Decisionally Impaired Persons in Research: Refining the Proposed Refinements

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): 1–5; 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. 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. , “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).

See Berg J.W. , “Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed Guidelines,” Journal of Law, Medicine & Ethics, 24 (1996): 18–35; Keyserlingk E.W. , “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. , “Clinical Research in Senile Dementia of the Alzheimer's Type,” in Melnick V.L. Dubler N. , eds., Alzheimer's Dementia: Dilemmas in Clinical Research (Clifton: Humana Press, 1985): 295–306.

See Sachs , supra note 1; and American College of Physicians, “Cognitively Impaired Subjects: Position Paper,” Annals of Internal Medicine, 111 (1989): 843–48.

See Glass K.C. Speyer-Ofenberg M. , “Incompetent Persons as Research Subjects and the Ethics of Minimal Risk,” Cambridge Quarterly of Healthcare Ethics, 5 (1996): 362–72.

“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).

See Jonas H. , “Philosophical Reflections on Experimenting with Human Subjects,” Daedalus, 96 (1969): 219–47.

Appelbaum P.S. , “Rethinking the Conduct of Psychiatric Research,” Archives of Internal Medicine, 54 (1997): 117–20.

See Sachs , supra note 1.

See Keyserlingk , supra note 2; and American College of Physicians, supra note 3.

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): 14–16.

See Moreno J. , Deciding Together: Bioethics and Moral Consensus (New York: Oxford University Press, 1995).

See DeRenzo E.G. Connelly R.R. 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. 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. , “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. 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. Rabins P.V. , eds., Issues in Geriatric Psychiatry (Basel: Krager, Vol. 19, 1989): 151–66.

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.

45 C.F.R. § 46 (1991).

45 C.F.R. § 46.102(I).

See Glass Speyer-Ofenberg , supra note 4.

45 C.F.R. § 46.303(d).

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).

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).

45 C.F.R. § 46.111(2).

See Levine R.J. , “Research in Emergency Situations,” JAMA, 273 (1995): 1300–02.

See National Commission, supra note 19.

45 C.F.R. § 46.606(b).

National Commission, supra note 19, at 8–9.

Id. at 9.

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).

Protection of Human Subjects: Informed Consent: Final Rules, 61 Fed. Reg. 51498-533 (1996).

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.

See Daugherty C.K. Geller G. , “Hope and the Limits of Research,” Hastings Center Report, 16, no. 5 (1996): 20–22.

Beauchamp T.L. Childress J.F. , Principles of Biomedical Ethics (New York: Oxford University Press, 4th ed., 1994).

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.

See Appelbaum P.S. Roth L.H. Lidz C. , “The Therapeutic Misconception: Informed Consent in Psychiatry Research,” International Journal of Law and Psychiatry, 5 (1982): 319–29; Appelbaum P.S. , “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. , “Information Disclosure, Subjects Understanding and Informed Consent in Psychiatric Research,” Law and Human Behavior, 12 (1988): 455–75.

See T.D., 626 N.Y.S.2d 1015; and Shamoo , supra note 10.

Tonelli M.R. , “Substituted Judgment in Medical Practice: Evidentiary Standards on a Sliding Scale,” Journal of Law, Medicine & Ethics, 25 (1997): 22–29.

See Dresser R. , “Dworkin on Dementia: Elegant Theory, Questionable Policy,” Hastings Center Report, 26, no. 6 (1995): 32–38.

45 C.F.R. § 46 (1991).

See Beauchamp Childress , supra note 30.

See, for example, Keyserlingk , supra note 2; American College of Physicians, supra note 3.

See Emanuel L.L. , “Advance Directives for Medical Care—A Case for Greater Use,” N. Engl. J. Med., 324 (1992): 889–95; and Davidson K.M. , “Physicians' Attitudes on Advance Directives,” JAMA, 262 (1989): 2415–19.

See Greco P.J. , “The Patient Self-Determination Act and the Future of Advance Directives,” Annals of Internal Medicine, 151 (1991): 277–80.

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. 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. 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. Nelson C. , “Will Outpatients Complete Living Wills? A Comparison of Two Interventions,” Journal of General Internal Medicine, 6 (1991): 41–46.

See Wichman A. 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.

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.

Maryland Health Care Decisions Act, Md. Code Ann. Health-Gen. I & II §§ 5-601 et seq. (1994 & 1996 Supp.).

Cruzan v. Director, Missouri Department of Health , 497 U.S. 261, 282–85 (1990).

See Glass Speyer-Ofenberg , supra note 4.

See Burns C. , Legacies in Ethics and Medicine (New York: Science History Publications, 1977).

See Weatherall D. , Science and the Quiet Art: The Role of Medical Research in Health Care (New York: WW Norton, 1995).

See Rothman D.J. , Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Harper-Collins, 1991).

See Withington , supra note 28.

See Levine C. Dubler N.N. 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): 1–17.

21 C.F.R. pt. 50 (1996), 45 C.F.R. § 46 (1991); 61 Fed. Reg. 51498-533; and 60 Fed. Reg. 38353 (1995).

See Brody B.A. Katz J. Dula A. , Commentary, “In Case of Emergency: No Need for Consent,” Hastings Center Report, 27, no. 1 (1997): 7–12.

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): 65–94.

See DeRenzo Connelly Love , supra note 12.

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): 7–9, 11.

Dallas H. , “Standards for Surrogate Decision Making: What the Elderly Want,” Journal of Long-Term Care Administration, 17 (1989): 8–13; 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.

Patient Self-Determination Act, 42 U.S.C. §§ 1395 et seq. (1994).

See Wichman Sandler , supra note 42.