In defense of a social value requirement for clinical research

Bioethics

Volumn 31, Issue 2, 2017, Pages 77-86

  Wendler, David ^a   Rid, Annette ^b  

^a Department of Bioethics at the US NIH Clinical Center ^*  (United Kingdom)

^b KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

Clinical research; Exploitation; Moral integrity of researchers; Research ethics; Research policy; Social value

Indexed keywords

CLINICAL RESEARCH; CLINICAL TRIAL; HUMAN; MORALITY; PRACTICE GUIDELINE; RESEARCH ETHICS; SCIENTIST; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); ETHICS; MEDICAL ETHICS; MEDICAL RESEARCH; SOCIAL PSYCHOLOGY;

BIOMEDICAL RESEARCH; CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; HELSINKI DECLARATION; HUMANS; MORALS; SOCIAL VALUES;

EID: 85009103713     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/bioe.12325     Document Type: Note

References (48)

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14. We also believe that there are upper limits on net risks to participants that cannot be justified even by tremendous social value; however, we cannot pursue this question here. Ibid.
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20. Many guidelines and regulations also allow waivers or modifications of the requirement to obtain the informed consent of competent adults when the research meets specified conditions, typically including being low risk and involving little, if any interaction with the participants. There has been surprisingly little discussion of what justifies research without consent under these conditions. Although we will not discuss the issue here, we suspect that any successful justification for waiving or modifying informed consent—just like any successful justification for research with participants who cannot consent—will have to cite at least in part the social value of the research.
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25. Wendler, op. cit. note 10: 154–165.
26. Resnik makes a similar argument, although he claims that the SVR applies only to research that poses more than minimal net risks. Resnik, op. cit. note 6. In our view, this position is not tenable because any level of net risk to participants who cannot consent, however small, requires justification.
27. For example, Resnik briefly considers whether risk imposition justifies an SVR and concludes that _placing restrictions on consensual risktaking in research is paternalistic_. This response seems to assume both that paternalism is always ethically inappropriate and the justification for requiring social value must trace to the (paternalistic) protection of participants. Resnik, op. cit. note 6: 7 (preprint).
28. Those offering high-risk employment still have an obligation to reduce the risks where possible, suggesting that the risks of even highly valuable research should be reduced as well. Rid &Wendler, op. cit. note 8.
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33. Wertheimer grants that _to the extent that prospective participants are altruistically motivated to contribute to the generation of medical knowledge, . . . social value is required to warrant their confidence._ However, he suggests – wrongly, in our view – that social value considerations are irrelevant for most participants because they are motivated by self-interest.Wertheimer, op. cit. note 5: 7.
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38. Wertheimer’s argument also depends on his account of exploitation. For present purposes, we bracket possible criticism of his view and instead focus on showing that an SVR is a compelling way of avoiding exploitation — on Wertheimer’s own account – given current research practices.
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42. Wertheimer, op. cit. note 5. Resnik pursues a similar line of argument in Resnik, op. cit. note 6.
43. Resnik argues along these lines when he writes that _. . . scientists and institutions have numerous options for compensating the public for its investments in the science._ However, he does not consider that private investigators and sponsors are taking advantage of public funding that specifically contributes to their enterprise, and that this can justify instituting an SVR as a matter of public policy as we argue here. Resnik, op. cit. note 6: 8 (preprint).
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45. Resnik, op. cit. note 6.
46. Wertheimer, op. cit. note 5.
47. Moreover, if successful, this approach would also address the potential for participant deception or fraud discussed above (section 3.4) without insisting on an SVR.
48. Emanuel et al., op. cit. note 7.