Procedure Investigator: - Indicates on the Personnel eForm (FOR242) that individuals on the research team are licensed and/or credentialed, as applicable;
- Completes his(her) human subjects protection training and ensures all others involved in the research project complete their training requirements (see PRO100 Procedure for Evaluating and Training Individuals Involved in the Human Research Protection Program);
- Assures that all personnel responsible for obtaining consent are knowledgeable about the research protocol and are skilled, licensed, and/or credentialed, as applicable, for their role in the research project;
- Conducts research according to UAB policies and procedures, applicable federal, state and local regulations, and relevant professional standards and ICH-GCP guidelines (E6) (see GUI342), if applicable;
- Completes the section in the IRB Application eForm providing his/her qualifications (FOR200) and, as requested, credentials for conducting the research;
- Submits the departmental protocol oversight review form (PORF; e.g.,FOR205, FOR214) for full and expedited review protocols.
- Obtains additional information regarding training or other documentation of qualifications or licensure of investigators, as requested by the IRB.
Student-Investigator, in addition to the above: - Obtains the signature of faculty advisor who will provide oversight for conduct of the research by the student.
Reviewing Staff: - Confirms the qualifications section of the Personnel eForm is complete for review by the IRB;
- Confirms investigators, sub-investigators, research personnel, and those persons obtaining consent have completed initial and continuing human subjects education.
The IRB: - Evaluates whether the research personnel are qualified to carry out the research.
- When indicated, requests additional information, documentation of qualifications for proposed research.
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