Abstract
A questionnaire based study to review the status of the Ethical Review Committee (ERCs) was conducted in universities and research institutes involved in bio-medical and psycho-social research. Questionnaires were sent to 37 faculties of 11 universities. Thirty faculties responded. The 6 medical faculties were among the 8 faculties that had ERCs. Questionnaires were sent to 10 research institutes and 3 associations. Among 8 institutes and 2 associations that responded, only the Medical Research Institute and the Sri Lanka Medical Association (SLMA) had ERCs. Fifty percent of the ERCs had a specific application form and there was no uniformity in the information obtained from the researchers. Some application forms lacked essential information relevant to ethical review. Information on availability of consent forms, source of funding, investigations, control selection, review of literature, co-investigators' information, educational qualifications of the investigators are some of them. Sixty percent of ERCs had only academic staff or doctors as committee members. The recruitment of members to the committee did not follow a formal process and no institutional guidelines were available for ERC committee members. In the current context there is a need to establish a national framework for ethical review in Sri Lanka for educating resear chers and to regularize ethical review of research.
Highlights
At present much bio-medical research involving human and animal subjects is being conducted in Sri Lanka
The purpose of an Ethical Review Committee (ERC) in reviewing biomedical research is to contribute to safeguarding the dignity, rights, safety and well-being of all actual or potential research participants [1]
Even when an ethical review program was in place, the information requested in the application forms was inadequate and ethically relevant information was lacking in some application forms
Summary
At present much bio-medical research involving human and animal subjects is being conducted in Sri Lanka. While many of this research goes through a process of ethical review it is possible that some projects are not screened. It is a requirement of many internationally published bio-medical journals that a certificate of ethical clearance be available for the research study to be published. The purpose of an Ethical Review Committee (ERC) in reviewing biomedical research is to contribute to safeguarding the dignity, rights, safety and well-being of all actual or potential research participants [1]. ERCs should take into consideration the benefits and burdens of research be distributed fairly among all groups and classes of society [2]
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