Regulatory Affairs Certification (RAC) Practice Exam

The final authority for ensuring the adequacy of an Investigational New Drug (IND) informed consent document resides with the:

1. Clinical Trial Sponsor.

2. Institutional Review Board (IRB).

3. FDA.

4. Principal Investigator.

The correct answer is: Institutional Review Board (IRB).

The adequacy of an Investigational New Drug (IND) informed consent document is fundamentally the responsibility of the Institutional Review Board (IRB). The IRB is an independent committee established to review and oversee clinical research involving human subjects. Its primary function is to protect the rights and welfare of the participants by ensuring that the informed consent process is meaningful and that potential participants are fully informed about the nature of the study, the risks involved, and their rights as subjects. Specifically, the IRB evaluates the informed consent document to make sure it meets regulatory requirements and adequately communicates all necessary information, such as the purpose of the study, procedures involved, potential risks and benefits, and contact information for any questions. This ensures transparency and ethical standards are maintained, fostering participant trust. In contrast, while the clinical trial sponsor is responsible for the overall management of the trial and may develop the informed consent document, they are subject to IRB approval. The FDA’s role is regulatory oversight of the IND application process but does not directly engage in the adequacy of informed consent documents for particular studies. Meanwhile, the principal investigator holds responsibility for conducting the trial but must adhere to the standards set by the IRB regarding informed consent, including ensuring that participants are adequately informed prior to