Major changes proposed in federal regulations for protection of human research participants

Scientists invited to respond to proposed revisions of Common Rule.

By Sangeeta Panicker, PhD, and Jenna McGwin

On July 26, 2011, the Office of the Secretary of the Department of Health and Human Services (HHS), in coordination with the Office of Science and Technology Policy (OSTP), issued an advance notice of proposed rulemaking (ANPRM) [PDF, 286KB] aimed at revising the current U.S. federal regulations for protecting human research participants (45 CFR 46, the Common Rule). HHS and OSTP are recommending revisions to the regulations that are intended to reduce burden and ambiguity for researchers and institutions while providing better protection for human research participants and facilitating valuable research.

According to HHS and OSTP, the current regulations, which were developed over two decades ago, are inadequate for the oversight of the contemporary research enterprise, which includes multi-site studies, research involving biological specimen repositories, and the use of advanced technologies. The ANPRM specifically emphasizes the following potential revisions:

"1.	refinement of the existing risk-based regulatory framework;
2.	utilization of a single IRB [institutional review board] of record for domestic sites of multi-site studies;
3.	improvement of consent forms and the consent process;
4.	establishment of mandatory data security and information protection standards for all studies that involve identifiable or potentially identifiable data;
5.	establishment of an improved, more systematic approach for the collection of information on unanticipated problems and adverse events;
6.	extension of Federal regulatory protections to all research, regardless of funding source, conducted at institutions in the United States (U.S.) that receive some federal funding for research with human subjects; and
7.	improvement in the harmonization of regulations and related agency guidance.”

Some of the proposed revisions of particular interest to psychological scientists include revision and expansion of the categories of research that would be exempt from review, and a less onerous process for making the exempt determination. The proposed new rule also requires HHS’s Office for Human Research Protections (OHRP) to regularly review and update categories of research eligible for the expedited review process. Both of these proposed changes would, however, require that the research meet new data safety and information protection standards and consent requirements and that the participants be competent adults. In addition, the proposed changes recommend an elimination of continuing review for all minimal risk research that underwent expedited review, unless continuing review is justified for the protection of the research participants. Furthermore, continuing review of studies that were reviewed by a convened (full review) IRB would not be required if the study was in the data analysis phase.

OHRP has posted background materials on its website, including a comparison table that summarizes 19 changes in the Common Rule that are under consideration and their rationales.

The deadline for receipt of comments is no later than 5:00 p.m. on September 26, 2011. Comments may be submitted online through the Federal eRulemaking Portal at Regulations.gov. Enter the docket ID number (HHS-OPHS-2011-0005) in the “Enter Keyword or ID” field and click “Search.” On the next page, click on “Submit a Comment” and follow the instructions. You may also submit comments by hard-copy to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Any comments received will be posted to Regulations.gov.

Due to the breadth and complexity of the regulatory changes being considered, the American Psychological Association (APA) submitted a letter (PDF, 856KB) to OHRP on July 27, requesting an extension of the public comment period until November 26, 2011. Other scientific organizations have made requests for an extension as well. As this article was being prepared for posting, no decision had been announced regarding the extension request.

The APA’s Committee on Human Research will review the suggested revisions and draft detailed comments to submit to HHS. APA encourages psychologists to submit individual comments and to share their comments as well with the APA Research Ethics Office (by email or phone: (202) 336-6000).

Jenna McGwin, MS, is Research Ethics Program Associate in the APA Research Ethics Office. Sangeeta Panicker, PhD, is director of the Research Ethics Office and serves as staff liaison to the Committee for Human Research.