Microbiome-Based Diagnostics: Stakeholder Perceptions and Implications for the Regulatory Framework
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:
Address, Area, Award, Baltimore, base, Benefits and Risks, Bioethics Consultants, Chronic Disease, Clinical, communicable disease diagnosis, data security, Decision Making, Development, Diagnostic, Diagnostic tests, Discrimination, dysbiosis, Effectiveness, Ensure, Ethics, Evaluation, Face, Focus Groups, Future, genetic information, genetic testing, Goals, Grant, Health, Healthcare, Human, Human Genome Project, Human Microbiome, Individual, Industry, Informed Consent, innovation, Innovative Therapy, Interview, Knowledge, Laws, Legal, Marketing, Maryland, microbial, microbiome, microbiota transplantation, Motivation, multidisciplinary, novel diagnostics, Outcome, patient oriented, Patients, Perception, Physicians, Policies, Privacy, privacy protection, Probiotics, Provider, Recommendation, recruit, Regulation, Research, research and development, Research Personnel, Risk, risk minimization, Scheme, screening, Site, social, social stigma, Test Result, Testing, tool, United States National Institutes of Health, Universities, willingness, working group