Research monitoring and oversight encompass four types of activity [8
]: annual review of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring the integrity of data. These activities are intended as means of quality assurance in research, and as means of establishing expectations of rigorous and ethical conduct in research. However, there are very few empirical research data to demonstrate how well these practices fulfill these functions [9
], and the few epidemiological studies of monitoring and continuing review suggest much room for improvement [8
]. Furthermore, it is also taken on faith that when these activities do occur they contribute to the higher order aims of protecting human participants and promoting ethical conduct in research, but similar deficits in empirical evidence make these claims increasingly suspect and raise a deeper question about what we are trying to achieve through research ethics review, monitoring and oversight practices, and how.
According to the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans [11
], '(p)rinciples of accountability require that, regardless of the review strategy, the REB continue to be responsible for the ethics of all research involving human subjects that is carried out within the institution.' In interviews with REB members at several major Canadian universities, however, McDonald [6
] found them to be apprehensive about monitoring. This seems a reasonable response to the ambiguous message of the Tri-Council Policy Statement, which, in a subsequent section, states that '(b)eyond scrutinizing reports, the REB itself should not normally carry out the continuing ethics review, except in specific cases where the REB believes that it is best suited to intervene' [11
]. So, the committees most responsible for research ethics continue to be given few, if any, resources and little helpful guidance on these matters.
Our own hospital, St. Michael's Hospital, has taken the unusual step of implementing a monitoring programme with a full-time research ethics monitor. Through judicious use of skill, diplomacy and diligence, and with strong support from the hospital's research administration, we are forging what we believe is a fruitful new direction in research monitoring and oversight. We are working to create a climate and culture within the institution that support investigators with the myriad technical requirements of research, particularly the Canadian and US regulatory requirements for clinical trials, but also to provide them with meaningful opportunities to discuss and examine the complex ethical and regulatory issues that arise in the conduct of their research.
Our monitoring programme places strong emphasis on education. We provide investigators with detailed information about research responsibilities through regularly scheduled rounds and a variety of other educational activities, such as courses in the International Conference on Harmonisation's Good Clinical Practice guidelines [12
]. We conduct internal quality assurance audits of ongoing trials, initiated either by random selection, investigator request, or in response to specific events or concerns. We have also monitored informed consent discussions between research staff and prospective research participants, and we are currently planning to survey research participants themselves in order to gain a better understanding of their perspective.
These activities not only engage investigators with the issues, but they also provide the REB with a real and meaningful set of mechanisms to help it fulfill its obligations for monitoring and oversight. The REB members receive feedback about the actual conduct of the research that they approved, and this constitutes an important learning loop for their review of future proposals. The institution is also exercising due diligence by gathering more details about the conduct of its research, especially for investigator-initiated drug studies, in which the institution must assume sponsor responsibilities. Our researchers have responded very favourably to acknowledgement and support for the high standards of their conduct, and to recommendations for improvement, when these are warranted.