PER Vol. XVI, No.2, Spring 2003

Human Subject Regulations: Whom Are We Protecting From What, and Why?
Working to Align Incentives with Ethical Goals

by C. K. Gunsalus

C.K. Gunsalus is Special Counsel for the Office of University Counsel; Adjunct Professor for the College of Law; and Resident Associate, Center for Advanced Study at the University of Illinois, Urbana. Gunsalus was also the lead organizer of the conference on which this article is based.

There is considerable concern in professional societies and universities, especially in the behavioral and social sciences, over the problems surfacing in the application of human subject protection policies outside the biomedical arena. A working conference hosted by the University of Illinois Center for Advanced Study in April 2003[1] gathered a diverse group of scholars, federal officials, and representatives from disciplinary societies to share perspectives and information, and to discuss possible solutions to the dilemmas this is creating for university-based scholars whose work involves interactions with people. A paper in PER last year by Joan Sieber, Stuart Plattner and Philip Rubin[2] provided a compelling description of the problems surfacing as Institutional Review Boards (IRBs), their administrators and other university officials respond to a changing regulatory environment. Across the country, in a wide range of disciplines, there are increasing instances of hyperzealous interpretations of the regulations, including my favorite of the examples cited by Sieber, et. al., in which “A linguist seeking to study language development in a pre-literate tribe was instructed to have them read and sign a consent form.”[3]

The “mission creep” seen in IRBs across the country is stimulated by highly publicized university-wide research “shut downs” by federal regulators and the goal of limiting institutional liability, combined with sincere desire to assure protection of human subjects of research. The result, however well meaning, appears to have had a disproportionate effect upon research involving low-risk, low-harm methodologies in the social sciences and behavioral research.[4]

Unfortunately, more is at risk than misapplication of scarce resources: research in these areas is being delayed, sometimes forbidden or, perhaps more commonly, abandoned as word spreads about the difficulties of securing timely approval from local IRBs. Writing in Academe, Margaret Blanchard, the William Rand Keenan, Jr. Professor of Journalism and Mass Communication at UNC Chapel Hill, wrote of a faculty member in her department who used to give assignments involving current topics relevant to the lives of his students but, in light of IRB interactions,“says he now limits his class projects to 'bland topics and archived records.'”[5]

As mission creep has led IRBs to regulate fields totally unanticipated by the original drafters of the Common Rule,[6] the federal regulation governing research using human subjects, questions of academic freedom and of the First Amendment rights of researchers have begun to arise.[7]

Although these topics have been gaining increasing attention,[8] the Illinois Conference was the first targeted gathering of scholars and policy officials across a broad range of fields. Disciplines of those attending included anthropology, English, business, psychology, history, journalism, organizational behavior, law, ethnography, social work, philosophy, communications, sociology, and medicine. Federal officials from the National Science Foundation, Department of Education, and the Office of Human Research Protection attended[9].

The Illinois Conference focused on two sets of questions, the first definitional:

What is research? (Or, what is not research with human subjects as covered by the Common Rule?)

Second, we asked, more fundamentally perhaps:

Who are we protecting?

As these questions were examined, three distinct sources of the problems seen in non-biomedical research emerged at the conference: first, there are too many incentives in our present regulatory system for universities and their IRBs to focus on documentation of technical compliance (forms signed and properly filed) at the expense of substantive protections for human subjects. As Robert J. Levine stressed, “consent is a process, not an event.” This conflation of technical compliance with substantive ethical review is a significant complicating factor. Is there another way for a “good” IRB to demonstrate that it is meeting its obligations than to be able to document that all its signatures are in the right places? Some observers are concerned that the standards adopted by the new bodies offering accreditation for human subject protection programs, one of the more recent developments in the world of IRBs, may be increasing these bureaucratic incentives.

Second, too many people are “guessing” what others want them to do, a phenomenon I’ve dubbed “serial mind-reading." As we all know, mind-reading is an imperfect form of communication. In our current situation, IRB members “guess” what legal liabilities might exist, often without checking with their lawyers. Institutional officials “guess” what will protect them from the possibility of a death penalty shut-down. Researchers “guess” what might raise questions from their IRB and choose “safer” research. We must have better guidance, which should be more broadly disseminated. That is, we need consistency (and hence predictability) in IRB approval or disapproval of similar activities across institutions. While the local control of our IRB system allows review to be tailored to local knowledge and standards, it creates tremendous uncertainty and variability in areas where there are not shared understandings of harm, risk, the meaning of the applicable regulations and when they apply. For example, the definition of “minimal risk” is an area in which vastly better guidance must be provided when applied to research that does not involve physical discomfort or harm.

Finally, some forms of scholarship simply do not fit a regulatory model that derives from and focuses upon the protection of human subjects in biomedical research. Journalism, for example, puts a higher value on the public’s right to know than on the protection of the reputation of an individual who has been the subject of an investigative report, such as the proverbial crooked alderman. As put by Ivor Pritchard of the Department of Education at the conference, “an ethical journalist may responsibly “get” the subject of his or her story. An ethical psychologist may not.”

The stakes are high. In order to function soundly, compliance systems require acceptance and at least minimal respect from those who are regulated. Actions by IRBs that do not make sense to scholars and researchers in entire fields will impair (as they already may) the credibility of IRBs.

It became clear at the conference that the IRB community needs to hear and to respond to the accumulating concerns of researchers in non-biomedical fields and to listen non-defensively. No doubt, there are some uninformed, confused, inexperienced, and/or recalcitrant investigators who resent any oversight of their work. However, there is also significant evidence of very real problems even with “good” IRBs. Defensive attitudes that dismiss all concerns as unfounded, ignorant, misplaced, etc., do not help to protect human subjects of research. Substantive, thoughtful responses will.

Solutions proposed at the Illinois Conference include developing and disseminating better guidance on the application of existing definitions in the Common Rule, collecting and disseminating “best practices” on procedural matters, preparing information and drafting guidance for federal regulators and legislators as regulations and federal statutes are revised. For example, Robert Levine’s keynote speech, tracing the history of the Belmont Principles and the development of the Common Rule, highlighted the distance that has grown between the original regulatory meaning of “minimal risk” and its present application in some places. We must revisit the concept of the “vicissitudes of daily life” that we expect non-decisionally-impaired adults to accept, or at least endure, and issue better guidance for IRBs on it.

The Illinois Conference White Paper (under development) will also address how to differentiate research involving human subjects that is and is not covered. Many activities that involve “interactions” with humans are nonetheless not “covered research” involving human subjects and we need better to understand the difference. Responses to the panels elucidating federal policy and suggesting constructive directions by Ivor Pritchard of the Department of Education and Phillip Rubin of the National Science Foundation were helpful in sharpening the questions our community must resolve and that will be addressed in the White Paper.

In addition to developing better guidance on the meaning and coverage of present regulations, much improvement can be gained by disseminating procedural best practices. For example, one significant source of concern in many disciplines is the lack of appeal from IRB decisions applying the regulations to proposed activities. In fact, federal regulations—and many institutional policies—permit an appeal mechanism, but this is not widely known or understood nor is it clear how effective these appeal mechanisms are. Working with federal regulatory agencies, information on this and other aspects of how IRBs operate in practice is needed.

Relatedly, the Illinois White Paper will also describe various models for distributed responsibility that may assist both in reducing the burden on overworked IRBs and improving the quality of resulting oversight. There are many successfully operating models of oversight that provide accountability and meaningful protection for human subjects but do not require all scholarly activities to go through a central IRB.

Finally, the White Paper will examine the regulatory structure and explore possibilities for a more nuanced system of oversight. At the conference, participants debated whether there are potentially different levels of risk for research involving human subjects that would warrant different levels of review: 1) the current system requiring advance review and approval before certain activities (such as those involving more than minimal risk) may be undertaken; 2) a system providing for post-hoc complaints (perhaps applicable for endeavors such as oral history projects); and, 3) activities for which the recourse for addressing problems would be the legal system.

It does not detract from our broadly shared commitment to the ethical treatment and protection of human subjects of research to observe that our regulatory system is in need of improvements. There are many good ideas in circulation. The work of the Illinois Conference will be extended and joined with the efforts of others working toward such improvements.

[1] More information about the conference, and the positions papers submitted for it, can be found at: http://www.law.uiuc.edu/conferences/humansubject/index.asp

[2] Sieber, Joan E., Plattner, Stuart and Rubin, Philip, "How (Not) to Regulate Social and Behavioral Research," Professional Ethics Report, VolumeXV, Number 2, Spring 2002, pp. 2-4

[3] Ibid, p1.

[4] Gunsalus, C. K. "Human Subject Protections: Some Thoughts on Costs and Benefits in the Humanistic Disciplines." In Press. Available on conference website: http://www.law.uiuc.edu/conferences/humansubject/index.asp

[5] “Protecting Human Beings: Institutional Review Boards and Social Science Research,” Academe, May/June 2001. Available on-line at: http://www.aaup.org/publications/Academe/02mj/02mjftr.htm

[6] Code of Federal Regulations, Title 45. Public Welfare Department of Health and Human Services, National Institutes of Health, Office For Protection from Research Risks, Part 46: “Protection of Human Subjects.” Revised November 13, 2001; Effective December 13, 2001.

[7] Finkin, Mathew W. "Academic Freedom and the Prevention of Harm in Research in the Social Sciences and Humanities." Illinois Conference Proceedings. 2003. Available on conference website: http://www.law.uiuc.edu/conferences/humansubject/index.asp

[8] See guidance issued by the Division of Behavioral and Cognitive Sciences at the National Science Foundation at http://www.nsf.gov/bfa/dga/policy/hsfaqs.htm; advocacy efforts of the American Psychological Society at http://www.psychologicalscience.org/advocacy/irb; guidelines developed by the Oral History Association at http://www.law.uiuc.edu/conferences/humansubject/papers.asp, and Gunsalus, C. K. (2002), “Rethinking Protections for Human Subjects.” The Chronicle of Higher Education, November 15, 2002, p. B24.

[9] Representatives of the Centers for Disease Control were invited and accepted, but were unable to attend due to other pressing matters; epidemiological work can raise some of the same issues examined at the conference.

On May 23, 2003, the Office for Human Research Protections (OHRP) provided additional regulations[1] for the protection of prisoners as human subjects participating in biomedical or behavioral research conducted or supported by the Department of Health and Human Services (HHS). The new regulations address the fact that prisoners need additional safeguards because of the stress of making voluntary and educated decisions regarding participation as human subjects.

Institutional Review Boards (IRBs) review protocols involving prisoners as subjects and the research must now meet additional requirements. The new research requirements include elements such as: the risks must not be greater than risks that would be accepted by non-prisoner volunteers; control subjects must also be selected from among the prisoners; and participating in the research studies will have no effect on the parole chances of the prisoner. If the prisoners may not benefit from the research, then a consultation with experts, such as experts in penology, medicine and ethics, is also required before the research project can begin.

The new regulations also address the issue of a participant in a medical study becoming a prisoner during the study. In this instance, the IRB will review the protocol of the study and determine whether the subject can continue in the study.

BEING THE ME THAT NEVER WAS

by Brent Garland

I never truly felt whole until I cut off my arm.

This paradoxical statement is an illustrative example of the challenging ideas brought forth in physician-philosopher Carl Elliott’s newest book, Better Than Well: American Medicine Meets the American Dream. In this engaging, fresh and challenging look at “enhancement technologies,” Elliott takes a different approach than the recent tomes predicting either a disastrous loss of our “humanity,” or a wealth of benefits to be had by technological means.[1] Elliott’s approach is to instead look at our use of enhancement technologies as a method of revealing “pathologies in the way that we live,” and to examine more specifically the relationship between a fulfilling life and an “authentic” one.

One of the more intriguing aspects of Elliott’s inquiry is reflected in the title of the book. In several cases, the people utilizing the enhancement technologies report that they are finally their “true” selves as a result of these technologies—their true selves being someone they have never been. They are not merely made well, but are made “better than well.”

The obvious ethical question that arises is whether it is always “good” to utilize a technology that makes a person feel complete, fulfilled, or “better than well.” In the most extreme example of the paradox this question can produce, people with apotemnophilia, or the desire to be an amputee, only feel as if they are their “true” or authentic selves once they have a limb (or two) removed. Is healthy limb amputation an enhancing technology, one that is improving the individual’s well-being, or is it just playing into a psychopathology?

Before one gets the impression that this is a book whose primary focus is the bizarre, please note that nothing could be further from the truth. Elliott focuses on enhancement technologies that are fully familiar to anyone who has considered the issue: steroid use, anxiolytic drugs, selective serotonin reuptake inhibitors, cosmetic surgical procedures, and Ritalin, among others. To the extent that the discussion leads to technologies that are not intuitive, or are even shocking, this seems the result of two deliberate, and informative, choices in the book. The first is that Elliott chooses to use the common philosophical method of trying to determine a rule or principle relevant to the discussion at hand, then to examine whether such a rule works in an extreme case, such as that of the apotemnophiliac. If the rule or principle breaks down, this tells you something about the rule and about its assumptions.

The second choice[2] is to cast a deliberately wide net in considering what is an “enhancement technology.” The apparent operative definition Elliott uses is a minimal one, encompassing drugs and procedures which alter or “improve” existing human capabilities or characteristics. One benefit of this choice is that some technologies are included that typically haven’t been much discussed in the context of enhancement technologies, such as computer speech synthesis, accent reduction training, and endoscopic thoracic sypathectomy, a surgery that can relieve chronic blushing. As with the more extreme examples, these technologies also challenge assumptions about what constitutes an “enhancement,” and about whether a common set of rules or principles regarding enhancement technologies are discernable. A potential drawback of this approach is that Elliott only briefly addresses some of the core definitional questions of what should be considered an “enhancement technology,” and thus some of the more subtle aspects of this question are lost.[3]

The book as a whole takes a broad look at the questions posed by enhancement technologies and their potential uses, and places the inquiry in the larger framework of questioning the nature of identity. Elliott provides a new perspective for those who have already been considering the impacts of enhancement technologies, and a remarkable introduction for those to whom the subject is new.

Elliott, Carl, Better Than Well: American Medicine Meets the American Dream, New York: W.W. Norton & Company, 2003. US$26.95

[1] See, for example, “Utopia, Dystopia, or Just the Next Step?”, PER, Volume XV, Number 2, Spring 2002, for a review of books by Francis Fukuyama and Gregory Stock that examine enhancement technologies.

[2] One that could be either a strength or a weakness depending, in part, on the reader’s background in the issues.

[3] An excellent discussion on the difficulty of defining “enhancement technologies,” and of the distinctions between enhancement and treatment, is in a book edited by Erik Parens, entitled Enhancing Human Traits: Ethical and Social Implications (Georgetown University Press, 1998). Elliott refers to this work in his notes, and his declining to explore the issues more fully may simply be a recognition that this is a topic which requires a book-length treatment to address fully. That said, it would have been helpful to general readers to address the definitional issues more directly and in more detail than Better Than Well ultimately does.