Trust and confidence: towards mutual acceptance of ethics committee approval of multicentre studies.
OBJECTIVE
To compare issues raised by Human Research Ethics Committees (HREC) during the ethics review process and to determine the length of time taken to gain HREC approval for multicentre research studies.


METHODS
Review and analysis of HREC documentation and correspondence for all multicentre research studies were conducted through three HREC under the auspices of Cancer Trials Australia, Melbourne, Victoria, Australia, between November 1997 and March 2001 to determine the variance of documentation, correspondence and recommendations across the three HREC and the time taken for study approval.


RESULTS
Thirty-one projects were submitted to any two of the HREC (16 studies) or all three HREC (15 studies). The median time for study approval at an individual HREC was 75 days, but it was 111 days for approval at all participating sites. There were 554 clarifications or comments made by the reviewing HREC, the majority of which had no significant bearing on the ethical or scientific calibre of the study. There was only one study in which a significant protocol change was requested by a HREC.


CONCLUSIONS
Multicentre study approvals are delayed when submitted to multiple HREC. The three HREC raised similar issues without substantive differences in their recommendations. A process for the mutual acceptance of HREC recommendations could facilitate multicentre research.
Sarson-Lawrence
M
M
Cancer Trials Australia, Melbourne, Victoria 3050, Australia.
Alt
C
C
Mok
M T
MT
Dodds
M
M
Rosenthal
M A
MA
D001315:Australia; D026724:Ethical Review / Q000592:standards*; D028741:Ethics Committees, Clinical / Q000706:statistics & numerical data; D028744:Ethics Committees, Research / Q000706:statistics & numerical data*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards / Q000706:statistics & numerical data*; D035502:Trust