Guidance, Recommendations and Best Practices Publications and Workshops

The FNIH has worked and will continue to work with stakeholders and collaborators to support the development of best practices guidance and recommendations to inform gene drive research, development, testing and implementation for use by funders, regulators, policy makers and international organizations as appropriate.

Goals:

  • To initiate, organize and facilitate development and publication of guidance, recommendations and best practices for gene drive research stakeholders.

Guidance and Recommendations:

Guiding Principles:

  • Principles for Gene Drive Research. Emerson, et al., Science, 358 (6367):1135-6,2017. 
    The guiding principles for sponsors and supporters of gene drive research were developed by public and private sector organizations involved in sponsoring or supporting gene drive research. They describe the organizations’ commitment to mobilize and facilitate progress in gene drive research and development by supporting efforts of the highest scientific and ethical quality, inspiring a transparent approach and backing existing biosafety measures. To be considered as a signatory to these guiding principles, click here.

Risk Analysis Activities:

  • Results from the Workshop "Problem Formulation for the Use of Gene Drive in Mosquitoes". Roberts, et al. AM. J. Trop. Med. Hyg., 96(3):530-533,2017.
    In May 2016, the FNIH hosted a workshop (Agenda and Participant List) with global scientific and regulatory experts to systematically evaluate the potential risks associated with the use of gene drive mosquitoes intended to reduce the burden of malaria in Africa. During the workshop, participants undertook a problem formulation exercise, focusing on gene drive mosquitoes as a method for control of the malaria vector Anopheles gambiae in Sub-Saharan Africa. Participants discussed how relevant protection goals and hazards may help to inform risk assessments of investigational gene drive organisms, the design of gene drive research and future guidelines and regulations on the use of the technology. The published consensus points describe a systematic evaluation of hazards associated with the potential use of gene drive modified mosquitoes as a new tool for reducing the burden of malaria in Africa.
  • Problem Formulation Consultations for testing and use of gene drive-modified mosquitoes in Africa: The New Partnership for Africa's Development (NEPAD), the implementing agency of the African Union, held workshops in Accra, Ghana (October 2016); Nairobi Kenya (June 2017); Gaborone, Botswana (June 2017); and Libreville, Gabon (February 2018), bringing together representatives from regional biosafety and health regulatory authorities to discuss the concept of gene drive mosquitoes as a public health tool for reducing transmission of vector borne diseases. The FNIH provided facilitation support and attended the workshops. The participants were presented with background information on mosquito biology, ecology and role in malaria transmission, as well as technical information on genetic engineering and gene drive function. Informative precedents from biocontrol, genetically modified crops and medicines were reviewed. In addition, participants undertook an exercise in identifying potential hazards associated with this research, and in discussions on the applicability of regional harmonization in evaluating this technology. 
  • Risk Assessments: The FNIH aims to ensure impartial oversight of research on genetically modified mosquitoes through support of risk assessments conducted by qualified experts having no vested interest in the success of the product. Risk assessments commissioned to date:
    1. Independent risk assessment for contained laboratory studies on a sterile male strain of Anopheles gambiae 
    2. Independent ecological risk assessment for a small-scale field release of a sterile male strain of Anopheles coluzzii 

Gene Drive Stakeholder Workshops:

Talking About Gene Drive: Communications Workshop: The FNIH organized a one-day workshop in November 2017 in Baltimore, MD attended by more than 70 researchers conducting or interested in gene drive research for public health, conservation and agriculture applications. The workshop was designed to create a forum for participants to think collectively about how to discuss gene drive technology productively with the public. 

Stakeholder Engagement Best Practices for Novel Vector Control Methods Workshop: The FNIH sponsored a three-day workshop in November 2017 in Reston, VA that brought together bioethicists and stakeholder engagement practitioners. Participants discussed the development of guidance related to best practices for stakeholder engagement and informed consent for interventions intended to operate at the community, rather than individual, level as is the case for many vector control tools, including gene drive. A report based on the outcomes of this workshop is being developed.

Partners

Public-Sector Partners
Bill & Melinda Gates Foundation*
Open Philanthropy Project*
 
*Provided financial or in-kind support to this program.