BUSPH & Optum Labs Collaboration: Processes Involved in Accessing Optum Labs Data The goal of the BU School of Public Health (BUSPH) and Optum Labs (OL) partnership is to encourage public health and medical research using OL data through funded grants. To this end, our team has been tasked to support interested BU researchers by advising them on OL data availability and quality, communicating with OL, performing preliminary analyses, reviewing project submissions, facilitating collaboration with OL partners and supporting workshops and one-on-one sessions. Our support will include assisting BU researchers in the following three steps in order to finalize proposal based on OL data: 1. Evaluation of feasibility of project within the BUSPH team: This first step involves review of potential data elements through analyses in OL's Natural History of Disease (NHD) to identify associations and generate hypotheses. Interested investigators are expected to develop a one page description of their research including the following: significance and background, specific aims and the preliminary list of variables. 2. Exploratory analyses using OL data: This step requires developing a 3-page preliminary research application (PRA) which is reviewed by the BUSPH team. For applications submitted by the Clinical and Translational Science Institute (CTSI), the review is collaborative. This proposal is then submitted to the OL Research Review Committee (RRC) for scientific review and assignment of impact ranking. The end product is creation of preliminary research sandbox in which basic exploratory analyses may be performed to support grant application. 3. Submission of a detailed research application (DRA): The 10-15 pages DRA must be reviewed for scientific merit and quality by senior researchers within BUSPH (Rosenbloom, White, Berlowitz) prior to submission. Subsequently, it needs to be approved by the Optum Lab RRC. Once approved, Scope of Work (SOW) is signed and analytic sandbox is created. Each project has its own SOW, project plan and progress reporting. In performing their review, Optum Labs RRC will consider alignment with the mission of the Labs (improving patient care), uniqueness of the research question, overall design of the project, feasibility and policy impact, involvement of multiple partners and support needed from OL. Programming support to BU researchers for using NHD and preparatory work is pre-funded through the BUSPH team. The goal is to procure grants that will support analyses and to put in grant budgetary support to access OL data. Currently, BUSPH has several pre-approved credits allowing projects without grant support. Since OL data is de-identified, the BU IRB does not require any IRB paperwork or processes to conduct research. BUSPH Team members • Dan Berlowitz, MD,MPH- Lead Researcher (dberlow@bu.edu) • Lewis Kazis, ScD- Senior Researcher (lek@bu.edu) • Mark Glickman, PhD- Senior Researcher/Statistician (mg@bu.edu) • Guneet Kaur, PhD-Program Manager (guneetk@bu.edu) • Omid Ameli, MD- Programmer (oameli@bu.edu)