I2. Research declaration
The Research Declaration Form is a declaration of the feasibility of a medical research in a (research) centre in the Netherlands. This declaration supports the accredited medical research ethics committee (MREC) which is designated to assess the practicability of a medical scientific research. On the basis of the research declaration the MREC can make a weighted assessment.
The head of the department, the healthcare group manager or a person in a similar position compiles the research declaration. This can be done with the aid of the research declaration form.
More information can be found in the CCMO External Review Directive (RET 2012) (in Dutch), the research declaration is part of this directive. More information can also be found on the page regarding multicenter research.
As of the 1st of July 2015 the new RET 2012 entered into force. This new RET 2012 is a result of the new Insurance Decree (in Dutch), which also entered into force on the 1st of July 2015. On the base of the old Insurance Decree it was possible for each participating centre to take out human subjects insurance separately. This has changed under the new Insurance Decree. This decree requires the sponsor to make sure that the damage for all the participants is covered by one insurance contract. Therefore the information in the research declaration regarding the human subjects insurance has been removed. This adjusted research declaration applies to the primary submission of research files after the 1st of July 2015.
The new RET 2012 is not applicable to requests for a further decision on a research protocol which has been issued with a positive decision by the reviewing committee before the 1st of July 2015. The (old) CCMO External Review Directive 2012 and the accompanying (old) research declaration form from before the 1st of July 2015 applies to those researches.