Skip to main content

Table 1 The questionnaire to the national coordinators

From: Huge variation in obtaining ethical permission for a non-interventional observational study in Europe

  Question Answer possibilities
Q1 Did you have to apply to more than one body in order to get approval for the study? … yes
… no
… other, please specify
Q2 If Yes on Q1: Which bodies (committees) did you apply for consent? … a national committee/body
… a regional committee/body
… a local hospital intitutional research board
… other, please specify
Q3 How long was the application process from start to decision (weeks)? …. weeks
Q4 Did you have to get informed consent for this study? … yes, from the patient
… yes, from the family
… yes, but in retrospect from the patient
… No, not deemed necessary
Q5 Is there a specific regulation when you send data electronically to a common database in another country? … no
… yes, it must be specified in detail on the application
… yes, there is a seperate body and an independent application
Q6 Did you have to seek allowance to have your own (local) file/database with names of the included patients from your unit? … yes
… no
… never thought of it
Q7 If YES from patient or family on Q4, how often was consent denied? … never
… occasionally
… sometimes
… frequently
Q8 Do you consider (personal opinion) it necessary to have informed consent for such a study? … yes
… no
… uncertain
… other, please specify
Q9 All in all: How satisfied are you with the ethical clearance process for this study? … very satisfied
… satisfied
… neutral
… unsatisfied
… very unsatisfied
… other, please specify
Q10 What is your opinion of having a common EU regulation on research ethics, and that acceptance in one country will bind the rest (similar to drug-approval regulations) … I am in favour of this
… I am not sure
… I am against this
… Other, please specify
Q11 The name of your country