Sunday, 7 July 2013

IMB NEWS

Last Wednesday, the IMB have provided an update on the status of the S.I. No 543 implementation.

They have issued approximately 50 individual authorizations to date, but not that many project authorizations. Regarding the publication of the non-technical project summary of these project authorizations, the IMB are now considering the sensitivities and a safe way to make them public (see updates on their website).

PERSONAL SAFETY VS PUBLICATION NTPS


The NTPS is the Non-Technical Project Summary that every project manager should submit to the IMB as part of their project authorization application. 
The format and structure of the NTPS is established by the European Commission, and it is a requirement that it is written in language that is easily understood. In addition, the legislation requires that the NTPS should not contain proprietary or confidential information which might identify either the establishment where the study is conducted or the personnel involved. There are several measures that the IMB takes in collaboration with the project manager to ensure the applicant's anonymity and personal safety.