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NIH Aug 1, 2019 | R01

Microbiome-Based Diagnostics: Stakeholder Perceptions and Implications for the Regulatory Framework

Principal Investigator(s): HOFFMANN, DIANE E.;

Institution: UNIVERSITY OF MARYLAND BALTIMORE

FOA Number: PA-17-444

Abstract

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.

FUNDING AGENCY:

Funder:
NIH

Institute:
NATIONAL HUMAN GENOME RESEARCH INSTITUTE

Funding Type:
R01

Project Number:
R01HG010571

Start Date:
Aug 1, 2019

End Date:
May 31, 2023

PROJECT TERMS:

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