Introduction

CHAPTER SECTIONS

Identifying Those Engaged in Research


Section 1

Introduction

Clinical research involves people in a variety of ways. In addition to the well-recognized roles of researcher and research participant or subject, there may be service providers and others who are affected by the research but who are neither researchers nor subjects. Examples include family members, other patients, and clinical staff. Pragmatic clinical trials conducted in settings of routine clinical care can involve a variety of roles beyond the researcher and the subject roles and can present a challenge in identifying who is properly considered a subject.

In this chapter, we differentiate between researchers, research participants, service providers, and those affected by the research, and we describe the appropriate mechanisms of oversight for each role.

We also note that the term "engaged" in clinical research has a regulatory meaning and is reserved for researchers and institutions that meet specific criteria relevant to the research, as described in Section 3.

Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Human Subjects/Research Participants and Others Affected by the Research
  3. Identifying Those Involved in the Process of the Research
  4. Clinicians’ Duty to Participate in Pragmatic Research
  5. Case Studies From PRISM NIH Collaboratory Trials

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).


Version History

November 3, 2026: Made nonsubstantive edits for style and clarity as part of the biennial review (changes made by D. Seils).

July 7, 2023: Made nonsubstantive changes to the Resources sidebar (changes made by D. Seils).

Published September 21, 2022

current section :

Introduction

  1. Introduction
  2. Human Subjects/Research Participants and Others Affected by the Research
  3. Identifying Those Involved in the Process of the Research
  4. Clinicians’ Duty to Participate in Pragmatic Research
  5. Case Studies From PRISM NIH Collaboratory Trials

Citation:

O’Rourke P, Wilfond BS. Identifying Those Engaged in Research: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/ethics-and-regulatory/identifying-those-engaged-in-research/introduction/. Updated November 3, 2026. DOI: 10.28929/166.