Human subjects protections in biomedical enhancement research: Assessing risk and benefit and obtaining informed consent

Journal of Law, Medicine and Ethics

Volumn 36, Issue 3, 2008, Pages 546-549

  Mehlman, Maxwell J ^a,b   Berg, Jessica W ^a  

^a CASE WESTERN RESERVE UNIVERSITY   (United States)

^b CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 50249136608     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2008.303.x     Document Type: Review

References (89)

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17. Id.
18. 45 CFR §46.111(a)(3).
19. Id.
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49. Id. Informed consent may also have beneficial effects such as making participants more compliant with research since they will be fully informed of the requirements before agreeing to participate.
50. 45 C.F.R. 46.
51. 21 C.F.R. 50.
52. There are few exceptions to the documentation requirement; 46 C.F.R. 117.
53. 45 C.F.R. 46.1l6(a).
54. Subpart B of the HHS guidelines.
55. Subpart C of the HHS guidelines.
56. Subpart D of the HHS guidelines and 21 C.F.R. 50.50.
57. 45 C.F.R. 46.11l(b).
58. E. Juengst Annotating the Moral Map of Enhancement: Gene Doping, the Limits of Medicine and the Spirit of Sport in T. Murray, ed., Ethics, Genetics and the Future of Sport: Implications of Genetic Modification Selection (Washington, D.C.: Georgetown University Press, in press). Expertise does not refer to the ability of a specific physician to do a specific kind of procedure, but instead to whether the intervention is part of the practice of medicine. Thus, we would not expect or require a traditional informed consent discussion in a situation where a physician happens to be offering haircut services to his patients. Physicians can claim no special expertise in offering haircuts (although perhaps the physician in question is also trained as a barber). The point is that when we imagine the paradigm situation in which informed consent operates, the assumption is that the intervention is one for which a physician has special expertise, and thus a physician has an ethical and legal obligation to provide information to the patient/subject about the intervention in question - this is one of the primary reasons for placing a disclosure obligation on the physician.
59. C. Simon, M. Elder, E. Kodish, and L. Siminoff Altruistic Discourse in the Informed Consent Process for Childhood Cancer Clinical Trials American Journal of Bioethics 6, no. 5 (2006 40 47.
60. In some sense, this is what is being argued in the debate about access to experimental drugs before FDA approval. Who should make the determination about whether the risks and potential benefits are worthwhile? See, e.g., Abigail Alliance for Better Access to Experimental Drugs v. von Eschenbach. 128 S. Ct. 1069 (2008).
61. See Berg et al., supra note 47, at 58-60.
62. See, e.g. FDA Breast Implant Consumer Handbook - 2004 available at < http://www.fda.gov/cdrh/breastimplants/hand-book2004/localcomplications.html (last visited June 13, 2008).
63. For example, the INAMED breast implant brochure includes the following in the list of benefits: "may result in a more flattering, better proportioned figure, more clothing options, and may enhance your confidence and self-esteem.".
64. There is a broader question about how to weight individual versus societal risks and benefits. This is addressed in greater detail elsewhere. E. Juengst, and D. Rubin, Taking the Long View: Should Downstream Social Risks Influence the Review of Biomedical Research with Enhancement Applications? (in preparation).
65. But see supra note 9; Emanuel's argument that nothing is really coercive.
66. F. Malick, J. Howard, and J. Koo Understanding the psychology of the cosmetic patients Dermatologic Therapy 21, no. 1 (2008 47 53.
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68. 45 CFR 46.111(2).
69. Consent requirement may also be altered under 45 C.F.R. 46.1l6(c), which refers to research studying public benefit programs. However, neither the exceptions in (c) nor (d) apply to research involving "nonviable neonates." 45 CFR 46.205(c)(5).
70. For a more complete discussion of deception research, see R. Levine, Ethics and Regulation of Clinical Research (Baltimore: Urban and Schwarzenberg, 1986 221 228.
71. In one study, Mondafinil was given to alleviate "excessive sleepiness" associated with SWSD.
72. 45 CFR 46.408(a).
73. There are other situations in which individual are "vulnerable, " but medical care is certainly one of the most significant.
74. National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, 2001, at 85-92.
75. Id.
76. See Berg et al., supra note 47, at 288-290.
77. Current proposed guidelines expected.
78. 45 CFR 46.11l(a)(2).
79. For a discussion of some of the ethics issues raised by deep brain stimulation, including the role of famly decision makers see, e.g., Paul Ford and Cynthia Kubu Stimulating Debate: Ethics in a Multidisciplinary Functional Neurosurgery Committee Journal of Medical Ethics 32, no. 2 (2006 106 109.
80. See, e.g., Ditto et al. Advance Directives as Acts of Communication: A Randomized Controlled Trial Archives of Internal Medicine 161, no. 3 (2001 421 430.
81. For example, a woman's spouse or boyfriend is usually closely involved in making breast augmentation decisions. See, e.g., R. Bracaglia, R. Fortunato, and S. Gentileschi A Simple Way to Choose the Right Implant Volume in Breast Augmentation Aesthetic Plastic Surgery 29, no. 5 (2005 407 408. J. Tebbetts and T. Tebbetts An Approach that Integrates Patient Education and Informed Consent in Breast Augmentation Plastic and Reconstructive Surgery 110, no. 3 (2002 971 978.
82. See Simon et al., supra note 58.
83. See National Bioethics Advisory Commission, supra note 74. Whether we have sufficient protections for economic vulnerability in the traditional research context is a question beyond the scope of this paper.
84. H. Singh Gurm and D. G. Litaker Framing Procedural Risks to Patients: Is 99% Safe the Same as a Risk of 1 in 100? Academic Medicine 75, no. 8 (2000 840 842.
85. E. Kaw Medicalization of Racial Features: Asian American Women and Cosmetic Surgery Medical Anthropology Quarterly 7, no. 1 (1993 74 89.
86. Id., at 79.
87. See National Bioethics Advisory Commission, supra note 74.
88. F. Bokhari, R. Mayes, and R. M. Scheftler An Analysis of the Significant Variation in Psychostimulant Use across the U.S. Pharmacoepidemiology and Drug Safety 14, no. 4 (April 2005 267 275.
89. M. A. Spillman and R. M. Sade Clinical Trials of Xenotrans-plantation: Waiver of the Right to Withdraw from a Clinical Trial Should Be Required Journal of Law, Medicine & Ethics 35, no. 2 (2007 265 272.