Skip to main content

Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct

Completed

Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges. However, due to their intrinsic qualities of rapid spread and irreversibility, gene drive systems raise many questions with respect to their safety relative to public and environmental health. This report outlines the state of knowledge relative to the science, ethics, public engagement, and risk assessment as they pertain to research directions of gene drive systems and governance of the research process.

Description

The National Research Council of the National Academy of Sciences will convene an ad hoc committee to:

  • Review the state of the science of gene drive research that relies on genome editing techniques, such as CRISPR/Cas9 and other endonucleases, or other genetic modification approaches. The focus should be on identifying the key scientific techniques for reducing ecological and other risks that should be considered prior to field releases of organisms carrying gene drives. This will require characterizing and assessing environmental and other hazards to target and non-target organisms, and will also include consideration of developing appropriate mitigation strategies, such as reversal drives;
  • Using appropriate case studies that are based on likely applications of gene drive technologies to animals, plants, insect vectors, etc., examine the oversight mechanisms, including guidelines and regulations for:

-- Organisms containing gene drives in the laboratory or other contained, or semi-contained environments;
--
Organisms containing gene drives for use in field releases within the U.S.; and
--
Organisms containing gene drives for use in field releases in low and middle income countries.

This should include examination of the roles of institutional biosafety committees, national or local regulatory authorities, and international frameworks and instruments such as the Cartagena Protocol. An extensive review of international country specific regulations is not requested, except to the extent that such regulations are illustrative of the general context of oversight or exemplify unique approaches. The committee will also:

  • Determine the adequacy of the existing oversight mechanisms and risk assessment guidance to identify the immediate and long term potential environmental and public health implications raised by individual applications of gene drive technology. This should include safeguarding against accidental or intended misuse spanning the full developmental spectrum from laboratory to release. This may also include identification of gaps that regulators may need to address, although the committee should not attempt to develop specific proposals for new regulations;
  • Discuss relevant legal, social, or ethical considerations in selecting sites for field releases and engaging those living in or near potential release sites; and
  • Provide general principles that will guide responsible practices in gene drive research for the laboratory setting through to field releases for use by investigators, their institutions, the research funders, and regulators.

Collaborators

Committee

Co-Chair

Co-Chair

Member

Member

Member

Member

Member

Member

Member

Member

Member

Member

Member

Member

Member

Staff Officer

Sponsors

Foundation for the National Institutes of Health

National Institutes of Health

Staff

Keegan Sawyer

Lead

KSawyer@nas.edu

Audrey Thevenon

Lead

AThevenon@nas.edu

Subscribe to Email from the National Academies
Keep up with all of the activities, publications, and events by subscribing to free updates by email.