OUHSC policy mandates that all faculty, staff, residents, fellows, and graduate students engaged in research
involving human subjects who meet the definition of key study personnel complete both the initial
and continuing education requirements described below.
NEW! - Provost Memo, effective 4/16/2018**
- Education requirements must be completed prior to submitting to the IRB. This includes Initial Submission Packets and Continuing Reviews.
- Education requirements must be completed prior to adding new key study personnel via the Modification/Notification form in iRIS.
- Submissions that contain incomplete or expired training will be returned to the investigator until all requirements have been met.
Definition of Key Study Personnel:
Individuals who provide study-related services or assistance and have knowledge of the study protocol AND the identity of study participants
or their protected (identifiable) health information.
Initial Education Requirements:
** The IRB In-House Program has been eliminated as a separate requirement (see Provost's Memo above, dated 4/16/2018).
Local context information and OUHSC-specific requirements have been incorporated into CITI (effective May 1, 2018).**
Important Notice Regarding Email Addresses and CITI Accounts
Provide your OUHSC email address rather than your personal email address, such as Yahoo or Gmail when you create an account with CITI.
iRIS, the IRB's electronic submission system, will not receive your CITI course completion information if a third party email is provided.
Note: if you do not have an OUHSC email created yet, the typical address structure is: email@example.com.
University of Oklahoma Health Sciences Center is the institution name to search for and affiliate with when creating a CITI account.
**IMPORTANT: Effective May 1, 2018, the Written Attestation has been incorporated into the CITI training. Completion of the module and quiz will serve as documentation for a signed and dated Written Attestation document.**
Continuing Education Requirement:
CITI Refresher Web-Based Course
This course is required every three years.
The CITI Refresher Course is a comprehensive review of the basic course modules covering both biomedical and social/behavioral topics.
It includes updated material as it becomes available. The program will take several hours to complete depending upon your familiarity with the material.
If you have Non-OU Collaborators involved in your research, you must provide a current copy (within 3 years) of their CITI or equivalent human participant protection training required by their institution with your submission packet in iRIS.
Individuals who are not employees or students of OUHSC or one of its affiliates, can complete the CITI under University of Oklahoma Health Sciences Center using their institution's email address.
OUHSC/OU IT accounts/emails will not be provided for Non-OU Collaborators
Good Clinical Practice (GCP) Training:
NIH Policy: GCP Training Required for NIH-funded Clinical Trials
Effective January 1, 2017, “all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be training in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).”
Note than GCP training for researchers conducting clinical studies is in addition to the University’s human participant protection training. If your funding agency requires GCP training, you must maintain documentation related to that training. The OUHSC HRPP does not monitor GCP training compliance.
How to Access GCP Training in CITI:
GCP training for biomedical research is available through the University’s CITI Program subscription. If you would like instructions for how to access the University’s GCP training, please contact the OUHSC HRPP at 405-271-2045 or send an email to firstname.lastname@example.org.
NEW! - GCP for Social/Behavioral Research is now available in CITI through the University's CITI Program subscription. Contact the IRB Office for instructions on how to access the GCP training.