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Researchers, Officials Disagree on Privacy Rule

Additional training and best practice standards needed in regards to cancer research

THURSDAY, July 23 (HealthDay News) -- Cancer researchers and compliance officers often disagree on how to comply with the Health Information Portability and Accountability Act (HIPAA) Privacy Rule in regards to cancer research, and additional training and best practice standards are needed, according to a study published online July 20 in the Journal of Clinical Oncology.

Due to concerns of among members of the American Society of Clinical Oncology (ASCO) Cancer Research Committee, Elizabeth Goss, J.D., from Turner & Goss LLP in Washington, D.C., and colleagues surveyed 27 investigators and compliance officials from 13 institutions regarding how they planned to comply with the HIPAA Privacy Rule implemented in 2003 given three hypothetical research studies: a genetics study, creation and utilization of databases, and a survivorship study.

The researchers found that investigators and compliance officers agreed that protecting patient privacy was important, but disagreed about the proper standards for compliance necessary to protect patients. The disagreements were most pronounced for the creation and utilization of databases scenario, particularly regarding the definition of "future research use" of protected health information and the standards for a waiver of authorization for disclosure and use of such data.

"ASCO believes that disagreements related to compliance and the resulting delays in certain projects and abandonment of others might be eased by additional institutional training programs and consultation on Privacy Rule issues during study design," Goss and colleagues conclude. "ASCO also proposes the development of best practices documents to guide 1) creation of data repositories, 2) disclosure and use of data from such repositories, and 3) the design of survivorship and genetics studies."

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