Last month, the FDA released final guidance on transferring clinical investigation oversight from one IRB to another. This “changing of the guard” can occur for any number of reasons including IRB consolidation, workload obstacles, or financial considerations. However, it is important to remember that protection of the study participants involved remains paramount.
The FDA’s recommendations are designed to foster a fluid and well-documented transfer, which prevents lapses in approval windows or unacceptable compromises in subject protection. Here is a brief overview of the key considerations the guidance discusses:
- Identify: Clearly define what studies are being transferred, what IRB they are being transferred from and which IRB will receive them. Clearly communicate to all parties the number of studies, the risks they pose, and the reasons for the transfer. Investigators performing the research should always be considered a party to the transfer.
- Notification: All parties involved in the study transfer should have a discussion about their role and responsibilities prior to the actual event. The sponsor should notify the CRO (Contract Research Organization), as well as any DSMB’s (Data Safety Monitoring Board). The study’s IDE or IND should be updated as well to reflect the name and contact data for the receiving IRB as well as the effective date of transfer. Any studies that were being conducted under a local institution should have those institutions made aware that responsibility is being handed over to another IRB. The FDA recommends such institutions be given an option to enter into new written agreements with the receiving IRB or the ability to opt out of the central IRB arrangement if they feel it is inappropriate per their local needs or any special community issues.
- Retention of Records: All pertinent records relating to the research in question should be made available (via hard copy or electronic format) to the receiving IRB. This includes, but is not limited to: the protocol and any significant amendments, the most recently approved consent form, the investigator brochure, any IRB meeting minutes where the study research was reviewed, any unanticipated problem reports involving risks to the study subjects or others, study advertisements or recruitment tools, documentation of any IRB-conducted audits or site visits, and correspondence with the investigator, sponsor/CRO, and the FDA. The regulations state that IRB records must be kept for at least three (3) years after the research has completed, and the party assuming responsibility for the records has a legal obligation to adhere to the requirements of 21 CFR 56.115(b).
- Establish Effective Date of Transfer: Although this is not mandated by the regulations, the FDA recommends setting up an effective transfer date for the research oversight (including the previously mentioned records). A written agreement is preferred, and the receiving IRB may mandate the final transfer is contingent on their own review of the research, their approval of the study, or any required modifications to the protocol design they deem necessary to satisfy their own procedures or safety requirements.
- Review Before Acceptance: The receiving IRB has the option of performing an initial review of the study prior to the continuing review date set by the original review board. This can be done via convened Board – or an expedited review (if appropriate). In instances where the IRB’s are unfamiliar with each other (i.e. not at the same institution) or one where the original IRB’s review is under question, a full initial review is also recommended. Other options for the receiving IRB are to perform a Continuing Review at the time of transfer or to hold off review altogether until the next Continuing Review date (which was set by the original board). The receiving IRB must perform an initial or continuing review prior to any substantive changes to the research or consent documents.
- Continuing Review: The receiving IRB has the option of keeping the study’s established approval anniversary for continuing review purposes, or establishing a new date and/or approval window. If the receiving IRB chooses a new date, it must be within 1 year of their new review. If they opted not to conduct an initial or continuing review at the time of transfer, the approval window of the original IRB’s most recent review is presumed to remain intact.
- Consent Form Revisions: Any study consent forms that are transferred as part of a change in IRB oversight also require revision. Consent documents are required to have “[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” per 21 CFR 50.25(a)(7). Ergo, the consent will need to be updated with the new IRB’s contact information for any new participants that join the study. For subjects already enrolled in the research, a letter providing the new information can be dispatched to them if such communication satisfies the guidelines of the new IRB’s subject protection policy. Other changes may be requested by the receiving IRB to bring consent forms in line with such policies as a contingency for study approval or transfer.
- IRB Registration Update: If the receiving IRB did not review FDA-regulated products prior to the transfer event, it is obligated to update its registration per 21 CFR 56.106(e). This also applies if the research being transferred involves types of products that are new to the receiving IRB (for example, devices vs. drugs). The IRB should also update its registration if it intends to cease review of a certain type of FDA-regulated product, will no longer review research related to FDA oversight, or if it plans to disband. Such changes need to be revised in the registration within 30 days of implementation and can be done electronically at http://ohrp.cit.nih.gov/efile.
To view the entire final guidance document from the FDA, click here.
Questions About Transferring IRB Oversight of Your Study?
Do you have a study that needs to change its IRB? Contact Quorum for more information on how Quorum can help you manage the transfer.
Quorum Review’s Experience Receiving Studies Transferred from Another IRB
In 2009, a well-known IRB closed its doors after approving a protocol involving a fake surgical gel that was submitted by the U.S. government in an IRB sting operation. Subsequently, a large number of its active protocols and investigators were transferred to Quorum Review. Quorum had to manage a very large influx over an accelerated transition period (less than 6 weeks), and because of this event, Quorum gained valuable experience in how best to deal with large site volume study transfers.
In 2012, a renowned research hospital transferred an even larger number of clinical trials to Quorum’s oversight. By this point, Quorum had learned how to streamline the transfer process for sponsors and CROs. Quorum’s initial review of these studies was fashioned on Quorum’s own Periodic Review (also known as Continuing Review) process, which decreased the amount of required paperwork needed without compromising participant safety. Additionally, Quorum developed new Transfer of Jurisdiction documents and checklists to collect pertinent data for a comprehensive and ethical review.