Protecting human participants in long-term care research: The role of state law and policy

Journal of Aging and Social Policy

Volumn 16, Issue 3, 2004, Pages 13-33

  Kapp, Marshall B ^a  

^a SOUTHERN ILLINOIS UNIVERSITY   (United States)

Author keywords

Ethics; Law; Long term care; Regulation; Research

Indexed keywords

AGED; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CUSTODY; ETHICS; HEALTH CARE POLICY; HUMAN; LEGAL ASPECT; LONG TERM CARE; MEDICAL RESEARCH; PATIENT ADVOCACY; PATIENT SELECTION; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

AGED; BIOMEDICAL RESEARCH; HEALTH POLICY; HUMANS; LONG-TERM CARE; PATIENT ADVOCACY; PATIENT SELECTION; PROXY; UNITED STATES;

DECISION MAKING; ETHICS; HEALTH CARE; LEGISLATION;

EID: 5044237778     PISSN: 08959420     EISSN: 15450821     Source Type: Journal    
DOI: 10.1300/J031v16n03_02     Document Type: Article

References (34)

1. American Academy of Neurology Ethics and Humanities Subcommittee (1998). Ethical issues in clinical research in neurology: Advancing knowledge and protecting human research subjects. Neurology, 50, 592-95.
2. American College of Physicians (1989). Cognitively impaired subjects. Annals of Internal Medicine, 111, 843-48.
3. American Geriatrics Society Ethics Committee (1998). Informed consent for research on human subjects with dementia. Journal of the American Geriatrics Society, 46, 1308-10.
4. Baskin, S.A., Morris, J., Ahronheim, J.D., Meier, D.E., & Morrison, R.S. (1998). Barriers to obtaining consent in dementia research: Implications for surrogate decision-making. Journal of the American Geriatrics Society, 46, 287-90.
5. Bonnie, R.J. (1997). Research with cognitively impaired subjects: Unfinished business in the regulation of human research. Archives of General Psychiatry, 54, 105-11.
6. British Medical Research Council, Working Party on Research on the Mentally Incapacitated (1991). The Ethical Conduct of Research on the Mentally Incapacitated. London, UK: Author.
7. Capron, A.M. (1999). Ethical and human-rights issues in research on mental disorders that may affect decision-making capacity. New England Journal of Medicine, 340, 1430-34.
8. Derrickson, D. (1997). Informed consent to human subject research: Improving the process of obtaining informed consent from mentally ill persons. Fordham Urban Law Journal, 25, 143.
9. Dresser, R. (2001a). Dementia research: Ethics and policy for the twenty-first century. Georgia Law Review, 35, 661-90.
10. Dresser, R. (2001b). Advance directives in dementia research: Promoting autonomy and protecting subjects. IRB: Ethics & Human Research, 23, 1-6.
11. Dresser, R. (2000). Letter: Advance research directives: Implementation issues. Journal of the American Geriatrics Society, 48, 859-60.
12. Fleischman, A.R. (2001). Regulating research involving adults who lack decision making capacity. Pharos, 64, 12-17.
13. Flynn, L.M., & Honberg, R.S. (1998). Achieving proper balance in research with decisionally-incapacitated subjects. Journal of Health Care Law and Policy, 1, 174-92.
14. Hoffmann, D.E., & Schwartz, J. (1998). Proxy consent to participation of the decisionally impaired in medical research-Maryland's policy initiative. Journal of Health Care Law & Policy, 1, 123-153.
15. Institute of Medicine. (2001). Preserving public trust: Accreditation and human research participant protection programs. Washington, DC: National Academy Press.
16. Institute of Medicine (2003). Responsible research: A systems approach to protecting research participants. Washington, DC: National Academy Press.
17. Karlawish, J.H.T., & Casarett, D. (2001). Addressing the ethical challenges of clinical trials that involve patients with dementia. Journal of Geriatric Psychiatry and Neurology, 14, 222-28.
18. Kim, S.Y.H., Karlawish, J.H.T., & Caine, E.D. (2002). Current state of research on decision-making competence of cognitively impaired elderly persons. American Journal of Geriatric Psychiatry, 10, 151-165.
19. LeBlang, T.R., & Kirchner, J.L. (1996). Informed consent and Alzheimer's Disease research: Institutional review board policies and practices. In Becker, R. & Giacobini, E. (Eds.), Alzheimer's Disease: From Molecular Biology to Therapy. Boston: Birkauser.
20. Merz, J. (1998). IRB review: Necessary, nice, or needless? Annals of Epidemiology, 8, 479-81.
21. Michels, R. (1999). Are research ethics bad for our mental health? New England Journal of Medicine, 340, 1427-30.
22. Moreno, J.D., Caplan, A.L., & Wolpe, P.R., for the Members of the Project on Informed Consent, Human Research Ethics Group (1998). Updating protections for human subjects involved in research. Journal of the American Medical Association, 280, 1951-58.
23. National Bioethics Advisory Commission (1998). Research involving persons with mental disorders that may affect decisionmaking capacity. Bethesda, MD. Available at .
24. National Bioethics Advisory Commission (2001). Ethical and policy issues in research involving human participants. Bethesda, MD: U.S. Government Printing Office.
25. National Research Council (2003). Elder Mistreatment: Abuse, Neglect, and Exploitation in an Aging America. Washington, DC: National Academies Press.
26. Office of Inspector General, Department of Health and Human Services. (2000). Protecting human subjects: Status of recommendations. 0EI-01-97-00197. Washington, DC.
27. Rabins, P.V. (1998). Issues raised by research using persons suffering from dementia who have impaired decisional capacity. Journal of Health Care Law & Policy, 1, 22-35.
28. Schwartz, J. (2001). Oversight of human subjects research: The role of the states. In National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, Vol. II-Commissioned Papers and Staff Analysis. Bethesda, MD: U.S. Government Printing Office.
29. Uman, G.C., Hocevar, D., Urman, H.N., Young, R., Hirsch, M., & Kohler, S. (2000). Satisfaction surveys with the cognitively impaired. In Cohen-Mansfield, J., Ejaz, F.K., & Werner, P. (Eds.), Satisfaction Surveys with the Cognitively Impaired. New York: Springer Publishing Company.
30. U.S. General Accounting Office (2001). Human subjects research: HHS takes steps to strengthen protections, but concerns remain. GAO-01-775T. Washington, DC.
31. Wendler, D., Martinez, R.A., Fairclough, D., Sunderland, T., & Emanuel, E. (2002). Views of potential subjects toward proposed regulations for clinical research with adults unable to consent. American Journal of Psychiatry, 159, 585-91.
32. World Medical Association (2000). Declaration of Helsinki: Ethical principles for medical research involving human subjects (revised). Ferney-Voltaire, France: World Medical Association.
33. Yank, V., & Rennie, D. (2002). Reporting of informed consent and ethics committee approval in clinical trials. Journal of the American Medical Association, 287, 2835-38.
34. Yarborough, M., & Sharp, R.R. (2002). Restoring and preserving trust in biomedical research. Academic Medicine, 77, 8-14.