Informed Consent Overview - Module 2s Sec 4


Module 2 Objectives
Selecting Participants
Describing Research
Discussing Participation
Ensuring Readability
Assessing Understanding

Discussing Participation

nformed consent involves educating prospective participants, not merely disclosing information. Providing information is part of the process. The essential elements to be conveyed are discussed in the previous section, "Describing the Research." Discussions with prospective participants should take place with sufficient time for them to consider participation. Approaching them on the same day as the study would take place may not be sufficient. Participants may need time to think about their decision or to discuss their involvement with family, friends, or religious advisors. For best results, participants should be approached when they are willing to listen, and are open and ready to consider consenting.

The process of obtaining consent should include time for both discussion and reflection, as shown in the following steps:

  1. Obtain approval from the IRB.
  2. Present the prospective participant with the consent document.
  3. Read through the document together, taking time to explain significant or difficult points about the research or participation. Answer any questions. Be certain to discuss risks, benefits, and alternative therapies in addition to purposes and procedures.
  4. Give the prospective participant a copy of the consent document.
  5. Allow the participant time to take the document home and discuss participation, if desired, with family or friends.
  6. Meet with the participant again and ask open-ended questions about the nature of the study and participation to make certain he or she understands correctly. (See Assessing Participant Understanding in this module.)
  7. If the participant is willing, have him or her sign the consent document.

Consent Process: Simple and Consent Process: Complex illustrate the process of obtaining informed consent.


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