For Ministry of Health Director General Eng Huot, there is nothing philosophical about the need for a national ethics committee that would review medical research projects before they are allowed to start here.
“We must prevent human beings from getting used as guinea pigs,” he said.
The issue came up in Cambodia in 2000 when Bahamas-based Hansi International Ltd planned to test a homeopathic treatment on 3,000 Cambodian orphans. At the time, medical experts and NGOs raised objections, citing concerns that companies could begin to view Cambodia as a country where they could conduct tests cheaply and without fear of punishment in case something went unexpectedly wrong.
Until recently, Cambodia had only unenforceable guidelines for medical researchers. But in May, the Ministry of Health created the National Ethics Committee for Health Research and gave it the authority to review, question and either approve or disapprove medical research projects.
Any research that includes giving people medication or conducting blood tests must now be submitted to the committee for review, according to Eng Huot, who serves as the committee’s president.
Its standard operating procedures, now in a draft form, state that committee members are authorized to approve a project if they feel confident the project will respect “the dignity, rights, safety and well-being of all actual and potential research participants.”
“We are concerned not only with their health, but also with their human rights,” said Ung Sam An, acting director for the National Institute of Public Health and second deputy president of the Ethics Committee.
The 12 committee members—representatives from the various medical fields at the ministry and including one attorney—also look at potential long-term effects on subjects, he said.
If, at any time, a committee member has any doubt about whether a project could endanger the health of participants, members can ask researchers for clarification, and tell them to change their testing methods, Ung Sam An said.
The committee was established with support and funding from the European Commission Regional Malaria Control Program in Cambodia, Laos and Vietnam. Already, members have met three times and handled a great deal of work, said Frederick Gay, regional coordinator for the EC program.
Before the committee started its activities, some members attended medical ethics workshops to help them in their task, Gay said. “Cambodians are interested in sharing their experience and in discussing possibilities [with colleagues from other countries].”
Projects submitted to the committee by international and Cambodian institutions have included research into the efficiency of malaria medicine and a study of HIV-infection risk factors in a specific area of the country. One proposal focused on women’s health in the post-war era; another on the drop-out rate of monks.
Chheng Kannarath, a committee member and a epidemiology research team leader for the National Institute—an organization that serves as Cambodia’s health research and evaluation facility—cited one case in the US in which Johns Hopkins University had its federal research funding suspended because some of its projects were deemed unethical.
“It’s very difficult,” to make decisions as to the ethics of a project from a health, but also from a social and cultural standpoint,” Chheng Kannarath said.
The EC malaria program is due to end in December, and Gay said he is looking for funding to enable committee members to attend training workshops and to continue exchange visits with other regional ethics officials.