Continued Consent

You must ensure and document continued consent to participate. Utilizing the initial consent process periodically will help to determine a participant's willingness to continue. Elements that shoud be touched upon are:

• Continued Comprehension
• Research Procedures
• Risks
• Benefits
• Alternatives
• Confidentiality
• Disclosure of Potential Conflict of Interest
• Research-Related Injury
• Withdrawal

Especially important for continuing informed consent of the participant is the timely presentation of (1) any new information (if applicable), and (2) the verification that subjects understand that their participation remains voluntary and that they may withdraw at any time.

Once the research is completed, or completed for an individual participant, the participant should be debriefed according to the specifics of the research. Often results are not available until a significantly later date. The IRB will help to determine if all previously enrolled participants must be informed of the results, but an effort to determine if the participant would like to receive the results should be made, if applicable.