Information for Clinical Researchers

One Chart Compliance with 21 CFR Part 11 (Posted 8/6/12)

Health Services Research and the Privacy Rule (Posted 5/26/05)

Clinical Research and the HIPAA Privacy Rule (Posted 2/12/04)

Articles from HHS, CDC and NIH

Please note: In addition to the requirements listed in these articles, the IRB local requirements must be satisfied. The IRB must review and approve any authorization used with a research study.

HIPAA Privacy Rule and Institutional Review Boards (IRBs) (PDF File)

Complete text of letter from HHS Office of Civil Rights (OCR) advising that the HIPAA Privacy Rule does not require IRBs to review stand-alone HIPAA authorizations for compliance with Privacy Rule requirements. The letter further states that HHS regulations governing protection of human subjects (45 CFR Part 46) do not require that stand-alone HIPAA authorizations be reviewed or approved by IRBs. According to OCR, such review and approval is only required if the HIPAA authorization language is integrated into the informed consent document for human subject research.

CDC: HIPAA Privacy Rule and Public Health

Complete text (25 pages) of report issued by the Centers for Disease Control (CDC) to provide guidance to public health authorities in interpreting the HIPAA Privacy Rule as it affects public health. CDC recommends that public health authorities share the information in the report with covered health care providers to ensure implementation of the Privacy Rule while permitting authorized public health activities to continue.

NIH: Protecting Personal Health Information in Research

Complete text (32 pages) of booklet published by NIH to provide researchers with a basic understanding of the HIPAA Privacy Rule and how it may affect health research.


Use & Disclosure of PHI (Policy 6051) - 3 related forms