Decisionally Impaired Persons in Research: Refining the Proposed Refinements

Journal of Law, Medicine and Ethics

Volumn 25, Issue 2-3, 1997, Pages 139-149

  DeRenzo, Evan G ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL AND BEHAVIORAL RESEARCH; ETHICS; GOVERNMENT; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; JUVENILE; MEDICAL ETHICS; MENTAL CAPACITY; MENTAL DISEASE; MENTAL HEALTH THERAPIES; PATIENT SELECTION; PROFESSIONAL STANDARD; RESEARCH SUBJECT; REVIEW; RISK ASSESSMENT; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; MENTAL HEALTH THERAPIES;

ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; ETHICS, MEDICAL; FEDERAL GOVERNMENT; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; MENTAL DISORDERS; MINORS; NONTHERAPEUTIC HUMAN EXPERIMENTATION; PATIENT SELECTION; RESEARCH SUBJECTS; RISK ASSESSMENT; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES;

EID: 0031150481     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.1997.tb01889.x     Document Type: Article

References (84)

1. See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 1-5; R. Dresser, "Mentally Disabled Research Subjects: The Enduring Policy Issues," JAMA, 276 (1996): 67-72; P.J. Hilts, "New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests," New York Times, Dec. 27, 1996, at B28; D. Addington, "The Use of Placebos in Clinical Trials for Acute Schizophrenia," Canadian Journal of Psychiatry, 40 (1995): 171-76; S.J. Delano and J.L. Zucker, "Protecting Mental Health Research Subjects Without Prohibiting Progress," Hospital and Community Psychiatry, 45 (1994): 601-03; D.M. High, ed., Special Issue, "Ethical and Legal Issues in Alzheimer Disease Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); G.A. Sachs, "Advance Consent for Dementia Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19-27; G.A. Sachs et al., "Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent," Journal of Clinical Research, 42 (1994): 403-12; and D.R. Weisburd, Special Issue, "Ethics in Neurobiological Research with Human Subjects," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).
2. See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 1-5; R. Dresser, "Mentally Disabled Research Subjects: The Enduring Policy Issues," JAMA, 276 (1996): 67-72; P.J. Hilts, "New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests," New York Times, Dec. 27, 1996, at B28; D. Addington, "The Use of Placebos in Clinical Trials for Acute Schizophrenia," Canadian Journal of Psychiatry, 40 (1995): 171-76; S.J. Delano and J.L. Zucker, "Protecting Mental Health Research Subjects Without Prohibiting Progress," Hospital and Community Psychiatry, 45 (1994): 601-03; D.M. High, ed., Special Issue, "Ethical and Legal Issues in Alzheimer Disease Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); G.A. Sachs, "Advance Consent for Dementia Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19-27; G.A. Sachs et al., "Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent," Journal of Clinical Research, 42 (1994): 403-12; and D.R. Weisburd, Special Issue, "Ethics in Neurobiological Research with Human Subjects," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).
3. See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 1-5; R. Dresser, "Mentally Disabled Research Subjects: The Enduring Policy Issues," JAMA, 276 (1996): 67-72; P.J. Hilts, "New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests," New York Times, Dec. 27, 1996, at B28; D. Addington, "The Use of Placebos in Clinical Trials for Acute Schizophrenia," Canadian Journal of Psychiatry, 40 (1995): 171-76; S.J. Delano and J.L. Zucker, "Protecting Mental Health Research Subjects Without Prohibiting Progress," Hospital and Community Psychiatry, 45 (1994): 601-03; D.M. High, ed., Special Issue, "Ethical and Legal Issues in Alzheimer Disease Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); G.A. Sachs, "Advance Consent for Dementia Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19-27; G.A. Sachs et al., "Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent," Journal of Clinical Research, 42 (1994): 403-12; and D.R. Weisburd, Special Issue, "Ethics in Neurobiological Research with Human Subjects," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).
4. See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 1-5; R. Dresser, "Mentally Disabled Research Subjects: The Enduring Policy Issues," JAMA, 276 (1996): 67-72; P.J. Hilts, "New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests," New York Times, Dec. 27, 1996, at B28; D. Addington, "The Use of Placebos in Clinical Trials for Acute Schizophrenia," Canadian Journal of Psychiatry, 40 (1995): 171-76; S.J. Delano and J.L. Zucker, "Protecting Mental Health Research Subjects Without Prohibiting Progress," Hospital and Community Psychiatry, 45 (1994): 601-03; D.M. High, ed., Special Issue, "Ethical and Legal Issues in Alzheimer Disease Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); G.A. Sachs, "Advance Consent for Dementia Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19-27; G.A. Sachs et al., "Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent," Journal of Clinical Research, 42 (1994): 403-12; and D.R. Weisburd, Special Issue, "Ethics in Neurobiological Research with Human Subjects," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).
5. See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 1-5; R. Dresser, "Mentally Disabled Research Subjects: The Enduring Policy Issues," JAMA, 276 (1996): 67-72; P.J. Hilts, "New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests," New York Times, Dec. 27, 1996, at B28; D. Addington, "The Use of Placebos in Clinical Trials for Acute Schizophrenia," Canadian Journal of Psychiatry, 40 (1995): 171-76; S.J. Delano and J.L. Zucker, "Protecting Mental Health Research Subjects Without Prohibiting Progress," Hospital and Community Psychiatry, 45 (1994): 601-03; D.M. High, ed., Special Issue, "Ethical and Legal Issues in Alzheimer Disease Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); G.A. Sachs, "Advance Consent for Dementia Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19-27; G.A. Sachs et al., "Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent," Journal of Clinical Research, 42 (1994): 403-12; and D.R. Weisburd, Special Issue, "Ethics in Neurobiological Research with Human Subjects," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).
6. See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 1-5; R. Dresser, "Mentally Disabled Research Subjects: The Enduring Policy Issues," JAMA, 276 (1996): 67-72; P.J. Hilts, "New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests," New York Times, Dec. 27, 1996, at B28; D. Addington, "The Use of Placebos in Clinical Trials for Acute Schizophrenia," Canadian Journal of Psychiatry, 40 (1995): 171-76; S.J. Delano and J.L. Zucker, "Protecting Mental Health Research Subjects Without Prohibiting Progress," Hospital and Community Psychiatry, 45 (1994): 601-03; D.M. High, ed., Special Issue, "Ethical and Legal Issues in Alzheimer Disease Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); G.A. Sachs, "Advance Consent for Dementia Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19-27; G.A. Sachs et al., "Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent," Journal of Clinical Research, 42 (1994): 403-12; and D.R. Weisburd, Special Issue, "Ethics in Neurobiological Research with Human Subjects," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).
7. See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 1-5; R. Dresser, "Mentally Disabled Research Subjects: The Enduring Policy Issues," JAMA, 276 (1996): 67-72; P.J. Hilts, "New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests," New York Times, Dec. 27, 1996, at B28; D. Addington, "The Use of Placebos in Clinical Trials for Acute Schizophrenia," Canadian Journal of Psychiatry, 40 (1995): 171-76; S.J. Delano and J.L. Zucker, "Protecting Mental Health Research Subjects Without Prohibiting Progress," Hospital and Community Psychiatry, 45 (1994): 601-03; D.M. High, ed., Special Issue, "Ethical and Legal Issues in Alzheimer Disease Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); G.A. Sachs, "Advance Consent for Dementia Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19-27; G.A. Sachs et al., "Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent," Journal of Clinical Research, 42 (1994): 403-12; and D.R. Weisburd, Special Issue, "Ethics in Neurobiological Research with Human Subjects," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).
8. See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 1-5; R. Dresser, "Mentally Disabled Research Subjects: The Enduring Policy Issues," JAMA, 276 (1996): 67-72; P.J. Hilts, "New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests," New York Times, Dec. 27, 1996, at B28; D. Addington, "The Use of Placebos in Clinical Trials for Acute Schizophrenia," Canadian Journal of Psychiatry, 40 (1995): 171-76; S.J. Delano and J.L. Zucker, "Protecting Mental Health Research Subjects Without Prohibiting Progress," Hospital and Community Psychiatry, 45 (1994): 601-03; D.M. High, ed., Special Issue, "Ethical and Legal Issues in Alzheimer Disease Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); G.A. Sachs, "Advance Consent for Dementia Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19-27; G.A. Sachs et al., "Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent," Journal of Clinical Research, 42 (1994): 403-12; and D.R. Weisburd, Special Issue, "Ethics in Neurobiological Research with Human Subjects," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).
9. See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18, no. 1 (1996): 1-5; R. Dresser, "Mentally Disabled Research Subjects: The Enduring Policy Issues," JAMA, 276 (1996): 67-72; P.J. Hilts, "New York Court Strikes Down Rules on Psychiatric Studies, Halting Some Tests," New York Times, Dec. 27, 1996, at B28; D. Addington, "The Use of Placebos in Clinical Trials for Acute Schizophrenia," Canadian Journal of Psychiatry, 40 (1995): 171-76; S.J. Delano and J.L. Zucker, "Protecting Mental Health Research Subjects Without Prohibiting Progress," Hospital and Community Psychiatry, 45 (1994): 601-03; D.M. High, ed., Special Issue, "Ethical and Legal Issues in Alzheimer Disease Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994); G.A. Sachs, "Advance Consent for Dementia Research," Alzheimer Disease and Associated Disorders, 8, Supp. 4 (1994): 19-27; G.A. Sachs et al., "Ethical Aspects of Dementia Research: Informed Consent and Proxy Consent," Journal of Clinical Research, 42 (1994): 403-12; and D.R. Weisburd, Special Issue, "Ethics in Neurobiological Research with Human Subjects," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994).
10. See J.W. Berg, "Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed Guidelines," Journal of Law, Medicine & Ethics, 24 (1996): 18-35; E.W. Keyserlingk 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 V.L. Melnick et al., "Clinical Research in Senile Dementia of the Alzheimer's Type," in V.L. Melnick and N. Dubler, eds., Alzheimer's Dementia: Dilemmas in Clinical Research (Clifton: Humana Press, 1985): 295-306
11. See J.W. Berg, "Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed Guidelines," Journal of Law, Medicine & Ethics, 24 (1996): 18- 35; E.W. Keyserlingk 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 V.L. Melnick et al., "Clinical Research in Senile Dementia of the Alzheimer's Type," in V.L. Melnick and N. Dubler, eds., Alzheimer's Dementia: Dilemmas in Clinical Research (Clifton: Humana Press, 1985): 295-306
12. See J.W. Berg, "Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed Guidelines," Journal of Law, Medicine & Ethics, 24 (1996): 18- 35; E.W. Keyserlingk 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 V.L. Melnick et al., "Clinical Research in Senile Dementia of the Alzheimer's Type," in V.L. Melnick and N. Dubler, eds., Alzheimer's Dementia: Dilemmas in Clinical Research (Clifton: Humana Press, 1985): 295-306
13. . 3. See Sachs, supra note 1; and American College of Physicians, "Cognitively Impaired Subjects: Position Paper," Annals of Internal Medicine, 111 (1989): 843-48.
14. See K.C. Glass and M. Speyer-Ofenberg, "Incompetent Persons as Research Subjects and the Ethics of Minimal Risk," Cambridge Quarterly of Healthcare Ethics, 5 (1996): 362-72.
15. "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).
16. See H. Jonas, "Philosophical Reflections on Experimenting with Human Subjects," Daedalus, 96 (1969): 219-47.
17. P.S. Appelbaum, "Rethinking the Conduct of Psychiatric Research," Archives of Internal Medicine, 54 (1997): 117-20.
18. See Sachs, supra note 1.
19. See Keyserlingk et al., supra note 2; and American College of Physicians, supra note 3.
20. See T.D., 626 N.Y.S.2d 1015; and A.E. Shamoo, "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.
21. See J. Moreno, Deciding Together: Bioethics and Moral Consensus (New York: Oxford University Press, 1995).
22. See E.G. DeRenzo, R.R. Connelly, and R. Love, "Assessment of Capacity to Give Consent for Research: State-of-the-Art and Beyond," Journal of Health Care Law & Policy, forthcoming; P.S. Appelbaum and T. Grisso, "The MacArthur Treatment Competence Study I: Mental Illness and Competence to Consent to Treatment," Law and Human Behavior, 19 (1995): 105-26; T. Grisso 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; T. Grisso and P.S. Appelbaum, "The MacArthur Treatment Competence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatment," Law and Human Behavior, 19 (1995): 149-74; B.C. White, Competence to Consent (Washington, D.C.: Georgetown University Press, 1994); and B. Mishkin, "Determining the Capacity for Making Health Care Decision," in N. Bilig and P.V Rabins, eds., Issues in Geriatric Psychiatry (Basel: Krager, Vol. 19, 1989): 151-66.
23. See E.G. DeRenzo, R.R. Connelly, and R. Love, "Assessment of Capacity to Give Consent for Research: State-of- the-Art and Beyond," Journal of Health Care Law & Policy, forthcoming; P.S. Appelbaum and T. Grisso, "The MacArthur Treatment Competence Study I: Mental Illness and Competence to Consent to Treatment," Law and Human Behavior, 19 (1995): 105-26; T. Grisso 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; T. Grisso and P.S. Appelbaum, "The MacArthur Treatment Competence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatment," Law and Human Behavior, 19 (1995): 149-74; B.C. White, Competence to Consent (Washington, D.C.: Georgetown University Press, 1994); and B. Mishkin, "Determining the Capacity for Making Health Care Decision," in N. Bilig and P.V Rabins, eds., Issues in Geriatric Psychiatry (Basel: Krager, Vol. 19, 1989): 151-66.
24. See E.G. DeRenzo, R.R. Connelly, and R. Love, "Assessment of Capacity to Give Consent for Research: State-of- the-Art and Beyond," Journal of Health Care Law & Policy, forthcoming; P.S. Appelbaum and T. Grisso, "The MacArthur Treatment Competence Study I: Mental Illness and Competence to Consent to Treatment," Law and Human Behavior, 19 (1995): 105-26; T. Grisso 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; T. Grisso and P.S. Appelbaum, "The MacArthur Treatment Competence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatment," Law and Human Behavior, 19 (1995): 149-74; B.C. White, Competence to Consent (Washington, D.C.: Georgetown University Press, 1994); and B. Mishkin, "Determining the Capacity for Making Health Care Decision," in N. Bilig and P.V Rabins, eds., Issues in Geriatric Psychiatry (Basel: Krager, Vol. 19, 1989): 151-66.
25. See E.G. DeRenzo, R.R. Connelly, and R. Love, "Assessment of Capacity to Give Consent for Research: State-of- the-Art and Beyond," Journal of Health Care Law & Policy, forthcoming; P.S. Appelbaum and T. Grisso, "The MacArthur Treatment Competence Study I: Mental Illness and Competence to Consent to Treatment," Law and Human Behavior, 19 (1995): 105-26; T. Grisso 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; T. Grisso and P.S. Appelbaum, "The MacArthur Treatment Competence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatment," Law and Human Behavior, 19 (1995): 149-74; B.C. White, Competence to Consent (Washington, D.C.: Georgetown University Press, 1994); and B. Mishkin, "Determining the Capacity for Making Health Care Decision," in N. Bilig and P.V Rabins, eds., Issues in Geriatric Psychiatry (Basel: Krager, Vol. 19, 1989): 151-66.
26. See E.G. DeRenzo, R.R. Connelly, and R. Love, "Assessment of Capacity to Give Consent for Research: State-of- the-Art and Beyond," Journal of Health Care Law & Policy, forthcoming; P.S. Appelbaum and T. Grisso, "The MacArthur Treatment Competence Study I: Mental Illness and Competence to Consent to Treatment," Law and Human Behavior, 19 (1995): 105-26; T. Grisso 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; T. Grisso and P.S. Appelbaum, "The MacArthur Treatment Competence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatment," Law and Human Behavior, 19 (1995): 149-74; B.C. White, Competence to Consent (Washington, D.C.: Georgetown University Press, 1994); and B. Mishkin, "Determining the Capacity for Making Health Care Decision," in N. Bilig and P.V Rabins, eds., Issues in Geriatric Psychiatry (Basel: Krager, Vol. 19, 1989): 151-66.
27. See E.G. DeRenzo, R.R. Connelly, and R. Love, "Assessment of Capacity to Give Consent for Research: State-of- the-Art and Beyond," Journal of Health Care Law & Policy, forthcoming; P.S. Appelbaum and T. Grisso, "The MacArthur Treatment Competence Study I: Mental Illness and Competence to Consent to Treatment," Law and Human Behavior, 19 (1995): 105-26; T. Grisso 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; T. Grisso and P.S. Appelbaum, "The MacArthur Treatment Competence Study III: Abilities of Patients to Consent to Psychiatric and Medical Treatment," Law and Human Behavior, 19 (1995): 149-74; B.C. White, Competence to Consent (Washington, D.C.: Georgetown University Press, 1994); and B. Mishkin, "Determining the Capacity for Making Health Care Decision," in N. Bilig and P.V Rabins, eds., Issues in Geriatric Psychiatry (Basel: Krager, Vol. 19, 1989): 151-66.
28. 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. 14. 45 C.F.R. § 46 (1991).
29. 45 C.F.R. § 46.102(I).
30. See Glass and Speyer-Ofenberg, supra note 4.
31. 45 C.F.R. § 46.303(d).
32. 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).
33. 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).
34. 45 C.F.R. § 46.111(2).
35. See R.J. Levine, "Research in Emergency Situations," JAMA, 273 (1995): 1300-02.
36. See National Commission, supra note 19.
37. 45 C.F.R. § 46.606(b).
38. National Commission, supra note 19, at 8-9.
39. Id. at 9.
40. 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).
41. Protection of Human Subjects: Informed Consent: Final Rules, 61 Fed. Reg. 51498-533 (1996).
42. See T.D., 626 N.Y.S.2d 1015; C. Lehmann, "Family Testimony Reveals Human Dimension of UCLA Schizophrenia Research Controversy," Psychiatric News, Mar. 17, 1995, at 13; J.C. Becker, "A Mother's Testimony," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994): 17; R.M. Veatch, The Patient as Partner: A Theory of Human-Experimentation Ethics (Bloomington: Indiana University Press, 1987); N. Howard-Jones, "Human Experimentation in Historical and Ethical Perspectives," Social Science and Medicine, 16 (1982): 1429- 48; and C.F. Withington, "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.
43. See T.D., 626 N.Y.S.2d 1015; C. Lehmann, "Family Testimony Reveals Human Dimension of UCLA Schizophrenia Research Controversy," Psychiatric News, Mar. 17, 1995, at 13; J.C. Becker, "A Mother's Testimony," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994): 17; R.M. Veatch, The Patient as Partner: A Theory of Human-Experimentation Ethics (Bloomington: Indiana University Press, 1987); N. Howard-Jones, "Human Experimentation in Historical and Ethical Perspectives," Social Science and Medicine, 16 (1982): 1429- 48; and C.F. Withington, "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.
44. See T.D., 626 N.Y.S.2d 1015; C. Lehmann, "Family Testimony Reveals Human Dimension of UCLA Schizophrenia Research Controversy," Psychiatric News, Mar. 17, 1995, at 13; J.C. Becker, "A Mother's Testimony," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994): 17; R.M. Veatch, The Patient as Partner: A Theory of Human-Experimentation Ethics (Bloomington: Indiana University Press, 1987); N. Howard-Jones, "Human Experimentation in Historical and Ethical Perspectives," Social Science and Medicine, 16 (1982): 1429- 48; and C.F. Withington, "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.
45. See T.D., 626 N.Y.S.2d 1015; C. Lehmann, "Family Testimony Reveals Human Dimension of UCLA Schizophrenia Research Controversy," Psychiatric News, Mar. 17, 1995, at 13; J.C. Becker, "A Mother's Testimony," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994): 17; R.M. Veatch, The Patient as Partner: A Theory of Human-Experimentation Ethics (Bloomington: Indiana University Press, 1987); N. Howard-Jones, "Human Experimentation in Historical and Ethical Perspectives," Social Science and Medicine, 16 (1982): 1429-48; and C.F. Withington, "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.
46. See T.D., 626 N.Y.S.2d 1015; C. Lehmann, "Family Testimony Reveals Human Dimension of UCLA Schizophrenia Research Controversy," Psychiatric News, Mar. 17, 1995, at 13; J.C. Becker, "A Mother's Testimony," Journal of the California Alliance for the Mentally Ill, 5, no. 1 (1994): 17; R.M. Veatch, The Patient as Partner: A Theory of Human-Experimentation Ethics (Bloomington: Indiana University Press, 1987); N. Howard-Jones, "Human Experimentation in Historical and Ethical Perspectives," Social Science and Medicine, 16 (1982): 1429- 48; and C.F. Withington, "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.
47. See C.K. Daugherty and G. Geller, "Hope and the Limits of Research," Hastings Center Report, 26, no. 5 (1996): 20-22.
48. T.L. Beauchamp and J.F. Childress, Principles of Biomedical Ethics (New York: Oxford University Press, 4th ed., 1994).
49. 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.
50. See P.S. Appelbaum, L.H. Roth, and C. Lidz, "The Therapeutic Misconception: Informed Consent in Psychiatry Research," International Journal of Law and Psychiatry, 5 (1982): 319-29; P.S. Appelbaum et al., "False Hopes and Best Data: Consent to Research and the Therapeutic Misconceptions," Hastings Center Report, 17, no. 2 (1987): 20-24; and P.R. Benson et al., "Information Disclosure, Subjects Understanding and Informed Consent in Psychiatric Research," Law and Human Behavior, 12 (1988): 455-75.
51. See P.S. Appelbaum, L.H. Roth, and C. Lidz, "The Therapeutic Misconception: Informed Consent in Psychiatry Research," International Journal of Law and Psychiatry, 5 (1982): 319-29; P.S. Appelbaum et al., "False Hopes and Best Data: Consent to Research and the Therapeutic Misconceptions," Hastings Center Report, 17, no. 2 (1987): 20-24; and P.R. Benson et al., "Information Disclosure, Subjects Understanding and Informed Consent in Psychiatric Research," Law and Human Behavior, 12 (1988): 455-75.
52. See P.S. Appelbaum, L.H. Roth, and C. Lidz, "The Therapeutic Misconception: Informed Consent in Psychiatry Research," International Journal of Law and Psychiatry, 5 (1982): 319-29; P.S. Appelbaum et al., "False Hopes and Best Data: Consent to Research and the Therapeutic Misconceptions," Hastings Center Report, 17, no. 2 (1987): 20-24; and P.R. Benson et al., "Information Disclosure, Subjects Understanding and Informed Consent in Psychiatric Research," Law and Human Behavior, 12 (1988): 455-75.
53. See T.D., 626 N.Y.S.2d 1015; and Shamoo, supra note 10.
54. M.R. Tonelli, "Substituted Judgment in Medical Practice: Evidentiary Standards on a Sliding Scale," Journal of Law, Medicine & Ethics, 25 (1997): 22-29.
55. See R. Dresser, "Dworkin on Dementia: Elegant Theory, Questionable Policy," Hastings Center Report, 26, no. 6 (1995): 32-38.
56. 45 C.F.R. § 46 (1991).
57. See Beauchamp and Childress, supra note 30.
58. See, for example, Keyserlingk et al., supra note 2; American College of Physicians, supra note 3.
59. See L.L. Emanuel et al., "Advance Directives for Medical Care - A Case for Greater Use," N. Engl. J. Med., 324 (1992): 889-95; and K. W. Davidson et al., "Physicians' Attitudes on Advance Directives," JAMA, 262 (1989): 2415-19.
60. See L.L. Emanuel et al., "Advance Directives for Medical Care - A Case for Greater Use," N. Engl. J. Med., 324 (1992): 889-95; and K. W. Davidson et al., "Physicians' Attitudes on Advance Directives," JAMA, 262 (1989): 2415-19.
61. See P.J. Greco et al., "The Patient Self-Determination Act and the Future of Advance Directives," Annals of Internal Medicine, 151 (1991): 277-80.
62. See Sachs, supra note 1; D.M. High, "Advance Directives and the Elderly: A Study of Intervention Strategies to Increase Use," Gerontologist, 33 (1993): 342-49; J. Lynn and J.M. Teno, "After the Patient Self-Determination Act: The Need for Empirical Research on Advance Directives," Hastings Center Report, 23, no. 1 (1993): 20-24; G.A. Sachs, C.B. Stocking, and S.H. Miles, "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 J. Hare and C. Nelson, "Will Outpatients Complete Living Wills? A Comparison of Two Interventions," Journal of General Internal Medicine, 6 (1991): 41-46.
63. See Sachs, supra note 1; D.M. High, "Advance Directives and the Elderly: A Study of Intervention Strategies to Increase Use," Gerontologist, 33 (1993): 342-49; J. Lynn and J.M. Teno, "After the Patient Self-Determination Act: The Need for Empirical Research on Advance Directives," Hastings Center Report, 23, no. 1 (1993): 20-24; G.A. Sachs, C.B. Stocking, and S.H. Miles, "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 J. Hare and C. Nelson, "Will Outpatients Complete Living Wills? A Comparison of Two Interventions," Journal of General Internal Medicine, 6 (1991): 41-46.
64. See Sachs, supra note 1; D.M. High, "Advance Directives and the Elderly: A Study of Intervention Strategies to Increase Use," Gerontologist, 33 (1993): 342-49; J. Lynn and J.M. Teno, "After the Patient Self-Determination Act: The Need for Empirical Research on Advance Directives," Hastings Center Report, 23, no. 1 (1993): 20-24; G.A. Sachs, C.B. Stocking, and S.H. Miles, "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 J. Hare and C. Nelson, "Will Outpatients Complete Living Wills? A Comparison of Two Interventions," Journal of General Internal Medicine, 6 (1991): 41-46.
65. See Sachs, supra note 1; D.M. High, "Advance Directives and the Elderly: A Study of Intervention Strategies to Increase Use," Gerontologist, 33 (1993): 342-49; J. Lynn and J.M. Teno, "After the Patient Self-Determination Act: The Need for Empirical Research on Advance Directives," Hastings Center Report, 23, no. 1 (1993): 20-24; G.A. Sachs, C.B. Stocking, and S.H. Miles, "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 J. Hare and C. Nelson, "Will Outpatients Complete Living Wills? A Comparison of Two Interventions," Journal of General Internal Medicine, 6 (1991): 41-46.
66. See A. Wichman and A.L. Sandler, "Research Involving Subjects with Dementia and Other Cognitive Impairments: Experience at the NIH, and Some Unresolved Ethical Considerations," Neurology, 45 (1995): 1777-78.
67. 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.
68. Maryland Health Care Decisions Act, Md. Code Ann. Health-Gen. I & II §§ 5-601 et seq. (1994 & 1996 Supp.).
69. Cruzan v. Director, Missouri Department of Health, 497 U.S. 261, 282-85 (1990).
70. See Glass and Speyer-Ofenberg, supra note 4.
71. See C. Burns, Legacies in Ethics and Medicine (New York: Science History Publications, 1977).
72. See D. Weatherall, Science and the Quiet Art: The Role of Medical Research in Health Care (New York: W.W. Norton, 1995).
73. See D.J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Harper-Collins, 1991).
74. See Withington, supra note 28.
75. See C. Levine, N.N. Dubler, and R.J. Levine, "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.
76. 21 C.F.R. pt. 50 (1996), 45 C.F.R. § 46 (1991); 61 Fed. Reg. 51498-533; and 60 Fed. Reg. 38353 (1995).
77. See B.A. Brody, J. Katz, and A. Dula, Commentary, "In Case of Emergency: No Need for Consent," Hastings Center Report, 27, no. 1 (1997): 7-12.
78. C.R. MacKay, "The Evolution of the Institutional Review Board: A Brief Overview of Its History," Clinical Research and Regulatory Affairs, 12, no. 2 (1995): 65-94.
79. See DeRenzo, Connelly, and Love, supra note 12.
80. See brief literature review in E.G. DeRenzo, "The Ethics of Involving Psychiatrically Impaired Persons in Research," IRB: A Review of Human Subjects Research, 16, no. 6 (1994): 7-9, 11.
81. H. Dallas, "Standards for Surrogate Decision Making: What the Elderly Want," Journal of Long-Term Care Administration, 17 (1989): 8-13; and D.W Brock, "What Is the Moral Authority of Family Members to Act as Surrogates for Incompetent Patients?," Milbank Quarterly, 74 (1996): 599-619.
82. H. Dallas, "Standards for Surrogate Decision Making: What the Elderly Want," Journal of Long-Term Care Administration, 17 (1989): 8-13; and D.W Brock, "What Is the Moral Authority of Family Members to Act as Surrogates for Incompetent Patients?," Milbank Quarterly, 74 (1996): 599-619.
83. Patient Self-Determination Act, 42 U.S.C. §§ 1395 et seq. (1994).
84. See Wichman and Sandler, supra note 42.