Guidance for IRBs, Clinical 
Investigators, and  
Sponsors 
 
Considerations When Transferring 
Clinical Investigation Oversight to 
Another IRB  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research  
Center for Biologics Evaluation and Research  
Center for Devices and Rad iological Health  
Office of Good Clinical Practice  
 May 2014 Contains Nonbinding Recommendations 
 
Guidance for IRBs, Clinical Investigators, 
and  
Sponsors 
Considerations When Transferring Clinical 
Investigation Oversight to Another IRB 
 
 
Additional copies are available from: 
Division of Drug Information, WO51-2201 
Office of Communication 
Center for Drug Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave. 
Silver Spring, MD 20993-002  
 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
Email: DRUGINFO@fda.hhs.gov  
(Tel) 301-796-3400; (Fax): 301-847-8714 
and/or 
 Office of Communication, Outreach and  
Development, HFM-40  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
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Rockville, MD 20852-1448  
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm 
Email:  ocod@fda.hhs.gov  
(Tel) 800-835-4709 or 301-827-1800 
and/or 
Division of Industry and Consumer Education, WO66-5429 
Office of Communication, Education and Radiation Programs 
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Ave. 
Silver Spring, MD 20993-002 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm 
Email: DICE@cdrh.fda.gov  
 (Tel) 800.638.2041 or 301- 796-7100 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research  
Center for Biologics Evaluation and Research 
Center for Devices and Radiological Health 
Office of Good Clinical Practice  
 May 2014 
  Contains Nonbinding Recommendations 
 
 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.    BACKGROUND ............................................................................................................... 1 
III.   WHEN OVERSIGHT OF A PREVIOUSLY APPROVED CLINICAL 
INVESTIGATION TRANSFERS FROM THE ORIGINAL IRB TO ANOTHER IRB NOT 
PART OF THE SAME INSTITUTION ..................................................................................... 4 
IV.  SPECIAL SITUATIONS ............................................................................................... 12 
A.  Transfer of IRB Oversight from one IRB to Another IRB in the Same Institution and 
Temporary Transfer of IRB Review Responsibility .......................................................................... 12 
B.  Transfer of a Clinical Investigation to a New Research Site Requiring IRB Review ............... 13 
V.    ADDITIONAL QUESTIONS ABOUT TRANSFERRING OVERSIGHT OF A 
CLINICAL INVESTIGATION ................................................................................................. 13 
 
  Contains Nonbinding Recommendations 
 
1
Guidance for IRBs, Clinical Investigators and Sponsors  
Considerations When Transferring Clinical Investigation Oversight 
to Another IRB 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance.  
 
 
 
 
I.  INTRODUCTION  
 
This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), 
clinical investigators, and sponsors when oversight of a previously approved, ongoing clinical 
investigation under FDAs jurisdiction is transferred from one IRB to another IRB.  This 
guidance also addresses questions that have been previously raised concerning procedures and 
processes that are required and/or recommended by FDA when such oversight is transferred.   
FDA encourages individuals to contact the agency directly to discuss any unusual circumstances. 
 
To enhance human subject protections and reduce regulatory burden, FDA and the Office for 
Human Research Protections (OHRP) have been actively working to harmonize the agencies' 
regulatory requirements and guidance for human subjects research. This guidance document was 
developed as a part of these efforts.  For studies subject to 45 CFR part 46 (i.e., studies that are 
funded, conducted, or supported by the Department of Health and Human Services), OHRP 
issued a draft guidance entitled, Considerations in Transferring a Previously Approved 
Research Project to a New IRB or Research Institution.2    
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
 
II.    BACKGROUND 
 
                                                 
1 This guidance has been prepared by the Office of Good Clinical Practice, Office of Medical Products and Tobacco 
with input from the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and 
Research (CBER) and Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration.  
2 OHRPs guidance is available at:  http://www.hhs.gov/ohrp/newsroom/rfc/transferdraftdoc.html. 
  1  Contains Nonbinding Recommendations 
 
An IRB is any board, committee, or other group formally designated by an institution to review, 
approve the initiation of, and conduct periodic review of biomedical research involving human 
subjects.  The primary purpose of such review is to assure the protection of the rights and welfare 
of the human subjects.3  To prevent lapses in human subject protection, it is generally preferred 
that the same IRB retain oversight responsibility throughout the conduct of the trial, if possible.  
FDA recognizes, however, that clinical investigations that were originally approved by one IRB 
are sometimes transferred to another IRB for subsequent review and oversight.  These transfers 
may give rise to a number of legal, regulatory, administrative, and logistical considerations for 
the parties involved. 
 
The research entities involved in a transfer of IRB review responsibilities for a clinical 
investigation include: 
 
  The original IRB, which for the purpose of this guidance means the IRB originally 
designated to review a clinical investigation and that transfers oversight responsibility to 
another IRB;  
  The receiving IRB, which for the purpose of this guidance means the IRB that accepts 
responsibility for oversight of the clinical investigation;  
  The sponsor who initiates the clinical investigation; and 
  The clinical investigator who conducts the investigation. 
 
The transfer of review responsibility for a clinical investigation 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.  
This guidance discusses possible actions that sponsors, clinical investigators, and IRB staff for 
the original and receiving IRBs should consider before, during, and after any such transfer.  
Ideally, IRBs will have their own procedures and/or institutional policies in place to provide 
general guidance if oversight of a clinical investigation must be transferred to another IRB.     
 
We recommend that the original IRB work closely with the clinical investigator, the sponsor, 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, 
sponsors, clinical investigators, FDA, and others (e.g., institutional members, Data Safety 
Monitoring Board, Contract Research Organization (CRO)) is critical to ensuring a smooth 
transition to another IRB.  FDA recommends that any impending changes in oversight be 
communicated as early as possible in the transfer process.  In some situations, a transfer may 
disrupt study enrollment or other aspects of a clinical investigation, whether because of 
unforeseen difficulties in the transfer process or because of concerns arising from the study.  
FDA believes that providing this guidance will help to ensure that serious disruptions are rare. 
 
FDAs requirements place the responsibility for securing IRB review and approval on the 
clinical investigator in clinical investigations of new drugs and biological products,4 and on the 
                                                 
3 21 CFR 56.102(g).  
4 21 CFR 312.66. 
  2  Contains Nonbinding Recommendations 
 
sponsor in clinical investigations of medical devices.5  In practice, however, the party that 
actually initiates the transfer process varies depending on the circumstances necessitating the 
transfer and the parties involved.  For example, an institutions IRB may decide to transfer 
oversight for its pediatric clinical investigations to an IRB with such expertise within the same 
institution.  Whoever initiates the transfer of oversight, the clinical investigator and sponsor 
continue to be responsible for their respective regulatory obligations (e.g., making any 
modifications to the informed consent document required by the receiving IRB).6 
 
Although FDA regulations at 21 CFR parts 50, 56, 312, and 812 do not specifically address the 
issue of transfer of oversight from one IRB to another, the requirements governing review, 
oversight, and conduct of clinical investigations apply nonetheless.  While this guidance provides 
recommendations to facilitate such a transfer, it does not create or imply new requirements 
and/or responsibilities for IRBs, sponsors, or clinical investigators. 
 
Transfers of IRB oversight of a clinical investigation may occur for a number of different 
reasons, including cessation of IRB operations, consolidation of multiple IRBs into a single IRB, 
temporary inability of an IRB to meet its obligations, or as a result of IRB non-compliance.  
Specific examples include:  
 
  A medical school decides to transfer oversight responsibility for a category of its clinical 
investigations (e.g., drug research, device research) to another IRB. 
  A hospitals IRB realizes it has an excessive workload, but the institution does not want 
to establish an additional IRB and transfers oversight of some clinical investigations to 
another IRB. 
  A large multi-campus university decides to consolidate its human subject protection 
system by closing one or more of its existing IRBs and transfers oversight to an 
independent IRB. 
  A small institution has an insufficient number of clinical investigations to justify 
maintaining its own IRB and decides to cease operations of its IRB and transfer oversight 
of its clinical investigations to another IRB. 
  A sponsor decides to transfer IRB oversight from one IRB to another. 
  Financial or other considerations cause an IRB to cease operations. 
  An institution realizes its current IRBs are overburdened and establishes another IRB to 
share the workload. 
  A fire, flood, or other disaster temporarily prevents an IRB from fulfilling its 
review/oversight responsibilities. 
  An IRB is subject to administrative actions under 21 CFR 56.120 or has been disqualified 
under 21 CFR 56.121.7 
  A sponsor decides to transfer a clinical investigation when an investigator moves to a 
new research site.  
                                                 
5 21 CFR 812.40.  
6 See, e.g., 21 CFR 56.109, 21 CFR 312.66, and 21 CFR 812.40. 
7 21 CFR 56.121(b) provides that an IRB may be disqualified if FDA determines that the IRB has refused or 
repeatedly failed to comply with the applicable regulatory requirements and the noncompliance adversely affects the 
rights or welfare of the human subjects in a clinical investigation. 
  3  Contains Nonbinding Recommendations 
 
 
The complexity and duration of the IRB transfer process itself is expected to vary, depending on 
the reasons for the transfer, the parties involved, and the number and risk of the studies being 
transferred.  For example, transfer of IRB oversight due to purely administrative reasons such as 
consolidating IRB workload may be relatively quick and straight-forward, whereas a transfer of 
oversight due to the original IRBs non-compliance might be lengthier and involve more 
complicated legal, regulatory, administrative, and logistical considerations.  In general, the type 
of IRBs involved (e.g., academic, hospital-based, independent) would not affect the steps to 
consider when transferring oversight.8   
 
Section III of this guidance document provides recommendations concerning the transfer of IRB 
oversight from one IRB to another IRB that is not part of the same institution (including 
independent IRBs).  Section IV of this document addresses several special situations:  the 
transfer of oversight from one IRB to another IRB operating within the same institution, the 
temporary transfer of clinical investigation oversight to another IRB that occurs as a result of a 
natural disaster or for other reasons, and the transfer of a clinical investigation to a new research 
site requiring IRB review.  
 
III.   WHEN OVERSIGHT OF A PREVIOUSLY APPROVED CLINICAL 
INVESTIGATION TRANSFERS FROM THE ORIGINAL IRB TO ANOTHER 
IRB NOT PART OF THE SAME INSTITUTION 
 
When transferring IRB review and oversight of clinical investigations from one IRB to another 
IRB, FDA recommends that a plan for the transfer process be documented in a written agreement 
between the original and receiving IRBs, if appropriate.9,10  The agreement should address how 
the IRBs should handle, and document as appropriate, the following eight steps.  We describe 
each of these steps in more detail below.  Please note, this 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 clinical 
investigation(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; 
                                                 
8 FDA encourages the use of central IRBs, in appropriate circumstances, as a mechanism to reduce burden and 
delays in the conduct of multicenter clinical trials.  The goal of the centralized process is to increase efficiency and 
decrease duplicative efforts that do not contribute to meaningful human subject protection.  For additional 
information relating to the use of central IRBs, see FDAs Guidance, Using a Centralized IRB Review Process in 
Multicenter Clinical Trials, available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm127004.htm. 
9 FDA recognizes that for transfer of oversight to an IRB at the same institution, a written agreement may not be 
necessary as the process may be addressed by the institutions established procedures (assuming all appropriate steps 
described in Section III are covered).   
10 In general, some IRBs may have a policy not to transfer or accept a study until a final transfer contract or similar 
agreement is signed by both the original and receiving IRBs. 
  4  Contains Nonbinding Recommendations 
 
(7) Notifying the key parties; and 
(8) Updating IRB registration information. 
 
(1) Identifying those studies for which IRB oversight is being transferred. 
 
One of the first steps in the transfer process is determining for which studies IRB oversight is 
being transferred.  FDA 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 allow for 
effective planning, particularly when a large number of studies is being transferred.  The number 
of studies, the risk posed by them, and the circumstances leading to the transfer, as discussed 
below, will influence subsequent steps in the transfer process (e.g., whether records are obtained 
from the original IRB or the clinical investigator/sponsor, how the transfer date is established, 
and 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 clinical investigation, it should 
obtain copies of pertinent records to allow it to meet its review and ongoing oversight 
responsibilities for the study once transferred.11 Pertinent records include documents such as the 
research protocol and significant amendments; approved consent form; investigators brochure; 
minutes of IRB meetings at which the research was reviewed; reports of unanticipated problems 
involving risk to human subjects and others; reports of IRB-conducted audits, if any; and 
correspondence with the investigator, sponsor, and/or FDA.   
   
(a) Availability of pertinent records.   
 
With concurrence of the sponsor, the original IRB should make pertinent records 
available to the receiving IRB.12  This can be accomplished by providing the receiving 
IRB with paper or electronic copies of the pertinent records.13  It is important to note that 
the sponsors concurrence is necessary because the records may contain confidential 
commercial information.  Alternatively, the receiving IRB may decide to obtain the 
records directly from the clinical investigator and/or sponsor.  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 IRBs 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 clinical investigator and/or sponsor, 
                                                 
11 Obtaining pertinent records about studies in advance of oversight transfer should help receiving IRBs meet their 
procedural and review obligations for the studies once transfer is complete.  For example, under 21 CFR 56.108(a) 
and (b), IRBs must follow written procedures for certain review activities; these written procedures may be an 
important resource for determining the records that should be transferred.   
12 In some cases, sponsors may not agree to the transfer of records to a proposed IRB.  In such cases, the sponsor 
and/or investigator should work expeditiously to arrange for oversight by another IRB.  
13 For more information on creating, maintaining, and archiving electronic records for regulatory purposes, see 
FDAs guidance, Computerized Systems Used in Clinical Investigations, available at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf.    
  5  Contains Nonbinding Recommendations 
 
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 clinical investigations affected by the transfer.14  Such records should include:  any 
written agreement between the original and receiving IRBs; the title of the protocols 
being transferred; the expiration dates of IRB approval; the research sites affected; the 
names of the associated sponsors, clinical investigators, and CROs; 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 clinical investigations.  In addition, the original and 
receiving IRBs should keep adequate records of all communications to all affected 
sponsors, clinical investigators, and FDA, and comply with all other recordkeeping 
requirements.15   
 
(b) Retention of IRB records. 
 
Under FDA regulations, IRB records related to the review of a clinical investigation must 
be retained for at least three (3) years after the completion of the research, and the records 
must be accessible for inspection and copying by FDA at reasonable times and in a 
reasonable manner.16  Because FDA may require access to the records at any reasonable 
time, it is important for the agency to know whether the original IRB, the receiving IRB, 
the institution that housed the original IRB, a CRO or other responsible third party will 
maintain the records once clinical investigation oversight has been transferred.  The party 
that assumes responsibility for the records is responsible for ensuring that they are 
retained in accordance with 21 CFR 56.115(b).   
 
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 
FDA at reasonable times and in a reasonable manner.  For example, the original IRB may 
decide to transfer to the receiving IRB the records related to the clinical investigations 
that are still active and retain the records for closed clinical investigations, or the 
receiving IRB may choose to receive all of the records.17  When the original and 
receiving IRBs agree to share record retention responsibilities, FDA recommends that 
                                                 
14 Under some circumstances (e.g., if the original and transferring IRBs are located at the same institution), FDA 
recognizes that the records may be stored in a mutually accessible location.  Duplication of the study records would 
not be necessary.  If the files are mutually accessible, the IRBs should make appropriate arrangements for viewing 
and using the files.    
15 Under 21 CFR 56.115(a)(4), IRBs are required to keep copies of all correspondence between the IRB and the 
investigator(s).  
16 21 CFR 56.115(b).  IRBs may have their own record-keeping requirements that supplement FDAs requirements. 
17 If storage space is a concern, the receiving IRB could, for example, scan the records as certified copies of the 
originals so that they can be stored electronically, as long as the records remain accessible for inspection and 
copying by FDA. For additional information, see FDAs guidance, Computerized Systems Used in Clinical 
Investigations, available at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf.  
  6  Contains Nonbinding Recommendations 
 
they reach a clear understanding of their respective roles to avoid confusion and to ensure 
appropriate responsibility for and access to the documents.  
 
There may be circumstances when the original IRB reaches an agreement with the 
receiving IRB to retain some of the documentation for the transferred trials, yet may not 
be able to commit to retaining the documents for at least 3 years after the completion of 
the research.  For instance, if an IRB ceases operations but retains responsibility for some 
records for trials that are still ongoing, either by physically maintaining these records or 
by reaching a storage arrangement with a responsible third party.  In this instance, we 
recommend that the original IRB contact FDA to discuss possible retention 
arrangements.18  In this situation, the original IRB should make arrangements to transfer 
the documents to the receiving IRB or to another, responsible party. 
 
 (3) Establishing an effective date for transfer of oversight, including records, for the 
clinical investigation(s). 
 
FDA recommends establishing a transfer date for each clinical investigation, 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 an 
unanticipated problem should arise or if the clinical investigation needs to be quickly suspended 
or terminated.  When choosing a transfer date, the affected IRBs should allow enough time for 
all appropriate actions, communications, and agreements to occur.   
 
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 clinical investigation by the receiving IRB.  For example, if the receiving IRB decides 
to perform an initial review of the clinical investigation, 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 clinical investigation.  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, the 
transfer date may be determined according to the established procedures of that institution.   
 
                                                 
18 Factors to consider in selecting an appropriate record retention arrangement may include the reasons for the 
transfer, as well as the nature of the clinical investigations and the records.  Generally speaking, and depending on 
the specific facts, FDA would expect an IRB that has accepted record keeping responsibilities to retain the 
documentation for at least 3 years after closure of the IRB, in accordance with 21 CFR 56.115(b), or transfer the 
records to the receiving IRB.  
  7  Contains Nonbinding Recommendations 
 
When a large number of clinical investigations 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 is expected to 
inform all clinical investigators and/or sponsors, as appropriate, of the pending closure date.  If 
oversight by a new IRB cannot be obtained by the closure date, approval for the research would 
be considered suspended or terminated with no further subject enrollment.19, 20, 21  The original 
IRB must follow its written procedures for ensuring prompt reporting to its institutional officials 
and FDA of the suspension or termination, as required under 21 CFR 56.108(b)(3).22  In 
addition, sponsors of device studies must report to FDA and all reviewing IRBs and participating 
investigators any instances of IRB withdrawal of approval of an investigation or a part of an 
investigation within 5 working days after receipt of the withdrawal of approval.23 Sponsors of 
drug/biologic studies must report to FDA the discontinuance of a clinical investigation.24    
 
(4) Conducting a review by the receiving IRB, where appropriate, before it accepts 
responsibility for the study(ies).   
 
Because the regulations do not address transfer of IRB oversight, it is left to the receiving IRB to 
decide whether to conduct a review of the clinical investigation prior to the next continuing 
review date established by the original IRB.25  In practice, however, IRBs often choose to 
perform some type of review before accepting responsibility for a study, as part of their own due 
diligence efforts.   
 
A number of options are available to the receiving IRB, depending on the circumstances.  The 
receiving IRB may decide to: 
 
  Undertake an initial review, either by the convened IRB or under an expedited review 
procedure,26 if appropriate.  Review by the receiving IRB is strongly recommended 
where the quality of the review by the original IRB may be questionable, for example, 
where the transfer occurs because of noncompliance by the original IRB, as reflected in 
an FDA Warning Letter to that IRB.  In addition, the receiving IRB should also consider 
conducting an initial review for higher risk studies, such as those involving an exception 
                                                 
19 See 21 CFR 56.103. 
20 See 21 CFR 312.60, 21 CFR 312.66, 21 CFR 812.40, 21 CFR 812.42 and 21 CFR 812.64. 
21 When IRB approval of a clinical investigation is suspended or terminated, IRBs should establish procedures to 
ensure that the rights and welfare of currently enrolled subjects are protected, subjects are not put at risk, and 
subjects receive appropriate care during any period in which the IRB and clinical investigator are attempting to 
resolve any remaining issues.  For more information regarding suspensions or terminations of IRB approval, you 
may refer to FDAs guidance, IRB Continuing Review after Clinical Investigation Approval, available at:  
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf. 
22 See IRB Continuing Review after Clinical Investigation Approval, available at:  
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf.   
23 21 CFR 812.150(b)(2). 
24 21 CFR 312.31(a)(2). 
25 In other contexts, FDA recognizes that one IRB may rely on the review of another qualified IRB to avoid 
duplication of effort.  See 21 CFR 56.114 (Cooperative research). 
26 For categories of research that are eligible for review through an expedited review procedure, see:  
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm119074.htm.  
  8  Contains Nonbinding Recommendations 
 
from the informed consent requirements under 21 CFR 50.24, unapproved therapies with 
a high risk of morbidity and/or mortality, novel therapies including new cellular or gene 
therapies, and those flagged by the original IRB for more frequent review.  The receiving 
IRB may also decide to conduct an initial review if, for example, the IRB believes that 
there may be local issues that would warrant its review.  Initial review should also be 
considered where the receiving IRB has no familiarity with the original IRB, such that it 
may not be comfortable wholly relying on the original IRBs review and approval.  The 
IRB should consider whether to conduct an initial review of device studies to make an 
independent determination of significant or non-significant device risk, particularly when 
the transfer occurs because of noncompliance by the original IRB.27 
  Undertake a continuing review at the time of transfer, either by the convened IRB or 
under an expedited review procedure, if appropriate.  Continuing review may be 
appropriate when the receiving IRB already has responsibility for a site in a multi-site 
study (i.e., is familiar with the study because the receiving IRB has already reviewed and 
approved the study protocol). 
  Not undertake a review until the next continuing review date.  This option may be 
most appropriate for transfers due to logistical, administrative, or economic reasons.   In 
practice, however, IRBs often choose to perform some sort of informal assessment to 
ensure that the records appear to be in order and to help prepare for the continuing review 
when it comes due.  Because a request for IRB approval of a protocol or informed 
consent change may occur even before the continuing review date, it is important to note 
that receiving IRBs must perform either an initial or continuing review before approving 
substantive changes to the research or the informed consent document to ensure that they 
are sufficiently familiar with the study.28  
 
FDA regulations at 21 CFR part 56 make no provision for a grace period extending the conduct 
of research beyond the expiration date of IRB approval. When the receiving IRBs review of the 
transferred research does not occur prior to the end of the approval period specified by the 
original IRB, IRB approval expires automatically and all research activities involving human 
subjects must stop.  Enrollment of new subjects cannot occur after the expiration of IRB 
approval.29, 30  Overall, FDA expects that lapses of IRB approval will be a rare occurrence.  
 
FDA reminds receiving IRBs that they also have the authority to suspend or terminate approval 
of research in circumstances where the clinical investigation is not being conducted in 
accordance with the receiving IRBs requirements or has been associated with unexpected 
serious harm to subjects.31  The receiving IRB must promptly report any suspension or 
termination of IRB approval, including the reasons for the action, to the clinical investigator, 
                                                 
27 21 CFR 812.66. 
28 See 21 CFR 56.103(a), 21 CFR 56.108(a)(4), and 21 CFR 56.110(b)(2).  There is an exception to this general 
requirement:  changes necessary to eliminate apparent immediate hazards to human subjects may be initiated 
without IRB review and approval, as described in 21 CFR 56.108(a)(4). 
29 See, e.g., 21 CFR 56.103(a).   
30 For information regarding lapses in IRB approval and temporary continuing participation of already enrolled 
subjects, see FDAs guidance, IRB Continuing Review after Clinical Investigation Approval, available at:  
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf.   
31 21 CFR 56.113. 
  9  Contains Nonbinding Recommendations 
 
appropriate institutional officials, and FDA.32, 33  FDA recommends that sponsors also be 
informed of any suspension or termination and the reasons for such action.34 Informing sponsors 
of an IRB suspension or termination of the study allows sponsors the opportunity to address the 
IRBs concerns so that disruptions of the study can be minimized and any human subject 
protection issues can be addressed. 
 
Sponsors must also report such information to FDA.  Sponsors of drug/biologic studies are 
required under 21 CFR 312.31(a)(2) to report to FDA any information regarding the 
discontinuation of a clinical investigation in an information amendment to the Investigational 
New Drug (IND) application.  Sponsors of device studies are required under 21 CFR 
812.150(b)(2) to notify FDA and all reviewing IRBs and participating investigators of any 
withdrawal of IRB approval of an investigation or a part of an investigation within 5 working 
days after receipt of the withdrawal. 
 
(5) Confirming or establishing the date for the next continuing review. 
 
If the receiving IRB performs a review at the time of clinical investigation transfer (whether an 
initial or a continuing review), it may choose to maintain the anniversary date of approval 
established by the original IRB or decide to establish a new anniversary date.  If the receiving 
IRB decides to establish a new anniversary date, the new date must be within one year of the 
receiving IRBs review. 
 
If the receiving IRB does not conduct a review of the clinical investigation at the time of transfer, 
the date of clinical investigation 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 clinical investigation for one year 
effective July 1, 2011, and the clinical investigation is transferred to a new 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.  Note that review in accordance with a 
newly established expiration date would nonetheless need to be conducted prior to the original 
July 1, 2012 expiration date. 
 
(6) Determining whether the consent form needs to be revised. 
 
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.35  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 
                                                 
32 Ibid. 
33 For further information about reporting of suspensions or terminations of IRB approval, refer to FDAs guidance 
on IRB Continuing Review after Clinical Investigation Approval, available at:  
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf.  
34 We note that, the device regulations place this responsibility on investigators.  However, IRBs may nonetheless 
also choose to inform sponsors of a termination or suspension and the reasons for doing so.  21 CFR 812.150(a)(2). 
35 21 CFR 50.25(a)(7).   
  10  Contains Nonbinding Recommendations 
 
to subjects.  For subjects who are already enrolled (whether or not they are active), this may be 
accomplished in a number of ways, including sending a letter providing the relevant contact 
information.36  For new subjects, the informed consent, assent, and/or parental permission form 
must be revised to reflect the new contact information.37  The clinical investigator should 
promptly notify the IRB of any such administrative changes to the consent form.  
 
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.).38  Depending upon the types 
of changes needed, they may be conveyed to the clinical investigator and sponsor as required 
modifications to secure IRB approval for the clinical investigation at that site or sites and may 
require reporting to FDA.39 
 
(7)  Notifying the key parties. 
 
As discussed above, all key parties involved in the transfer of oversight (e.g., clinical 
investigator, sponsor, and original and receiving IRBs) should discuss their respective 
responsibilities before implementing the transfer.  In addition, the sponsor should notify pertinent 
entities involved in the clinical investigation (e.g., institutional members, Data Safety Monitoring 
Board, CRO), as and when appropriate.  After IRB transfer of oversight for the clinical 
investigation is complete, the sponsor must update the associated IND40 or IDE41 with the name 
and contact information of the receiving IRB and should include the effective date of transfer.   
 
For studies for which the original IRB acts as a central IRB, those local institutions/IRBs that 
have written agreements with the original IRB (to transfer review responsibility to that original 
IRB) should be notified that responsibility for the study is now being transferred to a new central 
IRB (receiving IRB).  We recommend that those local institutions/IRBs be given the option to 
enter into new written agreements with the receiving IRB or opt out of the central review 
arrangement if they do not believe central review by the receiving IRB is appropriate for their 
local institution (e.g., are concerned about the ability of the receiving IRB to adequately address 
local issues).42 
 
Additionally, when an IRB declines to accept oversight of a clinical investigation, FDA 
recommends that the IRB notify the appropriate party(ies) who initiated the transfer process 
(refer to page 3 for further information; parties responsible for initiating the transfer may not be 
those responsible for securing IRB review) to enable the clinical investigator and/or sponsor to 
make alternate arrangements for IRB review.   
                                                 
36 FDA does not require subjects who are already enrolled (whether or not they are active) to be re-consented for 
such minor changes; however, IRBs may choose to do so. 
37 21 CFR 50.25(a)(7). 
38 21 CFR 56.109(a) and (b). 
39 See, e.g., 21 CFR 56.109(a), 21 CFR 312.31, and 21 CFR 812.35. 
40 21 CFR 312.31(a). 
41 21 CFR 812.35(a)(4). 
42 For more information on the responsibilities of central IRBs and local institutions/IRBs with respect to central 
IRB review, see Using a Centralized IRB Review Process in Multicenter Clinical Trials, available at: 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm127004.htm. 
  11  Contains Nonbinding Recommendations 
 
 
(8)  Updating IRB registration information. 
 
The IRB registration rule at 21 CFR 56.106(e) requires that any IRB that decides to review FDA-
regulated research involving new types of FDA-regulated products, or decides to discontinue 
reviewing FDA-regulated research, must revise its registration within 30 days of the change in 
product type review or permanent cessation of the IRBs review of research.  A receiving IRB 
may therefore need to revise its registration if it previously did not review clinical investigations 
of FDA-regulated products or if it will assume the review for a new type of FDA-regulated 
product upon the acceptance of clinical investigations from an original IRB (e.g., the receiving 
IRB will now review clinical investigations of medical devices, whereas the IRB previously 
reviewed only clinical investigations of drugs).   Similarly, the original IRB may need to update 
its registration information if it will no longer be reviewing a certain type of FDA-regulated 
product, will no longer be reviewing FDA-regulated research, or plans to disband.  IRBs must 
revise their registration within 30 days of any such changes and may do so electronically through 
http://ohrp.cit.nih.gov/efile.43  
 
 
IV.  SPECIAL SITUATIONS  
 
A.  Transfer of IRB Oversight from one IRB to Another IRB within the Same 
Institution and Temporary Transfer of IRB Review Responsibility 
 
Transfer of oversight may occur from one IRB to another IRB that operates within the 
same institution for logistical, administrative, and/or budgeting reasons (e.g., 
consolidating IRB workload).  Transfer of oversight might also occur temporarily when a 
natural disaster or other disruptive event briefly suspends the functioning of the original 
IRB; in this case, the transfer is only temporary because responsibility for IRB review 
will eventually revert back to the original IRB.    
 
When the transfer occurs within the same institution (e.g., for logistical, budgeting or 
administrative reasons), the transfer process is generally expected to be simpler and more 
expeditious than the transfers described above in Section III as not all eight steps may be 
applicable.  For example, when oversight is transferred to another IRB at the same 
institution, the receiving IRB may decide not to conduct an initial or continuing review 
prior to the next continuing review date established by the original IRB, as such review 
may not be expected to substantively add to human subject protection.  The guidance 
provided in Section III for institution-to-institution transfers may be useful for within-
institution transfers.    
 
When a temporary transfer of IRB oversight occurs (e.g., due to a natural disaster) 
whether within the same institution or to a different institution, the guidance provided in 
Section III should be useful, but again, not all eight steps may apply.  The appropriate 
steps to effectuate oversight transfer will depend on the specific circumstances, including 
                                                 
43 IRBs that lack the ability to access the electronic registration system may send revisions, in writing, to the Office 
of Good Clinical Practice, Office of Special Medical Programs, Food and Drug Administration, 10903 New 
Hampshire Avenue, WO32-5103, Silver Spring, MD 20993-002. 
  12  Contains Nonbinding Recommendations 
 
the reasons for the transfer and the risk posed by the study.  In the case of a natural 
disaster, although the transfer may initially be thought to only be required for a short 
period of time, additional time may ultimately be needed before the original IRB is able 
to resume its oversight responsibilities. The original and receiving IRBs would need to 
ensure that study oversight does not lapse; adverse events are reported to the appropriate 
IRB, etc. during this interim period.    
 
B.  Transfer of a Clinical Investigation to a New Research Site Requiring IRB 
Review  
 
A sponsor may decide to transfer a clinical investigation to a different research site when, 
for instance, a clinical investigator relocates to that new site.  Because the transfer 
involves changes to the research (i.e., conducting the research in a new location, consent 
form revisions, possible changes in key staff, etc.), the sponsor or investigator must 
submit these changes to the receiving IRB for review and approval, prior to implementing 
the changes.44  In many cases, these changes represent a minor change to the research, 
which the IRB may review under an expedited review procedure.45  
 
Such a move to a new research site may or may not entail changing the IRB.  If the 
reviewing IRB changes as a result, then the considerations described in Section III apply, 
except initial or continuing IRB review must be conducted (an IRB may not approve a 
change in research without first conducting an initial or continuing review).46    
 
FDA notes that, even if the IRB remains the same when a study is transferred to a new 
research site, IRB review/approval for the new research site is required because such a 
move is considered a change in previously approved research.47  Additionally, the 
sponsor must notify FDA of any change in research site, clinical investigator, and/or IRB.  
For drug or biologics studies, this notification can generally be accomplished through an 
IND protocol or information amendment, whereas for device studies it can generally be 
accomplished in an IDE annual report.48  
 
V.    ADDITIONAL QUESTIONS ABOUT TRANSFERRING OVERSIGHT OF A 
CLINICAL INVESTIGATION 
 
Occasionally, during the course of its initial or continuing review of a transferred clinical 
investigation or at other times during oversight transfer, an original or receiving IRB may have 
                                                 
44 21 CFR 56.108(a)(4). For drug/biologic studies, clinical investigators are responsible for securing IRB approval 
under 21 CFR 312.66; for device studies, the sponsor is responsible under 21 CFR 812.35(a)(1) and (3). 
45 21 CFR 56.110(b)(2). 
46 See 21 CFR 56.103(a), 21 CFR 56.108(a)(4), and 21 CFR 56.110(b)(2).  There is an exception to this general 
requirement:  changes necessary to eliminate apparent immediate hazards to human subjects may be initiated 
without IRB review and approval, as described in 21 CFR 56.108(a)(4). 
47 Ibid. 
48 See 21 CFR 312.30, 21 CFR 312.31, 21 CFR 812.35, and 21 CFR 812.150(b)(5).  For a discussion of the types of 
changes in an IND study that require a new Form 1572, refer to Question 7 of FDAs Guidance  Frequently Asked 
Questions -- Statement of Investigator (Form FDA 1572),available at 
http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm214282.pdf  
  13  Contains Nonbinding Recommendations 
 
questions that are not resolvable through communications with the sponsor or clinical 
investigator.  In such situations, either IRB may contact FDA for additional guidance.  Affected 
sponsors and clinical investigators may also contact FDA in these situations.  Please use the 
following as an initial point of contact: 
  Center for Biologics Evaluation and Research (CBER) - Bioresearch Monitoring 
o
Branch, Division of Inspections and Surveillance, Office of Compliance and 
Biologics Quality  
  Phone:  (301) 827-6221 
  Email:  industry.biologics@fda.gov  
  Center for Drug Evaluation and Research (CDER) - Office of Scientific 
o
Investigations, Office of Compliance 
  Phone:  (301) 796-3150 
  Email:  cder-osi@fda.hhs.gov 
  Center for Devices and Radiological Health (CDRH) - Division of Bioresearch 
o
Monitoring, Office of Compliance 
  Phone:  (301) 796-5490 
  Email:  bimo@cdrh.fda.gov   
 
If you have specific questions about how to interpret this guidance, please contact FDA by phone 
at (301) 796-8340 or by e-mail at gcp.questions@fda.hhs.gov. 
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