By Kim Coghill

Washington Editor

A bioethics commission organized by former President Bill Clinton this week released a list of proposed recommendations aimed at protecting clinical trial participants in developing nations.

The National Bioethics Advisory Commission concluded its 18-month study on ethical issues in international research and is calling for a range of changes in the conduct. The non-binding recommendations are part of a report, ¿Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries,¿ submitted to President Bush April 18.

The 18-member NBAC was established in 1995 in order to provide advice and to make recommendations to the National Science and Technology Council and other government entities. The commission¿s charter expires in October and has not been renewed by Bush.

The study was initiated following public suggestions and in view of ¿the current landscape of international research that reflects the growing importance of clinical trials conducted by pharmaceutical, biotechnology and medical device companies,¿ according to a prepared statement by the commission.

¿The potential for exploitation is cause for a concerted effort to ensure that protections are in place for all persons participating in international clinical trials,¿ Harold Shapiro, president of Princeton University and chairman of the NBAC, said in a prepared statement.

Michael Werner, director of federal government relations and bioethics counsel for the Biotechnology Industry Organization, told BioWorld Today it is appropriate for the NBAC to be examining the rules as they apply to overseas trials ¿and we hope to do that as well. Our bioethics committee is going to be looking at international research also.¿

Among its recommendations, the commission said researchers and sponsors subject to U.S. regulations should be required to receive prior review by an ethics committee before conducting an overseas trial.

In addition, voluntary informed consent should be sought, the commission said.

¿Informed consent should be an ongoing process throughout the research and not merely an initial documentation of willingness to participate in the research,¿ Shapiro said.

In the area of research design, the commission recommends that members of any control group be provided with an established effective treatment, whether the treatment is available in the host country. The commission wrote: ¿No population, especially a vulnerable one, should be the focus of research unless some of the potential benefits of the research will accrue to that group after the trial.¿

Under the guidelines, trial researchers would have to involve the community in the design and implementation of the trial in order to ensure that it is responsive to the area¿s health needs.

Current U.S. regulations allow for the Office for Human Research Protections to determine whether another country¿s guidelines provide protections for research participants that are equivalent to those provided by the U.S. regulations. If they do, the other country is free to follow its own guidelines instead of the U.S. regulations.

The commission recommends that the U.S. government identify criteria and establish a process for determining whether the protection system for human participants in a host country or in a host country institution has achieved equivalent substantive ethical protections.

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