15 Questions for an IRB to Ask About Privacy

IRBs are responsible for protecting the welfare of study participants. This responsibility includes ensuring there are adequate measures in place to protect the privacy of study participants and to maintain the confidentiality of their data. Many IRBs also serve as the HIPAA privacy board for their institutions and, as such, have direct obligations under HIPAA. This resource is helpful in guiding IRBs on the questions to ask researchers in relation to privacy protections. This resource can also be used by researchers to consider what safeguards need to be in place during the design process, and what privacy procedures need to be described in the research protocol to facilitate the review process.

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