Help reform the Institutional Review Board (IRB) system!

Zachary Schrag writes:

Thank you for bringing attention to the debate about research ethics and IRB oversight of the social sciences the Monkey Cage blog.

I hope you can help spread the word about an unprecedented opportunity for social scientists to reshape the federal regulations that govern IRBs.

On 26 July 2011, 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) issued an advance notice of proposed rulemaking (ANPRM), opening up the Common Rule regulations on human subjects protections for substantial revision. The ANPRM concedes that there are problems with the way IRBs review social science, and notes that “Overregulating social and behavioral research in general may serve to distract attention from attempts to identify those social and behavioral research studies that do pose threats to the welfare of subjects and thus do merit significant oversight.” [emphasis added]

This notice signals the greatest opportunity in thirty years for social scientists to reshape federal IRB policy.

So far, however, I have not seen much about this from political scientists; for example, the American Political Science Association website seems not to have posted even a news item.

I wonder if you could suggest ways to alert the political science community. Comments are due before 5pm, eastern time, on 26 September 2011, so time is short.

The ANPRM is quite complex and poses 74 questions, many of them of relatively little interest to political scientists and other social scientists. To make things easier on social science organizations, I have posted a quick guide at

http://www.institutionalreviewblog.com/2011/08/quick-guide-to-anprm.html

I have also posted additional commentary and links to news articles at Institutional Review Blog, http://www.institutionalreviewblog.com/

4 Responses to Help reform the Institutional Review Board (IRB) system!

  1. Joseph August 12, 2011 at 7:27 pm #

    Thank you for posting this note. I think I can promise a 100% chance of a comment to the government. I have long felt that the heavy administrative burden on minimal risk research not only slows scientific discovery but overwhelms limited institutional resources (making truly problematic studies less likely to be detected).

  2. Tali Mendelberg August 17, 2011 at 10:02 am #

    Here is how you can provide your official comment to the government:

    1. Go to the Federal eRulemaking Portal: http://www.regulations.gov.
    2. Enter docket ID number HHS-OPHS-2011-0005 in the “Enter Keyword or ID” field and click on “Search.”
    3. On the next Web page, click on “Submit a Comment” action and follow the instructions.

    First read the summary of current problems and proposed changes at : http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html

  3. David August 17, 2011 at 1:39 pm #

    For those interested, you may also want to check out a symposium held in the July edition of PS (vol.41(3)) on IRB in political science.

  4. David August 17, 2011 at 1:39 pm #

    July 2008 that is…