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Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research

Published online by Cambridge University Press:  01 January 2021

Ana S. Iltis
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Extract

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study.

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 39 , Issue 3 , Fall 2011 , pp. 488 - 501
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

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References

The 17 federal agencies are the following: Departments of Agriculture, Energy, Commerce, Housing and Urban Development, Justice, Defense, Education, Veterans Affairs, Health and Human Services, Transportation, and the National Aeronautics and Space Administration, Consumer Product Safety Commission, Agency for International Development, Environmental Protection Agency, National Science Foundation, Social Security Administration, and Central Intelligence Agency. “Federal Policy for the Protection of Human Subjects; Notices and Rules,” 56 Fed. Reg. 28002–28032 (June 18, 1991).Google Scholar
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Research involving greater than minimal risk and offering subjects no prospect of direct benefit may be approved only if: (a) The risk represents a minor increase over minimal risk; (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in §46.408. (45CFR46.406).Google Scholar
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Id. According to the National Commission, “Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical or psychological examination, of healthy children” (see supra note 4 [1977], at xx). This definition was not incorporated into the Common Rule, Subpart D, which regulates pediatric research. According to the Common Rule, “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 C.F.R. 46.102.i). For research involving prisoners, the Common Rule stipulates that “Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons” (45 C.F.R. 46.303.d). The indexing to healthy persons in the definition of minimal risk in research regarding prisoners but not children has been the subject of extensive discussion.Google Scholar
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There is an additional requirement that appears in the report that serves as a further side-constraint on such research. When research that involves procedures or interventions “that are reasonably commensurate with those inherent in their actual or expected medical, psychological or social situations,” children who can assent may be better able “to make a knowledgeable decision about their participation in research, based on some familiarity with the intervention or procedure and its effects,” and requiring commensurability can “assure that participation in research will be closer to the ordinary experience of the subjects.” The Commission added a requirement that the research procedures be reasonably commensurate with their actual or expected situations and “the anticipated knowledge is of vital importance for understanding or amelioration of the subjects' disorder or condition” (see supra note 4 [1977], at 7–8). The commensurability requirement tells us that when research participation is more like the subjects' daily lives, children who can assent can make better decisions. The requirement that research experiences be commensurate with subjects' actual or expected situations raises several questions about the premise. It is unclear how a child might use anticipated future experiences to assent (or dissent). Moreover, are children who do not yet have a disorder or condition but are expected to develop it expected to undergo certain procedures so that they, too, qualify under the commensurability requirement? Insofar as the commensurability requirement helps potential subjects assent (or dissent), it may help prevent inappropriate inclusion, i.e., inclusion without proper permission. But inclusion in research posing a minor increase over minimal risk and no prospect of direct benefit is not limited to children who can assent, so the commensurability requirement does nothing to avoid their inappropriate inclusion. At best, commensurability appears to be a requirement because it might help some children some of the time to decide whether to give or withhold assent. Commensurability does not justify restricting participation only to children with the disorder or condition under investigation. Children with other disorders or conditions might have commensurable experiences such that they might meet the commensurability requirement. As long as those other children are scientifically appropriate subjects, it seems that children with other disorders or conditions might qualify for research participation in studies on other disorders or conditions. The National Commission implicitly refutes the possibility that commensurability might justify including children who do not have the disorder or condition under investigation by stating that commensurability should not be used to justify doing research but rather should be treated as an additional requirement that should be met when the other conditions are met. So it is not part of the argument for a class-based exception but rather an additional requirement that must be met when attempting to invoke the class-based exception. Class membership is necessary even though others might have commensurable experiences.Google Scholar
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If one wishes to reject this conclusion, one should be able to specify which premise is false. I would argue that if one rejects this argument, one also is likely to have to reject the class-based exception to the exclusion rule since class plays no essential role in justifying the exception. For example, it may be the case that parents in fact do not have the authority to expose children to a minor increase over minimal risk without the prospect of direct benefit. If that is the case, then one must reject the class-based exception to the exclusion rule.Google Scholar
We should note that the same justification used for children would not work for prisoners or the institutionalized as mentally infirm, despite the fact that the National Commission's Report on Research Involving the Institutionalized as Mentally Infirm specifically refers to the Report on Research Involving Children in addressing the exclusion rule and exceptions to it. Neither prisoners nor the institutionalized mentally ill have anyone in authority over them in quite the same way that parents are in authority over their children.Google Scholar