Hostname: page-component-78c5997874-j824f Total loading time: 0 Render date: 2024-11-04T03:39:20.544Z Has data issue: false hasContentIssue false
  • English
  • Français

Ethical and Legal Issues in Enhancement Research on Human Subjects

Published online by Cambridge University Press:  11 January 2011

MAXWELL J. MEHLMAN ,
JESSICA W. BERG ,
ERIC T. JUENGST  and
ERIC KODISH
Get access Rights & Permissions [Opens in a new window]

Extract

The United States, along with other nations and international organizations, has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. These policies govern research that might provide direct health benefits to participants and research in which there is no prospect for participant health benefits. There has been little discussion, however, about how well these rules would apply to research designed to improve participants’ capabilities or characteristics beyond the goal of good health. When mentioned at all in the literature, this so-called enhancement research, as opposed to research aimed at diagnosing, preventing, curing, or treating illnesses or medical conditions, is usually dismissed without explanation.

Type
Special Section: Open Forum
Information
Cambridge Quarterly of Healthcare Ethics , Volume 20 , Issue 1 , January 2011 , pp. 30 - 45
Copyright
Copyright © Cambridge University Press 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Moreno, JD. Mind Wars: Brain Research and National Defense. New York: Dana Press; 2006.Google Scholar

2. Botox Prescribing Information; 2007; available at http://www.botoxcosmetic.com/resources/pi.aspx (last accessed 31 Dec 2007).

3. U.S. Food and Drug Administration. Important information for augmentation patients about Mentor Memory-Gel® silicone gel-filled breast implants; 2006; available at http://www.fda.gov/cdrh/pdf3/p030053d.pdf (last accessed 24 Jun 2008); U.S. Food and Drug Administration. Patient labeling for INAMED® silicone-filled breast implants; 2006; available at http://www.fda.gov/cdrh/pdf2/P020056d.pdf (last accessed 24 Jun 2008).

4. U.S. Food and Drug Administration. Guidance for industry: Good reprint practices for the distribution of medical journal articles and medical or scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices; draft guidance; 2008; available at http://www.fda.gov/oc/op/goodreprint.html (last accessed 24 Jun 2008).

5. National Institutes of Health National Heart, Lung, Blood Institute Women’s Health Initiative; available at http://www.nhlbi.nih.gov/whi/ (last accessed 24 Jun 2008).

6. Juengst, E. The meaning of enhancement. In: Parens, E, ed. Enhancing Human Traits: Ethical and Social Implications. Washington, DC: Georgetown University Press; 1998;29–47.Google Scholar

7. Department of Health and Human Services, Agency for Healthcare Research and Quality. Short Stature: Criteria for Determining Disability in Infants and Children (Evidence Report/Technology Assessment 73); 2008; available at http://www.ahrq.gov/clinic/epcsums/shortsum.htm.Google Scholar

8. Johnson, T. What is 20/20 vision? 2004; available at http://www.uihealthcare.com/topics/medicaldepartments/ophthalmology/2020vision/index.html (last accessed 12 Jun 2008).Google Scholar

9. American Psychiatric Association. Healthy Minds, Healthy Lives: Gay, Lesbian, and Bisexual Issues; available at http://www.healthyminds.org/glbissues.cfm (last accessed 28 May 2008).Google Scholar

10. Apud, JA, Mattay, V, Chen, J, Kolachana, BS, Callicott, JH, Rasetti, R, et al. . Tolcapone improves cognition and cortical information processing in normal human subjects. Neuropsychopharmacology 2007;32:1011–20.CrossRefGoogle ScholarPubMed

11. Berg, JW, Mehlman, MJ, Rubin, DB, Kodish, E. Making all the children above average: Ethical and regulatory concerns for pediatricians in pediatric enhancement research. Clinical Pediatrics 2009;48:472–80.CrossRefGoogle ScholarPubMed

12. 45 C.F.R. § 46.111 (2008).

13. 45 C.F.R. § 46.111(b) (2008).

14. See note 11, Berg et al. 2009.

15. Castellanos, FX, Rapoport, JL. Effects of caffeine on development and behavior in infancy and childhood: A review of the published literature. Food and Chemical Toxicology 2002;40:1235–42.CrossRefGoogle ScholarPubMed

16. Tauer, CA. The NIH trials of growth hormone for short stature. IRB: A Review of Human Subjects Research 1994;16:1–9.CrossRefGoogle ScholarPubMed

17. Shah, S, Whittle, A, Wilfond, B, Gensler, G, Wendler, D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA 2004;291:476–82.CrossRefGoogle ScholarPubMed

18. 45 C.F.R. § 46.407 (2008).

19. In a letter from Donald L. Rosenstein, Chair NIMH IRB, to Michael Gottesman, Deputy Director, March 5, 2004, the proposed protocol was called “Effects of a single dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder: A function Magnetic Resonance study”; available at http://www.hhs.gov/ohrp/panels/jreview01/irbreq.pdf (last accessed 20 Oct 2009).

20. 45 C.F.R. § 46.204(b) (2008).

21. See note 20, 45 C.F.R. 2008.

22. 45 C.F.R. § 46.111(a)(2) (2008).

23. Berg, J. Owning persons: The application of property theory to embryos and fetuses. Wake Forest Law Review 2005;40:159.Google Scholar

24. Parfit, D. Reasons and Persons. Oxford: Oxford University Press; 1986:351–79.CrossRefGoogle Scholar

25. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; 1979; available at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm (last accessed 18 Feb 2008).Google Scholar

26. The FDA proposed regulations that would limit prisoners’ rights to participate in research, and prisoners initiated a lawsuit. Sun, M.Inmates sue to keep research in prisons. Science 1981;212:650–1CrossRefGoogle ScholarPubMed. The FDA withdrew its proposed regulations and never reissued them.

27. Office of Human Subjects Protections, National Institutes of Health. IRB guidebook; available at http://www.hhs.gov/ohrp/irb/irb_guidebook.htm (last accessed 20 Feb 2008).Google Scholar

28. See note 27, Office of Human Subjects Protections.

29. King, NMP, Robeson, R. Athlete or guinea pig? Sports and enhancement research. Studies in Ethics, Law and Technology 2007;1:1.CrossRefGoogle Scholar

30. Amateur Athletic Association Newsletter; December 2003; available at http://www.aafla.org/10ap/SportsLetter14-4/SLhome.html (last accessed 10 Jun 2005). As the newsletter explains, some critics deride the survey as unscientific.

31. World Anti-Doping Agency, http://www.wada-ama.org/en/index.ch2 (last accessed 20 Oct 2009).

32. See note 1, Moreno 2006.

33. Human experimentation: An overview on Cold War era programs: Testimony before the Legislation and National Security Subcommittee, House Committee on Government Operations, United States General Accounting Office (Sept. 28, 1994) (Testimony of Assistant Comptroller General Frank C. Conahan); available at http://archive.gao.gov/t2pbat2/152601.pdf (last accessed 18 Feb 2008).

34. Report of the Senate Committee on Veterans’ Affairs, 103d Cong. 2d Sess., Is military research hazardous to veterans’ health? Lessons spanning half a century (Comm. Print S. Prt. 103-97); available at http://www.gulfweb.org/bigdoc/rockrep.cfm#hallucinogens (last accessed 18 Feb 2008).

35. 32 C.F.R. § 219.101(f) (2005).

36. 10 U.S.C. § 980 (2006); 21 C.F.R § 50.24 (2008).

37. Brown, KD. An ethical obligation to our service members: Meaningful benefits for informed consent violations. South Texas Law Review 2006;47:919.Google Scholar

38. U.S. Army, Human Research Protection Office. Institutional policies and procedures, VI.B.2 (Possibility of coercion or undue influence) (2005); available at https://mrmc-www.army.mil/docs/rcq/HRPO_Policies_Procedures.pdf (last accessed 18 Feb 2008).

39. U.S. Army, Office of the Surgeon General. Reg. 15-2 I/11/89 (1989); available at https://mrmc-www.army.mil/docs/rcq/otsg15-2.pdf (last accessed 18 Feb 2008).

40. McManus, J, Mehta, SG, McClinton, AR, De Lorenzo, RA, Baskin, TW. Informed consent and ethical issues in military medical research. Academic Emergency Medicine 2005;12:1120–6.CrossRefGoogle ScholarPubMed