Ethical Challenges to Research

  • Greg A. Sachs
  • Harvey Jay Cohen

Abstract

For many years, one of the main items on the agenda of advocates for improved health care for older people has been the promotion of research on the medical problems that affect the elderly. Until the 1980s it was quite common for people over the age of 65 to be excluded from clinical trials, even from studies of disease that disproportionately affect the elderly, such as heart disease and cancer. Many clinical problems of older people received little or no research funding. Clearly, great strides have been made in the last two decades. There is a National Institute of Aging at the National Institutes of Health, geriatric medicine fellowships train investigators in research around the country, journals specializing in geriatric medicine and gerontology are flourishing, general medical journals abound with articles related to the care of the elderly, and clinical trials include older subjects, many even focus specifically on older adults. Yet, as research involving older human subjects has gone forward, many important ethical challenges to the conduct of this research have either surfaced or resurfaced.

Keywords

Nursing Home Nursing Home Resident Health Service Research Advance Directive Ethical Challenge 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Publications (OS) 78-0012, Appendix I; (OS) 78-0013, Appendix II; (OS) 78-0014. Washington, DC: US Dept of Health, Education, and Welfare; 1978.Google Scholar
  2. 2.
    Levine R J.Ethics and Regulation of Clinical Research. 2nd ed. New Haven: Yale University Press; 1986.Google Scholar
  3. 3.
    Sachs G A, Cassel CK. Biomedical research involving older human subjects.Law Med Health Care. 1990; 18: 234 - 243.PubMedGoogle Scholar
  4. 4.
    The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older patients with isolated systolic hypertension: final results of SHEP.JAMA. 1991; 265: 3255 - 3264.CrossRefGoogle Scholar
  5. 5.
    Zimmer AW, Calkins E, Hadley E, et al. Conducting clinical research in geriatric populations.Ann Intern Med. 1985; 103: 276 - 283.PubMedGoogle Scholar
  6. 6.
    Applegate WB, Curb JD. Designing and executing randomized clinical trials involving elderly persons.J Am Geriatr Soc. 1990; 38: 943 - 950.PubMedGoogle Scholar
  7. 7.
    Prentice ED, Antonson DL, Leibrock LG, et al. IRB review of a phase II randomized clinical trial involving incompetent patients suffering from severe closed head injury.IRB: AReview of Human Subjects Research. 1993; 15 (5): 1 - 7.PubMedCrossRefGoogle Scholar
  8. 8.
    Fost N, Robertson JA. Deferring consent with incompetent patients in an intensive care unit.IRB: A Review of Human Subjects Research. 1980; 2 (7): 5 - 6.Google Scholar
  9. 9.
    Olson CM. The letter or the spirit: consent for research inCPR. JAMA. 1994; 271: 1445 - 1447.PubMedCrossRefGoogle Scholar
  10. 10.
    Applebaum PS, Grisso T. Assessing patients’ capacities to consent to treatment.N Engl J Med. 1988; 319: 1635 - 1638.CrossRefGoogle Scholar
  11. 11.
    Fletcher JC, Dommel, FW Jr, Cowell DD. Consent to research with impaired human subjects.IRB: Review of Hu man Subjects Research. 1985; 7: 1 - 6.Google Scholar
  12. 12.
    High DM. Research with Alzheimer’s disease subjects: in consent and proxy decision making.J Am Geriatr 1992; 40: 950 - 957.Google Scholar
  13. 13.
    Sachs GA. Advance consent for dementia research.Alzheimer Dis Assoc Disord. 1994; 8 (suppl 4): 19 - 27.Google Scholar
  14. 14.
    American College of Physicians. Cognitively impairedsubjects (position paper).Ann Intern Med. 1989; 111: 843 - 848.Google Scholar
  15. 15.
    Melnick VL, Dubler NN, Weisbard A, et al. Clinical research in senile dementia of the Alzheimer type: suggested guidelines addressing the ethical and legal issues.J Am Geriatr Soc. 1984; 32: 531 - 536.Google Scholar
  16. 16.
    Hardwig J. What about the family?Hastings Cent Rep. 1990; 20 (2): 5 - 10.PubMedGoogle Scholar
  17. 17.
    Nelson HL, Nelson JL. Preferences and other moral sources.Hastings Cent Rep. 1994; 24 (suppl 6): S19 - S21.PubMedGoogle Scholar
  18. 18.
    Seckler AB, Meier DE, Mulvihill M, et al. Substituted judgment: how accurate are proxy predictions? Ann Intern Med. 1991; 115: 92 - 98.Google Scholar
  19. 19.
    Uhlmann RF, Pearlman RA, Cain KA. Physicians’ and spouses’ predictions of elderly patients’ resuscitation pref erences.J Gerontol Med. 1988; 43: M115 - 121.CrossRefGoogle Scholar
  20. 20.
    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Research Involving Children: Report and Recommendations. Publica tions (OS) 78-0004, Appendix; (OS) 78-0005. Washington, DC: US Dept of Health, Education, and Welfare; 1977.Google Scholar
  21. 21.
    Sachs, GA, Stocking CB, Stern R, et al. Ethics of dementia research: informed consent and proxy consent.Clin Res. 1994;42:403-412. Google Scholar
  22. 22.
    Sachs GA, Rhymes J, Cassel CK. The ethics of biomedical and behavioral research in nursing homes: guidelines for investigators.J Am Geriatr Soc. 1993; 41: 771 - 777.PubMedGoogle Scholar
  23. 23.
    Hofland B. Autonomy in long term care: background issues and a programmatic response.Gerontologist. 1988; 28 (suppl): 3 - 9.PubMedCrossRefGoogle Scholar
  24. 24.
    Collopy BJ. Autonomy in long term care: some crucialdistinctions. Gerontologist.1988;28(suppl):10-17. Google Scholar
  25. 25.
    Kane RA, Caplan AL, eds.Everyday Ethics: Resolving Dilemmas in Nursing Home Life. New York: Springer; 1990.Google Scholar
  26. 26.
    Bulger RE, Heitman E, Reiser SJ, eds.The Ethical Dimensions of the Biological Sciences.New York: Cambridge University Press; 1993.Google Scholar
  27. 27.
    Friedman PJ, ed. Integrity in biomedical research. Acad Med. 1993;68(suppl 9):S1-S102.Google Scholar
  28. 28.
    Association of American Medical Colleges.Teaching the Responsible Conduct of Research Through a Case Study Approach: A Handbook for Instructors. Washington, DC: Association of American Medical Colleges, 1994. FormedGoogle Scholar
  29. 29. Mills JL. Data torturing.N Engl J Med. 1993;329:1196Soc. 1199.Google Scholar
  30. 30.
    Shapiro DW, Wenger NS, Shapiro MF. The contributions of authors to multiauthored biomedical research papers.JAMA. 1994; 271: 438 - 442.PubMedCrossRefGoogle Scholar
  31. 31.
    Kassirer JP, Angell M. Financial conflicts of interest in biomedical research.N Engl J Med. 1993; 329: 570 - 571.PubMedCrossRefGoogle Scholar
  32. 32.
    Jones JH.Bad Blood: The Tuskegee Syphilis Experiment A Tragedy of Race and Medicine. New York: Free Press; 1981.Google Scholar
  33. 33.
    Bennett JC (for the Board on Health Sciences Policy of theInstitute of Medicine). Inclusion of women in clinical trials-policies for population subgroups. N Engl J Med. 1993;329:288-292.Google Scholar
  34. 34.
    Merkatz RB, Temple R, Sobel S, et al. Women in clinical trials of new drugs: a change in food and drug administration policy. N Engl J Med. 1993; 329: 292 - 296.PubMedCrossRefGoogle Scholar
  35. 35.
    Krahn MD, Mahoney JE, Eckman MH, et al. Screening for prostate cancer: a decision analytic view.JAMA. 1994; 272: 773 - 780.PubMedCrossRefGoogle Scholar
  36. 36.
    Eley JW, Hill HA, Chen VW, et al. Racial differences in survival from breast cancer: results of the national cancer institute black/white cancer survival study.DAMA. 1994; 272: 947 - 954.CrossRefGoogle Scholar
  37. 37.
    Hellman S, Hellman DS. Of mice but not men: problems of the randomized clinical trial.N Engl J Med. 1991;324:1585-1589.Google Scholar
  38. 38.
    Passamani E. Clinical trials-are they ethical?N Engl JMed.1991;324:1589-1592.Google Scholar
  39. 39.
    Rothman KJ, Michels KB. The continuing unethical use of placebo controls.N Engl J Med. 1994; 331: 394 - 398.PubMedCrossRefGoogle Scholar
  40. 40.
    Brett A, Grodin M. Ethical aspects of human experimentation in health services research.JAMA. 1991;265:1854-1857.Google Scholar
  41. 41.
    Lynn J, Johnson J, Levine Ri. The ethical conduct of health services research: a case study of 55 institutions’ applications to the support project. Clin Res.1994;42:3-10.Google Scholar

Copyright information

© Springer Science+Business Media New York 1997

Authors and Affiliations

  • Greg A. Sachs
  • Harvey Jay Cohen

There are no affiliations available

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