• 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:

    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

Return to Search Results

Share

Related Projects

+ Search results