IRB Federal Regulations Update

As explained earlier, the US federal regulations that govern IRBs are being overhauled top to bottom. (You can access the “Notice of Proposed Rulemaking”, or NPRM, here). This overhaul is consequential for all anthropological research. A period of public comment on the proposed  changes closes at 5 p.m. on December 7, 2015. (Additional information about the NPRM, including instructions on how to submit comments, can be found here, where you’ll also find the the federal Office for Human Research Protection’s summary of the proposed changes; the IRB professional association, Public Responsibility in Medicine and Research, has produced a longer chart comparing the current and proposed regulations which may be helpful as well.)

All anthropologists are encouraged to review the NPRM and submit comments that reflect your interests!

In addition, anthropologists Rena Lederman and Lise Dobrin will submit comments on behalf of the AAA, and they seek your opinions and advice on what the AAA comment should look like. They especially seek feedback on the following five questions (all page references are to the text in the first link above). While these are by no means the only proposals in the NPRM that would affect anthropological research, they represent areas about which Lederman and Dobin especially welcome advice, discussion, and examples. Please send your responses to and by December 1, 2015!

  1. The NPRM proposes to “exclude” from review oral history, journalism, biography, and forms of historical studies that focus directly on specific individuals (section _.101(b)(1)(ii); see NPRM p. 53946-8). Are there certain kinds of anthropological research that should be included in this category? (Note that “exclusion” is a new category, signifying that it would be entirely outside of IRB jurisdiction: unlike current “exemption”, IRBs would not need to be consulted at all about these forms of investigation.)
  1. The NPRM proposes to “exclude” from review research involving the use of educational tests, survey procedures, interview procedures, or public behavior observation, as long as the information is not individually identifiable, OR as long as a disclosure of responses could not reasonably place persons at risk (section _.101(b)(2); see NPRM p. 53950-1). In what ways (and for what reasons) do you think anthropological research fits this category of exclusion?
  1. The NPRM proposes that the Department of Health and Human Services further develop its list of research activities that present “no more than minimal risk” to human subjects (section _.110 and _.102(j); see NPRM p. 53985-6). Which broad categories of anthropological research do you think should be included on such a list?
  1. The NPRM proposes to “exempt” from review research that involves “benign interventions,” that is, encounters in which an adult provides verbal or written responses (which may even be recorded) that are “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects,” and not “offensive or embarrassing.” This exemption would be allowed so long as the individuals responding cannot be identified, or so long as disclosure of the responses “would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.” This exemption would be allowed even in cases of “authorized deception,” where subjects are prospectively informed that they may be misled about the nature or purposes of the research (section _.104(d)(3) and _.104(e)(1); see NPRM p. 53960). To what extent does anthropological research fit this proposed exemption?
  1. The NPRM proposes to change the definition of “human subjects” research to include all research with biospecimens, whether or not they are identified. What this means is that any “secondary” use of biospecimens (that is, work with banked specimens collected by others in research or nonresearch settings) will require researchers to obtain permission from the individual sources of those biospecimens: the NPRM proposes that this be done through some form of blanket consent for “future unspecified use,” obtained at the time of collection (section _.102(e) and _.101(b)(3)(i); see NPRM p. 53942-6). Would such a change impact anthropological research, and if so, how?