Congress Abstracts 2004

58

WHAT ABOUT HIPAA: INTEGRATING THE FEDERAL PRIVACY REGULATIONS INTO A RESEARCH STUDY. Camille Wicher, RN, MSN, JD, Dana Jenkins, and Ellen Zupa, RN, MS, Chief Nursing Officer, Roswell Park Cancer Institute, Buffalo, NY.

What the research nurse needs to know about integrating the federal privacy regulations, more affectionately known as HIPAA, into the research process and the informed consent.

The federal privacy regulations set the requirements, but do not mandate a process for implementing the HIPAA regulations into medical research. The requirements call for either a patient authorization, or a waiver of that authorization, to allow research staff to use protected health information (PHI). Research nurses must understand the requirements and how to obtain either the authorization or the waiver, as well as what PHI can be used and/or disclosed.

At Roswell Park Cancer Institute, a team including research nurses was assembled. The HIPAA research subcommittee studied the requirements as they pertain to research and developed authorization and waiver forms and a process for obtaining these. The entire research team was then educated on the requirements and the implementation process.

The current climate of protecting patient information requires a standard and consistent method that allows all nurses involved in cancer research to obtain, utilize, and share PHI within the legal parameters defined in the HIPAA regulations. This cannot be done without understanding, interpreting, and setting forth a plan to implement the regulations—and this plan must fit the organizational culture. The Roswell Park culture supports the oncology nurse determining what information is needed, who should have access to it, and at what point in the continuum. The team developed a policy and associated forms that ensured consistency and accuracy. The result of the learning, shared education, and attention to detail was a successful integration of the HIPAA regulations into the research effort at Roswell Park. Since April 14, 2003, every research study has included an authorization or waiver that allows the research team to use and/or disclose the PHI appropriately and productively.

The Roswell Park experience and templates can be of value to others with a similar focus on research and a shared interest in protecting the rights of those patients who agree to participate in clinical trials. With the oncology nurse at the center of the process, the result is empowering to the professional and the patient.