IMPROVE project research ethics committee approval questionnaire

(1) Your name, your country, today’s date

(2) Did you get research ethics committee approval for the study in your country?

(3) If you did not need ethical approval, please say what are the criteria for needing ethical approval, to make it clear why you did not need it.

(4) To how many different committees did you have to apply?

(5) If more than one committee, how many different versions of an application did you need to make?

(6) What documents or information were required?

(7) Did you, or your colleagues, need to appear in person, for example to be interviewed, as part of the application process?

(8) Please estimate the composition of the committee? Numbers of health care professionals, researchers, lay people

(9) Were any changes required before approval was given? If yes, please describe.

(10) How many hours of a person’s time did it take to obtain ethical approval for the study?

(11) How much did it cost you, not including the person’s time, to obtain ethical approval, or check that it was not needed? (Please use either your own currency or euros)

(12) Will you report back to the research ethics committee at the end of the study?

(13) Did you obtain consent from patients? If yes, was it written or spoken?

(14) Please describe any other part of the process to obtain research ethics committee approval which I have not asked about.

(15) Do you have any guidelines or protocol on obtaining approval from research ethics committees in your country or region?