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Current governing systems for biotechnology do not easily apply to gene drives due to their goal of intentionally spreading a genetic trait through a population, and the irreversibility of their effects on ecosystems. Also, their potential for transboundary effects will necessitate international cooperation.  Appropriate policy tools must be tailored to these factors and incorporate robust public engagement. Local and traditional knowledge can and should inform gene drive research, governments implementing gene drives should obtain the free, prior, and informed consent of the governed, and engagement activities can contribute to place-based capacity building.

Decision-making in issues of human and environmental health involves two closely related yet distinct topics: governance and public engagement. The NASEM report includes detailed discussion of both topics as related to the developing technology of synthetic biology and gene drives. Ultimately, although existing standards, policies, and frameworks may be generally relevant, gene drives have unique qualities that will require intentional deliberation to develop policy tools and guidance specific to the topic. Additionally, when indigenous peoples are concerned the issue of free, prior and informed consent is of critical importance.




The NASEM report adopts a broad definition of governance as “the process of exercising oversight through regulations, standards, or customs through which individuals and communities are held accountable,” which “encompasses a wide spectrum of policy tools, including norms and guidelines that stretch from traditional customs to regulation” (NASEM, 2016). The report also includes examples of policy tools that govern science and technology generally, organized according to the spectrum of governance type, and Adelman et al. (2017) conducted a review of guidance documents for research on, and testing of, genetically engineered insects and other pest arthropods, also organized by governance type, as well as by the phases of product testing.


Self-governance includes “guidance by professional societies or groups of scientists,” soft governance includes “guidance by regional and international organizations and bodies,” and national or federal governance includes “guidance by appropriate agencies in each country” (Adelman et al, 2017). The four phases of product testing are (I) laboratory studies, (II) field trials, (III) field releases, and (IV) post implementation surveillance (Carter & Friedman, 2016).


Gene drives have two distinguishing features from other types of biotechnology that carry important implications for their governance: “they intentionally spread a genetic trait through a population, and their effects on ecosystems are potentially irreversible” (NASEM, 2016). Current governing systems for biotechnology are based on “managing risk by containing genetically modified organisms,” which means that the opposing mechanism of gene-drive modified organisms raises the complication of transboundary effects. This will necessitate international cooperation toward policies agreeable between countries. Regarding irreversibility, the complications would pertain to “any unintended effects on other species or ecosystems,” which have “important implications not only for physical-material risk, but also for the perception and communication of harms and benefits” (NASEM, 2016), and reinforces the need for appropriate, effective, and tailored public engagement.




Within global health research, scientific advancement tends to precede thinking on appropriate and effective community, stakeholder, and public engagement. However, the latter is critical for the former to achieve positive outcomes. The NASEM report defines engagement as “seeking and facilitating the sharing and exchange of knowledge, perspectives, and preferences between or among groups who often have differences in expertise, power, and values” (NASEM, 2016). Further, it differentiates communities, stakeholders, and publics, respectively, as “groups of people who live near enough to a potential field trial or release site that they have a tangible and immediate interest in the project,” and people with “interests sufficient to justify engagement, but may not have geographic proximity to a potential release site,” and finally “groups who lack the direct connection to a project that stakeholders and communities have but nonetheless have interests, concerns, hopes, fears, and values that can contribute to democratic decision making” (NASEM, 2016).


Engagement of each of these categories of people must be considered on a global scale for two main reasons: (1) the laboratory study phase of gene-drive research predominantly occurs in high income countries like the US, UK, and Australia, while field tests typically occur in other parts of the world; and (2) the two distinguishing features of gene-drive modified organisms mentioned above (intentional release and irreversibility) will require scientists and governments to consider whether and how they may cross borders (NASEM, 2016).


The NASEM report outlines three main motivations for engagement: (1) “communities and stakeholders have knowledge that is essential to understanding the complex and variable social, political, economic, and ecological contexts in which gene drives will operate,” (2) “principles of justice demand both transparency in and well-informed consent to any future (experimental) trials that may affect communities of people and landscapes,” and (3) engagement creates opportunities for mutual learning that foster forward thinking” (NASEM, 2016).


In other words, local and traditional knowledge can and should inform gene drive research, governments implementing gene drives should obtain the consent of the governed, and engagement activities can contribute to place-based capacity building in numerous ways. Each of these factors becomes even more critical when the communities and stakeholders are indigenous peoples.


The Necessity of Free, Prior and Informed Consent


Basic to the human rights of indigenous peoples is the ability to exercise self-governance. In decision-making for synthetic biology and implementation of gene drives in the ecosystem, scientists, researchers and managers must properly inform, engage and work with affected tribal and indigenous groups and other local communities, per U.S. government policy as well as international recognition of the rights of indigenous peoples. The United Nations Declaration on the Rights of Indigenous Peoples includes numerous Articles relevant to potential implications of gene drive research, including the rights of indigenous peoples to self-determination, free, prior and informed consent, and practices and sites necessary for cultural identity and subsistence, among others (UNDRIP, 2008).


The right to free, prior and informed consent (FPIC) is of utmost importance in discussion of governance and engagement. “FPIC is a principle protected by international human rights standards that state, ‘all peoples have the right to self-determination’ and – linked to the right to self-determination – ‘all peoples have the right to freely pursue their economic, social and cultural development’” (FAO, 2016: 11). The United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), the Convention on Biological Diversity as well as the International Labour Organization Convention 169 all support FPIC, comprising “the most powerful and comprehensive international instruments that recognize the plights of Indigenous Peoples and defend their rights” (FAO, 2016: 11).


The FPIC Manual (FAO, 2016) defines each element of the concept: free, prior, informed, and consent. It is the latter that can be a sticking point for national governments when engaging with indigenous communities. In many cases, the requirement is for governments to consult with them when policies or actions may have tribal implications, which allows an opportunity to consider their perspectives and interests in the decisions that are ultimately made by the government. Consent, on the other hand, “refers to the collective decision made by the rights-holders and reached through the customary decision-making processes of the affected Indigenous Peoples or communities. Consent must be sought and granted or withheld according to the unique formal or informal political-administrative dynamic of each community” (FAO, 2016: 16).


In the US, federal policies and agency mandates do not require this, leading government officials to necessarily balk at seeking consent as the outcome of consultation, since it is beyond their statutory authority. Although the US was not an original signatory to the UNDRIP, in 2010, President Obama announced that the United States had changed its position and now supports the Declaration, “which—while not legally binding or a statement of current international law—has both moral and political force” (Announcement of U.S. Support, 2010: 1). In order for agencies to be able to implement any articles of the UNDRIP, specific directives and regulations need to be promulgated, which has not happened.


The FAO Manual describes a six-step process for achieving FPIC, which project managers should consider throughout all phases of a project life cycle. “For Indigenous Peoples themselves, FPIC is a tool to ensure that their priorities are taken into account.

The process allows them to be well informed about all aspects of the project that will affect them, to exercise control and manage their lands and territories, and to command respect for their cultural identity and self-determination, especially regarding their right to development as distinct peoples” (FAO, 2016: 19).

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