Details about informed consent procedures of randomized controlled trials should be reported transparently

Informing potential participants about the aims and procedures of a trial is mandatory when seeking their consent. A description of the potential benefits and harms of the intervention and control conditions is an integral part of the information that should be provided. The World Medical Association's Declaration of Helsinki from 1964 [1] is the most often used guideline when it comes to the content of informed consent. It states that “the nature, the purpose and the risk of clinical research must be explained to the subject by the doctor.” In addition, the Declaration of Helsinki explicitly states that consent should, as a rule, be obtained in writing.

Source: Journal of Clinical Epidemiology - January 29, 2019 Category: Epidemiology Authors: Daniel Kotz, Wolfgang Viechtbauer, Mark Spigt, Rik Crutzen Tags: Commentary Source Type: research