IRB Review of Research Staff Qualifications
Effective August 1, 2019, Principal Investigators are required to list all key personnel on the personnel page of the RAMS-IRB SmartForm. Investigators may add or remove research staff who are not key personnel without submitting an amendment to the IRB. Only changes to key personnel require an amendment.
For the purposes of submission in RAMS-IRB, “key personnel” are conflict of interest investigators (COI Investigators), including the PI and student investigator, medically/psychologically responsible investigator, and other personnel whose roles are essential to the conduct of the research.
Principal Investigator responsibilities regarding research staff have not changed. Per VCU IRB WPP IX-1 “Principal Investigator Eligibility and Statement of Responsibilities”, the following responsibilities of the Principal Investigator remain in effect:
- Ensuring that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
- Ensuring that research staff are qualified (e.g., appropriate training, education, expertise, credentials and, when relevant, privileges) to perform procedures assigned to them during the study, and conducting the research using only qualified and trained personnel.
- The Principal Investigator assumes full responsibility for the conduct of the study and for the protection of the rights and welfare of human subjects involved in the research. The PI is ultimately responsible for all activities related to the research protocol including the quality and timeliness of submission to the IRB.
The changes to requirements for RAMS-IRB submission do not impact other regulatory or institutional policy requirements for maintaining research staff rosters, delegation logs, or training logs.
The HRPP recognizes subjectivity in interpretation of the category “other personnel whose roles are essential to the conduct of the research.” As a point of guidance, the HRPP urges investigators to consider whether the absence of a certain skill set or role from the study personnel presented to the IRB could suggest that the proposed research team is not appropriate to complete the study or minimize risk as required by 45 CFR 46.111(a)(1).
Changes to the RAMS-IRB SmartForm will follow with a patch to the system this Fall.
Questions or comments may be directed to ORSP@vcu.edu.