Identifying Those Engaged in Research
Section 1
Introduction
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.
SECTIONS
Resources
Differentiating Between RCTs, PCTs, and Quality Improvement Activities
As discussed in this section of the Living Textbook, quality improvement activities, pragmatic clinical trials, and explanatory randomized controlled trials may involve different mechanisms for oversight and consent (Faden et al 2013; Finkelstein et al 2015).
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Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. 2013. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep. Spec No:S16-27. doi:10.1002/hast.134.
Finkelstein JA, Brickman AL, Capron A, et al. 2015. Oversight on the borderline: Quality improvement and pragmatic research. Clin Trials. 12:457-466. doi:10.1177/1740774515597682.
Melnick ER, Jeffery MM, Dziura JD, et al. 2019. User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. BMJ Open. 9:e028488. doi:10.1136/bmjopen-2018-028488.
Office for Human Research Protections (OHRP). 2010. Engagement of Institutions in Human Subjects Research (2008). https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html. Accessed August 17, 2022