The IRB requires that all principal investigators, co-investigators and designated research project coordinators receive and maintain certification in human subjects research and comply with the following by:

1. Including evidence of human subjects research training in all new project submission packages (exempt studies excluded).
2. Including evidence of human subjects research training in all continuing review submission packages.
3. Including evidence of human subjects research training in all amendment submission packages requesting a study team change and/or addition involving the principal investigator, co-investigator or project coordinator.
4. The evidence of human subjects research training submitted shall be current with a completion date within the past three years.
5. The evidence of human subjects research training shall consist of the appropriate GBMC IRB approved training course(s) or documented equivalent training obtained elsewhere.

IRBNet submission packages that do not contain the above-mentioned, required evidence of human subjects research training shall not be processed until such evidence is included.

The IRB has approved three training courses in human subjects research. These courses are available on the Collaborative Institutional Training Initiative’s (CITI) on-line training website. Click “CITI” below for instructions on how to register and access the courses:

The IRB approved CITI training courses and modules are as follows:

1. Basic Course in Biomedical Research with Elective Modules. All ten modules plus two elective modules must be completed with a score of at least 80% on all quizzes to pass the entire course.
2. Basic Course in Records-Based Research. All five modules must be completed with a score of at least 80% on all quizzes to pass the entire course. Investigators who limit their research activities to records-based research may limit their human subjects research training to this course.
3. Basic Course in Survey/Questionnaire Research. All six modules must be completed with a score of at least 80% on all quizzes to pass the entire course. Investigators who limit their research activities to the use of surveys and/or questionnaires may limit their human subjects research training to this course.

The IRB will accept evidence of comparable human subjects research training from an outside source provided the completion date is within the current three years; however, the IRB prefers that the above-mentioned GBMC IRB approved course(s) and modules be taken.

The IRB can, at its discretion, require an investigator or other research staff member to take any combination of the above-mentioned courses and/or individual modules regardless of the human subjects research training evidence provided.

For more complete details regarding the IRB’s human subjects research training requirements, click “SOP 4.5” below for the entire “Investigator Qualifications, Responsibilities and Training Requirements” policy:

The IRB Office staff is responsible for monitoring compliance with human subjects research training. Monitoring is accomplished by way of IRBNet’s track training option. This is a tool within the IRBNet system designed to monitor and share training records. All principal investigators, co-investigators and designated study coordinators must create an IRBNet account and upload evidence of their human subjects research training into their “User Profile” and electronically submit this evidence to the IRB Office. Click “IRBNet” below for instructions on how to access IRBNet and submit evidence of human subjects research training:

If you have questions or need assistance, please contact the IRB Office staff.