Research consent for cognitively impaired adults: Recommendations for Institutional Review Boards and investigators

Constantine G. Lyketsos, Jason Brandt, Paul Fishman, Michael Gloth, Vassilis Koliatsos, David Loreck, Marsden McGuire, Peter V. Rabins, Debra Wertheimer, Jack Schwartz, Anand Das, Greg Sachs, Marilyn Albert, Stephen McConnell, William Thies

Research output: Contribution to journalArticle

67 Citations (Scopus)

Abstract

Adults with cognitive impairment are considered a vulnerable population. The conditions associated with cognitive impairment, such as dementia and delirium, cause great suffering to affected patients and their families. Improving clinical care for these conditions depends on research involving cognitively impaired participants. Cognitive impairment is at times associated with partial or full impairment of the capacity to consent to research. This both limits the ability of the individual to consent personally to research participation, and also increases pressure upon Institutional Review Boards (IRBs) and investigators to place additional safeguards for the appropriate participation of cognitively impaired individuals in research. While the ethical and legal principles permitting and safeguarding the participation of cognitively impaired persons in research are generally agreed upon, there are no specific methods that operationalize these principles in a language that can be used by IRBs and researchers to guide their day-to-day work in this area. This document contains recommendations that IRBs and investigators can use to operationalize the informed consent process for individuals with cognitive impairment. In situations in which IRBs might not have specific policies in this area, this guideline may also serve as the foundation for such policies. The recommendations discuss when to consider that cognitively impaired participants might be involved in a research project, the use of screening for cognitive impairment, the conduct of assessments evaluating capacity to consent to research, situations in which proxies might consent for research participation in the place of cognitively impaired participants, how to go about identifying appropriate proxies, and how to deal with the loss of consent capacity in the course of a research project.

Original languageEnglish (US)
Pages (from-to)171-175
Number of pages5
JournalAlzheimer Disease and Associated Disorders
Volume18
Issue number3
DOIs
StatePublished - Jul 2004
Externally publishedYes

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Research Ethics Committees
Research Personnel
Research
Proxy
Aptitude
Delirium
Vulnerable Populations
Informed Consent
Psychological Stress
Dementia
Language
Cognitive Dysfunction
Guidelines
Pressure

Keywords

  • Cognitive impairment
  • Consent for research
  • Dementia

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Psychiatry and Mental health
  • Neuroscience(all)

Cite this

Research consent for cognitively impaired adults : Recommendations for Institutional Review Boards and investigators. / Lyketsos, Constantine G.; Brandt, Jason; Fishman, Paul; Gloth, Michael; Koliatsos, Vassilis; Loreck, David; McGuire, Marsden; Rabins, Peter V.; Wertheimer, Debra; Schwartz, Jack; Das, Anand; Sachs, Greg; Albert, Marilyn; McConnell, Stephen; Thies, William.

In: Alzheimer Disease and Associated Disorders, Vol. 18, No. 3, 07.2004, p. 171-175.

Research output: Contribution to journalArticle

Lyketsos, CG, Brandt, J, Fishman, P, Gloth, M, Koliatsos, V, Loreck, D, McGuire, M, Rabins, PV, Wertheimer, D, Schwartz, J, Das, A, Sachs, G, Albert, M, McConnell, S & Thies, W 2004, 'Research consent for cognitively impaired adults: Recommendations for Institutional Review Boards and investigators', Alzheimer Disease and Associated Disorders, vol. 18, no. 3, pp. 171-175. https://doi.org/10.1097/01.wad.0000137520.23370.56
Lyketsos, Constantine G. ; Brandt, Jason ; Fishman, Paul ; Gloth, Michael ; Koliatsos, Vassilis ; Loreck, David ; McGuire, Marsden ; Rabins, Peter V. ; Wertheimer, Debra ; Schwartz, Jack ; Das, Anand ; Sachs, Greg ; Albert, Marilyn ; McConnell, Stephen ; Thies, William. / Research consent for cognitively impaired adults : Recommendations for Institutional Review Boards and investigators. In: Alzheimer Disease and Associated Disorders. 2004 ; Vol. 18, No. 3. pp. 171-175.
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