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Study Committee on Clinical Research Ethics.
The Joint Study Committee on Clinical Research Ethics (JSCCRE) was established early in 2006 with the
goal of expanding society’s understanding of the ethical debate concerning international protections for
human subjects of clinical research and experimentation throughout the world. The topic of
international legal protections for human subjects of clinical research is particularly important and
germane to researchers who engage in research and experimentation in countries around the world.
This group includes Fulbright scholars in many fields, hence the early involvement of Fulbright grantees
and alumni in this project.
- Here are just some examples of the pertinent issues the JSCCRE will examine:
 Informed Consent in an International Context
- What constitutes genuine effective informed consent?
Under what circumstances is a Waiver of informed consent ethical?
What are differentiating features from inducement, undue inducement, coercion, exploitation, and deception in obtaining informed consent?
- Conducting Research in Other Countries
- Should the research trial be responsive to the health needs of the host country?
Should research be conducted in a developing country using
protocols which would not be permitted in a developed country?
Do research sponsors in developing countries have a responsibility
to ensure that research benefits are made available to the local
population when the trial is completed ?
- Standards of Care
- Is there a requirement to provide ancillary care during and after the research trial?
Are the “standards of care” of developed countries being promulgated worldwide as the standard of choice in clinical research trials despite host country economic inequalities?
What are the realities in applying the “best proven diagnostic and therapeutic method” versus the “highest attainable and sustainable therapeutic method” in research trials?
The idea for establishing a study committee originated at the Athens 2004 Fulbright International Interdisciplinary Conference where Thomas A. Gionis, MD JD presented a paper entitled "International Legal Protections for Human Subjects of Clinical Research." Dr. Gionis is affiliated with the American Board of Healthcare Law and Medicine (ABHLM). When the decision was made to fund this project, the ABHLM sought assistance from the Fulbright Academy of Science and Technology (FAST), an international organization established by alumni of the Fulbright Exchange program.
During the course of the coming year, ABHLM, FAST and other collaborating institutions will identify and further explore some of the pertinent issues related to clinical research ethics. One of the first tasks is developing an internet-based library of relevant laws, regulations, treaties and guidelines (see separate webpage). With the assistance of our advisory board, we also are preparing several short papers and presentations to help people understand the issues and the debate. A bibliography will also be posted on this website.
Initial funding for the Study Committee came from the ABHLM. Additional funding is being sought from private individuals, agencies, research institutions, and other organizations.
If you or your institution would like to be involved in the project, please contact:
- Thomas A. Gionis, MD JD LLM MBA MHA
Chairman, Joint Study Committee Clinical Research Ethics
TGionis@aol.com
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