next continuing
review date established by the original IRB.
In practice, however, such a review is often done. Depending on the circumstances of the
transfer and characteristics of the specific research project, the receiving IRB may decide
to undertake an initial review or a continuing review (either by the convened IRB or
under an expedited review procedure, if appropriate). For additional information on
continuing review, see OHRP’s “Guidance on IRB Continuing Review of Research”, at
http://www.hhs.gov/ohrp/policy/continuingreview2010.html).
Alternatively, the receiving IRB may decide to not conduct any review prior to the next
continuing review date established by the original IRB, especially if such a review is not
deemed to substantively add to human subject protections. In such a circumstance, some
receiving IRBs nonetheless may request the IRB chairperson, another IRB member, an
IRB administrator, or another qualified administrative staff member to perform an
informal assessment of the research project.
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OHRP reminds receiving IRBs that they have the authority to suspend or terminate
approval of research in circumstances, for example, where the research project is not
being conducted in accordance with the receiving IRB’s requirements or has been
associated with unexpected serious harm to subjects (45 CFR 46.113). The receiving
IRB must promptly report any suspension or termination of IRB approval, including the
reasons for the action, to the investigator, appropriate institutional officials, and OHRP
(45 CFR 46.103(b)(5)).
(5) Confirming or establishing the date for the next continuing review
If the receiving IRB performs a review at the time of research project transfer (whether
an initial or a continuing review), it may to choose to maintain the anniversary date
established by the original IRB or establish a new date of approval. If it is decided that a
new anniversary date will be established, the new date must be within one year of the
receiving IRB’s approval.
If the receiving IRB does not conduct an initial or continuing review at the time of
transfer, the date of research project approval by the original IRB is presumed to remain
in effect for the full approval period established at the time of the most recent review by
the original IRB. For example, if the original IRB initially approved the research project
for one year effective July 1, 2011, and the project is transferred to another IRB effective
October 1, 2011, the expiration date of IRB approval would continue to be July 1, 2012,
unless or until the receiving IRB establishes a new expiration date.
(6)Determining whether the consent form needs to be revised.
Under 45 CFR 46.116(a)(7), the informed consent document is required to contain “[a]n
explanation of whom to contact for answers to pertinent questions about the research and
research subjects’ rights, and whom to contact in the event of a research-related injury to
the subject.” Therefore, when a change in IRB oversight results in changes in the contact
information regarding subject rights and/or whom to contact in the event of research-
related injury, the new contact information must be provided to subjects (45 CFR
46.116(a)(7)). For subjects who were previously enrolled, this may be accomplished in a
number of ways, for example, with a postcard providing the relevant contact information.
For new subjects, the informed consent, assent, and/or parental permission form must be
revised to reflect the new contact information (45 CFR 46.116(a)(7)).
Other changes to the consent form may also be necessary, for example, if the receiving
IRB requires modifications to the consent form at the site(s) under its jurisdiction as a
condition of approval (e.g., changes in template language, changes in risks, etc.) (45 CFR
46.109(a) and (b)). Depending upon the types of changes needed, they may be conveyed
to the investigator as required modifications to secure IRB approval for the research at
that site or sites (See, e.g., 45 CFR 46.109(a)).
(7) Notifying the key parties.
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At the beginning of the process, it is important to notify pertinent groups (e.g.,
investigator, Data Safety Monitoring Board, etc.) of the transfer of responsibility of IRB
review, and to provide contact information of the receiving IRB.
(8) Addressing IRB regulatory issues.
Both the internal and external IRBs must have an active registration with OHRP before
reviewing human subjects research conducted or supported by HHS. When an institution
holding an OHRP-approved FWA relies upon an external IRB to review HHS-conducted
or -supported research, the institution holding the FWA must execute an IRB
Authorization Agreement (see http://www.hhs.gov/ohrp/assurances/forms/iprotsup.rtf)
with the institution or organization operating the IRB (45 CFR 46.103(a) and
46.103(b)(2)).
Temporary Transfers
Sometimes the transfer to the external IRB is temporary and the responsibility for IRB
review eventually will revert back to the original internal or original external IRB. This
may be the case when a natural disaster temporarily disrupts the functioning of an IRB.
In such cases, the transfer procedure back to the original IRB may only involve
identifying studies for which IRB oversight is being transferred (Action #1), and
ensuring availability and retention of pertinent records (Action #2), establishing an
effective date for transfer of oversight (Action #3), and notifying the key parties (Action
#7). As in all scenarios described in this guidance document, the appropriate actions
depend on the specific circumstances of the transfer.
Scenario 2. Same Engaged Institution: Transfer from One Internal IRB to Another
Internal IRB
A transfer from one internal IRB to another internal IRB is a common type of transfer,
especially in large institutions. Such transfers occur in a variety of situations such as the
following:
• A large multi-campus university decides to consolidate its human subject
protection system by closing one or more of its existing internal IRBs.
• An institution realizes its current IRBs are overburdened and establishes another
internal IRB to share the workload.
• An institution establishes a new internal IRB to oversee a category of existing
research studies, such as social-behavioral research, being conducted at the
institution.
• For the sake of administrative convenience, an institution with several internal
IRBs assigns an amendment or a continuing review application to whichever of its
IRBs has time available at its upcoming meeting.
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Similar to Scenario 1, such a transfer may involve eight actions for consideration:
(1) Identifying those studies for which IRB oversight is being transferred
This scenario may involve some or all of the same responsibilities and actions outlined in
Scenario 1 (described previously in this guidance document).
(2) Ensuring the availability and retention of pertinent records
The pertinent IRB records maintained by the original IRB should be made available to
the receiving IRB. Under Scenario 2, this can be accomplished by providing the
receiving IRB with physical access to, or paper or electronic copies of, the pertinent
records of the original IRB.
An engaged institution must be able to access documentation of IRB activities and
records relating to the research for at least 3 years after completion of the research at the
engaged institution (45 CFR 46.115(b)).
(3) Establishing an effective date for transfer of oversight, including records, for the
research project.
Human subjects research that is not exempt must have ongoing oversight by an IRB in
order to meet several regulatory requirements, including requesting proposed changes in
research, reporting unanticipated problems involving risks to subjects or others, and
exercising the authority to suspend or terminate research at any time (45 CFR 46.103 and
45 CFR 46.113). Therefore, while there is no regulatory requirement to establish a formal
transfer date, depending on the specifics of the situation, establishing an effective date to
transfer the research project from one internal IRB to another internal IRB will
sometimes be appropriate.
For example, if a hospital is establishing a new IRB to oversee ongoing research being
conducted at a remote ambulatory care center, establishing a formal transfer date can
foster continuity and minimize confusion regarding which IRB is responsible for review
and action if an unanticipated problem should arise. In contrast, if a university has
identified one of its IRBs to conduct all of its continuing reviews, then a formal transfer
date may be unnecessary.
(4) Conducting a review of the study(ies) by the receiving IRB, where appropriate, before
it accepts responsibility for the study(ies)
When a research project remains at the same engaged institution, 45 CFR part 46 does
not require the receiving IRB to review the project prior to the next continuing review
date established by the original IRB. So the decision of whether the receiving IRB
reviews the research project at the time of the transfer depends on administrative,
scientific, and other non-regulatory considerations.
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In some cases, such a review will be deemed unnecessary by the IRB or institution. In
other cases, the IRB or institution may determine it is appropriate for the IRB
chairperson, another IRB member, an IRB administrator, or another qualified
administrative staff member to perform an informal assessment of the research project.
And compelling reasons may occasionally exist to justify that the receiving IRB perform
a full initial review.
(5) Confirming or establishing the date for the next continuing review
The receiving IRB may choose to conduct initial or continuing review at the time of
transfer and may either maintain the date of anniversary approval date established by the
original IRB or establish a new approval date.
If the receiving IRB does not conduct a formal review of the research project at the time
of the transfer, research project approval by the original IRB is presumed to remain in
effect for the full approval period established at the time of the most recent review by the
transferring IRB.
(6) Determining whether the consent form needs to be revised
Revision of consent forms generally does not apply under Scenario 2 involving the
transfer of a project from one internal IRB to another internal IRB, because the receiving
IRB typically allows use of the previously-approved consent form.
(7) Notifying the key parties.
Depending on local administrative and logistical considerations, it may or may not be
appropriate to notify the investigator or other pertinent entities (e.g., Data Safety
Monitoring Board) of the transfer of responsibility of IRB review. For example, if the
institution is establishing a new internal IRB that specializes in research involving
children, then it would be appropriate to advise investigators affected by the change.
Conversely, if an institution has established a separate IRB to conduct continuing review
and this is reflected in the established procedures of the institution, no additional
notification may be necessary.
(8) Addressing IRB regulatory issues.
Both the IRBs (the transferring/original and receiving IRBs) must have active
registrations with OHRP before reviewing human subjects research conducted or
supported by HHS. Since both IRBs are internal to the institution, no IRB Authorization
Agreement is necessary.
Scenario 3. Transfer of the Research Project to a New Engaged Institution
Sometimes an investigator moves to a new research institution, and the ongoing human
subjects research project accompanies the investigator. In such cases, sponsors and
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funding agencies often have policies and procedures for research project transfer that
need to be followed.
Under Scenario 3, the new institution that becomes engaged in the research project can
select one of two options for the continued responsibility of IRB review:
Scenario 3a: Transfer of review responsibility to another IRB; or
Scenario 3b
: With approval of appropriate officials at both the original and the
new institutions, continuation of the review responsibility by the original IRB --
in this case there is no “receiving” IRB.
Under Scenario 3, the new institution that becomes engaged in this research project must
have or obtain an OHRP-approved Federalwide Assurance.
When the research project moves to a new institution and responsibility for review is
transferred to another IRB (Scenario 3a), the receiving IRB must conduct an initial or
continuing review of the research project before the new institution becomes engaged in
the human subjects research project (45 CFR 46.103(b)).
However, if appropriate officials at the original and new institutions have executed an
Authorization Agreement for the new institution to rely on the original IRB at the
original institution (Scenario 3b), a new initial or continuing review is not necessary.
Instead, since the transfer involves changes to the research (i.e., conducting the research
in a new location, consent form revisions, possible changes of key staff, etc.), a protocol
amendment must be submitted to the original IRB (45 CFR 46.103(b)(4)). In many cases
this amendment represents a “minor change” to the research that the original IRB may
review under an expedited review procedure (45 CFR 46.110(b)(2)).
The original IRB must review and approve these changes to the research project before
the new institution becomes engaged in the human subjects research activities, unless
these changes are necessary to eliminate apparent immediate hazards to the research
subjects (45 CFR 46.103(b)(4)).
The eight possible actions for consideration under Scenario 3 are summarized below:
Transfer of IRB Responsibilities
When a Research Project Moves from One Engaged Institution to Another
Actions for Consideration
Scenario 3a: Transfer of
Review Responsibility
to another IRB
Scenario 3b: Continuation
of Review Responsibility
by the Original IRB
1 Identifying those studies for which
IRB oversight is being transferred
The institutions and IRBs
need to clarify
responsibilities and
logistics.
The institutions need to clarify
responsibilities and logistics,
even though the IRB remains
unchanged.
2. Ensuring the availability and
retention of pertinent records
OHRP recommends the
transferring IRB or
institution make the
Since the IRB remains the
same, there is no need to make
the records available to a
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pertinent records available
to the receiving IRB.
The engaged institution
needs to have access to
IRB records for at least
three years after project
closure at that institution.
Record retention
requirements can be met
through a variety of
arrangements.
receiving IRB. The receiving
institution, however, may
request copies of certain records
held by the IRB or transferring
institution.
The engaged institution needs
to have access to IRB records
for at least three years after
project closure at that
institution. Record retention
requirements can be met
through a variety of
arrangements.
3. Establishing an effective date for
transfer of oversight, including
records, for the research projects.
Usually the transferring and
receiving institutions
establish the effective date
for project transfer and
advise their respective IRBs.
Usually the transferring and
receiving institutions establish
the effective date for project
transfer and advise the IRB.
4. Conducting a review of the
study(ies) by the receiving IRB, where
appropriate, before it accepts
responsibility for the study(ies)
The receiving IRB needs to
conduct an initial or
continuing review of the
project.
The IRB needs to review and
approve an amendment to the
research project.
5. Confirming or establishing the date
for the next continuing review
The receiving IRB
establishes a new continuing
review date, or confirms the
continuing review date set
by the original IRB.
Usually the continuing review
date remains the same.
6. Determining whether the consent
form needs to be revised
The IRB may require
changes to the consent form.
The IRB may require changes
to the consent form.
7. Notifying the key parties
The key parties are notified
by the investigator,
transferring institution,
receiving institution, or the
transferring IRB.
The key parties are notified by
the investigator, transferring
institution, receiving institution,
or the IRB.
8. Addressing IRB regulatory issues
If the new IRB is internal to
the newly engaged, FWA-
holding institution, no IRB
Authorization Agreement is
necessary.
If the new IRB is external to
the newly engaged
institution, an IRB
Authorization agreement is
necessary.
The newly engaged, FWA-
holding institution needs to
establish an IRB Authorization
Agreement with the original
IRB.
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Additional Information:
If you have specific questions about how to apply this guidance, please contact OHRP by
phone at (866) 447-4777 (toll-free within the U.S.), (301) 496-7005, or (240) 453-6900,
or by e-mail at [email protected].
