Can the preparatory research provision of the HIPAA Privacy Rule at 45 CFR 164.512(i)(1)(ii) be used to recruit individuals into a research study?
The preparatory research provision permits covered entities to use or disclose protected health information for purposes preparatory to research, such as to aid study recruitment. However, the provision at 45 CFR 164.512(i)(1)(ii) does not permit the researcher to remove protected health information from the covered entitys site. As such, a researcher who is an employee or a member of the covered entitys workforce could use protected health information to contact prospective research subjects. The preparatory research provision would allow such a researcher to identify prospective research participants for purposes of seeking their authorization to use or disclose protected health information for a research study. In addition, the Rule permits a covered entity to disclose protected health information to the individual who is the subject of the information. See 45 CFR 164.502(a)(1)(i). Therefore, covered health care providers and patients may continue to discuss the option of enrolling
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