OHRP seeks feedback on registration form change

What was voluntary now is required

OHRP is seeking comments from IRB members and others about proposed changes to the agency’s registration requirements, which apply to all IRBs that review human subjects research conducted or supported by HHS.

The comment period, which ends Oct. 4, 2004, is the next step before OHRP revises its proposal and, eventually, issues a final rule. The FDA also has published a proposed rule regarding IRB registration requirements for research subject to FDA regulations.

The chief difference in current practice and what OHRP has proposed, which can be found on the web site: www.hhs.gov/ohrp/news/irbnotice.pdf, is that IRBs now complete some of the registration information on a voluntary basis, and the proposed rule would make this same submission mandatory, says Irene Stith-Coleman, PhD, director of OHRP Division of Policy and Assurances in Rockville, MD.

"Some examples are the information on accreditation status of the IRB, as well as identifying the accrediting body," she says. "That’s voluntary and would be required under the proposed rule."

Also, IRBs would be required to submit information about active, HHS-supported protocols that are under ongoing review by the IRB, Stith-Coleman says.

"One piece of information that’s voluntarily submitted now that would not be required is active protocols that are under review, but which are supported by other departments and agencies than HHS," she explains. "That’s voluntarily submitted currently, and that would not be included anymore as voluntary even — we would restrict it to HHS-conducted and supported research, as opposed to going outside of the department."

The change from voluntary to required submission probably will have little impact on many IRBs, since the majority of IRBs already submit both the voluntary and required information, Stith-Coleman notes.

Some of the feedback already received by OHRP asks for clarifications about how the submissions to both FDA and OHRP will be handled, she says. "We indicate FDA-covered IRBs would also be submitting information to our site, as well. The IRBs covered by the FDA would submit registration information to the same HHS site that OHRP-covered IRBs are submitting to, which is currently happening right now."

One point that OHRP wants to make perfectly clear is that the proposed rule is not a requirement for IRBs to register all human subjects trials, and there are no regulations that would make this a requirement, Stith-Coleman says.

"Our regulations would not allow us to adopt such a policy on the part of IRBs," she says.

The proposed change will update requirements to meet current regulations regarding OHRP’s federalwide assurances.

"Regulations require institutions to designate their IRBs," Stith-Coleman says. "We need to know names and affiliation and additional information about IRB members themselves."

The agency also needs contact information on the IRB’s chair and the IRB office.

OHRP officials issued the proposed rule in July 2004, after reviewing a report by the OIG, published in 2003, recommending that all IRBs register with the federal government on a regular basis, Stith-Coleman notes. "After reviewing that recommendation, OHRP concluded that registration of IRBs would enable it to be identify more precisely the IRBs covered under our regulations and to keep an accurate update of IRBs, and to send out educational information and other information to IRBs."

"It allows us to more precisely understand who we’re covering and how to reach them in ways that would support improving health and welfare of subjects that are a part of research," Stith-Coleman adds.

Also, OHRP will be in a better position to determine whether IRBs have adequate staff and support, whether IRBs have kept their registration information up to date, including changes to member lists, Stith-Coleman says.

IRBs can register electronically, although signature pages need to be faxed to the agency. By the time the rule is made final, IRBs also should be able to provide updates electronically and the system may be capable of handling an electronic signature page, as well, Stith-Coleman says.

Until all comments are received and reviewed, OHRP can offer no estimate on when the rule will be made final, Stith-Coleman says.