AMDA Foundation - Informed Consent and Cognitively Impaired Patients

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Vol XVIII, Sep `05

Informed Consent and Cognitively Impaired Patients

Vol XVIII, Sep `05

The issue of obtaining informed consent for cognitively impaired individuals is a challenging one for long term care researchers. To help Research Network members address this difficult area, this year's Fall Conference will feature a session on "Consenting and Assenting Cognitively Impaired LTC Residents: Ethical, Operational, and Clinical Issues." Many experts have addressed this issue in the past. In the late 1990s, The National Bioethics Advisory Commission drafted a paper, "Research Involving Persons with Mental Disorders That May Affect Decision-making Capacity." This document offered several recommendations regarding informed consent and capacity. These included:

Any potential or actual subject's objection to enrollment or to continued participation in a research protocol must be heeded in all circumstances. An investigator, acting with a level of care and sensitivity that will avoid the possibility or the appearance of coercion, may approach people who previously objected to ascertain whether they have changed their minds.
For research protocols that present greater than minimal risk, an IRB should require that an independent, qualified professional assess the potential subject's capacity to consent. The protocol should describe who will conduct the assessment and the nature of the assessment. An IRB should permit investigators to use less formal procedures to assess potential subjects' capacity if there are good reasons for doing so.
A person who has been determined to lack capacity to consent to participate in a research study must be notified of that determination before permission may be sought from his or her legally authorized representative (LAR) to enroll that person in the study. If permission is given to enroll such a person in the study, the potential subject must then be notified. Should the person object to participating, this objection should be heeded.

To review the Executive Summary of the Advisory Committee's report, see www.georgetown.edu/research/nrcbl/nbac/capacity/Executive.htm. Other resources on this topic include:

http://irb.jhmi.edu/Guidelines/informedconsentguidance.html (Consent Guidelines and Q&A)
www.med.nyu.edu/irb/information_sheets/cog_imp.html (Tips on Informed Consent and Cognitive Impairment)

Among other important and controversial issues to be addressed at Research Network Conference sessions are:

Developing Research Priorities in Long Term Care in Collaboration with the Family Practice Information Network
Overcoming Barriers in Long Term Care Research: Lessons Learned from the AMDA Foundation's LTC Quality Improvement Partnership
Human Subjects Protection
Survey and Instrument Design
Developing Inclusion and Exclusion Criteria

Participation is limited, so register today for the Fall Research Network Conference.

CLICK HERE to access an online registration form for the Fall Research Network conference.

CLICK HERE to see the full agenda for the Fall Research Network conference.