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First Forum - Agenda
21 - 22 June 1999
BETHESDA, MARYLAND, USA

     
 

Agenda
During the opening address at the bioethics workshop in June, one of the issues raised was the challenge of how to develop an ethical approach to international research in settings that are inherently inequitable both in economic terms and in terms of political power. Even though a certain level of exploitation is part and part of clinical research wherever it is conducted, developing countries are particularly vulnerable. This applies to all parties at some level including the Ministry of Health, the researchers, and the local community in which the research is performed. The Belmont Report introduced the concept of distributive justice in an effort to ensure that the benefits and the burdens are fairly allocated in the domestic context in the US. CIOMS guidelines addresses the issue of research involving subjects in developing nations, although the formula is fairly general and of course is not legally binding. It seems that the broad issue of justice in the context of international research might prove valuable for discussion and would be relevant to the audience of the first global research bioethics forum. Based on some of the issues that were raised during the workshop, the agenda might involve some of the following topics.

 

 

 

 

12 - 14 FEBRUARY 2004
CAPE TOWN, SOUTH AFRICA

A follow-up Workshop will be held in February 2004 to explore developments in this area since the publication of the Report.  The Workshop, co-hosted by the South African MRC and the Nuffield Council on Bioethics

More Information

 

 

 


 


 

 
     

Can the ethics of performing research in developing nations be  separated from the broader issues of Human Rights?

Should the ethics of research on the very poor be discussed in isolation from the issues of maldistribution of wealth and of health care resources between and within nations? If no, will this hold urgent research hostage to interminable (and perhaps ineffectual) debates over large questions transcending health care? If yes, are researchers in any way complicit with these inequities?


Setting the research agenda: balancing the priorities of the community, the researcher and the country

Responsibility of the developing country hosts including the scientist, the NGO/ community representative, the Ministry of Health Responsibility of sponsors government /NGOs/ industry examples that work


Negotiating an agreement with the sponsor prior to the research taking place

Lessons learned from the NIH biodiversity program other examples


Inducements to the individual or the community

- Is any gift or community benefit provided by the sponsors of the research to the community of those studied appropriate or morally required? Could this be seen as a negative in some circumstances?

- Is consent fully voluntary when a potential subject has no other opportunity to obtain treatment? If not, is full voluntariness a requirement of ethical research?

Translation of research into practice
- Ensuring that results are disseminated
- Ensuring that funding is available
- Ensuring that infrastructure is available

Rules and Guidelines for conducting ethical research in developing countries

- The role of international guidelines in promulgating justice concerns as applied to population research. What are the limitations of current guidelines?

- Protections for especially vulnerable populations such as indigenous communities or victims of abuse or war in developing country settings

- May different ethical standards be used (e.g. for voluntariness, quality of informed consent, and provision of "best available proven treatment") when the proposed study is done on behalf of and for the benefit of members of the subjects' group (country, ethnic group, relatives)? Does this suggest an ethics of sacrifice for the group that is ruled out for research in developed countries, and is this acceptable? Does this depend on the ethics of the host country and target population?

 

 

HBE

John E. Fogarty International Center

Medical Research Council

NIH

NICHD

National Eye Institute


OPAS Brazil

National Institute on Drugs Abuse


Center for Disease Control and Prevention

Wellcome Trust

 National Institute of Dental and Craniofacial Research
 


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