Composition: The Users Committee will be composed of at least one member from each participating organization which includes Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, and Massachusetts General Hospital, representing the disciplines of pathology, surgery, and medical oncology, radiation oncology and biostatistics. Members will be appointed by the chairs with no pre-specified term limits. The current membership is presented below.
Purpose: The members of the HCC Breast Users Committee are charged with reviewing the feasibility and scientific validity of proposed clinical and health services research, qualitative improvement (QI) projects, and translational and laboratory-based projects using the specimens and clinical data available through HCC breast cancer-focused research protocols. The committee also recommends a review of qualitative studies and surveys being implemented within HCC as it relates to breast cancer that will require the use HCC investigator platforms (e.g., if a researcher needs to use existing datasets to identify and contact patients).
Scope: All research using clinical data and/or biospecimens from breast cancer patients treated at any of the participating institutions must be reviewed by the Users Committee and is subject to a required annual renewal process for ongoing projects. Generally exempt from this scope are studies that are pre-specified in prospective therapeutic clinical trials or which include IRB-approved amendments to existing protocols by the primary research team for that database or specimen bank. For example, use of archival tissue specimens for the purpose of assessing a pre-specified biomarker to determine eligibility into an IRB-approved clinical trial does not require additional Users Committee approval to proceed. In contrast, secondary use of clinical data and/or biospecimens from clinical trials not explicitly specified in the original IRB-approved protocol is subject to Users Committee review.