title: Nature and extent of changes in the patient's information sheets of international multicentre clinical trials as requested by Spanish Research Ethics Committees.
abstract: OBJECTIVE
  In the assessment of every clinical trial protocol, one of the critical tasks performed by research ethics committees (RECs) is an in depth review of the patient's information sheet (PIS). The objective of the study was to review the assessment of RECs in Spain regarding the PIS through the changes to be done in them in order to obtain RECs approval. Differences between changes requested by different RECs may provide some measure of the existing homogeneity amongst RECs as far as evaluation of PIS is concerned.
  
  
  METHODS
  This was a prospective study of 187 applications of multinational clinical trials (MCT) submitted in 2002-03 and for which the RECs and Spanish Medicines Agency evaluation process was completed by July 2003, reviewed by 62 RECs, for 85 hospitals and 29 primary care centres. The main assessment measures were PIS-related features and type of changes asked by RECs to be done in PIS.
  
  
  RESULTS
  One hundred and one of 183 approved applications of 24 protocols submitted had 307 queries raised from 41 RECs, of which 118 were related with changes in PIS. These 118 queries were raised by 38 RECs (61%; 38/62) in 66 applications (36%; 66/183). There were queries for all 24 protocols, but only for 2 studies (8%; 2/24) there were no queries related with PIS. In seven protocols all queries were associated with the PIS (29%; 7/24). 22% of RECs asked for a median of 14.5 copies of a separate PIS (in addition to those submitted with the protocol and the rest of documentation) for the assessment of the MCT. The number of pages of the PIS ranged from 3 to 6 with a mean number of 2,082 words. The type of changes in the PIS requested by the RECs were related with: risk/benefit and adverse events (27.1%), typographic changes and logistics information (19.5%), personal data protection (16.9%), explanation of procedures (11.9%), add some information (11.9%), word/sentence difficult to understand (8.5%) and delete some information (4.2%).
  
  
  CONCLUSIONS
  In this study, the general content and quality of the PIS were correct enough. Indeed, although the number of RECs asking for changes in the PIS was not low (61%), most of these changes were minor and affected only 36% of the submissions, with a median of 1 change per submission. Therefore, these data also suggest that there is a remarkable homogeneity across RECs in their evaluation of PIS. RECs have special interest in such aspects as benefit/risk information and confidentiality and data protection; in fact, almost half of the changes in PIS requested by RECs referred to those two items.
authors.affiliation: Medical Department, GlaxoSmithKline SA, Tres Cantos, Madrid, Spain. rafael.dal-re@gsk.com
authors.forename: Rafael
authors.initials: R
authors.lastname: Dal-Ré
authors.forename: Elena
authors.initials: E
authors.lastname: Morejón
authors.forename: Rafael
authors.initials: R
authors.lastname: Ortega
mesh_terms: D032962:Consent Forms / Q000592:standards / Q000706:statistics & numerical data; D030881:Disclosure / Q000592:standards / Q000706:statistics & numerical data*; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000592:standards / Q000706:statistics & numerical data*; D006801:Humans; D007391:International Cooperation; D015337:Multicenter Studies as Topic / Q000592:standards / Q000706:statistics & numerical data*; D013030:Spain