OHRP & FDA issue new guidance on transferring approved projects
Agencies answer industry's questions
As the hurricane season picks up and the potential for other types of emergencies continues, a research institution might find it necessary to transfer its IRB-approved research to another institution. Or an IRB simply might need to transfer a single study for a variety of reasons. Federal guidance on how to handle these contingencies now is available.
The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) recently issued separate, but collaborative, draft guidance on how research institutions can make this type of transfer as safely and efficiently as possible. IRBs and research institutions can make comments on the proposed guidance through Aug. 13, 2012.
OHRP's draft guidance states the goal is to assure continuous IRB oversight with no lapse in either IRB approval or the protection of human subjects.
"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throughout the transfer process to ensure an orderly transition and continued protection of human subjects," the OHRP draft guidance says.
The same language appears in the FDA's draft guidance, which also emphasizes effective communication among the IRBs, sponsors, investigators, FDA, and others.
OHRP developed the draft guidance after receiving numerous questions from the research community about this subject, says Irene Stith-Coleman, PhD, director of OHRP's division of policy and assurances.
"I remember back to Hurricane Katrina when there were institutions that were underwater," she explains. "Some of the questions the research institutions had involved what to do about the ongoing need for IRBs in situations like that."
Another event that might trigger a transfer of a research approval is when an institution is involved in a multisite study for the first time and it doesn't have the resources to create its own IRB, Stith-Coleman says.
Crises can arise and institutions want answers, which is why the guidance was written, she adds.
According to the OHRP draft guidance, the IRBs and institutions involved in a research project transfer should have written procedures and create a written agreement between the original and receiving IRBs, if appropriate. The agreement should address these eight actions:
- Identify those studies for which IRB oversight is being transferred.
- Ensure the availability and retention of pertinent records.
- Establish an effective date for transfer of oversight, including records, for the research project.
- Conduct a review of the study or studies by the receiving IRB, where appropriate, before it accepts responsibility for the study or studies.
- Confirm or establish the date for the next continuing review.
- Determine whether the consent form needs to be revised.
- Notify the key parties.
- Address IRB regulatory issues.
IRB authorization agreements have been in place for years, Stith-Coleman notes.
"These are agreements institutions use when they want that grant money but don't have the resources to create their own IRB and have to rely on an external IRB," she explains.
The draft guidance provides a framework for what agreements should address.
The OHRP and FDA guidance offer suggestions that could make these agreements more consistent across the human subjects protection industry.
"Relationships will be different with each IRB, but some of the considerations will be the same," Stith-Coleman says. "Based on OHRP's experience with IRB authorization or reliance agreements, we believe that IRBs are accustomed to entering into written agreements documenting their interactions with other IRBs.
"By clarifying the regulatory requirements and considerations involved in the transfer of a research study to another IRB or another institution, we believe this guidance will help institutions and investigators avoid unnecessary disruptions in their research activities," she adds. "In addition, the guidance should assist institutions that have expressed confusion about how to carry out such transfers and allow them to run their IRB systems in a more flexible way and lead to better protections to subjects."
For instance, OHRP recommends that the original and receiving IRBs have a clear understanding of which studies are being transferred, the risk posed by the studies being transferred, and the circumstances leading to the transfer.
Also, OHRP advises IRBs receiving a transferred research project to obtain copies of pertinent records, including sample consent forms, investigator's brochure, IRB meeting minutes, grant proposal and research protocol. And both the original IRB and the receiving IRB should maintain adequate records regarding the research projects affected by the transfer, including records of any written agreement between the two IRBs, the OHRP draft guidance says.
OHRP's draft guidance notes that federal regulations do not require the receiving IRB to review the project prior to the next continuing review date established by the original IRB, but OHRP suggests that this type of review often is and should be 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]," OHRP's guidance states.
It's important research institutions make comments on the guidance, Stith-Coleman says.
"I'm anxious for them to start putting some comments in there for the public record so if we have overlooked something we'll hear about it," she adds.
OHRP's draft guidance document was developed and reviewed internally before it was shared with FDA and other HHS agencies for review and comment, Stith-Coleman says.
"It was also shared with non-HHS Common Rule departments and agencies for review and comment," she says. "The draft guidance was then revised by OHRP in response to comments from federal agencies, and OHRP actively worked with FDA to harmonize both documents during the development of its draft document."
For more information about the new draft guidance, visit the OHRP website at http://www.hhs.gov/ohrp/newsroom/rfc/transferdraftdoc.html.
As the hurricane season picks up and the potential for other types of emergencies continues, a research institution might find it necessary to transfer its IRB-approved research to another institution. Or an IRB simply might need to transfer a single study for a variety of reasons. Federal guidance on how to handle these contingencies now is available.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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