AERA leads effort to examine proposed changes intended to improve practices for human research protection and promote research.
In late July, the U.S. 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) changes to federal regulations governing human research protections (45CFR46, Subpart A). The ANPRM seeks to protect research participants while advancing essential research. The potential changes are far reaching ranging from seeking to remove low-risk research with adult populations from consideration by Institutional Review Boards (IRBs) to introducing a new category of excused research that would not require IRB review but where otherwise exempt research would be registered and where research that only involves informational risk would not be reviewed by IRBs but could be alternatively governed by mandatory standards of data security.
AERA, along with the Federation of Associations in Behavioral and Brain Sciences (FABBS) and the Consortium of Social Science Associations (COSSA), is leading an effort across research associations and organizations to examine the many aspects of changes intended to improve practices for human research protection and promote research. On September 1, 2011, AERA hosted a full-day meeting of 21 representatives from relevant organizations, and is working on an analysis and the preparation of a joint response.
To examine the ANPRM and related information visit http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html. The deadline for comments is October 26, 2011 at 5:00pm, Eastern Daylight Time.