Abstract
Research on incompetent humans raises ethical challenges, especially when there is no direct benefit to these research subjects. Contemporary codes of research ethics typically require that such research must specifically serve to benefit the population to which the research subjects belong. The article critically examines this “same-population condition”, raising issues of both interpretation and moral justification. Of particular concern is the risk that the way in which the condition is articulated and rationalized in effect disguises or downplays the instrumentalization of incompetent individuals.
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Notes
And, with the same wording, in Art. 15 of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (Council of Europe 2005).
For example, the US Code of Federal Regulations, Title 45, Part 46, §46.406; and Sweden’s Act concerning the Ethical Review of Research Involving Humans, section 21. Cf. also the condition in the UK Clinical Trials Regulations, that enrollment of a minor should be allowed only if “some direct benefit of the group of patients involved in the trial is to be obtained from that trial.” (The Medicines for Human Use (Clinical Trials) Regulations 2004, Sched 1, Part 4, Para 9.) This condition is similar to the same-population condition in requiring a benefit for a group (as opposed to an individual), but different in that the relevant group is the group of research subjects.
See e.g. Wendler (2000), pp. 331–337, and Lewis (2002), pp. 602–605. Wendler and Lewis trace the origin of the subject’s condition requirement to Hans Jonas (1969). Jonas, however, could equally well be characterized as an early proponent of the same-population condition, and does not make any clear distinction between the two conditions.
As noted by Wendler, the same individuation problem arises in connection with the aforementioned “subject’s condition requirement” (Wendler 2000, p. 336).
This standard has been extensively discussed, see e.g. Buchanan and Brock (1990, pp. 112–122).
If indeed the same-population condition, when based on the assumption of hypothetical solidarity with one’s peers, serves to protect against exploitation, it does so for all individuals concerned, at all stages of research. Just like, for instance, requirements that research subjects not be put to significant risks, but unlike the necessity condition, the same-population condition could be thought to protect not only individuals who end up not being enrolled (since the same population would not benefit from the research), but also those who eventually do participate (since their participation can be assumed to accord with what they would want, and thus is not exploitative).
Wendler, for example, maintains that the relevant hypothetical preferences are the ones that the person would have under conditions that shape his or her actual preferences in real life, with little or no idealization of the person’s grasp of the facts, what he or she “really” wants, etc. However, he does not offer any argument for this position, and there are, in fact, good arguments to the contrary (see e.g. Broström and Johansson 2009, p. 269).
Also worth considering are the possibly more far-reaching problematic implications of giving weight to hypothetical preferences. Doing so invites the question why hypothetical consent could not be invoked as a general criterion for subjecting individuals to research—something that ethicists and legislators generally have not been prepared to do.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, Art. 15:1:ii, Declaration of Helsinki, 29 §, CIOMS, Guideline 13.
How restrictive this condition actually is clearly depends on details, of course, and more specifically on what features are taken to define the relevant group. Just by adding age as such a feature one opens the door for numerous opportunities to exploit vulnerable individuals. Healthy children, for example, could be enrolled as research subjects to the ultimate benefit of people suffering from any disease or disorder, as long as they are of roughly the same age.
Cf. the discussion of a relevant legal case in Kopelman (2002), where the author addresses the same idea in terms of a “public health model” of direct benefit to the individual, and notes that such a model seems to have been adopted on occasion. On this model, “a direct benefit might be a direct and individual benefit to each subject through a screening, monitoring, and abatement program, but might also be a benefit to the community by its gathering data for advocacy, future therapeutic breakthroughs, community improvements, and advances in public health and public education.” (p. 186.).
In the Explanatory report for the Oviedo Convention, the corresponding claim is formulated as follows: “[w]hile Article 16.ii restricts research in general by establishing a criterion of risk/benefit proportionality, Article 17 lays down a more stringent requirement for research without direct benefit to persons incapable of giving consent, namely only minimal risk and minimal burden for the individual concerned. Indeed, it is only in respecting these conditions that such research may be carried out without constituting an instrumentalisation of these persons contrary to their dignity” [our emphasis].
This question, it should be noted, applies to the necessity condition too.
For an overview see e.g. Meltzer and Childress (2008).
Declaration of Helsinki 27, The Oviedo Convention Art 17 2:ii, CIOMS 9.
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Acknowledgments
We would like to thank Morten Klemme Nielsen for helpful discussion. Thanks also to two anonymous reviewers for valuable comments and suggestions. This work would not have been possible without financial support from the Swedish Institute for Health Sciences.
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Johansson, M., Broström, L. Does peer benefit justify research on incompetent individuals? The same-population condition in codes of research ethics. Med Health Care and Philos 15, 287–294 (2012). https://doi.org/10.1007/s11019-011-9324-1
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DOI: https://doi.org/10.1007/s11019-011-9324-1