The increasing number of U.S.-sponsored or -regulated trials conducted abroad, the changing landscape of international research collaborations, and potential exploitation of participants from developing countries have prompted the National Bioethics Advisory Commission to issue several recommendations regarding the conduct of research in other countries.
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The reports 23 recommendations range in scope from choice of research designs and use of effective treatments to building the capacity for developing countries to conduct and review research.
Eric M. Meslin, Ph.D., former executive director of NBAC, said he hopes that researchers and reviewers will consider implementing the recommendations even though they are not mandated. The report is the result of 18 months of study and is the fifth to be produced by the Commission since its inception in 1995.
Key Recommendations
Some of the reports key recommendations delve into voluntary and culturally appropriate informed consent. The commission advises that consent should be an ongoing process and that researchers consult with community representatives to develop ways to ensure that participants understand the information in the consent process. Researchers should also accommodate cases in which the local customs require that the community leader or family members give consent as well.
Other key recommendations focus on research design involving those in the control group. The commission recommends providing members of control groups in a trial with established, effective treatments regardless of whether the treatment is locally available. The report also states that ethics review committees should assess trials in which placebos are given to the control group. Such cases, states the report, should be justified to and assessed by ethics review committees.
In the matter of post-trial benefits, the commission recognized the ethical challenge presented by lack of adequate health care access by a majority of the population in many developing countries. It suggested that research proposals should include an explanation of how drugs proven effective by a study would be made available to a host countrys population beyond the research participants.
The report drew criticism from patient health advocates, who believe that some of the recommendations are not strong enough. Public Citizen, Washington, D.C., issued a statement that said it thinks the recommendations would "put the U.S. in the unenviable position of endorsing ethics standards for American researchers that are lower than those required by the World Medical Associations Declaration of Helsinki."
It cites potential loopholes for exploitation, such as the ability to bypass "best current" therapy by providing therapies that are locally available for patients in clinical trials and the lack of a guarantee that interventions proven effective in the course of the trial will become available to the host country.
Best Current Therapies
Jack Killen, M.D., director of Division of AIDS at National Institute of Allergy and Infectious Diseases, disagreed with this assessment. Providing "best current" therapies as controls is a noble goal, he commented, but may result in an experiment that has no value for the participants. In such cases, the researchers may be comparing the new intervention to one that is unavailable in the host country.
Killen also noted that a requirement for post-trial availability would be unrealistic since the body of scientific evidence showing the effectiveness of a drug rarely comes from one single trial. Furthermore, he noted that the sponsors or funders of a clinical trial may not have the resources or the authority to change the practice and ensure widespread delivery in a foreign country.
Public Citizen also raised issue with the commissions recommendation that allows a study to be exempt from U.S. review by an institutional review board if the human subject protection system in the host country is determined to be adequate. The U.S. Office of Human Research Protections has the responsibility to determine which countries have review processes that are up to par with U.S. standards.
Ethics Infrastructure
To date, however, OHRP has provided no criteria for determining what constitutes equivalent protection nor made any determinations about other countries guidelines. The commission further recommended that such criteria and processes be developed.
Although a number of countries are only beginning to develop their ethics review infrastructure, Meslin said, local issues exist that can best be reviewed by the host country. U.S. protections may be able to help with technical issues that require the expertise of a more experienced system, he said.
Others have suggested that the most appropriate answer lies beyond or somewhere between the range of current conventions. From their standpoint, the guidelines contribute to the broad discussion of the international clinical trials topic, but it is not clear how the precise language of the guidelines contributes to the protection of human subjects nor how their interpretation may vary among different cultures and socioeconomic circumstances.
"In an area that is as sensitive and as controversial as this, it should not be surprising that many should have strong views," Meslin said. "This report is a balanced effort to try to accommodate a wide range of perspectives."
The commissions full report can be viewed at http://www.bioethics.gov/.
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