On June 24, the American Academy of Physical Medicine and Rehabilitation (AAPM&R) Quality Registry Project was determined by the Institutional Review Board (IRB) to be Exempt according to FDA 21CFR 56.104 and 45CFR46.104(b)(4): (4) Secondary Research Uses of Data or Specimens. View the letter here.
Why is this important?
Exempt studies are not subject to ongoing IRB oversight, but investigators or institutions often request that an IRB conduct the initial exemption determination, instead of establishing a self-exemption policy, to ensure an accurate assessment and avoid any conflicts of interest.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. 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.
Exempt status affirms (via a third-party organization) that AAPM&R’s Registry meets strict standards in protecting the rights and welfare of human subjects used in its research, while ensuring an accurate assessment of its quality reporting research platform and alleviating any conflict of interest issues.