Grant: Dissemination Events - Priority Announcement: Ethics

In traditional randomized trials, individual patients are enrolled after providing informed consent, randomized to receive a particular medical intervention, and followed to ascertain outcomes over time. Cluster randomized trials (CRTs), in contrast, randomly allocate intact groups (e.g., medical practices, villages, schools) to intervention or control conditions. They are commonly used to evaluate the effectiveness of interventions delivered at the group-level (e.g., water fluoridation treatments, methods of health care delivery, public health promotion campaigns). They are often used to evaluate interventions designed to improve the quality of patient care. Numerous ethics guidelines exist to protect human participants in research; however, their interpretation is not straightforward in CRTs. For example, obtaining informed consent is complicated by the fact that communities may need to be enrolled before individual participants are identified. Moreover, when interventions are delivered to the community as a whole it would be difficult for individuals to decide independently or withdraw to avoid potential harmful effects of an intervention. Consent may be obtained from a community representative, but it is not always clear who should fulfill this role and what their responsibilities should be. The lack of guidelines has led to a situation where research may be carried out with less than adequate ethical standards. On the other hand, strict enforcement of conventional rules may undermine the scientific quality of studies and may impede quality improvements in health care. After a five-year cross-disciplinary research project, we have developed a widely accepted set of guidelines for CRTs, supported by well-grounded moral reasoning. We are now applying for funding to disseminate these guidelines to research ethics committees. Their uptake will ultimately result in improvements in health research, accountability, and the protection of human subjects in research.