Abstract
Informed consent has been the most scrutinized and controversial aspect of clinical research ethics. Institutional review boards (IRBs), government regulatory agencies, and the threat of litigation have all contributed to increasingly detailed consent documents that hope to ensure that subjects are not misled or coerced. Unfortunately, the growing regulatory burden on researchers has not succeeded in protecting subjects, but has rather made the consent process less effective and has discouraged research on vulnerable populations. As a matter of fact, investigators and ethicists continue to identify failures of the consenting process, particularly concerning participation in research of older individuals. The challenges involved in ensuring appropriate consent from the elderly include physical frailty, reduced autonomy and privacy, and impaired decision-making capacity due to dementia, delirium, or other neuropsychiatric illnesses. Ageism among investigators also contributes to failure of informed consent. The evaluation and continuing re-evaluation of an individual’s decision-making capacity is critical but difficult. In the most extreme cases, the older adult’s ability to participate in the consent process is clearly impaired. However, in many instances, the decision-making capacity is only partially impaired but declines during the course of a research project. Implementing methods of effective communication may enable many frail elderly individuals to make informed decisions. Special challenges are posed by research on end-of-life care, which typically involves frail, older subjects who are uniquely vulnerable, and research is conducted in institutional settings where subtle violations of autonomy are routine. Clearly, the frail elderly represent a vulnerable population that deserves special attention when developing and evaluating an informed consent process. Two important ethical conflicts should be kept in mind. First, although vulnerable older patients must be protected, protection should not prevent research on this important population. Similarly, because informed consent documents are often written to prevent legal jeopardy, these technical documents, expressed in language sometimes difficult to understand, can prevent comprehension of basic issues, defeating the ethical purpose of human protection.
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References
Pullman D. Subject comprehension, standards of information disclosure and potential liability in research. Health Law J 2001; 9: 113–27.
Beecher HK. Ethics and clinical research. 1966. Bull WHO 2001; 79: 367–72.
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283: 2701–11.
Hogan DB, MacKnight C, Bergman H. Models, definitions, and criteria of frailty. Aging Clin Exp Res 2003; 15 (Suppl): 1–29.
Bayer A, Tadd W. Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval: descriptive study. BMJ 2000; 321: 992–3.
Horng S, Emanuel EJ, Wilfond B, et al. Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med 2002; 347: 2134–40.
Berg JW, et al. Informed consent: Legal theory and clinical practice, 2nd ed. Oxford: Oxford University Press, 2001: 352.
Sugarman J, McCrory DC, Hubal RC. Getting meaningful informed consent from older adults: a structured literature review of empirical research. J Am Geriatr Soc 1998; 46: 517–24.
Epstein LC, Lasagna L. Obtaining informed consent. Form or substance. Arch Intern Med 1969; 123: 682–8.
Kass NE, Sugarman J, Faden R, Schoch-Spana M. Trust, The fragile foundation of contemporary biomedical research. Hastings Cent Rep 1996; 26: 25–9.
Stineman MG, Musick DW. Protection of human subjects with disability: guidelines for research. Arch Phys Med Rehabil 2001; 82 (Suppl 2): S9–14.
Osuna E, Lorenzo MD, Perez-Carceles MD, Luna A. Informed consent: evaluation of the information provided to elderly patients. Med Law 2001; 20: 379–84.
Tymchuk AJ, Ouslander JG, Rader N. Informing the elderly. A comparison of four methods. J Am Geriatr Soc 1986; 34: 818–22.
Rikkert MG, van den Bercken JH, den Have HA, Hoefnagels WH. Experienced consent in geriatrics research: a new method to optimize the capacity to consent in frail elderly subjects. J Med Ethics 1997; 23: 271–6.
Alt-White AC. Obtaining “informed” consent from the elderly. West J Nurs Res 1995; 17: 700–5.
Christensen K, Haroun A, Schneiderman LJ, Jeste DV. Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatry Law 1995; 23: 353–65.
Bassett SS. Attention: neuropsychological predictor of competency in Alzheimer’s disease. J Geriatr Psychiatry Neurol 1999; 11: 200–5.
Royall DR, Cordes J, Polk M. Executive control and the comprehension of medical information by elderly retirees. Exp Aging Res 1997; 23: 301–13.
Kim SY, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer’s disease in providing informed consent for participation in research. Am J Psychiatry 2001; 158: 712–7.
Marson DC, Cody HA, Ingram KK, Harrell LE. Neuropsychologic predictors of competency in Alzheimer’s disease using a rational reasons legal standard. Arch Neurol 1995; 52: 955–9.
Marson DC, Mclnturff B, Hawkins L, Bartolucci A, Harrell LE. Consistency of physician judgments of capacity to consent in mild Alzheimer’s disease. J Am Geriatr Soc 1997; 45: 453–7.
Fitten LJ, Waite MS. Impact of medical hospitalization on treat-ment decision-making capacity in the elderly. Arch Intern Med 1990; 150: 1717–21.
Elliott C. Caring about risks. Are severely depressed patients competent to consent to research? Arch Gen Psychiatry 1997; 54: 113–6.
Lampinen P, Heikkinen E. Reduced mobility and physical activity as predictors of depressive symptoms among community-dwelling older adults: an eight-year follow-up study. Aging Clin Exp Res 2003; 15: 205–11.
Bonnie RJ. Research with cognitively impaired subjects. Unfinished business in the regulation of human research. Arch Gen Psychiatry 1997; 54: 105–11.
Cahill M, Wichman A. Research involving persons with cognitive impairments: results of a survey of Alzheimer disease research centers in the United States. Alzheimer Dis Assoc Dis-ord 2000; 14: 20–7.
Karlawish JH, Knopman D, Clark CM, et al. Informed consent for Alzheimer’s disease clinical trials: a survey of clinical investigators. IRB 2002; 24: 1–5.
Karlawish JH. Research involving cognitively impaired adults. N Engl J Med 2003; 348: 1389–92.
Warren JW, Sobal J, Tenney JH, et al. Informed consent by proxy. An issue in research with elderly patients. N Engl J Med 1986; 315: 1124–8.
Casarett DJ, Knebel A, Helmers K. Ethical challenges of palliative care research. J Pain Symptom Manage 2003; 25: S3–5.
Willison DJ, Keshavjee K, Nair K, Goldsmith C, Holbrook AM. Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness investigators. Patients’ consent preferences for research uses of information in electronic medical records: interview and survey data. BMJ 2003; 326: 373.
Moody HR. Ethics in an aging society. Baltimore: Johns Hopkins University Press, 1992: 288.
Boult, L, Dentler B, Volicer L, Mead S, Evans JM. Ethics Committee of the American Medical Directors Association. Ethics and research in long-term care: a position statement from the American Medical Directors Association. J Am Med Dir Assoc 2003; 4: 171–4.
High DM, Doole MM. Ethical and legal issues in conducting research involving elderly subjects. Behav Sci Law 1995; 13: 319–35.
Miller FG, Rosenstein DL. Reporting of ethical issues in publications of medical research. Lancet 2002; 360: 1326–8.
Bonetta L, Dove A, Watanabe M. The road to research is paved with restrictions. Nat Med 2003; 9: 630.
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Barron, J.S., Duffey, P.L., Byrd, L.J. et al. Informed consent for research participation in frail older persons. Aging Clin Exp Res 16, 79–85 (2004). https://doi.org/10.1007/BF03324536
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DOI: https://doi.org/10.1007/BF03324536