AP PSYCHOLOGY

Detailed explanation-1: -An IRB is a committee-operating under federal regulations, state laws and institutional policy-that reviews research involving human subjects to ensure the ethical and equitable treatment of those subjects. Includes representatives from the institutions whose research is reviewed.

Detailed explanation-2: -Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

Detailed explanation-3: -Yes, investigators are responsible for obtaining IRB approval before beginning any nonexempt human subjects research (45 CFR 46.109(a) and (d)).

Detailed explanation-4: -To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

Detailed explanation-5: -An IRB, or Institutional Review Board, is responsible for reviewing and approving research to ensure that the rights and welfare of human participants are protected.