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 or on the Job aids page.

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 training is lapsed, submissions cannot be approved.

CITI Training

ORSIRB uses the web-based Collaborative Institutional Training Initiative (CITI) Program website. Each group completes the CITI training appropriate to its human subjects research activities. Training requirements for each group are listed in the HRP-422-CHECKLIST-Required Training document found in the IRB library within the electronic IRB system. Documentation of human subjects training for all key study staff must be completed before a study will be approved.

Contact the IRB Administrator before starting training to identify which group training you need.

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.

Registering for CITI Training

Initial Training

  1. Register your account on CITI website.
  2. From the dashboard, select affiliate with your institution (ORISE, ORNL, Y-12) or Other DOE.
  3. Provide personal information.
  4. Create your user name and password.
  5. Complete information about Continuing Education Credits (CEUs).
  6. Provide additional personal information (gender, country, etc.).
  7. Provide institutional information.
  8. Select curriculum: The study staff should select the appropriate role for question 1.
  9. Questions 3-8 should be left blank or "not at this time" should be selected unless the researcher wants to take additional training that is not required by IRB.
  10. Open the course by selecting "Start Now."
  11. Complete the Integrity Assurance statement.
  12. Complete the required modules.

Refresher Training

  1. Log-in to the CITI website.
  2. From the dashboard, select "Records" at the top of the screen.
  3. From the course table, select the gradebook for the "Due Now" row.
  4. Complete the Integrity Assurance statement.
  5. Complete the required modules.

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.