Submit Comments to Federal Government on Proposed Changes to the Common Rule by January 6, 2016

The federal government currently has a Notice of Proposed Rulemaking (NPRM) open regarding potential changes to the common rule on protections of human subjects. These rules would affect many but not all political scientists in their research activities and the research approval process involving Institutional Review Boards (IRBs). You can read a summary of all the changes authored by the Consortium of Social Science Associations here, and a summary from HHS here.

One proposed change is removing the exemption for interviewing public officials from needing IRB approval. Peri Schwartz-Shea and Dvora Yanow have posted this notice to several organized sections, and with their permission we have re-posted it here for wider circulation. You can read more about the proposed changes regarding public officials exemption below, and submit a comment to the federal government here. More detailed instructions on how to submit a comment are also included below. APSA will also submit a comment.


We would like to alert you to the imminent January 6, 2016 deadline for comments on the federal Notice of Proposed Rulemaking (NPRM) with respect to changes to the current rules governing research with human subjects-i.e., institutional review boards (IRBs).

Of particular concern to political scientists, one of the proposed changes would eliminate the rule that exempts research with public officials from full IRB review. Should you have the time to file a comment, we urge you to take a stand against the proposed new language because of its far-reaching impact on political science research.

The text may be found at; search on “public officials” (it is a short paragraph). The proposed elimination of the exemption of public officials from full IRB review is justified on the grounds that public officials should not be “singled out for different treatment” than other kinds of research subjects.  The present regulation in effect protects researchers who interact with public officials on the record and then report their comments, even when that report is critical of those officials’ words or actions. The proposed change drops those protections (of researchers), treating public officials in the same manner as private citizens whose reputations, etc. need to be protected from harm. This treatment is at odds with legal rulings, as well as with foundational ideas of democratic accountability.

In New York Times v. Sullivan (376 U.S. 254 (1964)), the Supreme Court explicitly exempted public officials from the usual libel standard, requiring instead that officials demonstrate actual malice or reckless disregard of the truth before they could take action against journalists or others. The Court created this rule to overcome the chilling effects that the threat of a libel lawsuit posed to journalists, so that they and others writing in good faith could express their views without being concerned about potential litigation. The Court recognized that public officials have significant resources to deal with the press and contest perceived misrepresentations of them or their views. The existing public officials exemption in IRB regulations, which the NPRM proposes to eliminate, can be justified on similar grounds.

A number of colleagues engaged in interview research with public officials both in the U.S. and overseas, with whom we have discussed this proposed change, all agree that eliminating the exemption will create serious chilling effects on political science (and other, similar) research, given how central both the method and the subject are across the empirical subfields of the discipline.  Consider, as just one example, a project in which public officials are interviewed without promise of confidentiality and are named in the published work. If these same individuals don’t approve of how they are portrayed, then-without the public officials exemption-they could sue the researcher for “reputational harms” (one of the IRB categories for the protection of human subjects/participants).  Retaining the exemption eliminates this possibility.

Professor Zachary Schrag, the author of a major work on IRB policy history and practices, argues that “[a]t the very least, the public official exemption should be preserved” and that the exemption should be extended to all public figures. He notes that such an exemption would protect a greater range of research, including, for instance, with leaders of corporations, non-profit organizations, and other such entities who are often prominent public figures. (See

There is still time to file a comment outlining objections to this change. Comments explaining the impact of this proposed deletion with reference to this specifics of research projects would be most helpful.  In one of the public “Town Hall” meetings on the proposed revisions, one of the OHRP officials invited such evidence and explanation, in effect asking us to educate the decision-makers.

To submit a comment online, here is the direct link to the comment page:!submitComment;D=HHS-OPHS-2015-0008-0001

Should that not work:

1. Go to

2. Enter HHS- OPHS-2015-0008 in the search box [yes, there is a space after the first hyphen].

3. In the list of links that then appears, find the one that is open for comments on this specific NPRM, click on “Comment,” and follow the instructions.