Informed 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:
- Obtain approval from the IRB.
- Present the prospective participant with the consent document.
- 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.
- Give the prospective participant a copy of the consent document.
- Allow the participant time to take the document home and discuss
participation, if desired, with family or friends.
- 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.)
- 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.