Clinical research typically involves two distinct roles: researchers and research participants. Pragmatic trials conducted in the setting of routine clinical care can be more complex and can involve those with other roles. For example, some clinicians, while not considered researchers, may provide clinical services inherent to the research. In addition, some people, although not considered research participants, may be affected by the conduct of the research (eg, family members, clinical staff).

In pragmatic clinical trials, clinicians can be involved in the research process as researchers, service providers, research participants, or those affected by the research. Patients can be research participants or be affected by the research. Different regulations and oversight mechanisms apply to these roles.

In this chapter, we differentiate between researchers, service providers, research participants, and those affected by the research. Appropriate mechanisms of oversight for each are described.