Can a CRC obtain informed consent?

Can a CRC obtain informed consent?

• A. Only if delegated and permitted by IRB and local regulations
• B. Yes
• C. No
• D. Only with PI present

Answer: (A)

Obtaining informed consent can be delegated to trained study staff, including a clinical research coordinator, as long as the delegation is formally approved by the study’s IRB and allowed by local regulations. The PI remains responsible for the conduct of the consent process, but may delegate the actual consent discussion to qualified team members. For this to work, the CRC must be properly trained in the consent process, able to explain the study in the participant’s language, verify understanding, answer questions, and ensure voluntariness. They also must document the consent correctly on the approved consent form and follow the approved script and processes. If the IRB has not approved delegation or local rules prohibit it, a CRC cannot obtain consent. The PI does not have to be present at every consent session, but must be available for questions and remains accountable for the consent process.

Obtaining informed consent can be delegated to trained study staff, including a clinical research coordinator, as long as the delegation is formally approved by the study’s IRB and allowed by local regulations. The PI remains responsible for the conduct of the consent process, but may delegate the actual consent discussion to qualified team members.

For this to work, the CRC must be properly trained in the consent process, able to explain the study in the participant’s language, verify understanding, answer questions, and ensure voluntariness. They also must document the consent correctly on the approved consent form and follow the approved script and processes. If the IRB has not approved delegation or local rules prohibit it, a CRC cannot obtain consent. The PI does not have to be present at every consent session, but must be available for questions and remains accountable for the consent process.