Trust and confidence: towards mutual acceptance of ethics committee approval of multicentre studies

Abstract

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.

Ethics committee reviews and mutual acceptance: a pilot study

“…With the support of these three HREC and that of the Alfred Hospital, a series of workshops was conducted to establish a model for MA. In addition, we undertook a retrospective study of multicentre HREC submissions and documented that significant differences of scientific and/or ethical opinion between HREC were not seen when they independently reviewed the same submission 1 .…”

“…Although this has led to increased treatment options for many Australians, it has also led to an increased workload for the numerous voluntary members of human research ethics committees (HREC) throughout the country who must review each study and determine its ethical and scientific merit. In the case of multicentre studies, this increased workload might represent a duplication of time and effort when the HREC is not the first to review the study 1 .…”

A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval

“…The essential procedures of the study never changed substantially, despite exchanges of over 15,000 pages of material among the nine sites.'' Review processes and content varied widely across multiple IRBs [2,[6][7][8]10,[13][14][15][16][17][18][19][20][21][22][23][24][25]. This includes variation in the type of review, as well as variable reactions to the study protocol and materials.…”

Ethics committee approval of multicentre studies

“…I refer to the article by Sarson‐Lawrence et al. entitled ‘Trust and confidence: towards a mutual acceptance of ethics committee approval of multicentre studies’ 1 . Researchers involved in multicentre trials would endorse the findings of the study in terms of the increased time to obtain approval from multiple ethics committees.…”