On July 22, the Department of Health and Human Services (DHHS) released advanced notice for proposed revisions to the Common Rule . These changes reflect the most extensive changes since the Department of Health, Education, and Welfare published proposed rules for the protection of human subjects involved in research in 1979. The changes will be available for public comment until  September 26, 2011; there are 74 questions for which the HHS is requesting feedback. The attached table has been created by DHHS comparing 19 existing rules with the proposed changes and rationale for change (see attached).

Summary, as provided by DHHS:

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) [has issued an] advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM request feedback on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

In order to respond to this notice with one consolidated RTRN voice by capturing and compiling comments from the RCMI community, the DTCC is working with the RTRN leadership to:

• 1. Develop a summary of the proposed changes and possible impact for dissemination and discussion
• 2. Develop a web-based survey for collecting responses, questions, and concerns from the RTRN community (a link to the survey will be provided in a future notice and made available to the RTRN Community via the RTRN web site)
• 3. Set up a series of webinars over the coming weeks to discuss the proposed changes and implications

The first webinar will be held on Monday, August 1st  
(Topic:  Brief Summary of Proposed Rule Changes  and Open Discussion)

10:00 AM Hawaii
1:00 PM Pacific
2:00 PM Mountain
3:00 PM Central
4:00 PM Eastern
4:00 PM Puerto Rico

The second webinar will be held on Tuesday, August 2nd, as a repeat of the Monday Aug. 1st meeting.

CONFIRM ATTENDANCE AND RECEIVE MEETING ACCESS INFORMATION by e-mailing communications@rtrn.net, subject: ANPRM-Proposed Regulatory Changes

Additional meetings will be held bi-weekly, beginning the week of August 8th.

The goal of these activities is to not only respond to each of the 74 questions in the 92-page proposed changes document, but also to submit a consolidated brief in response on behalf of the entire Network. RTRN will submit a thoughtful, coordinated response to the DHHS by September 26, 2011.