Turkiye Klinikleri Journal of Medical Ethics-Law and History

.: REVIEW
Küçük ve Kısıtlılara Yönelik Klinik Araştırmalarda Velayet ve Vesayet: Geleneksel Derleme
Custody and Tutelage for Minor and Restricted People in Clinical Trials: Traditional Review
Perihan ÖZKAŞ AÇIKGÖZa
aİstanbul Medipol Üniversitesi Sosyal Bilimler Enstitüsü, Sağlık Hukuku ABD, İstanbul, Türkiye
Turkiye Klinikleri J Med Ethics. 2022;30(3):332-41
doi: 10.5336/mdethic.2022-89312
Article Language: TR
Full Text
ÖZET
 Kişilerin kendileri hakkında karar verebilmeleri, tıp etiği ilkelerinden özerklik ilkesi ile açıklanmakta, özerkliğini kullanabilmesi için de kişilerin, fiil ehliyetine sahip olması gerekmektedir. Fiil ehliyeti, ergin olmak, ayırt etme gücüne haiz olmak ve kısıtlı olmamak unsurlarının birlikte varlığı ile tam olabilmektedir. Bu unsurlardan bir kısmının eksikliği, fiil ehliyetinin de sınırlandırılması sonucunu doğurmaktadır. Fiil ehliyeti kısıtlı kişilerin tasarruf iradesi ancak veli veya vasinin kişi adına verdiği kararlar ile anlam kazanabilmektedir. Velayet ve vesayet kurum ve makamlarının küçük veya kısıtlı adına karar verebilme sürecine katılımını gerektiren durumlar uluslararası sözleşmeler ve yasal düzenlemelerle belirlenmiş olmakla birlikte, uygulamada, küçük ve kısıtlıların tıbbi müdahaleler için aydınlatılması, onamlarının alınması, onam kapasitelerinin ve iradelerinin anlaşılabilmesi konularında yetkili mercilerin sürece katılımı ile ilgili birtakım aksaklıklar görülebilmektedir. Tıbbi müdahaleleri koruyucu, tedavi edici, rehabilite edici, palyatif veya araştırmalar gibi sınıflamalara tabi tutmak mümkündür. Tıbbi müdahalenin hukuka uygun olması için kişinin bilgilendirilmiş onamı, müdahalenin gerekliliği ve tıbbi standartlara uygunluğu, tıbbi müdahalenin yetkili kişi ve kurumlarca yapılabilmesi gibi birtakım şartların sağlanmış olması gerekmektedir. Pandemi sürecinde küçük ve kısıtlıların klinik araştırmalara alınması ile ilgili olarak gündeme sıklıkla gelmiş olan çekinceleri gidermek adına, vesayet ve denetim makamlarının klinik araştırmalara katılıma dair karar verebilme yetkisinin tartışılması, makalenin amacını oluşturmaktadır.

Anahtar Kelimeler: Klinik çalışma; araştırma etiği; yasal vasiler; bilgilendirilmiş onam
ABSTRACT
 The fact that people can make decisions about themselves is explained by the principle of autonomy from the principles of medical ethics, and in order to use their autonomy, people must have the capacity to act. The capacity to act can be complete with the coexistence of the elements of being mature, having the power of discrimination and not being restricted. The lack of some of these elements leads to the limitation of the capacity to act. The will of persons with limited capacity to act can only gain meaning with the decisions made by the parent or guardian on behalf of the person. Although the situations that require the participation of the guardianship and guardianship institutions and authorities in the decision-making process on behalf of minor or restricted persons are determined by international conventions and legal regulations, in practice, it is still possible to encounter problems with the competent authorities who are responsible for informing minor and restricted persons for medical interventions, obtaining their consent, and understanding their consent capacity and will. It is possible to classify medical interventions as preventive, curative, rehabilitative, palliative or research. In order for the medical intervention to be in compliance with the law, certain conditions such as the informed consent of the person, the necessity of the intervention and compliance with medical standards, and the medical intervention to be performed by authorized persons and institutions must be met. The purpose of the article is to discuss the decision-making authority of the guardianship and supervisory authorities regarding the participation in clinical trials, in order to eliminate the drawbacks that have frequently come to the fore regarding the inclusion of minor and restricted individuals in clinical trials during the pandemicdemic processs.

Keywords: Clinical trial; research ethics; legal guardians; informed consent
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