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Skip to content Skip to search Skip to footer Institute for Informatics, Data Science & Biostatistics Open Menu Back Close Menu Search for: Search Close Search AboutAbout Centers &＃038; Affiliated EntitiesCenters &＃038; Affiliated Entities The Center for Applied Clinical Informatics The Center for Population Health Informatics Office of Health Information and Data ScienceOffice of Health Information and Data Science OHIDS Leadership Office of the Chief Research Information Officer Becker Medical Library Governance – HDRC Research International Education &＃038; Training People EducationEducation Doctor of Philosophy in Biomedical Informatics and Data Science Master of Science and Certificate Programs in Biomedical Informatics Master of Science in Biostatistics and Data Science (MSBDS) Master of Science in Biostatistics (MSIBS) Certificate in Genetic Epidemiology Biomedical Informatics and Data Science at I2DB (BIDS@I2DB) Summer Research Internship Biomedical Informatics andData Science (BIDS) Fellowship Program for Inclusion and Diversity Among Individuals Engaged in Health-Related Research (PRIDE) Clinical Informatics Fellowship Consultation &＃038; ServicesConsultation &＃038; Services Data brokerage and warehouse Biostatistics REDCap MDClone News Events Connect Governance Open Search Human Data Review Committee As Chief Data Scientist for the School of Medicine, Dr. Philip Payne leads the Human Data Review Committee (HDRC), which was jointly developed by WashU Executive Faculty and BJC leadership to provide a structure and economic model for leveraging data assets in situations where de-identified human data can help advance science and medicine via for-profit companies in alignment with institutional missions. WashU-BJC joint policy effective Jan. 1, 2022: Human data to be deidentified and disclosed to for-profit entities for the purposes of product development must be reviewed and approved by the Human Data Review Committee (HDRC) via the process outlined below. The full written policy is available here (internal access only). Please read the information here and use the button below to propose a disclosure when ready. You will be taken to the Office of Health Information and Data Science&＃8217;s single-intake form for services. Please select “Request for Initial Joint Governance Review” for consideration by the HDRC and allow five business days for this initial review. Contact [email protected] with questions. Propose a disclosure Policy background and purpose Historically, a broad variety of agreements have been developed and executed for research and/or technology development with little central coordination, leading to frequent faculty frustration, challenges tracking and understanding agreements, and diminished impact. Given that data are assets owned by the institutions (WashU and BJC), not by individual investigators, and that the use or disclosure of data are governed by applicable laws and institutional policies, it is important to centralize oversight and create a systematic, equitable and transparent approach to managing external data sharing partnerships with life science companies, professional services organizations and clinical research organizations. Goals of the policy are to: Accelerate biomedical research and advance science in support of the missions of WashU and BJC, particularly when such efforts involve collaboration with third parties Ensure we are acting as good stewards for data derived from patients and research participants Align decision-making with sound scientific and ethical principles Comply with all applicable laws, regulations and policies Simplify and clarify decision-making processes Definitions of &＃8216;data&＃8217; and &＃8216;research&＃8217; under the policy Data means all individual-level patient/participant data collected using the resources and/or under the auspices of the Institutions, whether in the course of clinical care or as part of a research study. Research means a systematic investigation – including research, development, testing, and evaluation – designed to develop or contribute to generalizable knowledge. Characteristics of Research may include IRB oversight, consent of participants, and scientific leadership by a Principal Investigator affiliated with the Institutions. What is/is not governed by the policy What is governed by the policy? Data that are disclosed to for-profit entities for the purposes of product development What is not governed under the policy? Data that are disclosed for the purposes of patient care or for research directly involving, managed by, or overseen by personnel of WashU. Parties responsible for review/approval The voting members of the Human Data Release Committee (HDRC) decide whether to approve or decline a proposed data disclosure. The HDRC is comprised of 12 total members, four of whom are voting members, with equal representation between WashU and BJC. The HDRC will balance numerous considerations to determine: If the proposed disclosure achieves important Institutional missions If the risks and challenges attendant to such proposed disclosure are substantially more significant than the perceived benefits of the disclosure Should the HDRC decline to approve a proposal, the members will facilitate working with the appropriate administrative units to determine whether the proposer has alternative options within the guidelines of this policy and in accordance with appropriate human subject and privacy protections to proceed. The proposer may resubmit the revision for consideration. If a declined after such further review and consideration, the matter may be referred and appealed to the chairs of the HDRC for still further review and consideration. How to propose a disclosure The following are required when proposing a disclosure: Project overview Details of the data to be disclosed (i.e., discrete data elements, as well as the Data sources – both at the institutional level, systems/database level) How the disclosure supports the missions of the institutions PI or WashU faculty/staff intellectual contribution to the project aims Summary of any sponsoring entity terms and conditions under which the data were collected if the data are retrospective, including any applicable data sharing plan Draft budget and other financial terms Draft agreement or term sheet (unless WashU drafting) Please read the information here and use the button below to propose a disclosure when ready. You will be taken to the Office of Health Information and Data Science&＃8217;s single-intake form for services. Please select “Request for Initial Joint Governance Review” for consideration by the HDRC and allow five business days for this initial review. Propose a disclosure Contact [email protected] with any questions. About Centers &＃038; Affiliated Entities The Center for Applied Clinical Informatics The Center for Biostatistics and Data Science The Center for Population Health Informatics The Center for Translational Bioinformatics Office of the Chief Research Information Officer Human Data Review Committee Research International Education &＃038; Training What is informatics? Institute for Informatics, Data Science & BiostatisticsWashington University School of Medicine660 S. Euclid Ave.Campus Box 8132Saint Louis, MO [email protected] Twitter ©2024 Washington University in St. Louis
