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Biomedical Research Involving Older Human Subjects

Published online by Cambridge University Press:  29 April 2021

Greg A. Sachs  and
Christine K. Cassel
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Extract

The increasing life expectancy and increasing proportion of the population over the age of 65 in most developing countries are both unprecedented demographic phenomena. In the United States, life expectancy has increased more in the last century than in all previous recorded history. Even in the last 20 years, there have continued to he unexpected and largely unexplainable declines in mortality rates leading to increasing numbers of people living beyond even the ages of 85, 90 or 100. It is not surprising, then, that there is a great interest in studies of aging among researchers in social science and policy studies. Further, since aging is generally associated with an increased risk of medical illness and declining function, research has been stimulated in many different health-related areas, such as clinical disease, basic molecular causes of aging, and health services research.

Type
Article
Information
Law, Medicine and Healthcare , Volume 18 , Issue 3 , Fall 1990 , pp. 234 - 243
Copyright
Copyright © 1990 American Society of Law, Medicine & Ethics

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References

Cassel, C.K., Brody, J.A., “Demography, epidemiology, and aging”, in Geriatric Medicine, Second edition, Cassel, , Riesenberg, , Sorensen, , Walsh, eds. New York, Springer-Verlag, 1990.Google Scholar
Cassel, C.K., “Certification: Another step for geriatric medicine”, JAMA 1987;258:1518–1519.Google Scholar
Levine, R.J., Ethics and Regulation of Clinical Research, Second Edition. New Haven, Yale Univerisity Press, 1986.Google Scholar
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “Research Involving Those Institutionalized as Mentally Infirm: Report and Recommendations.” DHEW Publication No. (os) 78–0006, Appendix, DHEW Publication No. (os) 78–0007, Washington, 1978.Google Scholar
Baker, M.T., Taub, H.A., “Readability of informed consent forms for research in a Veterans Administration medical center”, JAMA 1983;250:2646; Grundner, T.M., “On the readability of surgical consent forms”, N Engl J Med 1980;302:900–902; Riecken, H.W., Ravich, R., “Informed consent to biomedical research in Veterans Adminstration Hospitals”, JAMA 1982;248:344–348; LoVerde, M.E., Prochazka, A.V., Byyny, R.L., “Research consent forms: Continued unreadability and increasing length”, J Gen Intern Med 1989;4:410–412.CrossRefGoogle Scholar
LoVerde, et al, supra note 5.Google Scholar
Miller, R., Willner, H.S., “The two-part consent form: A suggestion for promoting free and informed consent”, N Engl J Med 1974;290:964–966.CrossRefGoogle Scholar
Schultz, A.L., Pardee, G.P., Ensinck, J.W., “Are research subjects really informed? (Informed Consent)”, West J Med 1975;123:76–80.Google Scholar
Cassileth, B.R., Zupkis, R.V., Sutton-Smith, K. et al. “Informed consent—why are its goals imperfectly realized?” N Engl J Med 1980;302:896–900.CrossRefGoogle Scholar
Riecken, et al, supra note 5.Google Scholar
Taub, H.A., Baker, M.T., “A reevaluation of informed consent in the elderly: A method for improving comprehension through direct testing”, Clin Res 1984;32:17–21; Stanley, B., Guido, J., Stanley, M. et al, “The elderly patient and informed consent: Empirical findings”, JAMA 1984;252:1302–1306.Google Scholar
Taub, and Baker, , id.Google Scholar
Cassileth, , supra note 9.Google Scholar
Stanley, et al, supra note 11.Google Scholar
Zimmer, A.W., Calkins, E., Hadley, E. et al, “Conducting clinical research in geriatric populations”, Ann Inter Med 1985;103:276–283.Google Scholar
Ratzan, R.M., “Cautiousness, risk, and informed consent in clinical geriatrics”, Clin Res 1982;30:345–353.Google Scholar
Zimmer, et al, supra note 15.Google Scholar
Faden, R.R., Beauchamp, T.L., A History and Theoruy of Informed Consent. Oxford, Oxford University Press, 1986.Google Scholar
Veatch, R.M., The Patient as Partner: A Theory of Human Experimentation Ethics. Bloomington and Indianapolis, Indiana University Press, 1987.Google Scholar
Levine, supra note 3Google Scholar
Kapp, M.B., “Medical treatment and the physician's legal duties”, In Geriatric Medicine, Second edition, Cassel, , Riesenberg, , Sorensen, , Walsh, eds. New York, Springer-Verlag, 1990.Google Scholar
Ramsey, P., The Patient as Person. Yale University Press, New Haven, 1970.Google Scholar
McCormick, R.A., “Proxy consent in the experimentation situation”, Perspect Biol Med 1974;18:2–20.Google Scholar
VanDeVeer, D., “Experimentation on children and proxy consent”, J Med Philosophy 1981;6:281–293.CrossRefGoogle Scholar
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “Research Involving Children: Report and Recommendations”.” DHEW Publications No. (OS) 78–0004, Appendix, DHEW Publication No. (OS) 78–0005, Washington, 1977.Google Scholar
Uhlmann, R.F., Pearlman, R.A., Cain, K.A., “Physicians’ and spouses’ predictions of elderly patients’ resuscitation preferences”, J Gerentology 1988;43:M115–121; Zweibel, N.R., Cassel, C.K., “Treatment choices at the end of life: A comparison of decisions by older patients and their physician-selected proxies”, The Gerontologist 1989;29:615–621.Google Scholar
Warren, J.W., Sobal, J., Tenney, J.H. et al, “Informed consent by proxy: An issue in research with elderly patients”, N Engl J Med 1986;315:1124–1128.CrossRefGoogle Scholar
Jonas, H., “Philosophical reflections on experimenting with human subjects”, In Experimentation with Human Subjects, ed. Freund, P.A.. New York, George Braziller, 1969.Google Scholar
Ibid.Google Scholar
Ibid.Google Scholar
Veatch, , supra note 18.Google Scholar
Cassel, C.K., “Research in nursing homes: Ethical issues”, J Am Geriatr Soc 1985;33:795–799.Google Scholar
Cassel, C.K., “Ethical issues in the conduct of research in long term care”, The Gerontologist 1988;28 (supl.):90–96.Google Scholar
Veatch, , supra note 19.Google Scholar
Stanley, B., Stanley, M., Guido, J. et al, “The functional competency of elderly at risk”, The Gerontologist 1988;28 (suppl.):53–58.Google Scholar
Tymchuk, A.J., Ouslander, J.G., Rahbar, B. et al, “Medical decision-making among elderly people in long term care”, The Gerontologist 1988;28 (suppl.):59–63; Tymchuk, A.J., Ouslander, J.G., Rader, N., “Informing the elderly: A comparison of four methods”, J Am Geriatr Soc 1986;34:818–822.CrossRefGoogle Scholar
National Commission, supra note 4.Google Scholar
Ibid.Google Scholar
American College of Physicians, “Cognitively impaired subjects (position paper)”, Ann Intern Med 1989;111:843–848.Google Scholar
National Commission, supra note 4.Google Scholar
Fletcher, J.C., Dommel, F.W. Jr., Cowell, D.D., IRB: Rev Human Subjects Res 1985;7:1–6.CrossRefGoogle Scholar
Cassel, , supra note 32.Google Scholar
ACP, supra note 38.Google Scholar
Brody, E.M., “Parent care as a normative family stress”, The Gerontologist 1985;25:19–29.Google Scholar
National Academy of Sciences, “The aging population in the twenty-first century: Statistics for health policy”, Gilford, D.M., ed. Wahington, D.C., NAS Press, 1988, pp.135–145.Google Scholar
National Commission, supra note 4.Google Scholar
Kane, R.A., Caplan, A., Eds. Everyday Ethics: Resolving Dilemmas in Nursing Home Life. New York, Springer Publishing, 1989.Google Scholar
Collopy, B.J., “Autonomy in long term care: Some crucial distinctions”, The Gerontologist 1988;28 (suppl.):10–17.CrossRefGoogle Scholar
Cassel, C.K., Jameton, A.L., “Dementia in the elderly: An analysis of medical responsibility”, Ann Intern Med 1981;94:802–807; Hauerwas, S., Suffering Presence: Theological Reflections on Medicine, the Mentally Handicapped, and the Church. Notre Dame, IN, University of Notre Dame Press, 1986.Google Scholar
Hoffman, P.B., Marron, K.R., Pillit, H. et al, “Obtaining informed consent in the teaching nursing home”, J Am Geriatr Soc 1983;31:565–569.Google Scholar
Ratzan, R.M., “The experiment that wasn't: A case report in clinical geriatric research”, The Gerontologist 1981;21:297–302.Google Scholar
Lipsitz, L.A., Pluchino, F.C., Wright, S.M., “Biomedical research in the nursing home: Methodolgical issues and subject recruitment results”, J Am Geriatr Soc 1987;35:629–634.CrossRefGoogle Scholar
Kaye, J.M., Lawton, P., Kaye, D., “Atttitudes of elderly people about clinical research on aging”, The Gerontologist 1990;30:100–106.Google Scholar
Jonas, , supra note 28.Google Scholar
Ibid.Google Scholar
Ibid.Google Scholar
Evans, D.A., Funkenstein, H.H., Albert, M.S. et al, “Prevalence of Alzheimer's disease in a community population of older persons: Higher than previously reported”, JAMA 1989;262:2551–2556.Google Scholar
Callahan, D., Setting Limits: Medical Goals in an Aging Society. New York, Simon & Schuster, Inc., 1987.Google Scholar