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2.4. Research Ethics Committees in Turkey

-Nurten Aksoy1 M.D., Ph.D. and 
 Sahin Aksoy2 M.D., Ph.D.
Harran University, Faculty of Medicine, Department of Biochemistry1 and 
Department of Medical Ethics and History of Medicine2, Sanliurfa-TURKEY

The history of science and medicine is full of good and bad events that all of those are to take lessons. One of which is the so-called scientific experiments conducted by Nazi doctors in 1940s. These occasions demonstrated that how doctors, who are expected to serve for the good of the humanity could go vicious. The medical community took its lesson from these experiences and Ethics Committees and Review Boards began to flourish in Europe and the U.S. in the 1960s and 1970s .[1]

Ethics Committees and Review Boards have played important roles in protecting the rights of both experimental subjects in scientific research and patients in health care institutions. We do not want to go to detail of neither the development of Ethics Committees in the world nor the benefits of having Ethics Committees and Review Boards in health care institutions, which is very well established. We just want to give some historical perspective of developing Research Ethics Committees in Turkey.

There was no Ethics Committee in Turkey until the 1980s. In those years the scientific journals wanted Ethics Committee approval from the researchers that played a fundamental role to set up these Committees in Turkey. The requirement for local ethics committee approval in multi centre researches was also a pushing factor for it. First research ethics committees were set up at Hacettepe University Medical Faculty and Gulhane Military Medical Academy in 1986. These were only ad hoc committees dealing with ethical issues in biomedical research.[2] In Turkey, there was no legal regulation of research on human beings until 1993. In that year, "the Regulation Relating to Drug Research" was issued. The main objectives of the regulation were to establish a central ethics committee and local ethics committees, and to provide an administrative control.[3] There are no compulsory clinical ethics lectures in the medical curriculum in those days, so it is also proposed that Research Ethics Committees play a central educational role by helping physicians to be aware of moral problems and by contributing to the training of research teams.

The main purpose of the regulation was defined as to establish the principles, stages and quality of scientific research on human beings necessary for experimentation on newly discovered chemicals and biological substances. The regulation contains some points which are extremely important for drug development and research, for example, stages of the drug research; qualifications required of the researchers; the duties of the local and central ethics committees; qualifications for membership of these committees; the necessary procedures for working on new drugs; specifications for protocols of clinical research and the procedures for admission, and sanctions. This regulation is derived from the Helsinki Declaration (1964, 1975, 1983, 1989) and the Turkish Medical Deontology Regulation (1960) and states that the researchers must obey the rules of these texts.[4]

After this regulation came a circular which the drug and pharmacy general directorate of the Ministry of Health issued on the 29th of December 1995. This circular stressed the importance of ethical principles and the obligation to maintain ethical rules at national and international levels.[5]

This circular also contains two guidelines: The Guideline of Good Clinical Practice (GGCP) and The Guideline of Good Laboratory Practice (GGLP). The GGCP clarifies the following points: 1) The basic principles of GCP; 2) The main rationale of the research design; 3) The protection of volunteers; 4) The responsibilities and working methods of ethics committees; 5) The informed consent of human subjects; 6) The duties and responsibilities of sponsors; 7) The purposes and responsibilities of monitoring and reporting; 8) The general qualifications and responsibilities of researchers; 9) The statistical analysis; 10) Quality guarantee; 11) Auditing and 12) Finance, insurance and economic responsibilities to the subjects.[6]

According to the Regulation[7], there were two different committees. One of them is 'Central Ethics Committee' and the other is 'Local Ethics Committee'. 'Central Ethics Committee' is set in the Ministry of Health, and it has 21 members each serves for the period of 2 years. The members are 3 pharmacologists from Medical Faculties, 3 clinicians from Medical Faculties, 3 pharmacists from Pharmacology Faculties, 1 representative from Turkish Medical Association, 1 representative from Turkish Pharmacists Association, 1 representative from Turkish Dentists Association, 3 clinicians from the Ministry of Health, 1 member from Drug Licensing Branch of the Ministry of Health, 1 faculty member from Law Faculty, 1 specialist from Forensic Medicine, 2 members from different offices of the Ministry of Health and 1 legal adviser from the Ministry of Health. Every member is required to have at least 10 years of experience in his or her respective fields.

The regulation requires the 'Local Ethics Committee' to be set in health institutions and consists of 3 physicians from clinical branches, 1 pharmacologist, 1 pharmacist, 1 biochemist, 1 pathologist, 1 medical ethicist and 1 invited expert. The functions of the local committee are described as:
To examine and evaluate the protocols and documents prepared for 1st and 2nd phase drug research as well as 3rd phase uncertified drug research, and send them to the Ministry in one month if they are approved.
To examine the protocols of 3rd and 4th phase drug research, decide if the protocol is applicable or not, and send the decision to the Ministry in written form.
To stop research if it is required by presenting the justification.
To evaluate and examine the applications which are conducted according to 11th article of the 'Turkish Medical Deontology Regulation'[8] , and the applications, which are routinely used.
To evaluate and make decisions on routine tests like the bio-efficiency researches of certified drugs.
The duties of central ethics committee in the Ministry are;
To review the documents and reports submitted to the Ministry by the local ethics committees, and give their approval or disapproval.
To make experts review the research proposal if needed.
To analyze and evaluate the local ethics committee reports, and declare an opinion regarding to continuation of the research from the next stage.
To examine the research proposals sent by the local ethics committees and submit their opinion in reply no later than 2 months.

Other than this governmental regulation and organization, there is another organization, which is a non-governmental organization, namely the Turkish Medical Association, which has had an ethics committee (TMAEC, Turkish Medical Association Ethics Committee) since February 1994. TMAEC takes a multidisciplinary approach; the members of the committee are academicians from medicine, nursing, philosophy, medical sociology/anthropology and law and are interested in "health and ethics". One of the aims of TMAEC is to develop solutions to medical ethics problems concerning specific issues, especially those raised by the Turkish Medical Association. The association's ethics committee has investigated and produced approximately twenty documents as guidance for physicians and one of these is dedicated to patient rights in medical research.[9]

The establishment of Research Ethics Committees has fundamentally changed the face of medical practice in Turkey, though it took some period of time. Both the patients in health care institutions who are subjected to scientific research and the animals which are used in experiments had become to be well treated and had been better protected.

Although Turkey has a long and firm tradition institutional and regulation wise, there had been some deficiency in ethical aspects of health care. However, this was due to the lack of organization in Bioethics community. The establishment of Turkish Bioethics Organization in 1994, and the start of publication of Turkish Journal of Medical Ethics (Turkiye Klinikleri Tip Etigi Dergisi) in 1993 have contributed a lot to improve the awareness on ethical issues in health care. 1990s have passed with the establishment and organization of Bioethics community, and the Research Ethics Committees and their spreading to all health care institution is one of the fruits of this awareness.

[1] Solbakk, J.H. eEthics Review Committees in Medical Research in Nordic Countries: History, Organization and Assignments', HEC Forum 3(4):1991:215-220.

[2] Gorkey, S. eEtik Komiteler', (Ethics Committees) Sendrom, (February):1994:84-87.

[3] Arda, B. (2000). gEvaluation of Research Ethics Committees in Turkeyh, Journal of Medical Ethics 26(6), pp. 459-61.

[4] Ibid. :460.

[5] Kayaalp, O. The Essentials of the Clinical Pharmacology.Ankara, Tas Kitabevi, 1996:79-90. (In Turkish)

[6] The Ministry of Health, Drug and Pharmacy Department, Circular No: 51748 (29 December 1995)

[7] Official Gazette No. 21480 (29 January 1993). gThe Regulation Relating to Drug Researchh.

[8] This article tells about the prohibition of any biological, physical, chemical and surgical interventions which are not proven to be safe. However it allows untested interventions which are not likely to be harmful but certain to save the life of the individual.

[9] Arda, B. eThe activities of Ethics Committee of the Turkish Medical Association'. International Journal of Bioethics, 7:3 (1996):235.

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