PROJECT DESCRIPTION (ABSTRACT) The use of artificial intelligence (AI) continues to accelerate in biomedical and behavioral research, with the ultimate goals of informing and improving healthcare. While the technical advances thus far are significant, sev- eral concerns have been introduced recently regarding the (unintended) consequences of such techniques. For example, problems related to dataset bias can manifest in multiple ways, including the use of non-representative populations; continued propagation of unrecognized system and process prejudices; and equitable access. Given the potential downstream harm, ethical, legal, and social issues (ELSI) must now be integrated alongside the use of data and AI in biomedical and behavioral research and care delivery. However, best practices for ELSI and ethical AI (ETAI) have yet to fully emerge and there is no standard way of documenting ELSI/ETAI consid- erations in the development and use of predictive models. Building on our platform, the PREdictive Model Index and Exchange REpository (PREMIERE), the goal of this 1-year R01 supplement is to develop (meta)data to document and share information around ELSI/ETAI, directly linking such information as part of a shared predictive model. To focus our efforts, we address the growing use of synthetic datasets to train and validate machine learning (ML) models. Synthetic datasets reflect the underly- ing statistical properties of actual real-world datasets and are promoted as a way of protecting private information while enhancing the overall data availability (i.e., for training). The use of generative adversarial networks (GANs) is illustrative. But improperly simulated datasets can result in an algorithm learning incorrectly and/or exacerbat- ing existing dataset biases, raising complex ELSI questions. Using these questions as a motivating use case, this supplement has three specific aims: 1) to examine the ethics of using synthetic datasets, namely through key informant interviews; 2) to establish guidance for a computational checklist for AI/ML and ELSI, leveraging a broad community of stakeholders; and 3) to develop and implement this checklist as part of PREMIERE, demonstrating how ELSI-related information is shared as part of a ML model by extending the Predictive Model Markup Language (PMML). To achieve these aims, we established a new collaboration between UCLA and Penn State University (PSU) to bring together interdisciplinary experts in AI/ML, biomedical informatics, law, ethics, communication, and healthcare. Together, we will plan a series of workshops that convene national ex- perts who have already agreed to participate in this endeavor. The results of these meetings will be increased awareness around the use of synthetic datasets and their complexities; published recommendations around their use; and methods for documenting ELSI/ETAI in the context of predictive ML models.