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 entity’s site. As such, a researcher who is an employee or a member of the covered entity’s 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 in a clinical trial without patient authorization, and without an Institutional Review Board (IRB) or Privacy Board waiver of the authorization. See our research section and frequently asked questions about the research provisions for more information about Institutional Review and Privacy Boards.
However, a researcher who is not a part of the covered entity may not use the preparatory research provision to contact prospective research subjects. Rather, the outside researcher could obtain contact information through a partial waiver of individual authorization by an IRB or Privacy Board as permitted at 45 CFR164.512(i)(1)(i). The IRB or Privacy Board waiver of authorization permits the partial waiver of authorization for the purposes of allowing a researcher to obtain protected health information as necessary to recruit potential research subjects. For example, even if an IRB does not waive informed consent and individual authorization for the study itself, it may waive such authorization to permit the disclosure of protected health information as necessary for the researcher to be able to contact and recruit individuals into the study.