Center for Identification and Study of Individuals with Atypical Diabetes Mellitus

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PROJECT SUMMARY/ABSTRACT RADIANT [Rare and Atypical DIAbetes NeTwork] is a nationwide network of researchers seeking to identify new rare, atypical forms of diabetes. To discover novel forms of atypical diabetes, the RADIANT investigators will perform genetic testing and deep phenotyping which may include some or all of the following: a physical exam, psychological and cognitive screening tests, laboratory data, and a variety of other clinical tests. This deep phenotyping will enable the investigators to look for patterns amongst patient-participants presenting with atypical diabetes. It will generate a significant amount of participant-specific health data, some of which will have unknown significance. RADIANT investigators are developing policies about which results to return and how to return them. In this supplement we focus on the return of non-genetic clinical results. Returning all results may not be beneficial (information overload); and yet deciding which results to return is not inherently value neutral. Returning results is further complicated by the fact that not all of the results are fully interpretable; leaving participants with information of unknown significance and investigators unsure of how to explain the uncertainty. We aim to explore what participants think they are signing up for when they agree to the return of results and whether investigators are prepared to return these results. The controversies being faced by the RADIANT consortium are five-fold: 1) which results to share; 2) how to disclose abnormal results; 3) whether and to what extent investigators have an obligation to provide an interpretation of research findings to participants; 4) whether participants can refuse to get research results that may be clinically actionable; and 5) what are the obligations of RADIANT investigators if participants elect not to receive results and/or elect not to allow the results to be shared with their HCPs. Given that these types of findings may become more common as discovery research continues to expand, it is important to understand how best to serve the needs and goals of both participants and investigators in an era where reporting back results is also becoming more commonplace. We aim to explore these questions with individuals who have atypical diabetes and the RADIANT investigators who study them. The timing of this project is ideal given that the 21st Century Cures Act goes into effect on April 5, 2021. The Cures Act gives patients fast and free virtual access to their clinical laboratory records, imaging data, and physician notes. We will explore the challenges raised by blurring practices in clinical care and research from the perspective of RADIANT participants and investigators, and the ability of physician-investigators and patient-participants to distinguish between the two. The outcome of the proposed study is highly generalizable to many other studies outside of diabetes genetics research given broad support for (patient and) participant access to their individual (clinical and) research results.