Thursday, September 8, 2011

Important changes to federal rules governing human subjects research

Colleagues,

I think it's important that you are aware of proposed changes to the Common Rule and regulations related to human subject research. My general impression is that the direction that the feds are going is quite positive, but there remain some concerns in the research community.

The best way to learn about this is by visiting http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html

This page links to DHHS's ANPRM [Advance Notice of Proposed Rule Making] for Revision to the Common Rule. Particularly noteworthy is the extension of the public comment period, which now runs through late October 2011.

Your disciplinary organizations have likely already weighed in on the proposed rule, and if you are interested, you may inquire there.

All researchers who work with human subjects should monitor these potential changes. But remember that nothing has changed yet, and the existing rules remain in effect. So no changes to NCSU IRB procedures have happened yet.

As usual, let me know if you have any questions or comments.