Question 25. Are there certain fields of study whose usual methods of inquiry were not intended to or should not be covered by the Common Rule (such as classics, history, languages, literature, and journalism) because they do not create generalizable knowledge and may be more appropriately covered by ethical codes that differ from the ethical principles embodied in the Common Rule? If so, what are those fields, and how should those methods of inquiry be identified? Should the Common Rule be revised to explicitly state that those activities are not subject to its requirements?
Answer: The Common Rule should cover only biomedical and behavioral research. It should be rewritten to exclude explicitly the social sciences, humanities, and journalism.
General comments on the scope of the Common Rule
For those interested in academic freedom, the most important questions in the ANPRM are those gathered as Question 25. I am heartened that OSTP and HHS have posed these vital questions, and I reply that the Common Rule should cover only the biomedical and behavioral research that Congress has authorized HHS to regulate.
Statutory authority covers only biomedical and behavioral research
As the ANPRM notes, the Common Rule draws its statutory authority primarily from 42 USC 289, which calls for the establishments of IRBs “to review biomedical and behavioral research involving human subjects.”
The ANPRM also cites 42 USC 300v, which established the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Section 300v(a)(1) of that title calls for membership in the commission to be split among three groups: (A) “individuals who are distinguished in biomedical or behavioral research,” (B) “ individuals who are distinguished in the practice of medicine or otherwise distinguished in the provision of health care,” and (C) “individuals who are distinguished in one or more of the fields of ethics, theology, law, the natural sciences (other than a biomedical or behavioral science), the social sciences, the humanities, health administration, government, and public affairs.”
Thus, federal law distinguishes between “biomedical or behavioral research” on the one hand and “the social sciences, the humanities, health administration, government, and public affairs” on the other. As the deputy general counsel of the Department of Health, Education, and Welfare put it in 1979, “if Congress had wished . . . to cover all human subjects research, rather than just biomedical and behavioral, it could have done so.”
The Common Rule should reflect the underlying statutes and apply only to biomedical and behavioral research.
The ANPRM notes that “While physical risks generally are the greatest concern in biomedical research, social and behavioral studies rarely pose physical risk but may pose psychological or informational risks. Some have argued that, particularly given the paucity of information suggesting significant risks to subjects in certain types of survey and interview-based research, the current system over-regulates such research.” I agree with the latter assessment.
Both the statute and the regulations were designed to address concerns raised in the 1973 Senate hearings. As the secretary of HEW explained in 1976,
The types of risk situations against which the regulations were designed to protect are suggested by the areas of concern which were addressed in the legislative hearings held in conjunction with the enactment of section 474 of the Public Health Service Act, 42 USC 289 1-3 (added by Pub. L. 93-348) . . .
The subjects addressed included the use of FDA-approved drugs for any unapproved purpose; psycho-surgery and other techniques for behavior control currently being developed in research centers across the nation; use of experimental intrauterine devises; biomedical research in prison systems and the effect of that research on the prison social structure; the Tuskegee Syphilis Study; the development of special procedures for the use of incompetents or prisoners in biomedical research; and experimentation with fetuses, pregnant women, and human in vitro fertilization . . .
The hearings did not address the risks of survey, observation, and interview-based research. Nor has the experience subsequent decades shown that this kind of research is particularly risky. One can find exceptions, but these are rare. Stuart Plattner put it well in 2006. “In all the years I was responsible for human-subjects issues at NSF, I never learned of one case in which a respondent was actually harmed from participation in anthropological research.” He concluded, “although the possibility of harm to participants in ethnographic research is real, the probability of harm is very low.”
As the ANPRM notes, “Over-regulating 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.”
Different scholarly disciplines adhere to different ethical codes
The U.S. IRB system was designed by experts in the ethics of medical and psychological experimentation. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research wrote the Belmont Report without any regard to the ethical codes developed by journalists or scholars in the social sciences and the humanities, and it is a poor fit for their work. Its insistence on the equitable selection of subjects is simply irrelevant when a researcher chooses people based on their unique characteristics. More significantly, instructions to “do no harm” cannot apply to investigative journalism and other forms of critical inquiry. IRBs have consistently proven themselves unable to make this distinction.
The new “excused” category may not work for research in which real names are the norm
When institutions do impose IRB authority on oral history and other research in which participants are generally identified, they can generally rule it exempt under the current Common Rule. But this category may disappear under the present proposal.
If that happens, this kind of research would be an awkward fit for the new “excused” category, which emphasizes privacy. While the new category rules “allow subjects to authorize researchers to disclose the subjects’ identities, in circumstances where investigators wish to publicly recognize their subjects in published reports, and the subjects appreciate that recognition,” its clear emphasis is on preserving the confidentiality of information. The present Common Rule does not require anonymity, but its emphasis on confidentiality has led IRBs to impose inappropriate demands on researchers, such as requiring oral historians to anonymize their narrators or destroy recordings and transcripts. If, as is likely, institutions determined that real-name research was not eligible for the new excused category, IRBs would find themselves reviewing research the ANPRM considers only a distraction.
Alternatively, institutions allow real-name research to proceed under the excused category. But if that were the case, then historians, journalists, and folkorists would find themselves submitting forms that said only that they did not intend to follow most of the provisions of the excused category. This would be nothing but a waste of time and paper.
Non-generalizability has proven an unreliable tool
ANPRM's Question 25 hints that regulators are considering letting journalists, historians and other humanists off the hook by declaring their work to be non-generalizable, and therefore not subject to regulation under the Common Rule.
The advantage of this approach is that it has something of a track record. The idea that "journalism, history, biography, philosophy" generally fall outside of the regulatory definition of research because they are not generalizable dates back at least to the 1999 report of the Human Subjects Research Subcommittee, Committee on Science, National Science and Technology Council, which argued that
a key aspect of research is that there be a systematic design in advance, generally utilizing a scientific approach or protocol, for the definite purpose of contributing to generalizable knowledge. Research can include a wide variety of activities including: experiments, observational studies, surveys, tests, and recordings designed to contribute to generalizable knowledge. It generally does not include such operational activities as: medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, fiscal or program audits, journalism, history, biography, philosophy, "fact-finding" inquiries such as criminal, civil and congressional investigations, intelligence gathering, and simple data collection or data collection for other purposes. However, some of these activities may include or constitute research in the specific circumstance where there is clear advance intent to contribute to generalizable knowledge with a formal scientific protocol.
In 2003, OHRP ruled that "most oral history interviewing projects are not subject to the requirements" of the regulation "primarily on the grounds that oral history interviews, in general, are not designed to contribute to 'generalizable knowledge.'" Most of the university policies excluding oral history from IRB jurisdiction do so on the grounds that it is not generalizable.
The ANPRM seems to suggest that the 1999 position might be "explicitly" written into the Common Rule, thus locking it in place and giving historians and narrators the freedom to converse without seeking official permission. For example, the Common Rule could be amended to read
For purposes of this policy, research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. This policy does not cover such operational activities as: medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, fiscal or program audits, journalism, history, biography, philosophy, "fact-finding" inquiries such as criminal, civil and congressional investigations, intelligence gathering, and simple data collection or data collection for other purposes.
If this were to happen, it could be a boon for scholars, research participants, and administrators alike. So the obvious response would be for historians and others to reply, "Why, yes, now that you mention it, we do not create generalizable knowledge!"
Yet this would leave problems.
For one thing, non-generalizability has proven an unreliable tool. OHRP has muddied the waters, apparently contending--for example--that "Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research" would constitute generalizable research because "the creation of such an archive would constitute research under 45 CFR part 46 since the intent is to collect data for future research."
This conflicts with OHRP’s earlier determination that "oral history interviews, in general, are not designed to contribute to 'generalizable knowledge." If generalizable means that some future researcher might conceivably use the information, then nothing is non-generalizable. Do not daily newspapers; criminal, civil and congressional investigations; and disease monitoring all create an archive for future research?
Moreover, as Robert Townsend of the American Historical Association has noted,
The argument [that oral history is not generalizable] prompted some derision from outside the field, from academics who interpreted the phrase to say simply “history is not research.” (As a case in point, the vice president for research at my own university, after a fairly contentious meeting on the subject, wished me well on my “non-research dissertation.”)
We also received a number of complaints from within the discipline. Some historians argue that history does contribute generalizable knowledge, even if it bears little resemblance to the scientific definition of the word. And faculty members at history of medicine departments and in the social science side of history warned that this position undermined both their institutional standing and their ability to obtain grants. They made it clear that however finely worded, stating that history did not constitute research in even the most bureaucratic terms could have some real financial costs to the discipline.
More fundamentally, no one can be sure what generalizable means. It is left undefined in the Common Rule. The Belmont Report version is longer, but hardly more helpful:
The term ”research" designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.
This goes some way to distinguish research from diagnosis of an individual patient--the main goal of that section of the Belmont Report--but I am not even sure of that; I would hope that an MRI operator diagnosing a patient has an objective and a set of procedures designed to reach that objective.
Nor does it distinguish science from journalism, which regularly permits conclusions to be drawn and expresses statements of relationships.
Conversely, qualitative social scientists debate whether their work is generalizable. So "generalizable" covers research that the National Commission did not want covered and leaves uncovered research that the Commission did seek to regulate.
Serious observers have noted the problem. Tom Beauchamp recently complained that "generalizable knowledge," like other terms, "can be understood in several ways." Rena Lederman has found that "the regulatory definition did little to resolve the very ambiguities within medical practice for which it was designed. Heroic efforts of clarification can be found in works that interpret the Common Rule for IRBs. Nevertheless, to this day it continues to be a frequent topic of debate in IRB circles." And in 2008, David Strauss of the Secretary’s Advisory Committee on Human Research Protections complained that "we shouldn't be reviewing research that we don't think needs to be reviewed because some folks 30 years ago, at the end of a long, hot day, decided to use the word 'generalizable' . . . We have to have language that makes sense to us."
The Common Rule can be rewritten to exclude the research that should not be subject to oversight
I can imagine various ways to align the Common Rule with the statutes and the known risks. One would be to exclude particular types of research from the scope of the regulation.
In 1979, twelve scholarly and educational organizations offered the following formula:
These regulations do not apply to research using legally competent subjects that involves neither deceit nor intrusion upon the subject’s person nor denial or withholding of accustomed or necessary resources.
In 2006, the American Association of University Professors offered similar proposal:
Research on autonomous adults whose methodology consists entirely in collecting data by surveys, conducting interviews, or observing behavior in public places, [shall] be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption.
Either one of these would achieve the ANPRM’s goal of “facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” There should also be a provision for community research that might involve children or adults who are not legally competent. For example, an anthropologist living in a community should not trigger IRB review simply because he or she occasionally speaks to a child.
The regulatory definition must change
In addition, the regulatory definition must change. The Common Rule currently claims to regulate “research” even though it has no statutory authority to do so. It should be rewritten to emphasize its applicability only to biomedical and behavioral research.
For example, in place of the current definition of research, it could present a definition of biomedical and behavioral research:
Biomedical and behavioral research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge about the structure and function of the human mind and body. It does not include research about specific individuals, social groups, or organizations.
Alternatively, we could borrow language about "health information" from 46 CFR 160.103 and insert it in the Common Rule:
For purposes of this policy, research means biomedical and behavioral research.
Biomedical and behavioral research means an investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge by systematically collecting health information. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Health information through intervention or interaction with the individual, or
(2) Identifiable private health information.
Health information means any information, whether oral or recorded in any form or medium relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual. It does not include incidental information about an individual's health, such as the mention of a past illness in the course of an interview about a broad range of subjects.
Either of these definitions would achieve many of the objectives of the ANPRM and bring the regulations into compliance with the underlying statute.
I do not expect that this definition will resolve all cases; every definition has a core and hazier penumbra. I therefore urge the establishment of a federal body that will offer guidance on the hard cases after consulting the scholarly societies whose members will be affected.
 Zachary M. Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (JHU Press, 2010), 100.
 Department of Health, Education, and Welfare, "Secretary‘s Interpretation of ‘Subject at Risk,’" Federal Register 41 (28 June 1976), 26572.
 Stuart Plattner, “Comment on IRB Regulation of Ethnographic Research,” American Ethnologist 33 (2006), 526.
 Jonathan T. Church, Linda Shopes, and Margaret A. Blanchard, "Should All Disciplines Be Subject to the Common Rule?," Academe, May-June 2002, 62-69; Malone, Ruth E., Valerie B. Yerger, Carol McGruder, and Erika Froelicher. “‘It’s Like Tuskegee in Reverse’: A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research,” American Journal of Public Health 96, no. 11 (November 2006): 1914-1919.
 U.S. Agency for International Development, “Guide for Interpreting the Federal Policy for the Protection of Human Subjects”, February 2, 1999, http://www.usaid.gov/our_work/global_health/home/TechAreas/commrule.html.
 Michael A. Carome, "Letter to Linda Shopes and Donald A. Ritchie, 22 September 2003," http://www.historians.org/press/IRBLetter.pdf (24 June 2008)
 “Michael Carome’s Email”, n.d., http://www.nyu.edu/research/resources-and-support-offices/getting-started-withyourresearch/human-subjects-research/forms-guidance/clarification-on-oral-history/michael-caromes-email.html.
 Robert B. Townsend, “AHA Today: Getting Free of the IRB: A Call to Action for Oral History”, August 1, 2011, http://blog.historians.org/news/1382/getting-free-of-the-irb-a-call-to-action.
 T. L. Beauchamp, “Viewpoint: Why our conceptions of research and practice may not serve the best interest of patients and subjects,” Journal of Internal Medicine 269 (April 2011): 383-387.
 Rena Lederman, “Comparative ‘Research’: A Modest Proposal concerning the Object of Ethics Regulation,” PoLAR: Political and Legal Anthropology Review 30, no. 2 (November 1, 2007): 305-327.
 Secretary’s Advisory Committee on Human Research Protections, Transcript, Sixteenth Meeting, 16 July 2008, 264.
 J. W. Peltason, "Comment on the Proposed Regulations from Higher Education and Professional Social Science Associations," IRB: Ethics and Human Research 2 (February 1980), 10
 “AAUP: Research on Human Subjects: Academic Freedom and the Institutional Review Board”, 2006, http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm.
 Frederick Schauer, “A Critical Guide to Vehicles in the Park,” New York University Law Review 83 (2008).