Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)

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INTRODUCTION, BACKGROUND, AND DEFINITIONS 33 semantic difficulties, which are related to substantive and theoretical differences. Three questions regarding terminology are addressed below: (1) what should individuals who volunteer to be part of a research study be called? (2) what elements and research contexts should be included in an HRPPP? and (3) what is accreditation? Subject or Participant? The committee received disparate, sometimes directly contradictory advice about what to call those individuals who participate in research but who are not investigators. Those studied in human research have been called “subjects,” “participants,” “patients,” “respondents,” “partners,” “interviewees,” “probands,” “volunteers,” and other terms. More recently, additional consideration has been given to the status of individuals who are identified by virtue of their relationship to the person who is the subject of the research, either because of biological or familial ties or because of membership in the same social, ethnic, or racial group. However, some of the terms apply only in a particular research context. Federal regulations and international guidelines refer to “human subjects” of research. The reason for this language is to distinguish the person being studied from the investigator, to make clear who is the object of study, and to signal a power asymmetry. The framework underlying the regulations is to “protect” the rights and interests of subjects, with the underlying premise being that those being studied are vulnerable when their interests conflict with those of science or investigators. The regulations are intended to make clear that when such conflicts arise, the human rights of subjects trump the scientific interests of investigators and their institutions. As discussed earlier, the initial framework for HRPPPs grew out of reaction against studies that put humans at risk for the benefit of science, particularly against their will or without their informed consent. It was natural to classify them as “human subjects,” to emphasize the power and information asymmetries, but without intending to imply a passive or demeaning role. This concept was further extended by focusing on “vulnerable” populations especially prone to coercion or at higher risk, such as children, prisoners, pregnant women, and those with diminished mental capacities. The “human subject” framework was fully intended to pit individual rights against collective interests, and therein lay its value. This framework of protection conflicts, however, with an alternative framework that sees research as a good in itself. Advocates (including prospective “human subjects”) have come to regard access to research as a right. AIDS activists argued for “drugs into bodies” and fundamentally reframed the debate about the role of individuals in research participation (Epstein, 1996). The same shift has spilled over into debates about women in health research, breast cancer research, and research on ethnic groups, minorities, and underserved populations (Batt, 1994; IOM, 1994, 1999; Love, 1995; Merkatz and Summers, 1997). 

INTRODUCTION, BACKGROUND, AND DEFINITIONS 34 Involvement in research is a topic of special sensitivity to at least some members of minority populations; and what to call those who volunteer for research is a matter of serious debate, but no consensus has been reached. At the committee's public forum, one African-American speaker strongly urged the committee to abandon the term “human subject” because it was demeaning, locked into place a policy framework that emphasizes powerlessness and passivity, and cast the discussion in the penumbra of the Tuskegee Study (Ashe, 2001). Advocates concerned about American Indians, breast cancer, and mental illness have reiterated this recommendation to the committee. Yet, it was an African-American legal scholar who argued for use of the word “subject” because it rightly emphasizes real-world vulnerabilities and comports with established regulatory language. Debates about words reflect not just differences in referents but also differences in rhetorical purposes. The term “subject” highlights the reality of information and power imbalances, whereas the term “participants” or “partners” reflects a moral aspiration. One expresses subjects' need to be protected, but the other expresses the regard for participants' direct contribution and involvement in an ideal research system. Underlying practical differences exist beyond these political and moral differences. A human subject in one study may be a seriously ill patient deciding among experimental treatments under the guidance of a health care professional. Yet the same regulations that cover the seriously ill patient cover a student of journalism interviewing prominent business figures, in which the “subject” may be considerably more powerful than the investigator, as well as those who respond to a survey (if it contains personal identifiers) and have only glancing contact with any investigator. Even within the confines of clinical trials for drugs, a person participating in the trial may truly be the healthy “subject” in whom a prospective drug is being tested for dose and toxicity, may be someone choosing among small twigs of an elaborate and extensive decision tree, or may be a desperately ill patient choosing among options that are all risky and experimental. Thus, no one word can fit snugly into all these situations. NBAC devotes a section of its forthcoming oversight report to its choice of a term. In the end it has chosen to use the neutral word “participant” because it avoids some sensitivities and is unlikely to be confused with investigators in context. This choice has a cost in that it diverges from formal regulatory language and loses the immediate sense of vulnerability that the regulatory language was intended to signal. Most members of the present IOM committee nonetheless concur with NBAC's choice, “participant,” primarily because many of the committee's recommendations reinforce the aspiration to involve participants more directly in research and its oversight. The committee will therefore refer to “participants” except in contexts in which a more precise term is preferred.