FAQs Archive

Q: 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.

Q: Will the HIPAA Privacy Rule hinder medical research by making doctors and others less willing and/or able to share with researchers information about individual patients?

We do not believe that the Privacy Rule will hinder medical research. Indeed, patients and health plan members should be more willing to authorize disclosures of their information for research and to participate in research when they know their information is protected. For example, in genetic studies conducted at the National Institutes of Health, nearly 32 percent of eligible people offered a test for breast cancer risk declined to take it. The overwhelming majority of those who refuse cite concerns about health insurance discrimination and loss of privacy as the reason. The Privacy Rule both permits important research and, at the same time, encourages patients to participate in research by providing much needed assurances about the privacy of their health information. The Privacy Rule will require some covered health care providers and health plans to change their current practices related to documenting research uses and disclosures. It is possible that some covered health care providers and health plans may conclude that the Rule’s requirements for research uses and disclosures are too burdensome and will choose to limit researchers’ access to protected health information. We believe few providers will take this route, however, because the Common Rule includes similar, and more rigorous requirements, that have not impaired the willingness of researchers to undertake Federally-funded research. For example, unlike the Privacy Rule, the Common Rule requires an Institutional Review Board (IRB) review for all research proposals under its purview, even if informed consent is to be sought. The Privacy Rule requires documentation of IRB or Privacy Board approval only if patient authorization for the use or disclosure of protected health information for research purposes is to be altered or waived.