Which statement is true regarding IRB responsibilities?

• A. To ensure the trial is completed on schedule.
• B. To protect the rights and welfare of subjects.
• C. To maximize sponsor profits.
• D. To verify data analysis methods.

Answer: (B)

The main obligation of an IRB is to protect the rights and welfare of research participants. This means they review a study to ensure that potential risks to subjects are minimized and reasonable in relation to any anticipated benefits, that participants are adequately informed and give voluntary consent, and that safeguards are in place to protect privacy and confidentiality. They also check that vulnerable populations are appropriately protected and that there is ongoing oversight through continuing reviews and safety reporting. Tasks like ensuring the trial finishes on schedule, maximizing sponsor profits, or verifying data analysis methods fall outside the IRB’s protective mandate and are handled by investigators, sponsors, or independent data or safety monitoring processes.