Education and Resources
Principal investigators and study staff should be familiar with the HRP-103-GENERAL-ORSIRB Principal Investigator Manual. The manual can be found in the IRB library within the electronic IRB system.
The institutional officials, administrator/staff, chairperson (chair), members, researchers, and others involved in the review or involved in the design, conduct, or reporting of the research or who participate in those aspects of the research that involve contact with human subjects or their data or biospecimens must complete initial training, and become familiar with applicable federal and state laws and institutional policies regarding human subjects research.
Training is valid for a three-year period, after which time the training must be renewed. If external study staff are included on a study, their training must be current. If training is lapsed, submissions cannot be approved. Additional training may be required for researchers at your Institution.[1]
CITI Training
ORSIRB uses the web-based Collaborative Institutional Training Initiative (CITI) Program website. Documentation of human subjects training for the principal investigator must be completed before an initial review of the study by the IRB. Documentation of human subjects research training for all key study staff must be completed before a study will be approved.
Contact the IRB Administrator before starting training.
CITI certificates are automatically uploaded to the electronic IRB system if email addresses are the same for both systems. If you use a different email address for CITI, send the completion certificate to the IRB Administrator or load to the electronic IRB system with your IRB submission.
Please contact the IRB Administrator for more information about using the CITI Program website.
Other Educational Resources
OHRP Online Education – This page provides educational materials to better understand the HHS regulations for the protection of human subjects.
OHRP Interactive Training – These resources will be most valuable for training investigators and new IRB staff and members, particularly community members, on how best to understand and fulfill these specific requirements for protecting human participants in research.
DOE Education and Resources – This page provides educational materials, resources, and tools.
[1] For all ORAU researchers, ORAU policy requires Responsible Conduct of Research (RCR) training through CITI.