Identifying Those Engaged in Research
Section 5
Case Studies From PRISM NIH Collaboratory Trials
We use 4 of the NIH Pragmatic Trials Collaboratory’s PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) NIH Collaboratory Trials as examples to explore how to identify those individuals or groups who need to be considered to determine to appropriate mechanism for oversight. The ultimate 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 Pragmatic Trials Collaboratory PRISM 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
|
Transcutaneous electrical nerve stimulation | 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
Embedded pragmatic clinical trials are can raise ethical and regulatory challenges (Califf and Sugarman 2015). As described in this chapter, there are human subjects as well as others who may be affected by the research. The US federal regulations only apply to human subjects, whereas institutional policies may apply to others. In addition, the conduct of research can involve study staff who are conducting the research as well as service providers who are performing routine clinical duties. Study staff and their institution must adhere to regulatory requirements of mandated training and an FWA for federally funded research, whereas service providers (and their institutions) are not subject to these requirements.
Therefore, identifying the research subject and those engaged in research is a critical, early step in the design of pragmatic clinical trial.
SECTIONS
REFERENCES
Califf RM, Sugarman J. 2015. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials. 12(5):436-41. doi: 10.1177/1740774515598334. PMID: 26374676.
Greco CM, Gaylord SA, Faurot K, et al. 2021. The design and methods of the OPTIMUM study: a multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain. Contemp Clin Trials. 109:106545. doi: 10.1016/j.cct.2021.106545. PMID: 34455111.