Skip to main content
SpringerLink
Log in
Book cover

Encyclopedia of Aging and Public Health pp 49–63Cite as

The Participation of Cognitively Impaired Elderly in Research

  • Reference work entry

Introduction

A significant body of literature has developed that addresses the various ethical issues arising in the context of the recruitment and enrollment into research protocols of cognitively impaired individuals, institutionalized individuals, and elderly persons. Much of this discourse has taken place between professionals in the medical, public health, and legal arenas. This article is not intended to debate the various points raised in these discussions. Rather, it is intended as a guide to the relevant issues for individuals involved in the professional care and caregiving of cognitively impaired elderly individuals, whether residing in their communities or in institutions, who may be called upon by their elderly patients, family members, or friends to assist in decisionmaking regarding their participation in research.

The need for such guidance is critical and growing. Estimates suggest that 4 million people in the United States currently have Alzheimer's disease and, among...

This is a preview of subscription content, log in via an institution.

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   299.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD   219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

References

  • Advisory Committee on Human Radiation Experiments (1996) Final report. The Committee, Washington, DC

    Google Scholar 

  • Alzheimer's Association (1997a) National public policy program to conquer Alzheimer's disease. Alzheimer's Association, Chicago, IL

    Google Scholar 

  • Alzheimer's Association (1997b) Position statement: ethical issues in dementia research. Alzheimer's Association, Chicago, IL

    Google Scholar 

  • American Association on Mental Retardation (2004) Fact sheet: aging older adults and their aging caregivers. Available at http://www.aamr.org/Policies (last accessed November 10, 2004)

  • American College of Physicians (1989) Cognitively impaired subjects. Ann Intern Med 11(10):843–848

    Google Scholar 

  • American Psychiatric Association (2000) Diagnostic and statistical manual of mental disorders, 4th edn (revised). American Psychiatric Association, Washington, DC

    Google Scholar 

  • Annas GJ, Glantz LH (1997) Informed consent to research on institutionalized mentally disabled persons: the dual problems of incapacity and voluntariness. In: Shamoo AE (ed) Ethics in neurobiological research with human subjects: the Baltimore conference on ethics. Gordon & Breach, Amsterdam, pp. 55–79

    Google Scholar 

  • Backlar P (1998) Anticipatory planning for research participants with psychotic disorders like schizophrenia. Psychol Public Policy Law 4:829–848

    PubMed  CAS  Google Scholar 

  • Bein PM (1991) Surrogate consent and the incompetent experimental subject. Food Drug Cosmetic Law J 46(5):739–771

    Google Scholar 

  • Bergler JH, Pennington AC, Metcalfe M, Freis ED (1980) Informed consent: how much does the patient understand? Clin Pharmacol Ther 27:435–440

    PubMed  CAS  Google Scholar 

  • Bisbing S, McMenamin J, Granville R (1995) Competency, capacity, and immunity. In: ACLM Textbook Committee (ed) Legal medicine, 3rd ed. Mosby‐Year Book, St. Louis, Missouri, pp. 27–45

    Google Scholar 

  • Bonnie RJ (1997) Research with cognitively impaired subjects: unfinished business in the regulation of human research. Arch Gen Psychiatry 54(2):105–111

    PubMed  CAS  Google Scholar 

  • Brock D, Buchanan A (1989) Deciding for others. Cambridge University Press, Cambridge

    Google Scholar 

  • Brookmeyer R, Gray S, Kawas C (1998) Projections of Alzheimer's disease in the United States and the public health impact of delaying disease onset. Am J Public Health 88:1337–1342

    PubMed  CAS  Google Scholar 

  • Buckwalter KC, Stolley JM, Farran CJ (1999) Managing cognitive impairment in the elderly: conceptual, intervention and methodological issues. Online J Knowledge Synth Nursing 6(10).

    Google Scholar 

  • Bylsma FW (1997) Huntington's disease. In: Nussbaum PD (ed) Handbook of neuropsychology and aging. Plenum Press, New York, pp. 245–259

    Google Scholar 

  • Callahan CM, Hendrie HC, Tierney WM (1995) Documentation and evaluation of cognitive impairment in elderly primary care patients. Ann Intern Med 122(6):422–429

    PubMed  CAS  Google Scholar 

  • Cassel C (1985) Research in nursing homes: ethical issues. J Am Geriatr Soc 33:795–799

    PubMed  CAS  Google Scholar 

  • Cassel C (1988) Ethical issues in the conduct of research in long term care. Gerontologist 28:90–96

    Google Scholar 

  • Code of Federal Regulations (2005) Title 45, §§ 46.101, 46.102(c), 46.111(a)(4), 46.116.

    Google Scholar 

  • Cohen‐Mansfield J, Droge JA, Billing N (1991) The utilization of the durable power of attorney for health care among hospitalized elderly patients. J Am Geriatr Soc 39:1174–1178

    PubMed  CAS  Google Scholar 

  • Council of Europe (1997) Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine. Available at http://conventions.coe.int/Treaty/EN/Treaties/html/164.htm (last accessed March 18, 2005)

  • Council for International Organizations of Medical Sciences, World Health Organization. (2001) International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland

    Google Scholar 

  • De Lisa J, J, Gans B (eds) B (1993) Rehabilitation medicine: principles and practice, 2nd ed. J.B. Lippincott, Geneva, Switzerland

    Google Scholar 

  • Dresser RS (1992) Autonomy revisited: the limits of anticipatory choices. In: Binstock RH, Post SG, Whitehouse PJ (eds) Ethics, values, and policy choices. Johns Hopkins University Press, Baltimore, Maryland, pp. 71–85

    Google Scholar 

  • Dresser R (2001) Dementia research: ethics and policy for the twenty‐first century. Georgia Law Rev 35:661–690

    PubMed  CAS  Google Scholar 

  • Dworkin R (1994) Life's dominion: an argument against abortion, euthanasia, and individual freedom. Vintage, New York

    Google Scholar 

  • Elliott C (1997) Caring about risks: are severely depressed patients competent to consent to research? Arch Gen Psychiatry 54:113–116

    PubMed  CAS  Google Scholar 

  • Evans DA, Funkenstein H, Albert MS, et al. (1989) Prevalence of Alzheimer's disease in a community population of older persons. J Am Med Assoc 262:2552–2556

    Google Scholar 

  • Faden R, Beauchamp T (1986) A history and theory of informed consent. Oxford University Press, New York

    Google Scholar 

  • Flanery M, Gravdal J, Hendrix P, et al. (1978) Just sign here. South Dakota J Med 31(5):33–37

    CAS  Google Scholar 

  • Fletcher JC (1973) Realities of patient consent to medical research. Stud Hastings Center 1(1):39–40

    Google Scholar 

  • Flynn LM (1997) Statement. Issues concerning informed consent and protections of human subjects in research: hearings before the Subcommittee on Human Resources of the House Committee on Government Reform and Oversight, 105th Congress

    Google Scholar 

  • Folstein MF, Folstein SE, McHugh RR (1975) Mini‐mental state. J Psychiatr Res 12:189–198

    PubMed  CAS  Google Scholar 

  • Garnett RW (1996) Why informed consent? Human experimentation and the ethics of autonomy. Catholic Lawyer 36:455–511

    Google Scholar 

  • Goodwin JS, Goodwin JM, Garry PJ (1983) Association between nutritional status and cognitive functioning in a healthy elderly population. J Am Med Assoc 249(21):2917–2921

    CAS  Google Scholar 

  • Gray B (1975) Human subjects in medical experimentation: a sociological study of the conduct and regulation of clinical research. Wiley, New York

    Google Scholar 

  • Grisso T, Appelbaum P (1998) Assessing competence to consent to treatment: a guide for physicians and other health professionals. Oxford University Press, New York

    Google Scholar 

  • Hansen L, Salmon DP, Galasko D, Masliah E, Katzman R, DeTeresa R et al. (1990) The Lewy body variant of Alzheimer's disease: a clinical and pathological entity. Neurology 40:1–8

    PubMed  CAS  Google Scholar 

  • Hassar M, Weintraub M (1976) “Uninformed” consent and the wealthy volunteer: an analysis of patient volunteers in a clinical trial of a new anti‐inflammatory drug. Clin Pharmacol Therapeut 20:379–386

    CAS  Google Scholar 

  • Hebert LE, Scherr PA, Bienias JL, Bennett DA, Evans DA (2003) Alzheimer disease in the US population: prevalence estimates using the 2000 census. Arch Neurol 60:1119–1122

    PubMed  Google Scholar 

  • High DM, Whitehouse PJ, Post SG, Berg L (1994) Guidelines for addressing ethical and legal issues in Alzheimer disease research: a position statement. Alzheimer's Dis Assoc Disord 8 (suppl 4):66–74

    Google Scholar 

  • Himes CL, Wagner GG, Wolf DA, Aykan H, Dougherty DD (2000) Nursing home entry in Germany and the United States. J Cross‐Cultural Gerontol 15:99–118

    CAS  Google Scholar 

  • Howard JM, De Mets D, The BHAT Research Group (1981) How informed is informed consent? Cont Clin Trials 2:287–303

    CAS  Google Scholar 

  • Kahn RL, Goldfarb AI, Pollack M, Peck A (1960) Brief objective measures for the determination of mental status in the aged. Am J Psychiat 117:326–329

    PubMed  CAS  Google Scholar 

  • Kapp M (1998) Decisional capacity, older human research subjects, and IRBs: beyond forms and guidelines. Stanford Law Policy Rev 9:359–365

    Google Scholar 

  • Kennedy GJ (2000) Geriatric mental health care: a treatment guide for health professionals. Guilford Press, New York

    Google Scholar 

  • Keyserlingk EW, Glass K, Kogan S, Gauthier S (1995) Proposed guidelines for the participation of persons with dementia as research subjects. Perspect Biol Med 38:319–361

    PubMed  Google Scholar 

  • Klepper H, Roty M (1999) Personal identity, advance directives, and genetic testing for Alzheimer disease. Genet Test 3:99–106

    PubMed  CAS  Google Scholar 

  • Lakshmanan M, Mion L, Frengley J (1986) Effective low‐dose tricyclic and antidepressant treatment for depressed geriatric patients: a double blind study. J Am Geriatr Soc 34:421–426

    PubMed  CAS  Google Scholar 

  • LeBlang TR, Kirchner JL (1996) Informed consent and Alzheimer disease research: institutional review board policies and practices. In: Becker R, Giacobini E (eds) Alzheimer's disease from molecular biology to therapy. Birkhauser, Boston, pp. 529–534

    Google Scholar 

  • Levine RJ (1988) Ethics and regulation of clinical research. Yale University Press, New Haven, CT

    Google Scholar 

  • Loue S (2001) Elder abuse and neglect in medicine and law: the need for reform. J Legal Med 22:159–209

    CAS  Google Scholar 

  • Lubasch AH (1982) Trial ruled in 1953 death case. NY Times September 14, pA‐14

    Google Scholar 

  • Manders M, de Groot CPGM, van Staveren WA, et al. (2004) Effectiveness of nutritional supplements on cognitive functioning in elderly persons: a systematic review. J Gerontol Ser A: Biol Sci Med Sci 59:M1041–M1049

    Google Scholar 

  • Manning CC (1993) The Medicare Alzheimer's demonstration. Elder Law J 1:113–137

    Google Scholar 

  • Markesbery WR (1998) Neuropathology of dementing disorders. Oxford University Press, New York

    Google Scholar 

  • Masliah E, Miller A, Terry RD (1993) The synaptic organization of the neocortex in Alzheimer's disease. Med Hypotheses 41:334–340

    PubMed  CAS  Google Scholar 

  • McCollum AT, Schwartz AH (1969) Pediatric research hospitalization: its meaning to parents. Pediatric Res 3:199–204

    CAS  Google Scholar 

  • Medical Research Council Working Party on Research on the Mentally Incapacitated (1991) The ethical conduct of research on the mentally incapacitated: report of the Working Party on Research on the Mentally Incapacitated. MRC Ethics Series. Medical Research Council, London

    Google Scholar 

  • Meisel A, Roth LH, Lidz CW (1977) Toward a model of the legal doctrine of informed consent. Am J Psychiatry 134:285–289

    PubMed  CAS  Google Scholar 

  • Molloy DW, Alemayehu E, Roberts R (1991) A standardized Mini‐Mental State Examination (MMSE). Am J Psychiatry 148:102–105

    PubMed  CAS  Google Scholar 

  • Morrow G, Gootnick J, Schmale A (1978) A simple technique for increasing cancer patients’ knowledge of informed consent to treatment. Cancer 42:793–799

    PubMed  CAS  Google Scholar 

  • National Bioethics Advisory Commission (2001) Ethical and policy issues in research involving human participants, vol. 1. U.S. Government Printing Office, Rockville, MD

    Google Scholar 

  • National Institutes of Health (2005) Certificates of confidentiality Kiosk. Available at http://grants1.nih.gov/grants/policy/coc/index.htm (last accessed February 7, 2005)

  • National Institutes of Health Clinical Center (1987) Policy and communications bulletin: consent process in research involving impaired human subjects. No. 87‐4. Department of Health and Human Services, Rockville, MD

    Google Scholar 

  • Oscar‐Berman M, Evert DL (1997) Alcoholic Korsakoff's syndrome. In: Nussbaum PD (ed) Handbook of neuropsychology and aging. Plenum Press, New York, pp. 201–215

    Google Scholar 

  • Park LC, Slaughter RS, Covi L, Kniffin HG Jr (1966) The subjective experience of the research patient: an investigation of psychiatric outpatients’ reactions to the research treatment situation. J Nervous Mental Dis 143:199–206

    CAS  Google Scholar 

  • Park LC, Covi L, Uhlenhuth EH (1967) Effects of informed consent on research patients and study results. J Nervous Mental Dis 145(5):349–357

    CAS  Google Scholar 

  • Petersen RC, Stevens JC, Ganguli M, Tangalos EG, Cummings JL, De Kosky ST (2001) Practice parameter: early detection of dementia: mild cognitive impairment (an evidence‐based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 56: 1133–1142

    PubMed  CAS  Google Scholar 

  • Post SG (1995) Alzheimer disease and the “then” self. Kennedy Inst Ethics J 4:307–321

    Google Scholar 

  • Riecken HW, Ravich R (1982) Informed consent to biomedical research in Veterans Administration hospitals. J Am Med Assoc 248(3):344–348

    CAS  Google Scholar 

  • Roman GC (1991) The epidemiology of vascular dementia. In: Hartmann A, Kuschinsky W, Hoyer S (eds) Cerebral ischemia and dementia. Springer, Berlin, pp. 9–15

    Google Scholar 

  • Rothman DJ (1991) Strangers at the bedside: a history of how law and bioethics transformed medical decision making. Basic Books, New York

    Google Scholar 

  • Sachs GA (1994) Advance Consent for dementia research. Alzheimer Dis Associated Disord 8:19–27

    Google Scholar 

  • Sachs G, Cassel C (1989) Ethical aspects of dementia. Neurol Clin 7:845–858

    PubMed  CAS  Google Scholar 

  • Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS (1994) Ethical aspects of dementia research: informed consent and proxy consent. Clin Res 42:403–412

    PubMed  CAS  Google Scholar 

  • Salmon DP, Bondi MW (1997) The neuropsychology of Alzheimer's disease. In: Nussbaum PD (ed) Handbook of neuropsychology and aging. Plenum Press, New York, pp. 141–158

    Google Scholar 

  • Scott v. Casey (1983) 562 F. Supp. 475 (N.D. Ga.)

    Google Scholar 

  • Solomon PR, Hirschoff A, Kelly B, et al. (1998) A 7‐minute neurocognitive screening battery highly sensitive to Alzheimer's disease. Arch Neurol 55:349–355

    PubMed  CAS  Google Scholar 

  • Stahelin HB, Monsch AU, Speigel R (1997) Early diagnosis of dementia via a two‐step screening and diagnostic procedure. Int Psychogeriatr 9:123–130

    PubMed  Google Scholar 

  • Tatara T (1995) An Analysis of State Laws Addressing Elder Abuse, Neglect, and Exploitation. National Center on Elder Abuse, Washington, DC

    Google Scholar 

  • Uhlenhuth EH, Park LC (1964) The influence of medication (imipramine) and doctor in relieving depressed psychoneurotic outpatients. J Psychiatric Res 2:101–122

    Google Scholar 

  • United States Census Bureau (2001a) The 65 years and over population: 2000. Census 2000 Brief. United States Census Bureau, Washington, DC

    Google Scholar 

  • United States Census Bureau (2001b) Statistical brief: sixty‐five plus in the United States. United States Census Bureau, Washington, DC. Available at http://www.census.gov/population/socdemo/statbriefs/agebrief.html (last accessed November 9, 2004)

  • Unverzagt FW, Gao S, Baiyewu O, et al. (2001) Prevalence of cognitive impairment: data from the Indianapolis Study of Health and Aging. Neurology 57(9):1655–1662

    PubMed  CAS  Google Scholar 

  • Usman MA (1997) Frontotemporal dementia. In: Nussbaum PD (ed) Handbook of neuropsychology and aging. Plenum Press, New York, pp. 159–175

    Google Scholar 

  • Valenti v. Prudden (1977) 58 A.D.2d 956, 397 N.Y.S.2d 181

    Google Scholar 

  • Williams RL, Rieckmann KH, Trenholme GM, Frischer H, Carson PE (1977) The use of a test to determine that consent is informed. Military Med 142:542–545

    CAS  Google Scholar 

Download references

Authors
  1. Sana Loue
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. School of Medicine, Case Western Reserve University, Cleveland, Ohio

    Sana JD Loue PhD, MPH

  2. School of Medicine, University Hospitals Case Medical Center Case Western Reserve University, Cleveland, Ohio

    Martha Sajatovic MD

Rights and permissions

Reprints and permissions

Copyright information

© 2008 Springer-Verlag

About this entry

Cite this entry

Loue, S. (2008). The Participation of Cognitively Impaired Elderly in Research. In: Loue, S.J., Sajatovic, M. (eds) Encyclopedia of Aging and Public Health. Springer, Boston, MA. https://doi.org/10.1007/978-0-387-33754-8_460

Download citation

  • DOI: https://doi.org/10.1007/978-0-387-33754-8_460

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-0-387-33753-1

  • Online ISBN: 978-0-387-33754-8

  • eBook Packages: MedicineReference Module Medicine

Publish with us

Policies and ethics

Search

Navigation