Tuesday, July 26, 2011

Comment Requested on OSTP/DHHS Advance Notice

Today, the Office of Science and Technology Policy (OSTP) and the Department of Health and Human Services (DHHS) published an advance notice of proposed rulemaking to protect human research subjects in the Federal Register. The 20-page advance notice requests comments to 74 questions. Comments are due no later than 5 p.m. on September 26, 2011. The intention of the advance notice is to revise Subpart A of 45 CFR 46. Except for a couple of very minor edits, Subpart A of 45 CFR 46 (referred to as “Common Rule”) has not been revised since 1981, even though there have been numerous calls for change.

The advance notice presents a unique opportunity to improve the current regulations by increasing or adjusting protections for human subjects, where needed, and reducing unnecessary burdens on IRBs, investigators, and institutions. But, any revisions to Subpart A of 45 CFR 46 must be carefully thought out: the unintended as well as intended consequences of proposed revisions must be considered. To ensure that OSTP and DHHS hear the public’s voice, it is critical that all organizations, large and small, respond to the advance notice. The number of comments received by OSTP and DHHS is vitally important to effect change or reposition their thinking on revised regulations.

I encourage your organization to respond individually as well as to participate in responses from professional organizations.

Marjorie A. Speers, Ph.D.
President and CEO

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