GE2P2 Global Foundation launches Center for Informed Consent Integrity
New Center to focus on innovation and effectiveness of key ethical imperative in research
10 March 2020 – Philadelphia, USA
Accelerating its mission to advance ethical resilience and scientific rigor in research and evidence generation, the GE2P2 Global Foundation today announced formation of the Center for Informed Consent Integrity.
As one of its first major programs, this new Center has launched an initiative to explore how informed consent can best evolve to respond to the challenges associated with the rapidly-emerging genomic medicine era. The Center will explore informed consent across cell & gene therapies – including basic research, clinical trials, compassionate use/expanded access, and post-approval clinical use, including the often decade-plus long-term follow-up required.
In parallel, the Center is now examining how informed consent is currently integrated into compassionate use/expanded access programs, which often involve investigational medicines before they have received major regulatory approval. The project is aggregating information on informed consent processes and policies in developer/manufacturer expanded access programs, how countries address informed consent in their regulations and guidelines around compassionate use, and how national and local ethics committees treat IC in their oversight role for these programs.
The Center will continue publication of its monthly digest – Informed Consent: A Monthly Review – which surveys strategic developments, innovation, insights and commentary from peer-reviewed journals and other sources. This digest and other information is now available at the Center’s new site: https://ge2p2global-centerforinformedconsentintegrity.org/
The Foundation also announced the leaders who will help build the new Center and its programs:
:: Paige Fitzsimmons, MA, will serve as Associate Director of the Center. Paige is a GE2P2 Global Foundation Associate Fellow, editor of Informed Consent: A Monthly Review, and Programs Manager, supporting the Foundation’s full portfolio of Centers and programmes.
:: Barbara Redman, PhD, MBE, will serve as Director of the Center. Barbara is a Foundation Senior Fellow, a founding Board member, and co-chairs the Foundation’s biopharma research ethics advisory program, among other contributions. She is an Associate Faculty member of the Division of Medical Ethics in NYU’s School of Medicine.
GE2P2 Global Foundation President David R. Curry commented: “Forming our new Center for Informed Consent Integrity represents another milestone in the growth of our young Foundation. This Center enables members of our community of practice to focus their considerable expertise and experience on strengthening the integrity of informed consent across the Foundation’s areas of focus, including health, human rights, humanitarian response, education and literacy, sustainable development and heritage stewardship. We believe that free and meaningful consent – based on evidence-based, accessible, understandable and materially-complete information – is a bulwark of ethically-resilient research, human rights, fundamental freedoms, and responsible governance.”
For more information, please contact:
David R Curry
President, GE2P2 Global
- mobile:[US] 267.251.2305
- email: david.r.curry@ge2p2global.org
About the Center for Informed Consent Integrity
The GE2P2 Global Foundation conducts its work through a “centers of excellence” structure which helps members of our community of practice to focus their extraordinary experience and energies.
The Center for Informed Consent Integrity will address informed consent broadly and holds that “consent” – grounded in open, evidence-based, accessible, understandable and materially-complete information – is the bulwark of human rights, fundamental freedoms, and responsible governance.
The Center will focus on consent in research contexts across all the Foundation’s action sectors including health, human rights, humanitarian response, education and literacy, sustainable development, and heritage stewardship.
This work includes producing knowledge sharing services Informed Consent :: A Monthly Review which aggregates and distills key literature and analysis around IC including governance, ethics review and oversight, content approaches, technology and assessment strategies/performance metrics.
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