Main characteristics of the 62 research ethics committees (RECs) involved in this study
| *Additional members included, among others, quality control personnel, pharmacologists from universities, and representatives from the regional health authorities (mainly in regional RECs). | |
| †Three additional RECs held ad hoc meetings. | |
| ‡Complete dossier includes protocol, investigator’s brochure, case report form, PIS, etc. | |
| §Only 40 (65%) of the RECs requested a fee. | |
| ¶Requested by 22% of RECs. | |
| **Median €580; range €240–1502. | |
| PIS, patient information sheet. | |
| No of members | Median 14; range 5–31 |
| Sex | |
| Male | Median 9; range 1–23 |
| Female | Median 5; range 1–10 |
| Background* | |
| Physicians | Median 8; range 2–23 |
| Lay members | Median 2; range 1–3 |
| Lawyers | Median 1; range 1–3 |
| Pharmacists | Median 1; range 1–3 |
| Nurses | Median 1; range 1–3 |
| Frequency of meetings† | |
| Every 2 weeks | n = 3 (5%) |
| Every 3 weeks | n = 2 (3%) |
| Monthly | n = 50 (81%) |
| Every 2 months | n = 4 (6%) |
| Documentation requested | |
| No of copies of the complete dossier‡ | Median 9; range 1–20 |
| No of additional copies of the protocol | Median 15; range 6–26 |
| No of copies of separate PIS¶ | Median 14.5; range 4–22 |
| Days for submission of documentation prior to the meeting | Median 14.5; range 7–25 |
| Fee requested by RECs§ prior to protocol evaluation | Median £389; range £161–1008** |