Twelfth FERCAP conference in Colombo :

Medical ethics' committees to protect patients and volunteers

By Dhaneshi Yatawara

Professor Vajira H.W. Dissanayake

The Nazi human experiments and mass murder under the guise of euthanasia, when exposed at the Nuremberg trials, became the eye opener for the world on the importance of ethics review in medical and scientific research. Trials of War Criminals before the Nuremberg Military Tribunals revealed to the world how researches could exploit, harm and cause death to innocent people on the name of medical advancement. Be it at war or in peace, research community of the world understood the gravity of the necessity of having ethics and ethic reviews for medical and scientific research. This paved the path to the Nuremberg Code which is a set of research ethics, principles for human experimentation set as a result.

An article written by a doctor by the name Henry Beecher in 1966 on unethical practices in medical experimentation within the 'New England Journal of Medicine' was instrumental in the implementation of federal rules on human experimentation and informed consent. "Though the understanding and guidelines were present at that time, there was no such mechanism to glue the research to ethics reviews," said President of the Sri Lanka Medical Association Professor Vajira H.W. Dissanayake, who is also a steering committee member of the Forum for Ethics Review Committees in Asia and the Western Pacific.

During the Tuskegee syphilis experiment conducted in United States between 1932 to 1972 it was revealed that the black men in this trial were grossly neglected and unethical. Prompted by this problem the US Government set up a National Commission and the outcome was the Belmonte report named after the Belmonte Conference Centre where the Commission first met when drafting the report, Prof. Dissanayake said, explaining how ethics in research grew to where it stands today. "It was there that the science world understood that researchers would need an institutional mechanism to ensure that researchers in that institution are working in an ethical manner," he said.

As a result various Committees were set up especially in the USA which were called as institutional review boards or IRDs. "But when it came to our part of the world we called them Ethic Review Committees. In Sri Lanka the first Ethic Review Committee was set up in 1981 in the Faculty of Medicine of the University of Colombo. We as a country have identified this and have started very early but however the mechanism really did not develop," Prof. Dissanayake said. "So although we started early we were lagging behind," he added. In the 1990s the World Health Organisation identified that there is a lot of research going on in the Asia Pacific region and the developing countries and not much of ethic reviews happening. Thus, they came up with Strategic Initiative for Developing Capacity in Ethical Review or better known as SIDCER. This initiative proposes to set up a regional forum to develop ethics' committees. Such were established in all parts of the world and the forum that was set up in Asia was Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP) established in 2000 and based in Thailand. "By establishing this sort of a set up, countries like Thailand where they had no establishments for ethic reviews today have excellent systems. On the other hand, Sri Lanka having a positive history for ethical reviews was lagging behind in establishing the institutional structure as there was nobody actually to lead it," he said.

"Today where many are promoting research and development contribution to develop the national economy standards of research need to be high. For example the Health Ministry is promoting research units in many regional hospitals that standards of these researches and ethics that they follow need to be at a recognised level," Prof. Dissanayake said.

According to Prof. Dissanayake what these research ethic review committees do is finding out whether there will be any harm to patients in the research and preventing patients being exploited. "Thus, the review committees are serving a very important role for that particular institution and also protecting the patient. When done voluntarily, people may do it if interested, or may not. But when there is adequate funding and established offices then people will be motivated to do it permanently," he said. Thus, the institutional set up needs permanent offices, buildings and staff. Is this costly? "Actually we are looking at a Rs. one million cost to establish it and run for one year. At the moment only the Colombo and the Jayewardenepura Committees have the basic facilities, he said. "There are institutions who are promoting this concept and the funding can come from multi-directions. The National Science Foundation, National Research Council, Health Research Council etc all are giving money to research, but where is the ethic review body?," said Prof. Dissanayake. Accordingly it is the Ethic Review Committees that are the mechanism to ensure that patients being subjected to research are not harmed and exploited.

Today the Government has the Clinical Trial Initiative which overlooks the research on drugs in Sri Lanka established few years ago done under the Ministry of Finance and Planning. "If we are to run clinical trials in Sri Lanka the first thing is that we have to ensure that the Ethic Committees have enough facilities to function independently. Otherwise you cannot prevent harm happening to patients," according to Prof. Dissanayake. "Fortunately today we have a Government bureaucracy positively understanding the importance of such a step. The secretary to the Finance Ministry Dr. P.B. Jayasundara has requested our proposals to the set up and Health Ministry Secretary is very interested in quickly establishing this," Prof. Dissanayake said, explaining the Government support to this urgent requirement. But for a better result the Ethic Committees should operate with professionalism at international standards, he said.

"What we want to do at the moment is not to have many Ethic Committees but to have eight. We are a small country and we have limited number of professionals suitable for the job. The Drug Regulatory Authority of Sri Lanka has recognised eight Ethic Review Committees - i.e. Medical Faculties of Colombo, Sri Jayawaradanapura, Kelaniya, Ruhuna, Peradeniya and Jaffna Universities, Medical Research Institute and Sri Lanka Medical Association. We need adequate support to bring these to function at an international standard," he added. These institutes need to operate independently as the information they deal with needs high confidentiality. "When asking for adequate funding it does not mean sky rocketing expenses. Just Rs one million for each committee to establish and to operate each year. This is actually less than the cost of a widely used car," he said.

The next step is to give the scientific and medical professionals a proper training on ethics review in order to have competent professionals. "Ethic review needs a specialised training. This is not given to any undergraduate now. But we need to train them when they are in the profession. We don't need foreign experts to train them. We already have competent local expertise trained abroad to train the upcoming professionals," he explained. According to him the cost per year for such training would not go beyond one million rupees.

The Financial gain that is expected is what the country would gain from researches which can return in ten fold. "For the country to gain such a financial benefit there should be an investment," he said. Accordingly the investment has to be in to establish ethic committees because when foreign sponsors come to Sri Lanka to conduct clinical trials, their first step is to send an auditor and the first thing that officer would do is examine the ethics committee. This is because the sponsors want to make sure trials are done in a manner where the patients are not harmed and otherwise if they are not careful they will have to face severe repercussions despite the millions of dollars they spend on research. "Patients will get exploited if we are ignorant and don't have proper systems in place," Prof. Dissanayake said. It is we as Sri Lankans that have to ensure research infrastructure is at international standards and norms, and if the standards are proper there will be no harm to our patients.