UAB Policy on Definition of "Legally Authorized Representative" for Decisionally Impaired Adults - IRB POL025

Abstract:
This policy states that consent may be obtained from an individual's legally authorized representative when that individual is unable to consent to participate in research for themselves. The document includes the definition of "legally authorized representative."
Effective Date:
1/22/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

 

HRPP Document:     POL025
Effective Date:   3/30/07
Revision Date:  1/22/10
Subject:  UAB Policy on Definition of "Legally Authorized Representative" for Decisionally Impaired Adults

POLICY STATEMENT

In accordance with federal regulations, where an adult individual in unable to consent to participate in research for themselves, consent may be obtained from that individual’s legally authorized representative. For purposes of research conducted at UAB, a legally authorized representative is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. Usually “the law of the jurisdiction in which the research is conducted” will be the state law where the research procedures will be performed.

Under Alabama law, there is no statute addressing the capacity of adults to consent to
procedures purely for research purposes (i.e., where no “treatment” is involved). Therefore, in order of priority, the following list describes those individuals the UAB IRB has determined may serve as a legally authorized representative for an adult incapable of consenting for him/herself for research performed within Alabama and applies both when the procedures involved in the research consist of medical treatment and when medical treatment is not involved :

  1. A legally appointed guardian;
  2. A health care proxy or an individual authorized to make medical decisions in conjunction with a durable power of attorney;
  3. A spouse;
  4. An adult child;
  5. A parent;
  6. Next of kin

 (For discussion about who is a legally authorized individual in relation to the participation of children in research, see POL015 UAB Policy on Definition of Child, Parent, Guardian.) When research studies are conducted outside the state of Alabama and intend to enroll adults that are incapable of making decisions for themselves, the investigators and IRB may seek advice from the UAB Office of Counsel on the definition of a legally authorized representative for the applicable jurisdiction.

Approved on March 1, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director