Respecting Autonomy and Enabling Diversity in Data-driven Research

Respecting autonomy and enabling diversity in data-driven research: Sharing patient and research participant health information across academic institutions, government, and industry can improve patient outcomes and accelerate breakthroughs in medical research. Artificial intelligence (AI) and large language modeling (LLM) in the clinical context can collect, harmonize, and interpret large amounts of data from diverse inputs including the internet, databases, and electronic medical records and hold great promise to continue to improve the research enterprise. Major players in the industry, including Epic, are currently integrating AI and generative AI technologies into academic medical centers across the country. But this is all being done in a legal structure not responsive to the risks and benefits of data-driven research, and in the context of patients and participants with low-literacy of current practices and/or strong concerns. This talk will focus on how to respect the autonomy of “participants” in the big data economy, specific challenges for health equity, and propose legal and policy solutions moving forward.

Professor Kayte Spector-Bagdady, JD, MBe, is health law and bioethics faculty at the University of Michigan Medical School and an Associate Professor of Obstetrics & Gynecology. She is the first to make tenure at the U-M medical school with JD as their terminal degree. She is also the interim co-director of the U-M Center for Bioethics and Social Sciences in Medicine, which won the 2022 American Society for Bioethics & Humanities (ASBH) Cornerstone Award. At U-M she is also the Chair of the Research Ethics Committee, the ethicist on the Michigan Medicine Human Data and Biospecimen Release Committee, and a clinical ethicist. She teaches the Responsible Conduct of Research as well as Research Ethics and the Law.

Prof. Spector is an Associate Editor of the American Journal of Bioethics and a member of the National Academies’ committee on Newborn Screening: Current Landscape and Future Directions. In the past, she was also Chair and lead author of the American Heart Association’s “Principles for Health Information Collecting, Sharing, and Use,” a member of the ASBH Board of Directors, and an Associate Director for President Obama’s Presidential Commission for the Study of Bioethical Issues.

The overarching goal of Prof. Spector’s work is improving the governance of secondary research with health data and specimens to increase the accessibility of data and generalizability of advances across diverse communities. To that end, she was the PI of a NHGRI K01 focusing on academic/private relationships in genetic research, and is the PI of an NCTAS R01 on hospitals sharing patient data with commercial entities and a Greenwall Faculty Scholar Award on the research integrity implications of generative AI. She has been PI or Co-I on ~$200M in funding.

Her recent articles have been published in The New England Journal of Medicine, Science, JAMA, Health Affairs, and Nature Medicine, and her research or expertise has appeared in the NY Times, The Washington Post, The Wall Street Journal, TIME, and CNN.

Professor Spector received her JD and MBe from the University of Pennsylvania Law School and School of Medicine after graduating from Middlebury College. She completed a research fellowship in bioethics at Michigan Medicine and is a former practicing drug and device attorney for the biotech industry.

Host or Publisher Emory University Center for Ethics