In addition to research participants and persons affected by the research, many individuals can be involved in the process of research but, depending on their roles, may be subject to different mechanisms of oversight. The 2 basic categories of involvement in the process of the research include:

• Persons conducting the research (study team members) who are subject to the federal regulation for research oversight because they are considered to be engaged in research
• Collaborators, clinicians, and service providers who are involved in certain aspects of trial implementation but are not subject to the federal regulations (though they are subject to the oversight of the institution that is conducting the research)

An important distinction is that between study team members and service providers. The NIH Pragmatic Trials Collaboratory's Ethics and Regulatory Core developed a handout, “Engagement in Research for Pragmatic Clinical Trials,” that clarifies this distinction. Sections of that handout are reproduced below.

Study Team Members

Study team members are best understood to be the individuals who design and conduct the research. Study team members include the principal investigator, coinvestigators, and research staff, such as research nurses, research coordinators, and data managers. In addition to research staff who are funded to work on the study, individuals performing related activities may meet the criteria to be considered study team members for purposes of oversight. The Office of Human Research Protections (OHRP) provides guidance on the criteria that make one subject to federal regulations. In general, those who interact with subjects for research purposes or have access to identifiable research data are considered to be study team members.

Determining whether a person who obtains a subjects’ informed consent for a study should be considered a study team member is more complicated. In general, a person obtaining informed consent is a study team member. However, federal guidance allows some flexibility for low-risk, noninterventional studies. In these studies, if a person’s role in the research is limited to obtaining consent, that person does not have to be considered part of the study team. The determination can be challenging, and investigators should work with their institutions to accurately identify who is a study team member.

Why Does It Matter?

When individuals or groups are identified as study team members, they and their institutions are considered to be “engaged in research,” and federal regulations for the protection of human subjects apply. In addition, study team members must complete human subjects research training as mandated by their institutions. If the study is funded by the US government, the site must obtain a Federalwide Assurance (FWA), a written agreement in which the institution accepts responsibility for protecting human subjects in research.

Service Providers

In some studies, the research team may rely on service providers to conduct specific aspects of the study intervention. For example, if the intervention includes routine acupuncture therapy, the researchers may contract with community acupuncturists to perform these services. OHRP guidance lists the conditions below that must exist 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 nonresearch 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)

The specific conditions also apply to individuals. To fall clearly within the category of a service provider, the individuals or 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 except for the flexibility of low-risk, noninterventional studies as described above. If the level of involvement falls outside these conditions, the persons conducting these activities should be classified as study team members and they and their institutions are considered engaged in the research and subject to the federal regulations.

Why Does It Matter?

Classification as a service provider, rather than a study team member, has implications for both individuals and institutions. As noted above, an institution that has any study staff members is considered to be 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 to be engaged in research and the training requirements and 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.

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, to ensure that the proposed research is designed and planned appropriately.