Informed Consent To Participation In Randomized Controlled Clinical Trials Cover Image

Informisani pristanak na učešće u nasumično kontrolisanim kliničkim ogledima
Informed Consent To Participation In Randomized Controlled Clinical Trials

Author(s): Vesna Klajn Tatić
Subject(s): International Law, Philosophy of Law, Sociology of Law
Published by: Institut za uporedno pravo
Keywords: informed consent; randomization; recruitment; Zelen’s plan; legislation;

Summary/Abstract: The present article is focused on certain exceptions from the absolute informed consent to participation in randomized controlled clinical trials. Examination over international, regional and national acts and professional rules, has shown a strong emphasis on request for informed consent. However, even though some of them would insist on informing the participants about the random nature of trials prior to issuing the consent, most of them agree on the fact that informed consent is not one of the unconditional principles and allow certain exceptions. Despite the dual nature of existing legal standards, the author proves that, from an ethical point of view, exceptions from a total informed consent should not be treated as a favorable mean in recruiting human subjects for trials. Research that demand modifications of informed consent due to significant methodological reasons does not need to be categorically excluded as long as it complies with the demand for non-exploitation and it respects the autonomy and dignity of participants.

  • Issue Year: 2012
  • Issue No: 2
  • Page Range: 94-110
  • Page Count: 17
  • Language: Serbian