Hostname: page-component-cd9895bd7-gxg78 Total loading time: 0 Render date: 2024-12-26T08:52:23.320Z Has data issue: false hasContentIssue false

Decisionally Impaired Persons in Research: Refining the Proposed Refinements

Published online by Cambridge University Press:  01 January 2021

Extract

The ethics of involving persons with cognitive impairments and/or mental illness in research continues to gain academic and public attention. Concerns about the ability of such persons to provide ethically and legally valid consent and about the appropriateness of their research involvement in certain categories of studies have resulted in publication of guidelines, position papers, standards, and court decisions. These analyses address not only when and from whom informed consent may be obtained but also under what conditions it is ethically permissible to involve persons in research who are too decisionally impaired to provide their own consent.

It is an advance in research ethics that there is heightened appreciation of the need for greater protections for, and possibly research participation limitations on, persons unable to give their own consent. In our zeal to protect potentially vulnerable subjects, however, we must craft new protections carefully. Prudence is required in shaping and implementing any new protections.

Type
Article
Copyright
Copyright © American Society of Law, Medicine and Ethics 1997

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

See, for example, Appelbaum, P.S., “Drug-Free Research in Schizophrenia: An Overview of the Controversy,” IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 15; Dresser, R., “Mentally Disabled Research Subjects: The Enduring Policy Issues,” JAMA, 276 (1996): 67–72; Hilts, P.J., “New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests,” New York Times, Dec. 27, 1996, at B28; Addington, D., “The Use of Placebos in Clinical Trials for Acute Schizophrenia,” Canadian Journal of Psychiatry, 40 (1995): 171–76; Delano, S.J. and Zucker, J.L., “Protecting Mental Health Research Subjects Without Prohibiting Progress,” Hospital and Community Psychiatry, 45 (1994): 601–03; High, D.M., ed., Special Issue, “Ethical and Legal Issues in Alzheimer Disease Research,” Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); Sachs, G.A., “Advance Consent for Dementia Research,” Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19–27; Sachs, G.A. et al., “Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent,” Journal of Clinical Research, 42 (1994): 403–12; and Weisburd, D.R., Special Issue, “Ethics in Neurobiological Research with Human Subjects,” Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).Google Scholar
See Berg, J.W., “Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed Guidelines,” Journal of Law, Medicine & Ethics, 24 (1996): 1835; Keyserlingk, E.W. et al., “Proposed Guidelines for the Participation of Persons with Dementia as Research Subjects,” Perspectives in Biology and Medicine, 38 (1995): 319–62; see High, , supra note 1; and Melnick, V.L. et al., “Clinical Research in Senile Dementia of the Alzheimer's Type,” in Melnick, V.L. and Dubler, N., eds., Alzheimer's Dementia: Dilemmas in Clinical Research (Clifton: Humana Press, 1985): 295–306.Google Scholar
See Sachs, , supra note 1; and American College of Physicians, “Cognitively Impaired Subjects: Position Paper,” Annals of Internal Medicine, 111 (1989): 843–48.Google Scholar
See Glass, K.C. and Speyer-Ofenberg, M., “Incompetent Persons as Research Subjects and the Ethics of Minimal Risk,” Cambridge Quarterly of Healthcare Ethics, 5 (1996): 362–72.CrossRefGoogle Scholar
“Decision of the Day: Constitutional Law Rules Over Research on Mental Patients Invalid,” New York Law Journal, 216, no. 112 (1996) (summarizing T.D. v. New York State Office of Mental Health); and T.D. v. New York State Office of Mental Health, 626 N.Y.S.2d 1015 (N.Y. Sup. Ct. 1996).Google Scholar
See Jonas, H., “Philosophical Reflections on Experimenting with Human Subjects,” Daedalus, 96 (1969): 219–47.Google Scholar
Appelbaum, P.S., “Rethinking the Conduct of Psychiatric Research,” Archives of Internal Medicine, 54 (1997): 117–20.Google Scholar
See Sachs, , supra note 1.Google Scholar
See Keyserlingk, et al., supra note 2; and American College of Physicians, supra note 3.Google Scholar
See T.D., 626 N.Y.S.2d 1015; and Shamoo, A.E., “Our Responsibilities Toward Persons with Mental Illness as Human Subjects in Research,” Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994): 1416.Google Scholar
See Moreno, J., Deciding Together: Bioethics and Moral Consensus (New York: Oxford University Press, 1995).Google Scholar
See DeRenzo, E.G., Connelly, R.R., and Love, R., “Assessment of Capacity to Give Consent for Research: State-of-the-Art and Beyond,” Journal of Health Care Law & Policy, forthcoming; Appelbaum, P.S. and Grisso, T., “The MacArthur Treatment Competence Study I: Mental Illness and Competence to Consent to Treatment,” Law and Human Behavior, 19 (1995): 105–26; Grisso, T. et al., “The MacArthur Treatment Competence Study II: Measures of Abilities Related to Competence to Consent to Treatment,” Law and Human Behavior, 19 (1995): 127–48; Grisso, T. and Appelbaum, P.S., “The MacArthur Treatment Competence Study HI: Abilities of Patients to Consent to Psychiatric and Medical Treatment,” Law and Human Behavior, 19 (1995): 149–74; White, B.C., Competence to Consent (Washington, D.C.: Georgetown University Press, 1994); and Mishkin, B., “Determining the Capacity for Making Health Care Decision,” in Bilig, N. and Rabins, P.V., eds., Issues in Geriatric Psychiatry (Basel: Krager, Vol. 19, 1989): 151–66.Google Scholar
These include the institutional review board (IRB) of the National Institute on Aging, the Maryland Attorney General's Working Group, relevant subcommittees of the ethics committee of the National Institutes of Health's Clinical Center, and the New York State Department of Health's Advisory Work Group on Human Subject Research Involving Protected Classes.Google Scholar
45 C.F.R. § 46 (1991).Google Scholar
45 C.F.R. § 46.102(I).Google Scholar
See Glass, and Speyer-Ofenberg, , supra note 4.Google Scholar
45 C.F.R. § 46.303(d).Google Scholar
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Summing Up: Final Report on Studies of the Ethical and Legal Problems in Medicine and Biomedical and Behavioral Research (Washington, D.C.: U.S. Government Printing Office, Mar. 1983).Google Scholar
See National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations: Research Involving Children (Washington, D.C.: U.S. Government Printing Office, 1977).Google Scholar
45 C.F.R. § 46.111(2).Google Scholar
See Levine, R.J., “Research in Emergency Situations,” JAMA, 273 (1995): 1300–02.CrossRefGoogle Scholar
See National Commission, supra note 19.Google Scholar
45 C.F.R. § 46.606(b).Google Scholar
National Commission, supra note 19, at 8–9.Google Scholar
Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research: Final Rules, 21 C.F.R. pt. 50 (1996), 45 C.F.R. § 46 (1991).Google Scholar
Protection of Human Subjects: Informed Consent: Final Rules, 61 Fed. Reg. 51498-533 (1996).Google Scholar
See T.D., 626 N.Y.S.2d 1015; Lehmann, C., “Family Testimony Reveals Human Dimension of UCLA Schizophrenia Research Controversy,” Psychiatric News, Mar. 17, 1995, at 13; Becker, J.C., “A Mother's Testimony,” Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994): 17; Veatch, R.M., The Patient as Partner: A Theory of Human-Experimentation Ethics (Bloomington: Indiana University Press, 1987); Howard-Jones, N., “Human Experimentation in Historical and Ethical Perspectives,” Social Science and Medicine, 16 (1982): 1429–48; and Withington, C.F., “The Possible Conflict Between the Interests of Medical Science and Those of the Individual Patients, and the Latter's Indefeasible Rights,” in The Relation of Hospitals to Medical Education (Boston: Cupples, Uphman, 1886): 14–17.Google Scholar
See Daugherty, C.K. and Geller, G., “Hope and the Limits of Research,” Hastings Center Report, 16, no. 5 (1996): 2022.Google Scholar
Beauchamp, T.L. and Childress, J.F., Principles of Biomedical Ethics (New York: Oxford University Press, 4th ed., 1994).Google Scholar
One solution that has been regularly suggested in the literature is use of research advance directives. Research advance directives have potential to protect decisionally impaired research subjects. This mechanism will be discussed in detail infra note 38 and accompanying text.Google Scholar
See Appelbaum, P.S., Roth, L.H., and Lidz, C., “The Therapeutic Misconception: Informed Consent in Psychiatry Research,” International Journal of Law and Psychiatry, 5 (1982): 319–29; Appelbaum, P.S. et al., “False Hopes and Best Data: Consent to Research and the Therapeutic Misconceptions,” Hastings Center Report, 17, no. 2 (1987): 20–24; and Benson, P.R. et al., “Information Disclosure, Subjects Understanding and Informed Consent in Psychiatric Research,” Law and Human Behavior, 12 (1988): 455–75.CrossRefGoogle Scholar
See T.D., 626 N.Y.S.2d 1015; and Shamoo, , supra note 10.Google Scholar
Tonelli, M.R., “Substituted Judgment in Medical Practice: Evidentiary Standards on a Sliding Scale,” Journal of Law, Medicine & Ethics, 25 (1997): 2229.Google Scholar
See Dresser, R., “Dworkin on Dementia: Elegant Theory, Questionable Policy,” Hastings Center Report, 26, no. 6 (1995): 3238.CrossRefGoogle Scholar
45 C.F.R. § 46 (1991).Google Scholar
See Beauchamp, and Childress, , supra note 30.Google Scholar
See, for example, Keyserlingk, et al., supra note 2; American College of Physicians, supra note 3.Google Scholar
See Emanuel, L.L. et al., “Advance Directives for Medical Care—A Case for Greater Use,” N. Engl. J. Med., 324 (1992): 889–95; and Davidson, K.M. et al., “Physicians' Attitudes on Advance Directives,” JAMA, 262 (1989): 2415–19.Google Scholar
See Greco, P.J. et al., “The Patient Self-Determination Act and the Future of Advance Directives,” Annals of Internal Medicine, 151 (1991): 277–80.Google Scholar
See Sachs, , supra note 1; High, D.M., “Advance Directives and the Elderly: A Study of Intervention Strategies to Increase Use,” Gerontologist, 33 (1993): 342–49; Lynn, J. and Teno, J.M., “After the Patient Self-Determination Act: The Need for Empirical Research on Advance Directives,” Hastings Center Report, 23, no. 1 (1993): 20–24; Sachs, G.A., Stocking, C.B., and Miles, S.H., “Empowerment of the Older Patient: A Randomized, Controlled Trial to Increase Discussion and Use of Advance Directives,” Journal of the American Geriatric Society, 40 (1992): 269–73; and Hare, J. and Nelson, C., “Will Outpatients Complete Living Wills? A Comparison of Two Interventions,” Journal of General Internal Medicine, 6 (1991): 41–46.Google Scholar
See Wichman, A. and Sandler, A.L., “Research Involving Subjects with Dementia and Other Cognitive Impairments: Experience at the NIH, and Some Unresolved Ethical Considerations,” Neurology, 45 (1995): 1777–78.Google Scholar
The working group was established by Maryland's attorney general to consider how the involvement of decisionally impaired persons in research is or is not included in the Maryland Health Care Decisions Act of 1993 and other issues related specifically to the involvement of persons with psychiatric disease in biomedical research. The working group was convened in 1995, and continues its work today.Google Scholar
Maryland Health Care Decisions Act, Md. Code Ann. Health-Gen. I & II §§ 5-601 et seq. (1994 & 1996 Supp.).Google Scholar
Cruzan v. Director, Missouri Department of Health, 497 U.S. 261, 282–85 (1990).Google Scholar
See Glass, and Speyer-Ofenberg, , supra note 4.Google Scholar
See Burns, C., Legacies in Ethics and Medicine (New York: Science History Publications, 1977).Google Scholar
See Weatherall, D., Science and the Quiet Art: The Role of Medical Research in Health Care (New York: WW Norton, 1995).Google Scholar
See Rothman, D.J., Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Harper-Collins, 1991).Google Scholar
See Withington, , supra note 28.Google Scholar
See Levine, C., Dubler, N.N., and Levine, R.J., “Building a New Consensus: Ethical Principles and Policies for Clinical Research on HIV/AIDS,” IRB: A Review of Human Subjects Research, 13, nos. 1 & 2 (1991): 117.Google Scholar
21 C.F.R. pt. 50 (1996), 45 C.F.R. § 46 (1991); 61 Fed. Reg. 51498-533; and 60 Fed. Reg. 38353 (1995).Google Scholar
See Brody, B.A., Katz, J., and Dula, A., Commentary, “In Case of Emergency: No Need for Consent,” Hastings Center Report, 27, no. 1 (1997): 712.Google Scholar
MacKay, C.R., “The Evolution of the Institutional Review Board: A Brief Overview of Its History,” Clinical Research and Regulatory Affairs, 12, no. 2 (1995): 6594.Google Scholar
See DeRenzo, , Connelly, , and Love, , supra note 12.Google Scholar
See brief literature review in DeRenzo, E.G., “The Ethics of Involving Psychiatrically Impaired Persons in Research,” IRB: A Review of Human Subjects Research, 16, no. 6 (1994): 79, 11.Google Scholar
Dallas, H., “Standards for Surrogate Decision Making: What the Elderly Want,” Journal of Long-Term Care Administration, 17 (1989): 813; and Brock, D.W., “What Is the Moral Authority of Family Members to Act as Surrogates for Incompetent Patients?,” Milbank Quarterly, 74 (1996): 599–619.Google Scholar
Patient Self-Determination Act, 42 U.S.C. §§ 1395 et seq. (1994).Google Scholar
See Wichman, and Sandler, , supra note 42.Google Scholar