The U.S. government is considering significant changes to the current guidelines for human subjects research. From the Office for Human Research Protections website (OHRP):
The U.S. Department of Health and Human Services has announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations – which have been in place since 1991 and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. The proposed changes are designed to strengthen protections for human research subjects.
The OHRP has provided an overview webpage of the proposed changes and also a table highlighting how the newly proposed rules will change existing policies. The government is presently soliciting comments on the proposed changes from the general public.
There has been national news coverage of this topic, and the LSA is examining how it might best respond to the proposal. Members of the LSA can also, of course, submit comments on their own as members of the general public. According the the OHRP website, “The ANPRM comment period closes 5:00 p.m. Monday, September 26, 2011.” (This appears to be sixty days after the posting of the proposal in the Federal Register, which occurred on July 26 rather than July 25 as indicated in the quote above).
Update: It appears that the deadline for comments has been extended to October 26.