As noted above, many individuals can be involved in the process of research, but depending on their role, they may be subject to different mechanisms of oversight. Those involved in the process of the research include:

• Those who are conducting the research (study team members) and are subject to research oversight (these people are considered to be “engaged” in research)
• Collaborators, clinicians, and service providers who provide certain aspects of the research and are not subject to research oversight (note: they are subject to the oversight of the providing organization)

An important distinction for pragmatic clinical trials is that between study team members and service providers. The NIH Pragmatic Trials Collaboratory's Ethics and Regulatory Core developed a handout for Engagement in Research for PCTs that clarifies this distinction; an excerpt is provided below.

Study Team Members

Study team members are best understood to be the individuals who design and/or conduct the  research. Study team members may include the principal investigator, co-investigators, and research staff (eg, research nurse, research coordinator, data manager). In addition to research staff who are funded to work on the study, there are criteria related to activities that make others a “study team member” for purposes of oversight, such as intervening or interacting with  subjects for research purposes, obtaining the informed consent of a subject, or having access to identifiable research data. Investigators should work with their institution as needed to accurately identify who is a study team member.

Why Does It Matter?

When individuals/groups are identified as study team members, they (and their institution) are considered “engaged in research,” and federal regulations for the protection of human subjects would apply. In addition, study staff would be required to complete human subjects research training (specific training as mandated by their institution), and if the study is federally funded, the site would be required to obtain a Federalwide Assurance (FWA).

Service Providers

In some studies, service providers may be used to conduct specific aspects of the study intervention (see Table). For example, if part of the intervention includes routine acupuncture treatment, the researchers may contract with community acupuncturists to perform these services. OHRP guidance lists the following conditions that must exist in order for an institution or organization to be considered a service provider and not “engaged” in research:

Institutions whose employees or agents perform commercial or other services for investigators, provided that all of the following conditions also are met:

• • the services performed do not merit professional recognition or publication privileges;
  • the services performed are typically performed by those institutions for non-research purposes; and
  • the institution’s employees or agents do not administer any study intervention being tested or evaluated under the (Office for Human Research Protections 2010)

To fall clearly within the category of a service provider, the individuals/groups must be providing the same service they provide for clinical care. Service providers must not enroll subjects or obtain informed consent for the research. If the level of involvement falls outside these conditions, the persons conducting these activities should be classified as study team members, which raises the issues of site requirements for an FWA and human subjects research training as described above.

Why Does It Matter?

There are implications for individuals as well as institutions. As noted above, an institution that has any study staff members is considered “engaged” in the research, which has implications for required human subjects training, and an FWA. In contrast, if an institution has only service providers, it is not considered “engaged” and research training requirements and the need for an FWA do not apply.

Individuals who are service providers do not need to complete and document human subjects research training, even if they are at an institution that is considered “engaged” in the research.

Therefore, investigators should review the OHRP guidance on this issue, which provides detailed scenarios under which institutions, individuals, and groups are considered engaged in research, or not engaged in research, in order to ensure that the proposed research is designed and planned appropriately.