Training Requirements for Research Involving Human Subjects:
Human Subjects Research Training
Training on ethical and regulatory issues involving human subjects is required for all Bassett personnel who are involved with research (see Protection of Human Subjects Handbook). Initial training is provided through the successful completion of the CITI web course at www.citiprogram.org and submission of the certificate from CITI to the IRB Office. CITI certification will be valid for three years. Study personnel should choose the module or modules that correspond to the content of their research. Please contact Beth Utter via email for specific instructions, beth.utter@bassett.org.
Good Clinical Practice Training
Good Clinical Practice Training is required every three years for all Bassett investigators and sub investigators who are involved in a clinical trial regulated by the Food and Drug Administration (FDA). Definitions of investigator and sub investigator are included in the document “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance.” Certification requires successful completion of a CITI web-based course titled “GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) and/or “GCP for Clinical Investigations of Devices” (www.citiprogram.org). Please contact Beth Utter via email for specific instructions, beth.utter@bassett.org.
Resources for IRB submissions:
Please refer to the Office for Human Research Protections (OHRP) human subjects regulations decision charts, linked here, to help decide if your project is exempt or requires IRB review. Researchers are encouraged to consult the IRB office if they have questions about whether their projects might be eligible for exempt review.
If you are looking for a specific IRB document, please contact Heidi Johnson via email, heidi.johnson@bassett.org. Bassett employees may also utilize the Research Institute page on the B-net for additional documentation and other resources.
