Etički kodeks medicinskih istraživanja s djecom

Ana Maria Varošanec, Mirjana Bjeloš, Mladen Bušić, Biljana Kuzmanović Elabjer, Leon Marković

Cilj rada: Razjasniti i ukazati na nejasnoće propisanih postupnika vezanih uz provedbu medicinskih istraživanja s djecom te pozvati na stručnu raspravu s ciljem dolaska do relevantne interpretacije propisa. Ispitanici i metode: Pregled literature predmetnih pravilnika, zakona i konvencija u digitalnom i tiskanom izdanju koja se odnose na etički kodeks istraživanja s djecom u medicinskim istraživanjima. Rezultati: Ukupno se nađe četiri pravilnika: Pravilnik za provedbu istraživanja u Kliničkoj bolnici „Sveti Duh“, Pravilnik za provedbu istraživanja Medicinskog fakulteta u Zagrebu te Etički kodeks istraživanja s djecom u medicinskim i nemedicinskim istraživanjima; tri zakona koja se odnose na istraživanja s djecom: Obiteljski zakon Republike Hrvatske, Zakon o zaštiti prava pacijenata te Zakon o provedbi opće uredbe o zaštiti podataka; Konvencija o pravima djeteta pri Ujedinjenim narodima te Hrestomatija hrvatskoga medicinskog prava. Očekivani doprinos području: Pregledom literature nađu se nejasne i nepotpune informacije o sudjelovanju djece u prospektivnim medicinskim istraživanjima na etički prihvatljiv način. Rad definira nejasnoće vezane uz izradu medicinskih istraživanja s djecom, posebice vremenske odrednice davanja informiranog pristanka za istraživanje od strane djeteta i zakonskog skrbnika, način osiguravanja tajnosti podataka i način osiguravanja pohrane podataka. S obzirom na neujednačene zaključke, iskazana je potreba ujednačavanja odrednica predmetnih zakonskih propisa.

Aim: To present the ambiguities of the relevant regulations related to medical research with children and call for an expert panel discussion in order to enhance and re-define the needed ethical protocols for such research. Patients and methods: A review of the literature of the relevant regulations, laws, and conventions in digital and printed editions related to the code of ethics in medical research with children. Results: There are four relevant regulations: Protocols for conducting research at the Clinical Hospital “Sveti Duh”, Protocols for conducting research at the School of Medicine in Zagreb, and the Codes of Ethics for research with children in medical and non-medical research; three laws related to research with children; Family Law of the Republic of Croatia, Law on the Protection of Patients’ Rights and the Law on the Implementation of the General Decree on Data Protection; Convention on the Rights of the Child at the United Nations and the Chrestomathy of Croatian Medical Law. Expected contribution to the area: A review of the literature revealed unclear and incomplete data on children’s participation in medical research in an ethically acceptable manner. The paper defined the ambiguities related to the design of medical research with children, in particular, who, when and how was obliged to give informed consent for research, how to ensure data confidentiality and data storage.
Given the uneven conclusions, the need to harmonize the determinants of the relevant legal regulations was outlined.