Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Reviews Preparatory to Research


Comment: Some industry groups expressed concern that the research provision would prohibit physicians from using patient information to recruit subjects into clinical trials. These commenters recommended that researchers continue to have access to hospitals' and clinics' patient information in order to recruit patients for studies.

Response: Under the proposed rule, even if the researcher only viewed the medical record at the site of the covered entity and did not record the protected health information in a manner that patients could be identified, such an activity would have constituted a use or disclosure that would have been subject to proposed § 164.508 or proposed § 164.510. Based on the comments received and the fact finding we conducted with the research community, we concluded that documentation of IRB or privacy board approval could halt the development of research hypotheses that require access to protected health information before a formal protocol can be developed and brought to an IRB or privacy board for approval. To avoid this unintended result, the final rule permits covered health care providers and health plans to use or disclose protected health information for research if the covered entity obtains from the researcher representations that: (1) use or disclosure is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research; (2) no protected health information is to be removed from the covered entity by the researcher in the course of the review; and (3) the protected health information for which use or access is sought is necessary for the research purposes.

Comment: A few commenters asserted that the final rule should eliminate the possibility that research requiring access to protected health information could be determined to be "exempt" from IRB review, as provided by the Common Rule (§ ___.101(b)(4)).

Response: The rule did not propose nor intend to modify any aspect of the Common Rule, including the provision that exempts from coverage, "research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publically available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or indirectly through identifiers linked to the subjects" (§ ___.101(b)(4)). For the reasons discussed above, we have included a provision in the final rule for reviews preparatory to research that was modeled on this exemption to the Common Rule.