Consenting and Reconsenting

DEFINITION

• Consenting involves the study participant giving permission to be involved in the study and agreeing to participate in the study details and procedures.
• Reconsenting occurs when circumstances arise when it is necessary to obtain consent again from participants who want to continue in the research study.
• Consent monitoring  is necessary to reduce the possibility of coercion and undue influence, ensure that the approved consent process is being followed, and includes observing  the informed consent process of research participants.

Policies/Procedures/Guidelines/Processes

• UMMC Policy on HIPAA Compliance Research

• The consenting process is documented through an informed consent document.
  • Written informed consent must be obtained from all human subjects prior to their participation in any research unless the requirement has been waived by the IRB.
• Reconsenting is required whenever there is a change in the protocol which differs from the terms that study participants organically agreed upon through the informed consent process.
  • If changes in the protocol impact the original informed consent document, an updated informed consent document but be approved by the IRB.
• Consent monitoring may be conducted by HRPP or IRB staff, IRB members or another appropriate party.
  • The IRB has the authority under 45 CFR 46.109(e) and 21 CFR 56.109(f) to observe or have a third party observe the consent process and the research.
  • There may be circumstances under which the IRB may determine that monitoring of the consent process by an impartial observer (e.g., consent monitor) is required.
  • If the IRB determines that consent monitoring is required, the IRB may consult with the Human Research Office Director, the Office of Integrity and Compliance, and others to develop an appropriate plan.
  • For consent monitoring, the following elements are evaluated
    • The informed consent process was appropriately conducted and documented
    • The participant had sufficient time to consider study participation, and to ask questions and have them answered
    • The consent process involved coercion or undue influence
    • The information was accurate and conveyed in understandable language
    • The participant appeared to understand the information and gave voluntary consent

Templates/Forms

• See the Design of ICF Section

Training:

• CREW Consenting Training
• Review the CITI Program Training- Informed Consent Module
• See Consent Monitoring in Section 10.4.5 University of Mississippi Medical Center Standard Operating Procedures Human Research Protection Program (HRPP), revised October 2, 2023 (intranet).