Published July 2, 2019
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Informed Consent Matrix for Clinical Trials
Creators
- 1. IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milano
- 2. BBMRI-ERIC
- 3. European clinical research infrastructures network - European Research Infrastructure Consortium (ECRIN-ERIC)
- 4. European Research Infrastructure for Translational Medicine (EATRIS)
- 5. European Bioinformatics Institute (EMBL-EBI) ELIXIR European intergovernmental organisation
Contributors
- 1. European Patient Forum
- 2. European AIDS Treatment Group
Description
This matrix aims to provide a minimum set of requirements for informed consent aimed at adults in the context of clinical trials. This Guide should be adapted to national settings and specific contexts. It mainly refers to multicentre interventional randomized clinical trials, but some suggestions can also be applied to non-interventional research.
The Guide covers:
• the processing of information: context, language, setting;
• topics and proposed wording; and
• general suggestions on wording, format, length of the information sheet.
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informed-consent-matrix-for-clinical-trials-july-2019.pdf
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