Box 4.3Informed Consent as a Structured Conversation

Items that should be discussed with participants face-to-face:

  1. Participant is being asked to consent to a research study
  2. Purpose of the study
  3. Procedures involved in the study
    • Procedures that differ from ordinary treatment (e.g., randomization, double blind, fixed protocol, placebo, wash-out periods)
    • Procedures that resemble ordinary treatment
  4. Nature and extent of risks/disadvantages
    • Risks/disadvantages that derive from research procedures (e.g., no guarantee of getting active treatment in placebo-controlled study)
    • Risks/disadvantages associated with the treatments provided
  5. Nature and extent of possible benefits
    • Possible benefits that derive from research procedures (e.g., generalizable knowledge about the participant being studied)
    • Possible benefits that derive from the treatments provided
  6. Alternatives to participation in research, including availability of treatments used in the study in ordinary clinical settings

Items that should be described in a consent form and that participants should have an opportunity to review before agreeing to participate in the study:

  1. Procedures for assuring confidentiality of information obtained about the participant
  2. Relevant investigator or institutional conflicts of interest (on the assumption that direct conflicts have been precluded)
  3. Opportunities for recourse in the event of perceived mistreatment or injury
  4. Information regarding compensation and medical treatment in the event of injury (in greater than minimal risk research)
  5. Person(s) to whom questions can be directed

From: 4, The Participant-Investigator Interface

Cover of Responsible Research
Responsible Research: A Systems Approach to Protecting Research Participants.
Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Participants; Federman DD, Hanna KE, Rodriguez LL, editors.
Washington (DC): National Academies Press (US); 2002.
Copyright © 2003, National Academy of Sciences.

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