See Reviewing Protocol Development Activities (PDA) applications  for information about reviewing PDAs, an administrative approval meant to only cover planning activities that do not involve human subjects.

See Not Human Subjects Research for guidance on projects that fall outside the definition of human subjects research including when applications are required, how to review NHSR application, and information on stakeholder engagement.

See Exemptions for information on the process for determining whether research involving human subjects is exempt from the Common Rule.

See Expedited Initial Reviews for information onreviewing initial review submissions under expedited procedures.