2015 | Diametros 44 | 89-109
Article title

Dyskusja wokół koncepcji świadomej zgody w kontekście badań naukowych z użyciem ludzkiego materiału biologicznego

Selected contents from this journal
Title variants
Informed Consent and Research Involving Human Biological Material
Languages of publication
Rozwój badań naukowych opartych na wykorzystaniu ludzkiego materiału biologicznego przyczynił się do poważnej dyskusji wokół koncepcji świadomej zgody w tych badaniach, szczególnie jej zakresu, formy i długości obowiązywania. Największe spory i wątpliwości budzi zakres zgody na badania naukowe, które będą prowadzone w przyszłości, a konkretny cel badań, miejsce i badacze są nieznani w chwili pobrania materiału, a także możliwość ponownego wykorzystania wcześniej zgromadzonego materiału. Taka sytuacja rodzi pytanie o sprawiedliwe oraz roztropne zrównoważenie godności i praw uczestników badań, a także obowiązków i praw badaczy. Proponuje się nowe formy zgody, niekiedy odbiegające znacznie od jej klasycznego modelu (np. zgoda blankietowa, zgoda rozszerzona i jej odmiany), mające na celu odpowiedzialne zrównoważenie konieczności ochrony interesów dawców oraz możliwości prowadzenia badań naukowych w medycynie. Znajdują one również zastosowanie w aktach legislacyjnych przyjętych w ostatnich latach na forum międzynarodowym i w niektórych krajach europejskich.
The development of research based on human biological material has contributed to a lively debate on the concept of informed consent in these studies, particularly its scope, form and length of validity. The biggest disputes and doubts concern the range of consent for research that will be conducted in the future, whose aim and place are unknown at the time of the sample collection, as are the future researchers and the ability to use the previously collected materials again. This situation raises the question of a just and prudent balance between the rights of participants in the research and the rights of researchers. New forms of consent have been proposed, which sometimes substantially diverge from the classical model (e.g. blanket consent or broad consent and its various kinds) in aiming towards responsible balancing between the necessity to protect the donors’ interests and the possibility of conducting research in medicine. These new concepts also find their application in legislative acts adopted internationally and in some European countries in the recent years.
Physical description
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Special Topic - New medical technologies and basic healthcare
Document Type
Publication order reference
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