The following are responsibilities of individuals who are associated with the IRB or who conduct research using human participants:
A. Principal Investigators
The principal investigator is the individual responsible for the conduct of research and, as such, must personally conduct or supervise the research. Investigators have the following responsibilities related to the IRB review process.
- Obtain and maintain certification through CITI before initiating research involving human participants.
- Review training materials and federal regulations regarding the protection of human research participants. Attend training sessions when provided by the institution.
- Review relevant federal regulations, legislation, and institutional assurance documents pertinent to the proper conduct of research in human participants, particularly those that are pertinent to subject populations involved in investigator’s research studies (e.g., children, cognitively impaired individuals, the emergently ill, pregnant women, fetuses and others).
- Submit and maintain active research protocols for human subjects research.
- Provide timely submission of continuing review reports, at least one month prior to the anniversary of the previous approval date.
- Train project staff members appropriately to ensure they are acting in congruence with current IRB policies and procedures.
- Submit timely IRB documentation.
- Assure the accuracy and completeness of all documents to the IRB.
- Use the most current version of IRB forms.
- Communicate IRB approvals to sponsors, unless sponsor requests a direct response
- Ensure that permission is obtained to use copyrighted materials
- Ensure that changes in approved research are not initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards.
- Provide written notification of a change in association with a research study or with the institution. These changes are recorded in the Board minutes.
- Promptly notify the IRB of protocol deviations that affect the risk/benefit ratio to participants or the integrity of the research study.
- Promptly inform the IRB of unanticipated problems involving risks to human participants or others. Principal investigators must notify the IRB when there is to be a review of their study by any regulatory agency. Routine “site visits” and the outcomes must be reported on the Status Request Form. A copy of all correspondence relating to the investigation must be submitted to the Board.
B. IRB Office Administrators
Responsibilities of the IRB administrators and other assigned Office of Research and Sponsored Programs staff as necessary and appropriate are as follows:
- The IRB administrators must complete mandatory OHRP training associated with the federal assurance process.
- Participate in other training as such training is available and appropriate.
- Receive, log in, and distribute for review all protocols to ensure that all necessary documentation is provided at the time of submission.
- In cooperation with the IRB Chair, prepare the agenda for each meeting.
- Attend all IRB meetings and provide accurate and complete minutes of the meeting, which serve as the official, permanent record of IRB actions. The draft minutes should be forwarded to the Chair prior to distribution.
- Distribute the minutes to Board members, with the protocols for the next meeting, for their review prior to the convened Board meeting.
- Collect comments and concerns from the reviewers. When appropriate, return materials to the principal investigator.
- Distribute, as needed, the IRB Standard Operating Procedures to faculty and departmental representatives.
- Receive and prepare all communication between the IRB and the principal investigator. This includes new protocols, IRB requests for additional information, continuing review reports, closing reports, amendments, adverse event reports and any other general correspondence generated by the members of the IRB.
- Maintain all IRB files, both open and archival.
- Provide review of submissions for final approval, checking against the formal documentation from the meeting and the correspondence surrounding the approval process.
- Assist Chair in the interpretation of the federal regulations and in the development of appropriate institutional instruments to maintain compliance.
- Manage the IRB database,
- Provide consultation to the Board at the meetings in areas of regulatory compliance.
- Direct and monitor the continuing review process.
- Regularly report to the Associate Vice President for Research and other University officials on the status of IRB work and decisions and prepare any reports requested by the Associate Vice President for Research and other University officials.
- Develop and implement educational programs relating to the protection of human research participants, for all individuals involved in research under the FWA.
- Monitor IRB policies and procedures for compliance with applicable regulations and state laws.
- Audit IRB operations regularly.
C. Associate Vice President for Research
The Associate Vice President for Research is the institutional official designated by the University of North Florida Federalwide Assurance as having the authority and responsibility to ensure that appropriate policy and procedures are in place to ensure the adequate protection human participants in research conducted under the auspices of the university. To fulfill these responsibilities, the associate vice president for research should:
- Complete mandatory OHRP training associated with the federal assurance process.
- Serve as a consultant to the IRB.
- Oversee the work of the IRB administrators.
- Oversee policy and procedure issues.
- Serve as consultant for federal regulatory authorities.
- Serve as authorized individual (Institutional Official) in compliance and regulatory matters.
- Provide recommendations for committee structure and function.
- Regularly review IRB minutes and records.
- Hear and respond to appeals on procedural matters regarding the IRB.
- Be responsible for all required institutional reports to sponsors and federal agencies.
D. Vice President for Academic Affairs of the University
As the university official responsible for maintaining the academic integrity of the institution, the Vice President for Academic Affairs of the University has the following responsibilities related to the IRB:
- Appoint members of the IRB and the Chair in consultation with the Associate Vice President for Research.
- Receive regular reports from IRB administrators and the IRB Chair on the operations and operational needs of the unit.
- Maintain familiarity with the federal requirements for IRB oversight of research.
- Ensure that university policy is reviewed and revised as needed so that the university is in compliance with federal regulations and the intent of the federalwide assurance.