Cancer researchers and compliance officials agree that patients enrolled in clinical trials are entitled to a high level of privacy protection, but there is significant tension between the two groups over how HIPAA rules should be implemented, according to the results of a survey by the ASCO Cancer Research Committee.
Elizabeth Goss, JD, and colleagues, led the study in which 27 individuals (13 investigators and 14 compliance officials) from 13 institutions were asked to describe the anticipated approach of their institutions to HIPAA privacy rule compliance in three hypothetical research studies: a genetics study, a survivorship study, and a research study.
The research study scenario, which involved biospecimens and data repositories, was the most prominent source of disagreement, according to the results. "The disagreements are seen most clearly with regard to the appropriate definition of a ‘future research use' of protected health information in biospecimen and data repositories and the standards for a waiver of authorization for disclosure and use of such data," the authors wrote. Compliance officials and IRB members voiced concerns about the protection of large repositories of data and called for such actions as patient reconsent and reauthorization. Investigators said that a cautious attitude could slow down or even block research endeavors (J Clin Oncol online, July 27, 2009).
In response, ASCO proposed the development of best practices documents to guide creation of data repositories, disclosure and use of data from such repositories, and the design of survivorship and genetics studies. Such guidelines should ease the burden of delayed or abandoned trials, they stated.