A multidisciplinary approach to honest broker services for tissue banks and clinical data: a pragmatic and practical model.

The last decade has seen significant advances in molecular biology (genomics and proteomics) and translational research. These new initiatives have resulted in a growing demand for specific, highly annotated human tissues and other biological specimens [1–3]. This growing demand has reinforced the importance of tissue banks as a major part of the necessary infrastructure of any institution/ research initiative seeking to address biologically and clinically relevant issues [4–6]. The NCI has an office dedicated to biospecimens [7] that has provided a document detailing best practices for repositories [8]. In addition, the International Society for Biologic and Environmental Repositories has also put together a “best practices” document incorporating suggestions from its members [9]. Similar initiatives have been undertaken in the US [10] and in the UK [11]. Finally there are variations of laws from state to state regarding the use of tissues and annotating data [12]. In addition, many of these research initiatives require extensive annotating information that is not present in one data source. Two areas particularly need annotating information. These are tissue-based research and health services based research, which requires patient information for research assessment. Health services research includes outcomes focused research, assessing impact of different therapeutic regimens, research focused on quality and safety of health care, research to evaluate quality assurance, quality control and errors, as well as research focused on impact of different information system on overall quality of health delivery, patient education and error reduction. The past few years have also seen a significant structured movement to protect the confidentiality of research study participants. Although the concept of an honest broker has been around for more than a decade, the advent of the Health and Insurance Portability and Accountability Act (HIPAA) [13] further emphasized the need for systems/ mechanisms to identify and remove personal health identifiers (PHI) from research information. It should be noted that HIPAA does not address research information except that it may become PHI if it is identified and in a covered entity. There are facility/institution-specific regulations mandating policies on patient confidentiality. The Institutional Review Board (IRB) also provides input and direction regarding policies and procedures impacting access to patient information. Finally institutions are also cognizant of prevailing views regarding legal and ethical issues. It is important to develop protocols to protect patient identifiers and confidentiality in the current environment. The need for data as well as the need for subject confidentiality protection resulted in a log jam blocking data aggregation and disbursement. This conflict exposed the lack of preparedness of major institutions to collect, collate and disburse data elements needed for projects while maintaining patient privacy. The result was that access to well documented tissue specimens, using normalized descriptors, became an important impediment to the progress of research projects [14]. The Cancer Registry and the Health Sciences Tissue Bank engaged in discussions to evaluate mechanisms for addressing this issue. The major players in the research field were identified. The Health Sciences Tissue Bank, the Pathology Laboratory Information System, the Cancer registry, the Clinical Research Informatics Service, the Clinical Outcomes group, Radiation and Medical Oncology, Pathology and Oncology Informatics and the “Electronic Medical Record” team were considered key players. This list might not encompass every possible entity that could play a role; nonetheless it captures the major players involved in the aggregation and provision of specimens and data. Policies and procedures were established to serve as guiding principles.