Guidelines for Faculty Advisors on Student-led IRB Protocols
Introduction
Emerson allows students to perform human subjects research in the role of Principal Investigator (Student PI) on projects that have been reviewed and approved by the IRB. However, at least one qualified Faculty Advisor is required to provide oversight and guidance for a Student PI’s IRB protocol. The Faculty Advisor is an active mentor to the Student PI, and shares the responsibility for the ethical conduct of the research with the student. The IRB holds the Faculty Advisor(s) responsible for the overall management of an approved research protocol in conjunction with the Student PI. Management of the research encompasses the ethical, administrative, fiscal, and applied elements of a project.
Faculty Advisor Oversight
The Faculty Advisor provides oversight and guidance 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 required CITI 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.
- Quality Control: Prior to submission, ensure the protocol is complete, detailed, and makes sense. Protocols that are poor quality or lacking substantial information will be returned directly to the Faculty Advisor and Student PI for correction/revision.
Protocol Review Process
- Assist Student PI with any questions, revisions, or corrections requested by IRB.
- If protocol requires Full Board review, attend IRB meeting with Student PI to minimize likelihood of protocol being tabled or returned for significant revisions.
Conduct
- 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.
Completion
- Study Status: Ensure Student PI closes IRB protocol upon completion, before they leave Emerson.
- Recordkeeping: Ensure study records are maintained securely for 3 years after completion, even if Student leaves Emerson.
Faculty Advisor Qualifications
Faculty Advisor responsibilities may only be carried out by a full-time member of the Emerson faculty. Exceptions to this restriction must be reviewed and approved by the IRB. Faculty Advisors are required to complete the same CITI training required of all PIs on human subjects research protocols.