Considerations When Transfering Clinical Investigation Oversight to Another irb

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

 OHRP’s guidance is available at:  

http://www.hhs.gov/ohrp/newsroom/rfc/transferdraftdoc.html

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Contains Nonbinding Recommendations 

 

 

2 

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. 

 

FDA’s requirements place the responsibility for securing IRB review and approval on the 

clinical investigator in clinical investigations of new drugs and biological products,

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 and on the 

                                                 

3

 21 CFR 56.102(g).  

4

 21 CFR 312.66. 

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