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Strani pravni život
2012, br. 2, str. 94-110
jezik rada: srpski
vrsta rada: izvorni naučni članak
Informisani pristanak na učešće u nasumično kontrolisanim kliničkim ogledima
Institut društvenih nauka, Beograd

Sažetak

Ovaj rad usresređen je na ispitivanje mogućnosti nekih izuzetaka od potpunog informisanog pristanka na učešće u nasumično kontrolisane kliničke oglede. Pregled međunarodnih, regionalnih i nacionalnih pravnih propisa i tzv. staleškog prava pokazao je da je zahtev za informisanim pristankom snažno naglašen u njima. Međutim, čak i ako neki od njih izričito zahtevaju da se učesnici ogleda obaveste o činjenici nasumičnosti pre nego što daju svoj pristanak na učešće, većina njih priznaje da informisani pristanak nije jedan bezuslovan princip i dopuštaju izuzetke u nekim slučajevima. Uprkos dovosmilenosti postojećih propisa, autor dokazuje da, sa jedne etičke tačke gledišta, izuzeci od potpunog informisanog pristanka ne bi trebalo da se koriste kao pitanje pogodnosti odnosno olakšavanja u vrbovanju ljudi kao subjekata ogleda. Istraživanje koje zahteva modifikacije informisanog pristanka iz važnih metodoloških razloga ne mora da bude kategorički isključeno sve dok se obavlja u skladu sa zahtevom o neiskorišćavanju i dok se u istraživanju dosledno poštuju autonomija i dostojanstvo učesnika.

Ključne reči

informisanim pristanak; nasumičnost; vrbovanje; Zelenov plan; zakonodavstvo

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