Appendix F

Study Methods

COMMITTEE COMPOSITION

The National Academies of Sciences, Engineering, and Medicine (the National Academies) appointed a committee of 13 experts to undertake the statement of task. Members provide the perspectives of academia, industry, government, and the nonprofit sector and have experience in synthetic biology, biosafety, microbiology, public health, bioinformatics, and risk assessment. Appendix D provides the biographical information for each committee member.

MEETINGS AND INFORMATION GATHERING

The committee deliberated from approximately January 2017 to February 2018. To respond to its charge, the committee gathered information and data relevant to its statement of task by conducting a review of available literature and other publicly available resources, inviting experts to share perspectives at public meetings, and soliciting public comments online and in person. The study was conducted in two phases. In Phase 1 of the study, the committee met several times in person and held webinars to gather information, understand the needs of the relevant federal agencies, and develop a tool for assessing the biodefense threat to guide the study’s second phase. During this phase, the committee defined the type of framework that would guide the assessment of concerns, identified major categories of relevant technologies and applications to assess, and discussed the factors to include in the assessment. In Phase 2, the committee met additional times and incorporated further input and data gathering to refine the framework for assessing potential biodefense concerns. It applied this framework to analyze specific potential applications of synthetic biology and to identify current areas of concern created by synthetic biology.

Over the course of the study, the committee held seven meetings in Washington, D.C., and Irvine, California. Three of these seven meetings included an open information-gathering component. During these open meetings, the committee heard from a variety of academic and private-sector researchers, as well as federal government officials. These meetings focused on understanding the current and near-term research being conducted in the field of synthetic biology and relevant adjacent scientific fields, understanding the current operations and research occurring within the federal government, understanding the existing concerns of biodefense and biosecurity professionals, and enlisting the assistance of these academics and professionals to scan the horizon for potential future technol-

ogy developments and emerging threats. The remaining four meetings were closed to the public and served as time for the committee members to deliberate and write their report. The three open meetings are detailed below.

The first open meeting, held January 26–27, 2017, in Washington, D.C., provided an opportunity for the committee to discuss the study charge with the sponsor, as well as relevant needs of nonsponsor government agencies. The committee also heard a general overview of synthetic biology, a report out on previous work that had been performed by the President’s Council of Advisors on Science and Technology and the JASON advisory group relevant to this study, and a presentation from another group that had done risk analyses and framework development for the U.S. Department of Defense.

The second meeting, held May 24–25, 2017, in Washington, D.C., included speakers who reviewed relevant aspects and current research on DNA synthesis, assembly, and engineering; on virus engineering, transmissibility, and zoonosis; on the idea of “ease of use” and its applicability to potential risks arising from synthetic biology; and an exercise in horizon-scanning and looking to the future.

The third meeting, held July 6–7, 2017, in Washington, D.C., included speakers who presented on the current state of public health and military preparedness; on efficacy of design in synthetic biology, focusing on what is truly possible and what is still not possible; on the current state of human modulation; and on emerging technologies that might assist or abet overcoming existing technical barriers.

The committee also held two public webinars. The first was held March 10, 2017, and included talks on how to approach creating a strategic framework to assess the potential risks of synthetic biology, as well as a review of some of the objectives and accomplishments of the biological weapons program of the Soviet Union.

The second webinar was held March 23, 2017, and included a talk on a review of prior attempts at frameworks and strategies to assess potential risks of synthetic biology. Both of these webinars were advertised and open to the public, although the committee did not accept questions or comments from the public during these webinars because their primary purpose was to serve as information-gathering activities for the committee.

PUBLIC COMMUNICATION

The committee’s two largest data-gathering meetings, in May and July 2017, provided opportunities to interact with additional stakeholders, including interested researchers and other parties. These participants contributed their views during open discussions following speaker presentations. The committee also worked to make its activities as transparent and accessible as possible for those who may not have been able to attend in person. The study website, http://nas-sites.org/dels/studies/strategies-for-identifying-and-addressing-vulnerabilities-posed-by-synthetic-biology, was updated regularly to reflect the recent and planned activities of the committee. Study outreach included a study-specific e-mail address for submitting comments and questions to the committee.

Following the release of the study’s interim report in August 2017, the study committee requested input from the public via an online survey. The survey was distributed widely through existing National Academies mailing lists, through the social and professional networks of the study committee, and through the Engineering Biology Research Consortium’s mailing list. Public comments were collected, and the committee members reviewed all comments and incorporated relevant and applicable commentary into their work on the final report.

Any information provided to the committee from outside sources or through the online comment tool is available by request through the National Academies’ Public Access Records Office.

Invited Speakers

The following individuals were invited speakers at meetings and data-gathering sessions of the committee:

Chris Anderson

University of California, Berkeley

Ralph Baric

University of North Carolina

Ronald Breaker

Yale University

Tom Burkett

Baltimore Underground Science Space

Rocco Casagrande

Gryphon Scientific

Susan Coller-Monarez

Department of Homeland Security

Drew Endy

Stanford University

Aaron P. Esser-Kahn

University of California, Irvine

John Glass

J. Craig Venter Institute

Michael Jewett

Northwestern University

Lawrence Kerr

U.S. Department of Health and Human Services

George Korch

U.S. Department of Health and Human Services

Jens H. Kuhn

NIH/NIAID Integrated Research Facility at Fort Detrick

Devin Leake

Ginkgo Bioworks

Corey Meyer

Gryphon Scientific

Piers Millett

Biosecure, Ltd.

Polina Anikeeva

Massachusetts Institute of Technology

Kavita Berger

Gryphon Scientific

Roger Brent

Fred Hutchinson Cancer Research Center

Sarah Carter

Science Policy Consulting

Christophoer Chyba

Princeton University

Patrik D’haeseleer

Lawrence Livermore National Laboratory

Gerald L. Epstein

Office of Science and Technology Policy

Carolyn M. Floyd

Office of the Director of National Intelligence

D. Christian Hassell

U.S. Department of Defense

CDR Franca Jones

Armed Forces Health Surveillance Center

Gregory Koblentz

George Mason University

Sriram Kosuri

University of California, Los Angeles

Todd Kuiken

North Carolina State University

Monique Mansoura

Massachusetts Institute of Technology

Paul Miller

Synlogic

Steve Monroe

U.S. Centers for Disease Control and Prevention

Richard Murray

California Institute of Technology

Colin Parrish

Cornell University

Ryan Ritterson

Gryphon Scientific

Dan Tawfik

Weizmann Institute of Science, Israel

Harry Yim

Genomatica

Megan Palmer

Stanford University

Amy Rasley

Lawrence Livermore National Laboratory

Howard Salis

Pennsylvania State University

Luke Vandenberghe

Harvard University