Office of the Provost

Memorandum

TO: Campus Presidents, Deans, Faculty, Staff, Postdoctoral Fellows, and Students of the Schools of the Provost’s Area
FROM: James V. Maher
DATE: March 21, 2003

Education and Certification Program in Research Practice Fundamentals (RPF) Module 6: Privacy Requirements for Researchers Under the Health Insurance Portability and Accountability Act (HIPAA)

I am pleased to announce that the sixth module of our online educational program is now available. This module addresses the HIPAA privacy requirements for researchers.

As outlined in the November 12, 2002, letter to the research community, HIPAA is a federal law that established, among other things, mandatory rules governing the privacy of all patient identifiable health information. (This letter can be viewed on the IRB website at http://www.irb.pitt.edu/hipaa/hipaa_forms.htm.)

Certain provisions of HIPAA address the use and disclosure of identifiable health information for research purposes. HIPAA, together with the current federal policy regulations governing human research subject protection, will primarily have an enormous impact on two aspects of human subject research: 1) access to and use of identifiable health information to facilitate research subject recruitment; and 2) retrospective research studies involving the use of existing identifiable health information. Successful completion of Module 6 will provide compliance certification to carry out human subject research using patient records.

Those who must complete Module 6 are as follows:

• “Key personnel,” faculty, staff and students who are directly involved in human subject research that involves:

the collection of medical record information or
the generation of information that will be placed in medical records.

If you meet the above criteria, you must complete Module 6 before April 14, 2003, in order to continue to qualify for IRB approval of protocols. I apologize for the relatively short notice. The content of this module had to be designed to meet the needs of several constituencies of our research community, and this delayed its deployment.

Module 6 can be accessed on the RPF Website (http://rpf.health.pitt.edu/rpf) Please note that links to tables outlining RPF modules that users are required to complete are also available from that site.

As with the other modules, Module 6 was designed to make the most efficient use of your time while responding to the imperative that members of our research community be knowledgeable in this critical subject area. Certification in Module 6, once attained, remains in effect for three years.

Thank you for your prompt attention to this most important matter.

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