The FDA’s two proposed rules on human subject protections drew dozens of comments as 2022 came to a close, with some voicing concerns about additional informed consent requirements and suggesting FDA think deeper about single IRB reviews for cooperative research.

Participant protections and informed consent

The proposed rule on the protection of participants/IRBs would remove the need for continuing reviews of trials only analyzing data, unless IRBs determine otherwise, in addition to revising continuing review recordkeeping requirements and updating informed consent requirements.

A number of stakeholders, including the Pharmaceutical Research and Manufacturers of America (PhRMA), the Association of American Medical Colleges (AAMC), the Association of Clinical Research Organizations (ACRO), and Public Responsibility in Medicine and Research (PRIM&R), have concerns about the first rule’s informed consent requirements.

According to their comments, PRIM&R, ACRO and AAMC believe that requiring the disclosure of how participant information/biospecimens may be used in future research during informed consent is unrealistic. In its comments, PRIM&R said that, as is, the rule’s language does not offer enough guidance for drafting adequate consent forms — but “more importantly, the provision ignores the basic fact that researchers may not know, in advance, how data generated by their study will be used in the future.”

PhRMA and AAMC also commented on the proposal to include key information at the beginning of informed consent that would be most likely to help patients/patient representatives decide whether they want to participate in a trial. While PhRMA strongly supports the requirement, it urged for clarification on what is considered key information, as it could cause “considerable disagreement amongst sponsors, investigators, CROs and IRBs.” It also pointed out that it would likely take industry some time to update established informed consent processes to meet the requirement.

The trade group suggests FDA consider using the most important aspects of the five-factor approach outlined in the revised Common Rule’s preamble instead, which it believes would satisfy the proposed key information requirement.

AAMC added that while it recognizes the benefits of imparting such information, “the regulations’ sole emphasis on the format and structure of a document undermines HHS’ important perspective that ‘informed consent is a process, not just a form.’”

Waivers in cooperative research

The second proposed rule would require U.S. institutions participating in FDA-regulated cooperative research to use single IRBs for all domestic trials, with exceptions, and enact new recordkeeping requirements for trials using outside IRBs (CenterWatch Weekly, Oct. 3, 2022).

PhRMA also recommends that, instead of a list of exceptions to the second proposed rule’s single IRB requirement, the agency use waivers in situations where a cooperative research sponsor feels single IRB review is not appropriate. The group believes the proposal’s current approach is overbroad and has implementation challenges.

“A narrowly tailored waiver process, which is already authorized under FDA’s current regulations, would bring greater internal consistency to IRB review of FDA-regulated cooperative research and greater harmonization with the revised Common Rule and NIH’s single IRB review frameworks,” PhRMA commented.

On the single IRB requirement, AAMC proposes that FDA take time to fully understand the costs, benefits and burdens surrounding single IRB reviews, suggesting a two-year implementation period to see if more guidance, exceptions or flexibilities are needed.

Read the comments on the proposed rule on human subject protections and IRBs here: https://bit.ly/3Gn1wXg.

Read the comments on the proposed rule on IRB review and cooperative research here: https://bit.ly/3CsywvS.