TEMPLATE SUBJECT INFORMATION FROM 1 APRIL 2019 CRITERION FOR REVIEW OF INFORMATION LETTER

The Template subject information, which helps researchers to write a concise and clear information letter for research subjects, will apply as a criterion for the review of the submitted information letter by the review committee (accredited MREC or CCMO) for newly submitted research files as from 1 April 2019. This means that from then on the template no longer has a non-committal character.

For non-study-specific components, deviations in the submitted information letter will not be accepted without adequate justifications from 1 April. The CCMO previously already made the use of the text from the template for section 10 (Use and storage of data and body material) mandatory. or the other (study-specific) components, the recommendations in the template for conciseness and appropriate language use will play an important role in the review by the review committee from 1 April.

More information can be found at E1/E2. Information leaflet and consent form research subjects of the standard research file.

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