Research is changing. Recent years have seen a shift away from studies performed at single academic centers to larger, multisite projects involving numerous institutions in disparate geographic locations. The number of citations on PubMed for multicenter studies increased by 1.6–3 fold for each 5-year interval between 1985 and 1999 (McWilliams et al. 2003
). While the shift is especially true in medicine, where clinical trials are often conducted as multicenter studies, the multisite design is of increasing importance in other fields, including health services research. A multisite study provides investigators with the opportunity to research different programs using a shared study design and methodology. Different sites investigate different services or programs, but have a common protocol. As a result, it becomes possible to measure “the same outcomes with the same instruments using the same timeframe across differing programs at multiple sites” (Dewa et al. 2002
). Multisite studies are valuable, because the involvement of different centers means that the results obtained may be more generalizable than those of a single-center study. The existence of the common research protocol renders the outcomes of the various sites comparable.
Multisite protocols, like all research, must be approved by local institutional review boards (IRBs) before investigators can proceed. This means that ethics approval must be sought separately from research ethics boards at each site in a multisite study. As well, studies affiliated with both hospitals and universities must seek ethics approval at both institutions. Some have questioned the effectiveness of this system. Christian et al. (2002)
state that the effectiveness of IRBs has been undermined because of the IRB system's failure to adapt to the changing research environment. Indeed, the current procedure for research ethics review, which involves seeking out ethics approval from each individual local committee, is not very conducive to collaborative, multisite research. The process of obtaining ethics review at multiple sites can be a daunting task, consuming time, money, and energy. One study in the U.K. indicated that extra funding had to be sought to cover the cost of applying to 125 local ethics review boards (Tully et al. 2000
) The time, effort, and valuable research dollars spent on obtaining ethics review for a multisite project can be a source of irritation and resentment for many investigators (Personal communication 2003
). They do not feel the extra administrative hurdles contribute toward the protection of research subjects, as requests from individual boards may differ considerably.
Some even go so far as to accuse the process of slowing the improvement and advancement of health care services by impeding project implementation. The inconsistency in ethics review, then, while a potential problem in all research, is especially problematic for multisite research. Inconsistency can result in subjects at different sites being afforded varying levels of protection. Without a standardized process for the interpretation of research ethics guidelines by IRBs, it is possible that subjects at Site A are better protected than their counterparts at Site B. Further, the money spent on securing multisite ethics approval does not represent the best use of research funds. There is concern, then, that large amounts of research funds—and therefore taxpayer dollars—are being squandered on repetitive, inconsistent, and unnecessary multiple ethics review processes. Money diverted to potentially unnecessary IRB review translates into less money spent on an actual study objective of improving health care services, raising questions regarding the ethics of such an opportunity cost. With the misdirected focus arising from the amount of money, manpower, and time required to seek multisite ethics review, some authors have pondered the question as to whether the system may even present an “unethical barrier” to potentially beneficial research activities (Tully et al. 2000
The problems associated with multisite IRB review are of particular relevance to health services research, as multisite studies are of increasing importance in this field. Weinberger et al. (2001)
, for example, write that multisite randomized controlled trials in health services research offer “numerous advantages” over single-site studies. First, multisite studies enhance external validity, increasing the generalizability of research results. Second, when the subject of the research is a condition with a “low incidence or prevalence, small event rate in the outcome … and/or large variation in the distribution of cost,” a multisite study may be the only way to assure the requisite statistical power (Weinberger et al. 2001
, p. 628). Finally, in a multisite study, the necessary sample size can be gathered faster. Weinberger et al. explain that this faster recruitment has a further advantage—since the study can be completed more rapidly, the “timeliness of the findings is enhanced.” They emphasize that this is of special importance in health services research, where investigators are frequently asked by health care organizations and policymakers to provide them with results as quickly as possible.
This last point, moreover, underscores why slow and inefficient ethics review for multisite research is of particular concern to health services researchers. The need for rapid dissemination of results to private and public entities for purposes of health care policy making makes speed a pressing factor for investigators on health services research projects. Unnecessary delays caused by a potentially ineffective multisite ethics review system can therefore affect the timeliness of health services research, with effects on subsequent health care policy and decision making.
The following paper examines this issue of whether the current system for ethics review of multisite research is adequate, or whether there exist alternative methods that should be considered. First, the available literature on this matter will be examined, including empirical studies describing the variability of, and problems with, multisite research ethics review. Second, reasons for variability in research ethics board review will be explored. Finally, potential solutions to the problem of multisite ethics review will be considered, including the implementation of special multisite review boards, mechanisms to facilitate communication and cooperation between ethics boards, and the notion of education or training and certification for ethics board members.