Center for Informed Consent Integrity
About Us
The GE2P2 Global Foundation is an integrated NGO [foundation/501[c]3] and public benefit corporation focused on advancing scientific rigor, ethical resilience and integrity in research and evidence generation across the sciences – informing governance, policy and practice.
We act through a community of practice operating in more than 30 countries with members elected by the GE2P2 Global Foundation’s Board of Directors. This community includes scientists, researchers, clinicians, ethicists, independent scholars from across academic disciplines, leaders from multilateral organizations, governments, NGOs and civil society, and field practitioners from across sectors. We employ a thematic “centers of excellence” structure which helps our members focus their extraordinary experience and energies.
The Center for Informed Consent Integrity engages informed consent as the bulwark of human rights, fundamental freedoms, and responsible governance. It must be exercised in open, non-coercive, supportive, documented contexts and grounded in evidence-based, accessible, understandable and materially complete information.
The Center’s work:
:: We publish Informed Consent: A Monthly Review – a digest which aggregates and distills key literature and analysis around informed consent and assent. Focus areas include governance, ethics review and oversight, practical approaches, emerging technologies, comprehension aids, and assessment strategies/performance metrics. The digest also explores societal perspectives on the uses of consent/assent, which are often embedded in political and legal systems. Our work intendeds to provide context over and across jurisdictions and diverse cultural, political and economic contexts.
:: We respond to calls for public consultation and other forms of direct contribution in refining draft laws, regulations, standards, policies, guidance, and deliberative processes which address consent as generated by the United Nations system, multilateral agencies, governments and country regulatory bodies, non-governmental organizations, civil society organizations, academic institutions, professional societies, and commercial organizations.
:: We provide direct advisory support to global organizations facing complex, real-world ethical, governance, and operational challenges associated with consent/assent.
:: We leverage the analysis, insights and solutions generated above to inform our voice – in public discourse, in the academic literature, and, when indicated, in asymmetric action.
We recognize and broadly align the current “ecology”[1] 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]
[1] 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]
Reflects inputs from
Barbara Redman
Paige Fitzsimmons
Christine Gispen
Getnet Yimer
Lisa DeTora
Michael Young
Beate Aurich
Fernando Lolas
Jane Kang
Richard Klein
David Curry
Center for Informed Consent Integrity 