Table 1 The questionnaire to the national coordinators

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

…