ALEXANDRIA, Va. - A study conducted by the American Society of Clinical Oncology (ASCO) finds that different interpretations of the U.S. Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule can result in significant delays or abandonment of important clinical cancer research projects. The study also outlines measures that research sites can undertake to resolve these differences and speed the pace of research. The study results were published online today by the Journal of Clinical Oncology in an ASCO special article, "The Impact of the Privacy Rule on Cancer Research: Variations in Attitudes and Application of Regulatory Standards."
The ASCO study examined differences in application of the HIPAA Privacy Rule between clinical researchers and compliance officers, who ensure that the site is complying with all regulatory requirements. While the interviews demonstrated that both research and compliance officials agree that patient’s cancer diagnoses should receive a high level of privacy protection, their interpretations of HIPAA compliance standards differed in some areas – both between interviewees at the same sites and from one site to another. Differing interpretations of the rule were seen most clearly in defining “future research use” of protected health information in tumor sample (biospecimen) and data repositories and the authorization waiver standards for disclosure.
Biospecimens have traditionally been widely used in cancer research. HIPAA instituted additional regulations regarding the use of these specimens with its implementation in of the Privacy Rule in 2003. However, in the years since its implementation, ASCO members have faced situations where the rule has slowed or even blocked certain types of studies that would benefit people with cancer and cancer survivors.
“ASCO is fully committed to protecting the privacy of people with cancer who participate in the clinical research process. However, we are concerned that a lack of clarity on the use and application of HIPAA privacy rules is causing unnecessary delays in important research,” said Richard L. Schilsky, MD, immediate ASCO Past-President and one of the study’s co-authors. “Biospecimen-based research is critical for advancing our efforts to develop personalized cancer care. To maximize our potential in cancer research, it is crucial that researchers and compliance officers are on the same page when it comes to the HIPAA Privacy Rule.”
ASCO’s Cancer Research Committee designed the qualitative research project using a team of three interviewers who spoke with 27 individuals (13 clinical researchers and 14 compliance officials) from 13 research sites. They were asked to describe how their sites would comply with the Privacy Rule in three hypothetical research studies. The scenarios focused on studies of cancer survivors, familial cancer syndromes and creation and use of data biospecimen repositories.
In the conclusion, ASCO proposes several strategies to resolve differing interpretations of HIPAA, including ongoing institutional training programs to improve communication among researchers and compliance officials on HIPAA-related issues and developments. ASCO also recommends developing case-study based federal guidance documents and cancer-specific model practices documents to guide creation of data repositories, disclosure and use of data from these repositories, and the design of survivorship and genetics studies.
In addition to the recommendations of the study, ASCO is also pursuing changes to HIPAA to allow for use of biospecimens in future cancer research. The Department of Health and Human Services Office for Civil Rights (which administers HIPAA) will be making modifications to the Privacy Rule as a result of provisions of the American Recovery and Reinvestment Act of 2009. ASCO sent a letter to the Office of Civil Rights encouraging the agency to use this as an opportunity to clarify the “future research use provisions.”
“In my experience, patients and families generally want to participate in research because they realize the potential benefits for them and future cancer patients. It is very frustrating that inefficient and ineffective policies get in the way of a genuine willingness to be involved,” said Michael Link, MD, immediate past chair of ASCO’s Cancer Research Committee.
This project was limited by the three design issues that may affect the ability to generalize the findings. The issues are: (1) the limited number of sites; (2) the fact that the compliance officials at each institution may have slightly different perspectives on compliance; and (3) convenience sampling of sites conducting cancer research studies. Despite these limitations, data from the interviews revealed consistent themes.
The American Society of Clinical Oncology (ASCO) is the world's leading professional organization representing physicians who care for people with cancer. With more than 27,000 members, ASCO is committed to improving cancer care through scientific meetings, educational programs and peer-reviewed journals. For ASCO information and resources, visit asco.org/presscenter. Patient-oriented cancer information is available at www.cancer.net.