Before initiating a trial, which approvals must the investigator obtain from the IRB/IEC?

Before initiating a trial, which approvals must the investigator obtain from the IRB/IEC?

• A. Written approval for recruitment procedures only.
• B. Approval for the informed consent form only.
• C. Approval for recruitment procedures only.
• D. Written and dated approval/favorable opinion for the protocol, the written informed consent form, consent form updates, subject recruitment procedures, and any other written information to be provided to subjects.

Answer: (D)

The essential idea is that an IRB/IEC must review and give written, dated approval for every document and procedure that will interact with participants before the study begins. That means the protocol itself, the written informed consent form, any updates to the consent form, the procedures for recruiting subjects, and any other written information that will be provided to subjects. Having approval for all of these items in one comprehensive authorization ensures that participant rights, safety, and welfare are protected and that consent documents are clear and appropriate. Approving only one element—such as recruitment or the consent form—without also approving the protocol and other materials would leave critical aspects unreviewed, so only the full, written, dated approval for all relevant items is sufficient.

The essential idea is that an IRB/IEC must review and give written, dated approval for every document and procedure that will interact with participants before the study begins. That means the protocol itself, the written informed consent form, any updates to the consent form, the procedures for recruiting subjects, and any other written information that will be provided to subjects. Having approval for all of these items in one comprehensive authorization ensures that participant rights, safety, and welfare are protected and that consent documents are clear and appropriate. Approving only one element—such as recruitment or the consent form—without also approving the protocol and other materials would leave critical aspects unreviewed, so only the full, written, dated approval for all relevant items is sufficient.