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| Sunday, 29 May 2005 |
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Researchers must be protected -Prof. Fernando Prof. Anoja Fernando underscores the need to introduce appropriate regulations and guidelines to protect research participants, in the backdrop of newer technologies in medicine and science. Prof. Fernando who is the Senior Professor in Pharmacology, Faculty of Medicine, University of Ruhuna, pointed out at a recent seminar that areas such as assisted reproductive technologies, genetics, cloning and stem cell research could be considered as new areas. She explained that 'Research' is a systematic investigation designed to produce knowledge pertaining to human subjects and may involve direct interactions or interventions with the subjects or indirect activities. It was desirable to refer to research subjects as research participants. General ethical considerations are applicable to all types of research, human and animal, biomedical and behavioural. They include ethics of publication, conflict of interest, plagiarism, falsification and fabrication of results as well. Prof. Fernando outlined the three basic ethical principles that govern research involving human beings as, respect for persons, beneficence and justice. 'Respect for persons' acknowledges the dignity and freedom of every individual, leading to the concept of autonomy, and when applied to research, it requires obtaining informed consent from all potential research participants. The principle of 'Beneficence' requires the researchers to maximise the benefits and minimise the risks or harm associated with research. 'Justice' requires equitable selection and recruitment of research participants and fair distribution of the benefits of research. Albeit until the middle of the twentieth century, ethical concerns in the practice of medicine were centred on therapeutic medicine, during the latter half of the century, ethical and regulatory requirements for the conduct of research have been developed globally, often in response to ethical violations by researchers themselves. Many countries rely on national and/or international ethical guidelines for research. The Federal Regulations for the protection of Human Subjects (USA), the Nuremberg Code of 1947, the Declaration of Helsinki of 1964,, the 1979 Belmont Report, the CIOMS/WHO International Guidelines for Biomedical Research of 1993 and the Guidelines for Externally Sponsored Research of 2002, are some of the regulatory mechanisms in place at present. Ethical Review Committees or Institutional Review Boards are required to evaluate proposed research activities using criteria given in the guidelines and regulations. Researchers are expected to submit a detailed research protocol, taking into account all ethical aspects of the research, such as the procedure for obtaining informed consent, risk benefit assessment and maintenance of confidentiality. They may refrain from commencing the research until obtaining committee approval. This approval may be a requirement for presentation or publication of research findings and for obtaining research funds. In Sri Lanka, Ethical Review Committees exist in all faculties of medicine, the Sri Lanka Medical Association, the Medical Research Institute and certain hospitals, Prof Anoja Fernando further noted. (RM) |
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