BOX 5-3Adherence to Human Rights and to Bioethical Principles

Legally binding human rights and established human rights norms have been influential in framing the appropriate use of medical interventions.^a Human rights language has long been conflated with biomedical ethics language, but their normative purpose and impact are different. Human rights are universal in their framing, although national translation in individual countries may incorporate cultural and religious differences. Human rights are legally actionable and belong to both individuals and collectivities. The language of policies and guidelines in biomedicine may use “rights” language, such as the “right of the child to an open future”; however, this is an ethical concept and not a legally recognized right of the child.

The need to develop governance approaches to encompass HHGE provides a potential opportunity to use and develop the content of internationally recognized human rights to influence future laws, policies, and regulatory responses around HHGE. However, the possibility of using human rights to frame, delimit, or expand concepts such as the freedom to conduct scientific research, the right of everyone to benefit from scientific advances, the right of children to the highest attainable standard of health, or even the rights of future generations has not yet been discussed by international bodies deliberating on HHGE. The feasibility of charging existing international and national supervisory or regulatory bodies with oversight of such rights in this specific context remains to be determined. This is an area that could be further explored as one foundation for future HHGE governance and is an approach being explored by the WHO Committee.

A foundational aspect for any use of HHGE is consideration of bioethics principles. Since the establishment of the Nuremberg Code in 1947, the field of biomedical research has benefited from international ethical guidance responsive to scientific developments (CIOMS, 2016; UNESCO, 2015; WMA, 2013). These norms, while self-regulatory in nature, have been influential in prospectively addressing areas of public concern, such as deliberate interventions in the human germline. Different reports and organizations present and interpret bioethical principles in slightly different ways, but they share many common features (NASEM, 2019a). In its 2017 report on human genome editing, for example, the U.S. National Academies identified seven principles to guide the development of governance for human genome editing that reflect this set of norms: promoting well-being, transparency, due care, responsible science, respect for persons, fairness, and transnational cooperation (NASEM, 2017). The Nuffield Council on Bioethics, in its report on genome editing and human reproduction, stated that two “overarching principles” should guide the use of HHGE interventions for them be ethically acceptable: they “should be used only where the procedure is carried out in a manner and for a purpose that is intended to secure the welfare of and is consistent with the welfare of a person who may be born as a consequence of treatment using those cells”; and they “should be permitted only in circumstances in which it cannot reasonably be expected to produce or exacerbate social division or the unmitigated marginalization or disadvantage of groups within society” (NCB, 2018, p. xvii). The WHO's Expert Advisory Committee on human genome editing has articulated six values, principles, and goals for good governance of these technologies: “a. Clarity, transparency and accountability; b. Responsible stewardship of resources; c. Inclusiveness, solidarity, and the common good; d. Fairness, non-discrimination, and social justice; e. Respect for the intrinsic dignity of the person; and f. Enforcement capacity” (WHO, 2020).

Because decision making about HHGE is ultimately a function of individual jurisdictions, countries should only permit the use of HHGE if they have engaged in thorough scrutiny of how any proposed application conforms with the human rights and ethical principles discussed above.

a

Notable legal human rights instruments with regard to HHGE are the Convention on the Rights of the Child (1989), the Convention on Human Rights and Biomedicine (Oviedo) (1997), and the Convention on the Rights of Persons with Disabilities (2006).