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Agenda: Sex as a Biological Variable (SABV) Policy for Studies Using Non-Human Primates in Neuroscience Research

January 4, 2024, 9:00AM-3:00 p.m. ET

9:00 AM Welcome and Opening Remarks

Dr. Andrew Rossi, NIMH

9:05-9:35 AM Invited Presentation: “The Sex as a Biological Variable (SABV) Policy, Practice, and Promise for Biomedical Research”

Speaker: Chyren Hunter, Ph.D., Associate Director, NIH Office of Research on Women’s Health

The NIH Policy “Consideration of Sex as a Biological Variable (SABV) in NIH-funded Research” went into effect for NIH applications and awards in January 2016. It summarizes NIH's expectation that SABV will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. This talk will review the scientific case for SABV, what it is, what it is not, and the expanding impact of SABV on biomedical and biobehavioral research. The status of implementation, seven years on since publication, will also be discussed. Balancing the application of the policy with the challenges facing investigators navigating the limited availability of animal models is critical to the collective goal of evidence-based treatments to advance health.

10-minute Q&A from online audience

9:45-10:15 AM Invited Presentation: “Constraints on Availability of Female and Male Nonhuman Primates (NHPs) for Biomedical Research and Why This Matters”

Speaker: Matthew Arnegard, Ph.D., Senior Scientific Advisor, Division of Program Coordination, Planning, and Strategic Initiatives, NIH

To further set the stage for subsequent panel discussions, this presentation will summarize public information on the nature of the current NHP shortage. In addition, the presentation will explain how the mating systems of the most requested NHP species further limit the availability of females for juvenile to peak breeding age classes. In underscoring the critical roles that NHP models play in NIH-funded brain research, the speaker will also present examples of male and female NHP sample sizes from selected basic, technology development, and translational neuroscience studies published in 2023.

10-minute Q&A from online audience

*10-minute coffee break*

10:35-11:05 AM Panel Discussion: “What the SABV policy is and is not.”

Chair: Chyren Hunter, Ph.D., Associate Director, NIH Office of Research on Women’s Health
Panelists: Jan Zimmerman, Ph.D., University of Minnesota; Daniel Salzman, M.D., Ph.D., New York University; Bettina Buhring, Ph.D., Office of Research infrastructure Programs, NIH

  1. Scientific and resource issues to justify single-sex studies.
  2. Small samples, equal numbers of males and females, power, and rigor. Best practices for NIH applicants.
  3. How SABV policy applies to the use of post-mortem tissue, ipSCs, or other biospecimens.
  4. Responsible use of NHP resources and potential NHP resource sharing.

10-minute Q&A from online audience

11:15-11:45 AM Invited Presentation: “Ethics of SABV: Discussion of 3Rs, importance of including both sexes from an ethical and societal perspective.”

Speaker: Rebecca Walker, Ph.D., Professor of Philosophy, University of North Carolina

10-minute Q&A from online audience

11:55 AM–1:00 PM Lunch Break

1:00-1:30 PM Panel Discussion: “Best practices for transitioning to research using both sexes.”

Chair: Amy Orsborn, Ph.D., University of Washington
Panelists: Joni Wallis, Ph.D., University of California Berkeley; Elisabeth Murray, Ph.D., NIMH; Julia Shaw, Ph.D., National Institute of Allergy and Infectious Diseases; Katalin Gothard, M.D., Ph.D., University of Arizona

  1. Factoring SABV into experimental design and planned analyses.
  2. Housing and animal care considerations.
  3. Discussion of strategies for how investigators can work with their institutions to comply with SABV policy (e.g. adding female monkeys to existing male-only facilities).
  4. Planning for cost and resources required for increasing the number of NHPs.
  5. Phased SABV compliance in the context of NIH awards.

10-minute Q&A from online audience

*10-minute coffee break*

1:50-2:20 PM Panel Discussion: “SABV and NIH Review”

Chair: Heidi Friedman, Ph.D., NIH Center for Scientific Review
Panelists: Roger Janz, NIH Center for Scientific Review; Camillo Padoa-Schioppa, Ph.D., Washington University
Mauricio Rangel-Gomez, Ph.D., NIMH; Andrew Rossi, Ph.D., NIMH

  1. How SABV policy is managed in peer review and how this may change when the new peer review factors are implemented.
  2. How to balance the constraints of resource limitations against the significance and innovation of applications when evaluating justifications for single-sex studies.
  3. What are Program expectations for SABV? Program strategies for working with PIs in the consideration of both sex studies.

10-minute Q&A from online audience

2:30-3:00 PM Summary and General Discussion

Drs. Mauricio Rangel-Gomez, Andrew Rossi, and invited panelists.