Identifying Study Team Members in RSRB (IRB) Submissions
Determining who needs to be listed as a ‘study team member’ on an Institutional Review Board (IRB) submission depends on the Reviewing IRB’s policies/requirements. Similarly, funding agencies may have differing definitions of who is considered ‘key personnel’.
University definition of study team members
At the University of Rochester, individuals are considered study team members when they:
- Act as a Principal Investigator, Co-Investigator, Sub-Investigator, or Study Coordinator;
- Interact with human subjects (e.g., facilitating the informed consent process, manipulating subject’s environment for research purposes, conducting research procedures);
- Are involved in collecting, reporting, or analyzing identifiable subject data;
- Function outside of regular work practice (e.g., student administering research testing); and/or
- Are faculty advisors/mentors providing direct oversight of student research.
Caveat if involvement is limited to regular work responsibilities
If an individual is functioning within their regular work responsibilities and their involvement in the research is limited to those work responsibilities only, without further contribution to the research, then they are generally not considered study team members.
For example, a phlebotomist working at a central laboratory who performs a blood draw on a subject via a clinical lab requisition would not be considered a study team member.
When the RSRB is the Reviewing IRB
The Research Subjects Review Board (RSRB) requires all study team members, as defined above, to be identified in the Click IRB submission.
- Only study team members with current Human Subject Protection (HSP) training should be added to IRB submissions. HSP training appears on a submission’s Training Details tab in Click as ‘Human Research’ (under the ‘Curriculum’ heading).
- Do not include:
- Team members from external sites who will receive IRB approval from their own IRB.
- External collaborators who are not engaged in research conduct (e.g., handing out recruitment information at an external site or providing prospective subjects with information about contacting the study team).
- If additional individuals join the study team following initial IRB approval, they must be added to the IRB submission via modification and the modification must be approved before the additional team member(s) can engage in the research.
- Existing study team members with a lapse in HSP training must cease involvement in human subject research activities until refresher training is completed. The RSRB may not approve:
-
- New studies when study team members have lapsed HSP training;
- Existing studies at the time of continuing review when training for key personnel has lapsed
Adding external team members/collaborators
When an individual external to the University is collaborating with University of Rochester (UR) faculty (as part of the UR site) and meets the definition of study team member, as defined above (e.g., members of the community and/or individuals affiliated with community-based organizations/agencies), they should be identified as ‘External Team Members’ in the Click IRB submission (reference the Click IRB Study Staff Guide for instructions).
Note:
- As with internal team members, only external study team members with current Human Subject Protection (HSP) training should be added to IRB submissions (reference our HSP Training for External Personnel page).
- The protocol should clarify what roles/tasks the non-UR site/staff will be engaged in and include information regarding how the Principal Investigator will oversee research conduct at the non-UR site.
- If the external individual is engaged in the research on behalf of their role/position at a non-UR research location or facility and the research is federally funded, the non-UR facility is considered a separate research site, requiring a Federalwide Assurance and IRB site approval (reference OHSP Policy 504: IRB Reliance and Collaborative Research). External research personnel would then be managed as described in the drop-down below (multi-site research).
In accordance with SMART IRB recommendations, the Relying IRB (i.e., the IRB that delegates the responsibility of IRB review and approval to the RSRB) is responsible for ensuring their local site research staff have ‘adequate education, training, and qualifications to perform the research’. Other than the site-Principal Investigator, study team members engaged in the research at other participating sites should not be identified as study team members in the Click IRB submission.
When an External IRB is the Reviewing IRB
In accordance with SMART IRB recommendations, the Research Subjects Review Board (RSRB) requires all study team members, as defined above, to be identified in the Click IRB submission.
- Only study team members with current Human Subject Protection (HSP) training should be added to IRB submissions. HSP training appears on a submission’s Training Details tab in Click as ‘Human Research’ (under the ‘Curriculum’ heading).
- External research personnel should only be identified in the Click IRB submission as a ‘Local Study Team Member’ when they are engaged in the research as part of the local University of Rochester site. Reference the information above under ‘When the RSRB is the Reviewing IRB – Single-Site Research’.
- If additional individuals join the study team following initial IRB approval, they must be added to the IRB submission via modification and the modification must be approved before the additional team member(s) can engage in the research.
Frequently asked questions (FAQs)
Reference our Click IRB FAQs for more information.
Reference our HSP Required Training FAQs for more information.
Statisticians only need to be identified as a study team member on an IRB submission when/if they have access to identifiable subject data. Bear in mind, this determination may be dependent on the level of access the statistician has to the data. Study data may be coded for the statistician to perform analysis. ‘Coded’ means that the data is still identifiable to the study team because they hold the key linking the identifiable information to the coded information, but if the statistician does not have access to the key, they would not be able to identify the data and therefore would not need to be identified as a study team member.
For additional information on what ‘coded’ means versus de-identification, reference OHSP Explains: Coded vs. De-Identified; Anonymized vs. Anonymous.
No, only the Principal Investigator needs to be listed on the submission. However, if the RSRB determines the proposal is human subject research, the Principal Investigator is responsible for adding all study team members, as described above, to the submission.