Microbiome-Based Diagnostics: Stakeholder Perceptions and Implications for the Regulatory Framework
Institution: UNIVERSITY OF MARYLAND BALTIMORE
FOA Number: PA-17-444
Project Narrative There is much that is not yet known about the implications of microbiome-based diagnostic or screening test results and, similar to the early days of genetic testing, it is possible that existing laws and regulations that did not contemplate these technological advancements are not adequate to address concerns they raise. The proposed project will evaluate the existing legal and regulatory frameworks regarding these new products and their use and assess patient and provider perspectives on their value, utility and potential for misuse in order to inform future regulatory approaches for these tools and ensure their appropriate use in patients. The overall goal of the project is to inform and support policy and regulatory approaches that stimulate scientific discovery, identify and address problems or gaps in the current regulatory and legal framework and encourage innovation while ensuring that new microbiome-based products are safe and effective.
NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Aug 1, 2019
May 31, 2023