Faculty Advisor Responsibilities
UTA’s IRB allows students to perform human subject research in the role of Principal Investigator (Student PI) to perform and report on their research activities. However, a qualified Faculty Advisor is required to provide oversight for all Student PI human subject research. The Faculty Advisor is responsible for the QUALITY and TIMELY SUBMISSION of their Student PI’s IRB protocol, and for the CONDUCT of the research.
At a minimum, the Faculty Advisor must provide oversight in the following areas:
PREPARATION & PROTOCOL SUBMISSION
- Design: Work with Student PI to design the study including methodology, procedures, logistics and the informed consent process, and assist in the completion of IRB application materials.
- Education: Ensure Student PI completes training and understands the IRB submission process.
- Time Management: Ensure Student PI submits the IRB protocol with sufficient time to allow for IRB review process and conduct/completion of the study.
- Master’s students should submit at least one semester in advance of planned graduation.
- Doctoral students should submit at least 9 months in advance of planned graduation.
- IRB protocols submitted in the same semester of planned graduation are not guaranteed to complete the IRB review process in sufficient time.
- Protocols with greater complexity will take more time for review and approval: multi-site studies, collaborations with non-UTA sites/personnel, school/ISD permissions, external data transfers, FDA, greater than minimal risk, studies involving hazards, special facility requirements.
- Quality Control: Student protocols are automatically routed to the Faculty Advisor in the electronic system for sign-off before submission to the IRB. Prior to sign-off, ensure the protocol is complete, detailed, and makes sense. Do not rely on the IRB or IRB Staff to correct or complete the protocol, improve its quality, or make suggestions on research design. Protocols that are poor quality or lacking substantial information will be returned directly to the Faculty Advisor for resolution.
- Assist Student PI with any questions, revisions, or corrections requested by IRB.
- If necessary to meet with IRB Staff for assistance, attend the meeting with Student PI.
- If protocol requires Full Board review, attend IRB meeting with Student PI to minimize likelihood of protocol being tabled or returned for significant revisions.
- Compliance: Monitor activities to ensure procedures are followed in accordance with approved protocol and ensure that all modifications are approved by IRB prior to initiation.
- Quality Control: Routinely review data collection to ensure quality.
- Recordkeeping: Ensure data is collected and maintained in the secure, confidential manner described in the protocol.
- Reporting: Report problems with the research, subject injuries, or non-compliance.
- Study Status: Ensure Student PI closes IRB protocol upon completion, before they leave UTA.
- Recordkeeping: Ensure study records are maintained securely for 3 years after completion, even if Student leaves UTA.