Global Forum on Bioethics in Research First Meeting for the Eastern Mediterranean and Arab Forum on Bioethics in Research Cairo, Egypt. 12 – 14 August 2008 Sandra Realpe Ethics Officer Edlyn Jimenez-Santos Ethics Fellow Geneva, Switzerland

Outline Introduction to the GFBR –Mission, Aims –GFBR Meetings –GFBR Partners –GFBR Secretariat Elements for a framework to facilitate a Global Forum

Mission & Aims Mission: Bring together key stakeholders from developing, developed countries to debate the ethics, social, legal, and public policy issues related to health research in international settingsAims: –Strengthen the protection of human participants in international health research –Provide a forum for developing country perspectives on ethical issues in research –Build capacity for ethical review of research –Encourage the long-term joint management of research protocols

GFBR Meetings GFBR1 Bethesda GFBR1 Bethesda Partnerships between research sponsors and investigators involved in clinical trials in developing countries (1999) GFBR6 Blantyre GFBR6 Blantyre What happens when the research is over? Post-trial obligations of researchers and sponsors (2005) GFBR2 Bangkok GFBR2 Bangkok Capacity building for ethics review in developing countries (2000) GFBR7 Karachi GFBR7 Karachi Ethical issues in research involving public health, health systems, and health services (2006) GFBR3 Cape Town GFBR3 Cape Town Bioethics and public health research, including ethical guidelines related to post-trial access to drugs (2002) GFBR8 Vilnius GFBR8 Vilnius Fostering research ethics infrastructure in the developing world and transition societies (2007) GFBR4 Brasilia GFBR4 Brasilia Ethics of Genomic Research (2002) GFBR9 Auckland December, 2008 GFBR9 Auckland Ethics of research involving indigenous peoples and vulnerable populations (December, 2008) GFBR5 Paris GFBR5 Paris Sharing the benefits from research in developing countries: equity and intellectual property (2004) GFBR10 Santiago September, 2009 GFBR10 Santiago Conflicts of interest in health research (September, 2009)

GFBR Partners Institut national de la santé et de la recherche médicale

GFBR-Secretariat Funded through a 2-year grant from the Science and Society programme of the Sixth Framework Programme for Research (FP6) of the European Commission [Project name: Health Research Ethics] Hosted by the Council on Health Research for Development (COHRED) Managed by a part-time ethics officer, assisted by a full time fellow from a developing country Communication pathways: GFBR Newsletter and GFBR website

Elements for a framework to facilitate a Global Forum Rationale The context of health research continues to evolve as it increases in number worldwide. With this evolving context comes emerging ethical issues pertinent to the design, management, and governance of research involving human participants, which challenge various stakeholders' capacity to keep up or stay ahead. Increasing multi-centered research, rates of migration, innovations in biotechnology, and investments in genetic research, among others, signify a global research context posing global challenges. Thus, a global platform of discussion/solutions is indicated.

Elements for a framework to facilitate a Global Forum Challenges –International ethical guidelines prescribe principles that most stakeholders agree on. However, disagreements lie in the application of these principles –Potential for conflict - discussions on research ethics are often polarised among research stakeholdersOpportunity To benefit from these challenges, they must be re- appropriated to stimulate dialogue

Elements for a framework to facilitate a Global Forum Invitation Dialogue needs a venue where there is no expectation of an immediate resolution of conflicting opinions, but an occasion for airing the most relevant issues emerging in the international arena of bioethics in research Venue must facilitate a discussion of disagreements where all voices are heard Dialogue can be a powerful tool for promoting collaboration among the different stakeholders in health research ethics, and stimulate rethinking and better informed arguments Dialogue has a potential for influencing good research practice

Thank you! شكرا لك