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, Institutional Review Boards (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 Rule’s 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 sheet and frequently asked questions about the research provisions
for more information about the Common Rule
and Institutional Review and Privacy Boards
Date Created: 12/20/2002
Last Updated: 03/14/2006