VI Personnel and Training

Identify all individuals who will participate in the design, conduct, or reporting of any portion of this research project and assure that each is committed to the assigned role.

PI and Investigator(s) and Other Key Study Personnel – listed in the IRB application, are individuals, qualified by training and experience, and who are directly involved in conducting the research with human subjects by interacting or intervening for research purposes, including participating in the consent process by either leading it or contributing to it; or who are directly involved with recording or handling identifiable private information, related to those subjects for the purpose of conducting the research.

Verify that all study personnel are current with their human subject research training:

All persons planning to conduct Human Research—faculty, staff, students and faculty advisors of students—must complete an online Collaborative Institutional Training Initiative (CITI Training) prior to IRB approval, including research that may be deemed exempt. Proof of CITI Training completion by all members of the research team must be submitted with the application for IRB review. Study staff may not participate in Human Research until their CITI Training is completed. CITI Certification is valid for a three-year period, after which time the training must be repeated. Enroll in CITI Research Ethics and Compliance Training.

Find here which CITI courses you are required to complete.

In addition, all Study personnel on FDA-regulated or NIH-funded clinical trials must complete the CITI Good Clinical Practice (GCP) training.

Verify that all study personnel are current with their conflict of interest disclosure: All study personnel must disclose whether they have any disclosable outside interests in the online eCOI system.

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