Novel and Exceptional Technology and Research Advisory Committee (NExTRAC)

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About

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 SciencePolicy@od.nih.gov.

Charter

AUTHORITY

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. §§ 1001-1014).

OBJECTIVES AND SCOPE OF ACTIVITIES

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).

DESCRIPTION OF DUTIES

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.

AGENCY OR OFFICIAL TO WHOM THE COMMITTEE REPORTS

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

SUPPORT

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

ESTIMATED ANNUAL OPERATING COST AND STAFF YEARS

The estimated annual cost for operating the Committee, including compensation and travel expenses for members, but excluding staff support, is $205,134. The estimated annual person-years of staff support is 1.5 at an estimated annual cost of $234,133.

DESIGNATED FEDERAL OFFICER

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 official to whom the committee reports.

ESTIMATED NUMBER AND FREQUENCY OF MEETINGS

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 of Health and Human Services (Secretary) at the request of the DFO in accordance with 5 U.S.C. 552b(c) and 41 C.F.R. 102-3.155 including specifying the specific exception(s) that justifies closure. 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, an annual report of closed or partially-closed meetings 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.

DURATION

Continuing.

TERMINATION

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.

MEMBERSHIP AND DESIGNATION

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, as defined by 18 U.S.C. § 202. 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.

SUBCOMMITTEES

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.

RECORDKEEPING

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 any applicable exemptions under the Freedom of Information Act, 5 U.S.C. 552(b) and 41 C.F.R. 102-3.170.

FILING DATE

June 30, 2023

APPROVED

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

Signed on June 15, 2023

Members

Chair

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

Members

BAKKEN, Suzanne, PhD, RN, FAAN, FACMI, FIAHSI
Alumni Professor of the School of Nursing
Professor of Biomedical Informatics
Vagelos College of Physicians & Surgeons
Columbia University
New York, NY 10032

CAINDEC, Karen
Chairperson
Board of Directors
Southcentral Foundation
Anchorage, AK 99508

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

COLLINS, James, PhD
Virginia M. Ullman Professor of Natural History and the Environment
Faculty Group Leader of Global Change Biology Faculty Group, School of Life Sciences
Professor, Center for Evolution and Medicine Affiliated Faculty
Lincoln Center Affiliated Faculty, Lincoln Center Applied Ethics
Arizona State University
Tempe, AZ 85287

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

HYUN, Insoo, PhD
Director
Center for Life Sciences and Public Learning
Museum of Science
Boston, MA 02114

KHETERPAL, Sachin, MD, MBA
Associate Dean for Research Information Technology
Professor of Anesthesiology
University of Michigan Medical School
Ann Arbor, MI 48109

LESHNER, Alan I., PhD
Chief Executive Officer, Emeritus
American Association for the Advancement of Science
Potomac, MD 20854

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, MA 02139

RICHARDSON, Sarah M., PhD
Chief Executive Officer
Microbyre, Inc.
Berkeley, CA 94710

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

SAUNDERS, Kevin O., PhD
Associate Professor
Department of Surgery
Duke University School of Medicine
Durham, NC 27710

WYATT, Letisha R., PhD
Associate Professor of Neurology,
School of Medicine
Director of Diversity in Research,
OHSU Research & Innovation
Oregon Health & Science University
Portland, Oregon 97239

Reports and Recommendations

Meetings

Working Group Activities

 

Working Group on Engaging the Public as Partners in Clinical Research

BACKGROUND:

NIH is the steward of the Nation’s largest public investment in clinical research, investing nearly $18 billion in fiscal year 2022. NIH employs a broad spectrum of approaches to advance clinical research discoveries, such as harnessing emerging digital health technologies, integrating real-world data through EHRs, piloting innovative clinical trial designs, and more. At the heart of this enterprise are the dedicated members of the public who partner with researchers in hopes of turning discoveries into improved health.

While emerging technologies can make clinical research more accessible to potential participants, the recent COVID-19 pandemic has clearly illustrated that more can be done to promote the inclusive environment needed to truly advance health outcomes for all. Additionally, recent Community Conversations held in support of NExTRAC’s deliberations reinforced the necessity of trust and transparency for building effective research partnerships with participants and the broader public. To turn these conversations into action, NIH is furthering its commitment to engaging the public as partners in the design and planning of clinical research to produce outcomes important to them, as well as strategies for dissemination of study findings. Through this approach, NIH can strengthen bi-directional engagement in clinical research, foster transparency and trust, and create outcomes that provide value to the people it aims to serve.

CHARGE:

The NExTRAC is charged with establishing the ENGAGE Working Group to develop a vision and framework for including public voices in the design and planning of NIH-funded clinical research, as well as widespread dissemination of study findings. The public should be defined broadly, including people with and without specific health conditions as well as their communities. This framework should outline approaches appropriate for the breadth and diversity of NIH-funded clinical research studies and assess the potential:

  • Opportunities and challenges of varying levels of engagement activities for different types of clinical research studies, considering potential trade-offs in research investment (e.g., cost, time) and benefits for improved trust, participation, outcomes, research uptake, implementation of new interventions, etc.; and
  • Impact and value of engagement with patients, communities, and the broader public on clinical research, including on the quality and significance of research, relevance of the findings to diverse communities, methods of building trust to improve adoption of evidence-based practices, as well as other relevant considerations deemed appropriate by the Working Group.

In addressing this charge, the Working Group shall consult with the NIH Advisory Committee to the Director (ACD) and convene public consultations including, but not limited to, patient partners, caretakers, community representatives, research participants, patient advocacy organizations, clinical researchers, and local health providers, to provide recommendations regarding:

  • How different engagement methods may be used for clinical research in general, as well as research employing novel technologies, unknown data capabilities, and potentially sensitive datasets;
  • Optimal timing for meaningful engagement activities across the spectrum of the design and planning of the clinical research study, as well as dissemination of study findings so that evidence-based practices are adopted in the community; and
  • Approaches for public engagement in NIH clinical research to be equitable and inclusive.
DELIVERABLES:

The Working Group will provide regular updates to both the NExTRAC and ACD prior to presenting its final framework and findings to the NExTRAC for potential endorsement by Summer 2025.

Working Group on Data Science and Emerging Technology

Charge:
  • 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

Charge:
  • 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

Charge:
  • 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