Research Involving Human Participants

OUHSC Education Requirements

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. 

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Submission Requirements:

  • 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.

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Initial Education Requirements
:

  1. CITI Basic Course (Web-based training)

    ~  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 updated 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:firstname-lastname@ouhsc.edu.


    ~  University of Oklahoma Health Sciences Center
    is the institution name to search for and affiliate with when creating a CITI account.


    IMPORTANT:

    *Good Clinical Practice is an optional course and will not suffice alone as meeting the CITI requirement.
    **
    Responsible Conduct of Research completed through the Graduate College will not suffice as human subject protections training.

  2. Attendance at the IRB In-House Education Program

  3. Written Attestation

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Continuing Education Requirement:

  1. CITI Refresher Web-Based Course: required every two 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.
 

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Non-OU Collaborators:

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