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Ethical issues in informed consent with substance abusers.

B S McCrady1, D A Bux

  • 1Center of Alcohol Studies, Rutgers, State University of New Jersey, Piscataway 08854-8001, USA. bmccrady@rci.rutgers.edu

Journal of Consulting and Clinical Psychology
|May 4, 1999
PubMed
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Informed consent for individuals with substance use disorders presents challenges. Researchers often recruit vulnerable participants but employ methods to ensure comprehension and minimize coercion, though confidentiality limits are not always disclosed.

Area of Science:

  • Clinical Research Ethics
  • Substance Abuse Treatment
  • Psychiatry

Background:

  • Individuals with alcohol and drug use disorders (AUDs) pose unique challenges to the informed consent process in clinical research.
  • Ensuring voluntary and comprehending participation is critical, yet substance abuse can impair decision-making capacity.

Purpose of the Study:

  • To examine the informed consent practices of federally funded clinical investigators when recruiting participants with AUDs.
  • To identify challenges and effective strategies in obtaining informed consent from this vulnerable population.

Main Methods:

  • A survey was administered to 91 federally funded clinical investigators (51% response rate) focusing on informed consent procedures for substance abusers.
  • The survey assessed recruitment practices, competence assessment, comprehension checks, handling of emergent issues (e.g., suicidality, child abuse), and use of collateral information.
Keywords:
Biomedical and Behavioral ResearchEmpirical Approach

Related Experiment Videos

Main Results:

  • The majority of investigators (57%) recruited participants susceptible to coercion, but most implemented procedures to mitigate this risk.
  • Two-thirds used objective measures for competence and comprehension; nearly all had policies for serious adverse events, though less than half disclosed confidentiality limits.
  • A significant proportion of researchers encountered intoxicated, suicidal, or homicidal participants, or reports of child abuse/neglect.

Conclusions:

  • While researchers employ various methods to ensure valid informed consent from substance abusers, challenges remain, particularly regarding confidentiality.
  • The study suggests the need for specific guidelines to navigate the complexities of informed consent in clinical trials involving individuals with AUDs.