We recognize and broadly align the current “ecology” of international declarations, covenants, conventions, guidances, frameworks, codes and similar instruments referencing consent/assent/agency/ autonomy – at varying levels of focus and depth. We assess this ecology to be evolving, imperfect, incomplete and sometimes contradictory.
Nonetheless, it forms the base from which we believe an “architecture” of robust, integrated, effective global guidance around consent can evolve and be realized in practice. [see our strategic programme 2035-40]
The guidance instruments listed below comprise a variety of forms and formats, are for the most part non-binding, and proceed from a diverse range of sources. This list is evolving and indicative, not exhaustive.
Nuremberg Code [1947]
Universal Declaration of Human Rights [1949]
International Covenant on Social, Economic and Cultural Rights [1966]
International Covenant on Civil and Political Rights [1966]
Convention on the Rights of the Child [1989]
Belmont Report [1979]
Universal Declaration on Bioethics and Human Rights [2005]
WMA – Declaration of Helsinki [2024 revision integrating Declaration of Taipei [2016]
CIOMS – International ethical guidelines for health-related research involving humans [2016]
CIOMS – Clinical research in resource-limited settings [2021]
CIOMS – Patient involvement in the development, regulation and safe use of medicines [Oct 2022]
INSERM – Global Ethics Charter for the Protection of Healthy Volunteers in Clinical [2024]
WHO – Guidance for best practices for clinical trials [25 September 2024]
UNESCO – First Draft of the Recommendation on the Ethics of Neurotechnology [October 2024]
WHO – Guidance for human genome data collection, access, use and sharing [20 November 2024]
ICH E6(R3) [GCP] Principles, Annex 1 [January 2025]
ICH: ICH E6(R3) [GCP] Annex 2 [[in development – Feb 2025]
WHO guidance on the ethics of health research priority setting [in development – Feb 2025]
Center for Informed Consent Integrity 