Are some of the criteria so subjective that inconsistent determinations may be made by Institutional Review Boards (IRB) and Privacy Boards reviewing similar or identical research projects?
Under the HIPAA Privacy Rule, IRBs and Privacy Boards need to use their judgment as to whether the waiver criteria have been satisfied. Several of the waiver criteria are closely modeled on the Common Rules criteria for the waiver of informed consent and for the approval of a research study. Thus, it is anticipated that IRBs already have experience in making the necessarily subjective assessments of risks. While IRBs or Privacy Boards may reach different determinations, the assessment of the waiver criteria through this deliberative process is a crucial element in the current system of safeguarding research participants privacy. The entire system of local IRBs is, in fact, predicated on a deliberative process that permits local IRB autonomy. The Privacy Rule builds upon this principle; it does not change it. Nonetheless, the Department will consider issuing guidance as necessary and appropriate to address concerns that may arise during implementation of these provisions. See the fact s
Related Questions
- Are some of the criteria so subjective that inconsistent determinations may be made by Institutional Review Boards (IRB) and Privacy Boards reviewing similar or identical research projects?
- Our organization requires review of all research projects by our Institutional Review Board (IRB). Do we need to secure final IRB approval for the proposal process?
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
