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Improving participant comprehension in the informed consent process.

Elizabeth Cohn1, Elaine Larson

  • 1School of Nursing/Adelphi University, Garden City, New York 11530, USA. cohn@adelphi.edu

Journal of Nursing Scholarship : an Official Publication of Sigma Theta Tau International Honor Society of Nursing
|September 1, 2007
PubMed
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Participant understanding of informed consent in clinical research remains a challenge. Effective strategies require diverse communication methods and personalized interaction for better comprehension.

Area of Science:

  • Clinical Research Ethics
  • Patient Education
  • Informed Consent Process

Background:

  • Participant comprehension of informed consent is crucial for ethical clinical research.
  • Existing literature highlights persistent challenges in ensuring adequate understanding.
  • Regulatory oversight has increased, yet comprehension gaps persist.

Purpose of the Study:

  • To critically analyze studies on participant comprehension of informed consent in clinical research.
  • To identify effective intervention strategies for improving understanding.

Main Methods:

  • An integrative literature review was conducted.
  • Searches included CINAHL, PubMed, and Cochrane databases (1996-2007).
  • Included descriptive or interventional studies in non-psychiatric adult populations.

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Main Results:

  • 23 studies met inclusion criteria from 980 identified.
  • Interventions included simplified documents, multimedia, and consent educators.
  • No single intervention consistently improved comprehension; definitions and measures varied.

Conclusions:

  • Deficiencies in participant comprehension of clinical research persist.
  • No single intervention guarantees improved understanding.
  • Effective consent processes likely need varied communication and one-to-one interaction.