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Ethics review of multi-centre trials: where do we stand?

Article Excerpt
It has been a decade since the Office of the Inspector General, U.S. Health and Human Services (OIG), issued its landmark report, Institutional Review Boards: A Time for Reform. (1) The OIG report talked of major changes in the research environment, with more multi-centre trials (MCTs) and increased commercialization of research. The purpose of this article is to review recent developments in terms of ethics (2) review of MCTs within the Canadian context.

The OIG report described a number of important findings, all of which apply to the Canadian context as well:

* The number of studies reviewed by each REB has increased enormously, without a commensurate increase in resources and with continued lack of appropriate expertise on IRBs.

* Insufficient attention was given to monitoring the study after initial approval.

* Healthcare institutions have become dependent on revenues from commercially sponsored clinical research.

* There is concern about lack of independence of REBs and institutional pressure to approve trials, resulting in concern about conflict of interest.

* There was insufficient training for investigators and Board members.

The OIG called for a variety of measures to improve the system, including an increased role for Data Safety Monitoring Boards (DSMBs). However, the OIG did not advocate centralization of IRB function.

In a previous article in this journal, Enzle and Schmaltz reviewed the issue of MCTs in the Canadian context, and focused on the issue of centralization of ethics review. (3 They observed that article 1.2 of the Tri-Council Policy Statement (TCPS) (4) could be interpreted to limit the possibility of central review of MCTs. The TCPS initially assumed that an REB would be under the purview of an individual institution. Although this was later amended to allow delegation, Enzle and Schmaltz addressed multiple reasons why an institution might choose to use its own REB for ethics review of all studies involving the institution or its personnel, including regulatory compliance, management of liability, and quality of review. They noted that there was no regulatory or other requirement for ethics review within the institution. Rather, there was the requirement that the institution be accountable for research done under its auspices. Concern of the institution regarding liability was intertwined with a desire on the part of the institution to maintain control of ethics review as part of a broader administrative oversight of what is done in the institution. Finally, Enzle and Schmaltz addressed the inherent strengths and weaknesses of multiple ethics review. Strengths included a greater possibility of identification of key issues if more eyes observed a trial. However, concomitant weaknesses included redundant use of resources and inconsistencies between sites which could result in delays to the research. Although they reviewed examples of centralized REBs at that time, there was limited experience in this regard.

The key issue with moving toward centralized REB review can be summarized as follows. Under the current system of individual REB review, the opinion of each REB represents the consensus opinion of a number of individuals. However, centralizing ethics review to one REB necessarily means that there is only one consensus opinion. Multiple REB reviews mean that there will be more variability in response. A key issue is whether this variability is desirable.

Enzle and Schmaltz observe that differing REB opinions provide an opportunity for the critical study of a concern arising from a lone dissenter at a single REB, which could potentially be recognized by the REB as a whole in its decision. The authors however do not provide supporting data. There are abundant arguments to the contrary. (5) Numerous studies from disgruntled investigators address inefficiencies, inconsistencies and other negative consequences of multiple reviews of...

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