Former Rambam physician assists Addis Ababa Medical School in Ethiopia in obtaining certification to conduct experiments with human subjects, who give informed consent. Research will be conducted according to all World Medical Association regulations.
In the wake of talks given in Ethiopia by Prof. Moshe Berant, chair of the Independent Review Board of the Rambam Health Care Campus, the country’s Addis Ababa Medical School has obtained formal certification from the World Health Organization (WHO) to conduct research with human subjects. This makes the school a member of a family of world centers that performs such research according to international regulations as stipulated by the International Conference on Harmonization of Good Clinical Research Practice (ICH-GCP).
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Prof. Moshe Berant © Pioter Fliter |
“Ethiopia is an attractive site for clinical research,” says Prof. Berant, who served as a pediatrician at Rambam for more than 20 years prior to his retirement, and as chairman of its Helsinki Committee, an institutional review board for research involving human subjects, in Israel. “Researchers from many countries are interested in conducting clinical research projects in collaboration with scientists in Ethiopia. The varied population incorporates many ethnic backgrounds, there are numerous specific diseases that need to be studied, as well as highly qualified doctors who can collaborate,” he continues. “In short, the possibility of professional and scientific dialogue is very good.”
Experimentation on humans is governed by strict regulations, and must be reviewed and approved by a specifically constituted Board, explains Prof. Berant. Researchers must demonstrate that their projects are intended to advance science and aid the sick. Sites are required to have in place a regulated system of Ethics on Biomedical Research. For researchers to publish findings in medical journals, they need the approval of an independent review board (IRB) that checks the validity of their hypothesis, protocols and the ability to answer proposed questions. They must also prove that subjects have given their informed consent. Candidates have to be fully aware of the potential dangers risks and side effects of their participation, as well as its possible advantages.
Always, according to Prof. Berant, the consideration given to human beings must override scientific or research interests. Researchers need to find the way to strike a balance between dangers risks and benefits.
“When the Ethiopians were close to getting WHO certification and wanted to go the last yard, they approached agreed with the suggestion of Prof. Karl Skorecki, Director of Medical and Research Development at Rambam, who suggested that I, as chair Chair of the Independent Review Board at Rambam , go to Ethiopia,” says Prof. Berant. In September 2009, he arrived there to lead workshops in the form of dialogues - and help, as he puts it, “to tighten loose corners. “
“I would like my hosts considered to invite me to disseminate this to additional medical centers throughout the country Ethiopia, and I even look forward to a pan-African meeting on this subject,” says Prof. Berant. “I feel good to have been able to render good services."