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, which can be found at http://www.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 http://www.regulations.gov.
The American
Psychological Association’s Committee on Human Research (CHR)
will review the suggested revisions and draft detailed
comments to submit to HHS. CHR encourages APA members to
submit individual comments and to contact the [log in to unmask]">APA Research Ethics Office at 202.336.6000 with concerns
regarding the proposed changes to the regulations for the
protection of human research participants.
For
additional information regarding the ANPRM, please see the
August edition of the
Psychological Science Agenda
(available
August 24, 2011).
