Proposed Clinical Studies

ETHICS AND CLINICAL TRIAL PARTICIPATION

Datura stramomium

Clinical trials are not merely the "brainchildren" of clinicians and researchers. They are also the bravery and hopes of the people that put their lives on the line to participate. These issues become all the more critical in areas where people have less access to modern care--and thus, too often serve as guinea pigs, sometimes joining studies out of sheer desperation for access to any kind of care. Too often, the needs of the community are ignored. Of course, this is not always the case, and many studies are conducted by good people in collaboration with local communities. Studies that FIAR develops will adopt this model and will be rooted in the needs of the affected community.

In order to address these issues, FIAR has adopted the guidelines for the inclusion, care and treatment of participants as they have been codified in a statement produced by participants in the 2001 Conference on Ethical Aspects in Developing Countries (see Science, 2002 Dec 13;298:2133-2134 or click here). FIAR will adhere to the framework developed at that meeting:

The Fair Benefits Framework

Fair Benefits
Benefits to Participants During the Research

Improvements to health and health care
Collateral health services unnecessary for research study

Benefits to Population During the Research

Collateral health services unnecessary for research study
Public health measures
Employment and economic activity

Benefits to Population After Research

Reasonable availability of effective intervention
Research and medical care capacity development
Public health measures
Long-term research collaboration
Sharing of financial rewards from research results

Collaborative Partnership

Community involvement at all stages
Free, uncoerced decision-making by population bearing the burdens of research.

Transparency

Central publicly accessible repository of benefits agreements
Process of community consultations