Identifying Those Engaged in Research
Section 5
Case Studies From PRISM NIH Collaboratory Trials
In this section, we describe 4 of the NIH Collaboratory Trials supported through the NIH HEAL Initiative’s Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program as examples to explore how to identify the individuals or groups who should be considered as subjects, study team members, or others involved in research in order to determine the appropriate mechanism for oversight. The goal of accurately identifying the research participant is to apply the appropriate methods for respecting their autonomy and protecting their rights and welfare.
Table. NIH Collaboratory Trials: Identifying the Research Participants, Study Team, and Service Providers
| Study | Intervention | Research Participants | Study Team | Non–Study Team Service Provider |
| FM-TIPS
|
Addition of transcutaneous electrical nerve stimulation to routine physical therapy | Patients with fibromyalgia | Researchers at a health center who designed and oversee the research | Physical therapists |
| GRACE | Guided relaxation and acupuncture | Patients with sickle cell disease | Researchers at 3 health centers who designed and oversee the research
|
Acupuncturists
|
| NOHARM | EHR-embedded patient- and clinician-facing decision support | Patients undergoing surgery | Researchers at a health center who developed the clinical decision support tool and training in pain management | Inpatient nurses, physical or occupational therapists, post-anesthesia care unit or postoperative nurses |
| OPTIMUM (Greco et al 2021) | Group-based mindfulness-based stress reduction | Patients with chronic low back pain | Researchers at 3 health centers who designed and oversee the research | Mindfulness instructors who conduct the training sessions in partnership with primary care physicians at the health centers
|
Abbreviations: EHR, electronic health record; PRISM, Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing.
Conclusions
Clinical research involves several people in different roles: researchers and the study team, research subjects, and service providers and others who may be affected by the research. Oversight and application of federal regulations differ for each of these roles. While the US federal regulations for the protection of research subjects apply only to human subjects, there may be institutional policies that apply more broadly. Members of the study team must adhere to regulatory requirements of mandated training and have an institutional FWA for federally funded research. In contrast, service providers are not subject to these requirements.
Identifying each of these roles can be challenging, especially in pragmatic trials that are embedded in routine clinical care. Identifying the research subject and those engaged in research is a critical, early step in the design of pragmatic clinical trial.