A research team is a group of people who work together towards a common research goal. Research teams vary in size and members vary in specialization. For UI IRB purposes, a research team includes persons in direct contact with research subjects during study procedures and/or with access to subjects' identifiable, private information or biospecimens for research purposes. Direct contact includes communication via telephone, virtual conferencing platforms or online surveys. While the PI has ultimate responsibility for the conduct of the study, research team members are equally responsible for ensuring that the study is conducted in compliance with all federal, state, institutional and industry regulations.

The Office of Human Research Protections provides guidance to determine when the activities of personnel result in their institutions being “engaged” in research. For University of Iowa personnel, their activities are reviewed by the University of Iowa IRB and covered by the University of Iowa Federalwide Assurance (FWA). The following conditions result in an institution being “engaged” in human subjects research requiring that their institution hold a FWA approved by OHRP:

  1. Institutions receive funding directly from HHS for human subjects research even if personnel at another institution conduct all research activities.
  2. An institution’s agents or employees intervene for research purposes with any human subjects, whether procedures are invasive or non-invasive.
  3. Employees or agents of the institution manipulate the environment of human subjects for research purposes.
  4. Employees or agents of the institution interact with human subjects for research purposes.
  5. Employees or agents of the institution obtain informed consent of research subjects.
  6. Employees or agents of the institution obtain identifiable private information or identifiable biospecimens for research purposes, regardless of whether these employees or agents have direct contact with research subjects.

Whether individual research team members perform specific functions as part of the research or ‘wear many different hats’, each member has general responsibilities while involved in the conduct of a research study:

  1. Complete all trainings required by the IRB and the study Sponsor.
  2. For ‘key personnel’, disclose any potential financial interests that might impact the research, including any financial interests of their spouse and/or dependent children.
  3. Conduct the study ethically using the principles outlined in the Belmont Report.
  4. Conduct all study activities as approved by the IRB.
  5. Conduct study activities for which authority is delegated by the Principal Investigator.
  6. Comply with all UI policies and procedures and all applicable federal, state, and local laws during the conduct of the study.
  7. Maintain participant privacy during data collection and the confidentiality of data after collection.
  8. Notify the PI immediately of events that are reportable to the IRB and the Sponsor.

Additional responsibilities may be assigned to a single research team member or may be shared by multiple team members depending on the complexity of a study or on the number of active studies a PI is conducting. Research team members may:

  1. Serve as HawkIRB delegate for the PI.
  2. Recruit subjects and schedule study visits.
  3. Conduct the informed consent process following IRB-approved procedures. Ensures subjects and/or their representatives understand what they are being asked to do and voluntarily consent.
  4. Manage research subject compensation using IRB approved practices.
  5. Receive, manage, and dispense investigational drugs or devices.
  6. Assist with preparing grant applications and budgets.
  7. Order supplies for the study and clean and maintain lab equipment used during study activities.
  8. Enter information into databases (e.g. subject information, samples, subject registries, etc.).
  9. Serve as the point of contact for subjects for general questions about the study.
  10. Meet with IRB Compliance Monitoring staff from the HSO and/or the Sponsor during site visits.
  11. Other tasks as assigned by the PI.

Research team members may come from the community, a non-UI organization, or another institution. They need not be actively appointed faculty, staff, or students of the University of Iowa. If personnel are not affiliated with the University of Iowa, but are engaged in human subjects research activities, their activities must still be reviewed by an IRB. If the individual has an appointment at an institution with an IRB, typically their institutional IRB should review and approve the research, unless the project has federal funding and uses a single IRB model. When an individual does not belong to an institution with an FWA or IRB, they may be added as a non-UI team member in HawkIRB. The UI IRB Standard Operating Procedures and Researcher Guide (Section II, Part 3.C and Part 8) outline the policy regarding non-UI team members. All research team members named on a HawkIRB application are required to complete human subjects protection training and complete the eCOI disclosure form.

For more information, contact the University of Iowa IRB at irb@uiowa.edu.