Turkiye Klinikleri Journal of Medical Ethics-Law and History

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İnsan Araştırmalarının Etik Boyutu; Türkiye'deki Araştırma Yönetim Süreçlerinin Değerlendirilmesi
Ethical Dimension of Human Research; Evaluation of Research Management Processes in Turkey
Banu BURUKa
aTOBB Ekonomi ve Teknoloji Üniversitesi Tıp Fakültesi Dekanlığı, Tıp Tarihi ve Etik ABD, Ankara, TÜRKİYE
Turkiye Klinikleri J Med Ethics. 2022;30(1):67-79
doi: 10.5336/mdethic.2021-84157
Article Language: TR
Full Text
ÖZET
 Gönüllü içeren araştırmalar, en temelde girişimsel ve etkileşim araştırmaları olarak ayrıldığında, girişimsel araştırmalarda gönüllüler için araştırma kaynaklı bir zarar olma olasılığı her zaman daha fazladır. Bu nedenle bu tür araştırmalar için etik kurul onayı alınmaması söz konusu olamaz. Ancak etkileşim araştırmaları farklı kategorilere ayrılabilir ki bu kategorilerden hangilerinde gönüllü için göz ardı edilebilir bir zarar unsuru olduğunun tespit edilebilmesi, etik kurul onayı gerekliliğini de ortadan kaldırabilir. Gönüllüye ait ne gibi verilerin hangi şartlarda, ne zaman, nasıl, ne için toplanmış olduğuna dair detaylar bu tespitte kullanılır. Ancak söz konusu detayların somut bir şekilde ortaya konulamaması, araştırma sürecinin etik kurul onay alınma safhasında karmaşaya ya da önemli bir safhanın atlanmasına neden olmaktadır. Bu makalede, özellikle fonlayıcı kurumlar ya da bilimsel dergiler cephesinde gerçekleşen söz konusu karmaşanın temelindeki 4 ana sorun tanımlanmıştır. Bu sorunlar sırası ile etik kurul onay gerekliliğinin ne zaman sorgulanması gerektiği, minimal riskin eksik kalan tanımı, ulusal mevzuattaki kişisel veri tanımlarının uyumsuz ve yetersiz olması ve de etik kurul onay muafiyet kararının sorumlusunun tanımsız olmasıdır. Nihai amaç olarak, her soruna ilişkin gerekçe ve mevcut durumun tartışılması ile bu sorunların tespit edilmesi ve çözülmesine yönelik kolaylaştırıcı öneriler sunulmuştur.

Anahtar Kelimeler: Gönüllü içeren araştırma; araştırma etiği; etik kurul onayı; muafiyet
ABSTRACT
 Human research is essentially divided into two grups; interventional and interaction studies. The probability of research-induced harm for volunteers in interventional research is always higher. Therefore, it is not possible to obtain an ethics committee approval for such studies. However, interaction studies can be categorized into different categories, and determining which of these categories has negligible harm for the volunteer may eliminate the need for ethics committee approval. The details of the volunteer's data, under what conditions, when, how and for what, are used to determine the ethical committee approval requirement. However, the inability to reveal these details in a concrete way causes confusion or skipping an important phase in the ethical committee approval phase of the research process. In this article, four main problems underlying the aforementioned confusion, especially for funding institutions or scientific journals, are identified. These problems are, when it is necessary to question the necessity of ethical committee approval, the incomplete definition of minimal risk, the incompatibility and insufficient personal data definitions in the national legislation, and the undefined responsibility of the ethics committee approval exemption decision. As the ultimate goal, facilitating suggestions for discussing the justification and current situation of each problem and identifying and solving these problems are presented.

Keywords: Human research; research ethics; ethics comm ittee approval; exempt
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