News

Deadline is extended for comments on proposed federal changes in human research protections

New deadline is October 26, 2011.

In response to a request (PDF, 856KB) from the American Psychological Association (APA) and other scientific organizations, the Department of Health and Human Services (HHS) has announced (PDF, 141KB) an extension by one month of the deadline for public comments on the proposed changes in federal regulations for the protection of human participants.  The new deadline is October 26, 2011.

As reported previously, HHS issued a call on July 26, 2011, for public comments on an advance notice of proposed rulemaking (ANPRM) [PDF, 286KB], aimed at revising the current U.S. federal regulations for protecting human participants (45 CFR 46 Subpart A, the Common Rule).

A preliminary review by APA staff and APA’s Committee on Human Research indicates that the proposed revisions to the current regulations would have a substantial effect on the conduct of behavioral and social science research.  Provisions being carefully examined include:  expansion of the types of research that qualify for expedited and exempt (“excused”) status, mandatory data security and information protection standards based on the HIPAA Privacy Rule for all research, one institutional review board (IRB) of record for multi-site studies, open-ended general consent for future use of research data, and extension of the regulations to all research conducted at institutions that receive some federal funding from a Common Rule agency.  APA plans to submit detailed comments on the ANPRM and encourages individual scientists to submit comments as well. 

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. Comments will be accepted until 5:00 p.m. on October 26, 2011.

Questions and comments about the proposed revisions and APA’s response may be sent to Jenna McGwin of the APA Research Ethics Office.