Novel and Exceptional Technology and Research Advisory Committee (NExTRAC)

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The Novel and Exceptional Technology and Research Advisory Committee is a federal advisory committee that provides recommendations to the NIH Director and a public forum for the discussion of the scientific, safety, and ethical issues associated with emerging biotechnologies.  NExTRAC proceedings and reports are posted to the OSP Web site to enhance their accessibility to the scientific and lay public.

Public input on NExTRAC activities is always welcome, and interested members of the public may contact us at



Authorized by 42 U.S.C. 282(b)(16), section 402(b)(16) of the Public Health Service (PHS) Act, as amended. The Novel and Exceptional Technology and Research Advisory Committee (Committee) is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2).


The Committee will provide advice to the Director, National Institutes of Health (NIH), on matters related to the conduct and oversight of research involving emerging technologies in biomedical science (also referred to as emerging biotechnologies).


The Committee makes recommendations on research involving the use of, and developments in, emerging biotechnologies. The Committee will address scientific, safety, ethical, and social issues associated with areas of emerging biotechnology research for which the NIH requests advice or guidance.

As necessary, and with the approval of the Designated Federal Officer (DFO), the Committee and its subcommittees may call upon special consultants, assemble ad hoc working groups, and convene conferences, workshops, and other activities.


The Committee will advise, consult with, and make recommendations to the Director, NIH.


Management and support services will be provided by the Office of Science Policy (OSP).


The estimated annual cost for operating the Committee, including compensation and travel expenses for members, but excluding staff support, is $142,901. The estimated annual person-years of staff support is 0.7 at an estimated annual cost of $131,445.


The Director, OSP, will assign a full-time or permanent part-time OSP employee as the Designated Federal Officer (DFO) of the Committee. In the event that the DFO cannot fulfill the assigned duties of the Committee, one or more full-time or permanent part-time OSP or NIH employees will be assigned as DFO and carry out these duties on a temporary basis.

The DFO will approve or call all of the Committee’s and subcommittees’ meetings, prepare and approve all meeting agendas, attend all Committee and subcommittee meetings, adjourn any meeting when it is determined to be in the public interest, and chair meetings when directed to do so by the Director, NIH or the Director, OSP.


Meetings of the full Committee will be held approximately 2 times within a fiscal year and as requested by the DFO. Meetings will be open to the public except as determined otherwise by the Secretary in accordance with subsection (c) of section 552b of Title 5 U.S.C. Notice of all meetings will be given to the public. In the event a portion of a meeting is closed to the public, as determined by the Secretary, in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act, a report will be prepared which will contain, at a minimum, a list of members and their business addresses, the Committee’s functions, dates and places of meetings, and a summary of the Committee’s activities and recommendations made during the fiscal year. A copy of the report will be provided to the Department Committee Management Officer.




Unless renewed by appropriate action, the Novel and Exceptional Technology and Research Advisory Committee will terminate two years from the date the charter is filed.


The Committee will consist of up to 25 voting members, including the Chair, appointed by the Director, NIH. A majority of the voting appointed members must be knowledgeable in relevant emerging scientific fields (e.g., gene therapy, gene editing, synthetic biology). As needed, the Committee may include persons knowledgeable in fields such as public health, laboratory safety, occupational health, protection of human participants in research, the environment, ethics, law, public attitudes or related fields. All appointed members must be eligible to serve as and will serve as Special Government Employees.

Appointed members will be invited to serve for overlapping four-year terms. A member may serve after the expiration of that member’s term until a successor has taken office. A quorum for the conduct of business by the full Committee will consist of a majority of currently appointed members.


As necessary, subcommittees and ad hoc working groups may be established by the DFO within the Committee’s jurisdiction. The advice/recommendations of a subcommittee/working group must be deliberated by the parent advisory committee. A subcommittee/working group may not report directly to a Federal official unless there is statutory authority to do so.

Subcommittee membership may be drawn in whole or in part from the parent advisory committee. All subcommittee members may vote on subcommittee actions and all subcommittee members count towards the quorum for a subcommittee meeting. Ad hoc consultants are not members, do not count towards the quorum and may not vote. A quorum for a subcommittee will be three members. The Department Committee Management Officer will be notified upon establishment of each standing subcommittee and will be provided information on its name, membership, function, and estimated frequency of meetings.


Meetings of the Committee and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws, and Departmental policies. Committee and subcommittee records will be handled in accordance with General Records Schedule 6.2, Federal Advisory Committee Records, or other approved agency records disposition schedule. These records will be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.


June 30, 2021


By Lawrence A. Tabak, D.D.S., Ph.D., Acting Director, NIH

Signed on June 7, 2021



BLOSS, Cinnamon, PhD
Herbert Wertheim School of Public Health and
Human Longevity Science
University of California, San Diego
La Jolla, CA 92093


Professor and Presidential Impact Fellow
Department of Entomology
Texas A&M University
College Station, TX 77843

ALBRITTON, Lorraine M., PhD
Professor Emeritus
Department of Microbiology, Immunology, and
College of Medicine
The University of Tennessee Health Science Center
Memphis, TN 38163

Department of Veterinary and Biomedical Sciences
University of Minnesota
Saint Paul, MN 55108

GRONVALL, Gigi Kwik, PhD
Associate Professor
Department of Environmental Health and Engineering
Johns Hopkins Bloomberg School of Public Health
Baltimore, MD 21202

LEE, Benhur, MD
Department of Microbiology
Ward-Coleman Chair in Microbiology
Icahn School of Medicine at Mount Sinai
New York, NY 10029

Chief Executive Officer, Emeritus
American Association for the Advancement of Science
Potomac, MD 20854

Former Executive Vice President
Pfizer Inc.
New York, NY 10017

OSSORIO, Pilar N., PhD, JD
Professor of Law and Bioethics
University of Wisconsin
Madison, WI 53706

OYE, Kenneth, PhD
Professor, Political Science and Data, Systems and Society
Director, Program on Emerging Technologies
Center for International Studies
Massachusetts Institute of Technology
Cambridge, Massachusetts 02139

PORTEUS, Matthew, MD, PhD
Professor of Pediatrics (Pediatric Stem Cell Transplantation)
Department of Pediatrics
Stanford Medical School
Stanford University
Stanford, CA 94305

RILEY, Margaret F., JD
Professor, School of Law
Professor of Public Health Science
School of Medicine
Professor of Public Policy
Batten School of Leadership and Public Policy
University of Virginia
Charlottesville VA 22903

TURNER, Leigh, PhD
Professor, Health, Society & Behavior
Program in Public Health
University of California
Irvine, CA 92697

Incoming Members

Director, Office of Biosafety
Director of Containment Operations and Quality Assurance
Tulane University
New Orleans, LA 70118

CALLIER, Shawneequa, JD
Associate Professor of Clinical Research and Leadership
School of Medicine and Health Sciences
George Washington University
Special Volunteer, National Human Genome Research Institute
Washington, DC 20037

HYUN, Insoo, PhD
Center for Life Sciences and Public Learning
Museum of Science
Bioethics Affiliate,
Center for Bioethics
Harvard Medical School
Boston, MA 02114

Associate Professor
Department of Surgery
Duke University
School of Medicine
Durham, NC 27710

Reports and Recommendations


Working Group Activities


Working Group on Data Science and Emerging Technology

  • Define and characterize the types of research questions that require increasing granularity and aggregation of data about individuals that are likely to be addressed through emerging technologies, considering:
    • Goals of such research studies and how they advance the NIH mission
    • Emerging technologies that may generate potentially sensitive datasets
    • Data types generated and their sources (e.g., digital health devices, EHR platforms) with an emphasis on exploring new data types or unique sources
    • Data science platforms and tools that facilitate data access, combination, and analysis (e.g., artificial intelligence, cloud computing)
  • For those questions and technologies defined above, consult with stakeholders to discuss and assess the value of and potential implications for individuals, groups, and society, considering:
    • Attitudes and perspectives about sharing participant data to advance biomedical research, specifically through the lens of balancing research risk (e.g., privacy, autonomy) with research deliverables
    • How these perspectives may evolve depending on the context of who is to benefit or assume risk, whether it be at the individual level, through the community, or broader society’s expectations for public health advancement

Working Group Roster

Working Group to Establish a NExTRAC Framework

  • Describe effective approaches for prospectively identifying emerging biotechnologies or specific applications with reasonable potential to have important scientific, safety, or ethical considerations
  • Conceptualize a framework for NExTRAC deliberation of issues surrounding emerging biotechnologies and applications, including:
    • Guiding principles for when an emerging biotechnology or its applications would significantly benefit from further public deliberation
    • A potential process by which the NExTRAC will consider or evaluate any given emerging biotechnology or its applications
  • The working group will consider
    • Applications of emerging biotechnologies, given that the way the biotechnology is used often generates the safety, social, or ethical issues
    • Effective horizon scanning approaches; focusing on biotechnologies and applications that are reasonably anticipated vs. hypothetical
    • Cross-cutting issues that may be relevant for a variety of emerging biotechnologies and applications
    • Strategies for committee engagement and soliciting feedback

Working Group Roster

Gene Drives in Biomedical Research Working Group

  • Consider whether existing biosafety guidance is adequate for contained laboratory research utilizing gene drive technology
  • Outline conditions (if any) under which NIH could consider supporting field release of gene drive-modified organisms

Provide advice on the following issues:

  • Given the diverse applications and species that may be used in gene drive research with different risks, is the current landscape of biosafety guidance adequate for contained research?
  • What knowledge and conditions should be in place to help ensure that field release research of gene drive-modified organisms could be conducted safely and ethically?

Working Group Roster