Sri Lanka should adopt national ethics revision mechanism on clinical trials

As protecting human lives critically vital



The critical importance of Sri Lanka adopting a national-level mechanism to review ethics of clinical trials, in a bid to protect human lives, was taken up as a key issue at last week’s high-profile international medical parley in Colombo.

After three decades of being relegated to the back burner, it is time Sri Lanka accorded top priority to the introduction of an accreditation system to minimize harm and maximize benefits in this crucial sphere, says Prof. Vajira H. W. Dissanayake, President, Sri Lanka Medical Association (SLMA).

"China, Thailand, Taiwan and Philippines, which initiated their respective accreditation systems long after Sri Lanka are way ahead developing science and technology, while we, as a nation, continue to lag behind despite activating the national ethics revision process in 1981", he noted.

"We need to introduce the accreditation process on the lines of the National Science Foundation (NSF) at a national level", the professor told a select group of journalists on the sidelines of the 12th annual FERCAP (The Forum for Ethical Review Committees in Asia and the Western Pacific) International Conference and General Assembly, at the Waters Edge.

"The NSF is keen that we come up with recommendations so that it can work towards a national accreditation system in coordination with the Health Ministry, he underscored. "It is also good news that the Clinical Trials Act is now being drafted".

Delegates from the Asian Pacific Region and other parts of the globe participated in this international parley convened under the theme "Development, Ethnicity and Ethical Health Research". The event was hosted and co-organized by the SLMA, Colombo University and NSF.

The four-day conference provided a forum for various stakeholders to discuss state-of-the-art practices within the framework of ethics in medicine and research. The sessions extended opportunities for dialogue among individuals and networks of ethically motivated, adequately informed and responsible stakeholders to assure the public about the protection of the rights and safety of human participants in the conduct of research.

An eminent professional in the sphere of Anatomy and Medical Genetics, Dissanayake said the FERCAP Confab was hosted by Sri Lanka at a crucial time when the country is looking at rapid economic development through investment in research and development.

In that backdrop, developing the necessary human resources and infrastructure to conduct research in an ethical manner is vitally important, he pointed out. "The idea of the FERCAP discussion was to promote an ethics review system in countries including Sri Lanka".

Thailand, Taiwan and Philippines were "late comers" to the arena but are today way ahead by developing their own ethics review systems while Sri Lanka continues to lag behind despite initiating the process three decades ago, he continued.

"I have always wanted to host FERCAP in Sri Lanka because of the enormous contribution it makes to protect human subjects taking part in research by developing capacity for research ethics review in the Asia Pacific Region, including Sri Lanka", he elaborated.

Drawing attention to the importance placed on this accreditation mechanism, the professor said that in Thailand, they coordinate with the National Research Council (NRC), which is on a higher level than the Health Ministry. "FERCAP, for its part, plays a lead role in the endeavor of developing these systems".

The Prime Minister of Thailand is the Chairman of the NRC, said Prof. Sottiporn Chittmitraprap, General-Secretary of this apex institution.

Any research project in Thailand is examined by the NRC, he explained. "We need to protect humans when conducting clinical trials".

He said the advancement of medical science is based on expertise and new research. Expressing his gratitude to FERCAP, which aims to support each country set up its own accreditation system, he observed "we would like to have some knowledge and expertise transfer to strengthen our system".

"These guidelines helped us to set up and promote different institutions", emphasized Prof. Marita Reyes, a member of the Philippine Health Research Ethics Board.

"Our participation in many a diverse forum sponsored by FERCAP inspired us to form our own national accreditation system. This means the accreditation is official and is promoted by the national government", he noted.

As a country with a long tradition of history and culture, Sri Lanka is the appropriate place where participants could enjoy discussing and exchanging ideas about how ethnicity and culture affect the conduct of research, said Prof. Kenji Hirayama, Head of the Immunogenetics Department, Institute of Tropical Medicine, Japan.

"It is apt to deliberate on our theme for this year ‘Development, Ethnicity and Ethical Health Research’ in Sri Lanka, where there is diversity", he noted.

"There should be a local mechanism in Sri Lanka for the NSF to take on based on our recommendations", Prof. Dissanayake insisted. "Initially, we need to evolve a voluntary system with FERCAP recognition aimed at improving the mechanism in the country, which can later be taken over by a national system with accreditation".

Ethics Committees have to be trained to examine research proposals and determine whether they will harm a person or not. There has to be capacity building and guidelines to develop, he noted.

Funding agencies include ethics as a part of their budgets but financial allocation for research is not a component in Sri Lanka’s national budget, it was observed.

Of course, capacity building and funding go hand-in-hand, the professor stressed. "It is also time to invest in infrastructure as otherwise nobody will come to Sri Lanka for research purposes".

"We need to give incentives to members serving on our committees", Dissanayake emphasized, referring, in particular to veteran journalist, Ms. Kumudini Hettiarachchi, who devotes so much of time and energy and spends her own funds to make a remarkable contribution.

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