Public Policy Matters

Call for Comments on Revision of Important Federal Research Regulations

As all federally funded researchers know, there are strict regulations governing the conduct of research with human subjects, including the requirement that an Institutional Review Board (IRB) review and approve research protocols.

Promulgated and adopted in the 1970s, the regulations created many problems for researchers, including the fact that different agencies and IRBs interpreted and applied them differently. Consequently, 17 major funding agencies got together sometime around 1991 to reach a common understanding, with HHS taking the lead in its 45 CFR 46 (Title 45, Part 46 of Code of Federal Regulations), hereafter known as “"The Common Rule.”

Although this resulted in significant improvements (including more clearly articulated lists of “exempted areas”), it didn’t fix everything, so complaints have continued over the two decades since. Therefore, the government is now undertaking a revision of the “Common Rule” designed to address the remaining problems, and all interested parties are invited to review the draft and submit comments. The original deadline was September 26, but it has been extended to an as yet unknown date. Watch the HFES Web site for an update on the extended due date for comments.

The announcement and instructions for reviewing and commenting on the revision are presented below. The most intensive and relevant review of this revision is being carried out by the American Psychological Association. HFES members with an interest in these regulations are encouraged to respond.

OHRP solicits comments on proposed changes to the regulations for human research participant protections (The Common Rule)
"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) aimed at revising the current federal regulations for protecting human research participants (45 CFR 46, the Common Rule). These revisions are intended to reduce regulatory burden while providing better protection for human research participants, and facilitating valuable research. 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. 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 http://www.regulations.gov."

Back to the Table of Contents for the September 2011 HFES Bulletin

Download a .pdf version of this issue

Archive of past HFES Bulletin issues (in .pdf format)