Barriers to conducting clinical research in reproductive medicine: Egypt Mohamed Aboulghar, M.D. Department of Obstetrics and Gynecology, Cairo University; and The Egyptian IVF Center, Maadi, Cairo, Egypt
There are many barriers to scientific research in Egypt, including lack of funding, lack of a scientific atmosphere, and ‘‘brain drain’’ of scientists who produce high quality research. (Fertil Steril 2011;96:805–6. 2011 by American Society for Reproductive Medicine.)
Barriers to research There are many barriers to scientific research in Egypt. The lack of funds to finance scientific research is an eternal problem. The government spends 0.4% of the budget on scientific research, most of which are allocated to salaries of administrators. The private sector has minimal contribution to research. Apart from the financial factor, there is an extreme lack of a scientific atmosphere. This is shown in the attitude of the government in several aspects, such as appointment of unsuitable and uninterested people for research positions. The rules for promotion in academic positions (universities, research centers) do not follow competition based on scientific merits and interest for research. Another factor is the difficulty for researchers to publish their work in high quality world journals. This is attributed to several reasons including the lack of ability to write good research protocols in the form of a scientific manuscript. The language barrier may not allow excellent work to be published in a top journal. Cooperation between different authors is not always smooth. In our center, it was decided by a consensus that the first author is the one who suggests the research idea, formulates the protocol and writes the manuscript at the final stage and is the one to decide the sequence of authors according to the effort spent by each author. Scientists who produce good quality research are generally highly respected and honored in western societies. In our area, researchers are seldom appreciated. Excellent Egyptian researchers easily find their way in North America and Western Europe, where they are welcomed and find an excellent scientific atmosphere, good economic compensation, and appreciation of their work. This brain drain deprives the country from the ability to build an advanced scientific community.
Institutional review board approval Institutional review board (IRB) approval does not present a significant barrier to research in Egypt. In general, the local ethical committees approve the research protocol in less than two weeks. The IRB of the university usually takes four to six weeks. They often request modification or minor changes to improve the protocol and the consent form. The protocol is rarely totally rejected. According to government regulations, certain types of trials are required to be approved of the central IRB of the ministry of health. This Received August 31, 2011; accepted August 31, 2011. M.A. has nothing to disclose. Reprint requests: Mohamed Aboulghar, M.D., The Egyptian IVF Center, 3, st. 161 Hadaek El Maadi, Maadi, Cairo 11431, Egypt (E-mail: [email protected]
includes phases 1, 2, and 3 trials on new drugs and the approval usually takes three to six months to obtain. Younger universities in Egypt should have properly constituted and functioning systems for independent ethical review of research. This will include the establishment of effective research ethics committees. This will reduce the burden on ethical research committee of Cairo University which serves several universities. An American Aid project helped several new universities to establish the ethics committee (1). The fact remains that many studies are done in the Third World that simply could not be done in the countries sponsoring the work. The funding company found out that due to the lack of proper ethical committees, studies could be done quickly. The New England journal of medicine has taken the position that it will not publish unethical reports regardless of their scientific merits (2).
Funding of research Funding of research is a major problem; the budget allocated of scientific research in universities and research institutions is very limited. The ministry of high education and scientific research has central funding from the European Union through several projects which are renewed on a regular basis. Some of these projects are purely Egyptian, while others are multinational between Egypt and one or more European countries. American aid programs rarely support research as they are mainly interested in health care projects. In our center (The Egyptian IVF center) which is a private center, funding is mainly autonomous. A percentage of the income is allocated to research every year depending upon the number and budget of protocols presented. Phase 3 trials and some drug trials are sponsored by pharmaceutical companies who pay as compensation for the effort of the center. All income from these sources is allocated to sponsor new research protocols. Sometimes we ask a pharmaceutical company to support a research protocol by a grant. Around 90% of our research is self-sponsored. Hospitals and other medical centers are generally neutral. They do not obstruct research; however, they do not actually support them. Scientists should realize that some of the responsibility for achieving government support rests on them. The researchers must know how to right a protocol asking for funding. It should be clear and complete to convince the authorities of the importance of the research (3).
Challenges in recruiting research subjects It is difficult to have consent from the patient to be randomized in research protocols for surgical trials. It is less difficult for drug trials
Fertility and Sterility Vol. 96, No. 4, October 2011 Copyright ª2011 American Society for Reproductive Medicine, Published by Elsevier Inc.
or follow-up studies. It is easier to include educated patients, less educated and illiterate patients are suspicious from the nature of the research, and are more difficult to convince and include in the study. Younger women are more likely to accept joining a clinical trial. And they go through the consent form rapidly. The mean BMI among infertile Egyptian women is around 30. This makes it very difficult to include patients in most of the studies in which one of the inclusion criteria is a normal BMI range. Most of the studies require regular extra visits and blood sampling for the patient which is difficult in the traffic of a city like Cairo. Many patients are uncomfortable with the idea of inclusion in a research protocol. They believe it is dangerous and they are suspicious even when the protocol is explained to them.
The process of informed consent The work in our center is group work and patients could be treated by any doctor (11 doctors work in the center). The principal investigator, like any other doctor suggests that the patient could be enrolled in the research protocol. Any one of the doctors involved in this particular study is responsible for explaining the protocol to the patients and asks for her consent. She has to read the consent form and sign it. The doctor will explain everything to her and the nurse will answer additional questions which will arise in subsequent visits.
Barriers to multi-center trials There are no legal obstacles to multicenter trials in Egypt. However, they are rarely done because of the lack of close cooperation between different centers and wide discrepancy between the numbers of cycles performed in each center. There were several trials to perform multi-center studies, though very few were successful. However, our center participated in several multi-center, multi-national studies.
Training of junior investigators There is no special program for training young investigators. However, for those who are interested, some half-day courses are offered at the annual meeting of the Middle East fertility Society. Senior re-
searchers train young interested clinicians and they involve them in the practical part of the work. Designing studies and writing manuscripts require special interest among the young physicians. However no special training is required by IRB. It depends upon interest and abilities of junior investigators who learn from seniors. Many young doctors are not interested in research. It is important to encourage young people to be involved in research. Good research should be one of the priorities in the career of young doctors. Funding must be increased for research. Financial benefit for young researchers is important. Opportunity for scholarships should be opened.
Regulations of research Regulations of research are very liberal in Egypt, apart from the international requirements and regulations the field for research is open in Egypt. Embryo research, stem cell research, and all innovative research are allowed. There is a complete ban on research on gamete donation as all types of gamete donations are not allowed in Egypt.
How to improve research opportunities and productivity Significant gaps exist between the clinical ability and surgical skills on one hand and the interest and knowledge about research on the other hand. Young clinicians are often underpaid and they struggle to take extra part-time jobs to raise their income. The financial problem distracts the clinician from spending time and effort on research. The most important element needed in order to perform research in a clinic is the availability of trained, motivated researchers. The basic training of our clinician does not include training in how to design a clinical trial and what are the different types of study designs. The few young clinicians who are interested to perform research had to learn by themselves, from the literature and support of senior researchers. Incentives must be given to researchers to substitute for any lost income from the time spent in research. This is difficult in university and government hospitals and is only possible in private centers. Improving working conditions, salaries, and introducing methodology of research at all levels of medical education is a significant step.
REFERENCES 1. McMillan JR, Conlon C. Nuffield Council on Bioethics. The ethics of research related to health care in developing countries. J Med Ethics 2004;30:204–6.
2. Angell M. The ethics of clinical research in the Third World. N Engl J Med 1997;337:847–9.
Conducting clinical research in Egypt
3. Vose PB, Cervellini A. Problems of scientific research in developing countries. IAEA Bulletin 1983;25: 37–40.
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