Melinda Gormley is blogging her experiences as a 2015-2016 AAAS Science and Technology Policy Fellow in the Environmental Protection Agency.
December, 2015
Washington, D.C.
Intent and Interpretation: What do the Changes to the Common Rule mean for History?
The Policy for the Protection of Human Subjects, a.k.a. the Common Rule, is undergoing its first significant revision since 1981. The proposed changes list many types of research that will be excluded from the policy, including oral history, journalism, biography, and historical scholarship activities. (See my November post for more information.) (link to this)
The goal of adding exclusions to the Common Rule, according to the group overseeing this policy revision, which is the Department of Health and Human Service’s Office of Human Research Protections (OHRP), is “to better calibrate the level of review to the level of risk.” Adding exclusions will alleviate the burdens that the Common Rule is currently having on important, non-invasive, low-risk research involving human subjects.
Excluded activities will not need to adhere to the Common Rule and will not be required to undergo review by an Internal Review Board (IRB). Having a list of exclusions aims to clarify what is and is not human subjects research so that it is easier to determine whether or not your research must obey the Common Rule. Learn more by watching OHRP’s video on exclusions.
While I see the benefits of excluding some historical and journalistic activities from the Common Rule, I worry about unforeseen consequences. In particular if the exclusion goes into effect as it is written now, it could cause problems for history as a discipline including decreasing governmental funding for historical research on scientific, technology, and medical topics.
What do the Changes Mean for History?
The exact wording in the Notice for Proposed Rulemaking (NPRM) marked for “exclusion” identifies, “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected” (NRPM, page 18; Section .101(b)(1)(ii)).
Of the eleven activities proposed as exclusions, only this one names academic disciplines. The others call attention to sources of information, methods of research, or uses of materials. This concern was raised in response to the July 2011 Advanced Notice of Proposed Rulemaking (ANPRM) and is summarized in the NPRM released on September 8, 2015.
“A significant minority of commenters opposed the exclusion of any fields of study, arguing that the activity itself rather than the academic discipline or training of the investigator should be the basis for the assessment of whether the activity should be excluded” (NPRM page 18).
The choice of wording in the NPRM is causing confusion about exactly what is being excluded. At the October 22, 2015 meeting of OHRP’s external advisory committee, called the Secretary’s Advisory Committee on Human Research Protections (SACHRP), a sub-committee voiced the concern that not all historical and journalistic activities will fall outside of the definition research in the Common Rule. The SACHRP sub-committee recommended to “revise 101(b)(1)(ii) to emphasize that the nature and purpose of the activity warrant the exclusion, not the academic discipline of the investigator.” They proposed the following rewording.
“Activities whose purpose is to collect and share evidence-based portrayals of specific individuals (with their knowledge and consent) who have themselves been selected as a result of the relevance of their personal experiences to the phenomena being studied.”
After comments from Jerry Menikoff, the Director of OHRP, and members of SACHRP, it was decided to merge the original language in the NPRM with the language suggested by the SACHRP sub-committee. (To see the recommendations about exclusions in general and about historical and journalistic activities, watch from 4:12:00 to 4:19:30 of day 2 of the October 2015 meeting.) SACHRP held two more days of meetings on December 3-4, 2015 during which they drafted their final recommendations for OHRP before the deadline. SACHRP members agreed to the following language.
“Oral history, journalism, biography, historical and other scholarship activities whose purpose is to collect and share evidence-based portrayals of specific individuals who have been selected as a result of the relevance of their personal experience to the phenomena being studied.”
OHRP doesn’t have to adopt the recommendations proposed by SACHRP.
Neither SACHRP nor OHRP consider it problematic for the exclusion to state “oral history, journalism, biography, and historical scholarship activities.” The intent of the proposed wording, according to OHRP, is to call attention to these types of activities, and not disciplines.
My concern is the difference between the original intent of the wording and possible interpretations after the policy goes into effect. As was evident during the rulemaking process, people may look at this exclusion and assume that it pertains to the entire disciplines of history and journalism. This is likely to continue to be the case if the wording is not clarified.
As a historian, I suggest alternative language for the exclusion. I prefer phrasing along the lines of the following:
· Oral history and journalistic interviews, biographical and historical scholarship, and other research activities that focus directly on the specific individuals about whom the information is collected.
· Activities that focus directly on the specific individuals about whom the information is collected such as oral history interviews, journalistic interviews, biographical scholarship, and historical scholarship.
Intent and Interpretation
Fueling my worry that this doesn’t bode well for history are the problems facing the humanities in the United States, the types of research supported by the National Science Foundation (NSF) that legislators have called into question, and the NSF’s definition of what it funds. Let me give you a few worst-case scenarios.
NSF funds research, and historical endeavors are excluded from the Common Rule because they do not fit the definition of research in this policy, viz. “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (section 45 CRF part 46.102d; my italics). Therefore, historical and journalistic activities that are not generalizable are excluded from the Common Rule. My concern is that NSF could stop supporting altogether research that does not contribute to generalizable knowledge or stop supporting research involving human subjects that does not fit the definitions laid out by the Common Rule. (See my November post for additional discussion). (link here before posting)
The NSF does specifically fund historical research though its Science, Technology, and Society (STS) program and attacks on NSF-funded research have included several proposals funded by the STS program. I worry that a legislator looking to axe this program or drastically decrease its budget could likewise find fodder through the Common Rule.
The Common Rule’s NPRM notes that, “The exclusions also identify certain research activities that are sufficiently low-risk and nonintrusive that the protections provided by the regulations are an unnecessary use of time and resources, whereas the potential benefits of the research are substantial” (page 16). Problems facing the humanities in recent years make me question the extent to which the potential benefits of historical research are seen as substantial enough to garner continued federal financial support.
Am I being overly pessimistic and paranoid? In one breath I tell myself that I am. In the next I decide I’m not. Then I worry about who may read this post and use what it says to attack my discipline.