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Related Experiment Videos

Evaluating the quality of informed consent.

Jeremy Sugarman1, Philip W Lavori, Maryann Boeger

  • 1Phoebe R. Berman Bioethics Institute, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA. jsugarm1@jhmi.edu

Clinical Trials (London, England)
|November 11, 2005
PubMed
Summary

Evaluating informed consent quality is crucial for clinical research. The Brief Informed Consent Evaluation Protocol (BICEP) offers an efficient, participant-accepted method to assess and improve the informed consent process.

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Area of Science:

  • Clinical Research Ethics
  • Informed Consent Process Evaluation

Background:

  • Informed consent is vital for protecting participants' rights in clinical research.
  • Effective methods are needed to evaluate and improve the quality of informed consent.

Purpose of the Study:

  • To develop and validate the Brief Informed Consent Evaluation Protocol (BICEP) for assessing informed consent quality.
  • To test the practicality and generalizability of BICEP in diverse clinical research settings.

Main Methods:

  • Developed and implemented the Brief Informed Consent Evaluation Protocol (BICEP), a brief telephone-based assessment.
  • Administered BICEP to participants immediately after the informed consent process for VA Cooperative Studies Program trials.
  • Collected data from 632 participants across multiple medical centers.
Keywords:
Biomedical and Behavioral ResearchEmpirical Approach

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Main Results:

  • BICEP implementation was reported as easy by site coordinators, with an average duration of 8.8 minutes.
  • Participants generally evaluated the informed consent process positively.
  • Developed a coding system yielding an Informed Consent Aggregate Score (ICAS) and a Therapeutic Misconception Aggregate Score (TMAS).

Conclusions:

  • The BICEP is an efficient, acceptable tool for evaluating informed consent quality among participants and research staff.
  • While satisfaction is generally high, BICEP data suggest opportunities exist to enhance the informed consent process in research.