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Abstract
Influencing legislative processes and policy development in order to improve research ethics
H. Fischer, P. Fabrice
Issues:
In many countries the AIDS movement organised Community Advisory Boards (CAB) to deal with issues such as, inter alies, protection of participants in domestic clinical trials. How can CABs influence legislative processes and policy development in order to improve research ethics for PLWH&A at the domestic level?
Description:
At the occasion of a European Union-mandated reform of the French legislation on research ethics, Act Up, as a member of the French CAB engaged in legislative lobbying which won, inter alies : compulsory disclosure of trial protocols to patient organizations; patient participation in Trial Advisory Boards (TAB) tasked with vetting and monitoring clinical trials; power to TABs to amend consent forms ; written standard-of-care commitments for participants who leave trials.
This paper will present the specific intelligence gathering strategies deployed to identify the key decision-makers in each parliamentary group, and to recruit a qualified Member of Parliament in both Lower and Higher House to be our champion. We will also present a system which was put in place for monitoring in quasi-real time objections to our requests from Members of Parliament, to adapt our lobby documents, and to pressure the Health Ministry against opposing our amendments.
Lessons learned:
by engaging in legislative lobbying on Parliament, the CAB
a) generated unprecedented research ethics outcomes not only for HIV but for all of medicine, and
b) established a sustainable relationship with health authorities of consultation on all legislative and regulatory reform impacting ethics, care and health coverage.
Recommendations:
where not existing yet, IAC participants should support the creation and funding of national CABs ; existing CABs should seize relevant legislative opportunities to engage in more formalized forms of advocacy on legislative and executive branches, for instance along the lines delineated in the model above ; doing this can generate advocacy progress well above and beyond initial scope.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
TUAE0305
Suggested Citation
"H.Fischer, et al.
Influencing legislative processes and policy development in order to improve research ethics.
Oral abstract session:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
TUAE0305"
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