06/2020: Education/Training Announcement

The HRPP Office is offering training and informational sessions via Zoom. Contact us at 405-271-2045 or email irb@ouhsc.edu to learn more and/or to schedule your training session. 

Education and Training

OU 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 (KSP) complete both the initial and continuing education requirements for OUHSC as described below.  

Who is Considered "Key Study Personnel (KSP)"?

The education requirements apply to all individuals who meet the definition of key study personnel (KSP). 

KSP are individuals who:

  1. provide study-related services or assistance; and 
  2. have knowledge of the protocol, and 
  3. the identity of study participants or their identifiable protected health information. 

Initial Training Requirements

Investigators and KSP engaged in human research must complete the CITI Human Research Basic Course in subject matter germane to the nature of research being conducted. There are three (3) courses available for investigators to choose from to complete. This training must be completed before the IRB can accept, process, or approve new studies. 

Click here to access the CITI Program website and training courses. 

*IMPORTANT* When creating a new account or modifying an existing account that was created under another institution: 

  • Affiliate with University of Oklahoma Health Sciences Center 
  • Use your OUHSC email address if available. This will allow your CITI training information to feed into your iRIS user account. 
Users must select and complete one course that is germane to the nature of research being conducted:
  • Group 1: Biomedical Research, or 
  • Group 2: Social/Behavioral Research, or 
  • Group 3: Biomedical & Social/Behavioral Research 

Continuing Education

CITI training must be renewed once every three years. Users are notified via email from CITI when training is due to expire. 

Click here to access the CITI Program website and training courses. 

**If you have forgotten your username or password: Use the "Forgot...?" links provided by CITI. The HRPP / IRB Office cannot provide user passwords. DO NOT CREATE A NEW ACCOUNT.

IRB Submission Requirements

The requirements outlined below will help investigators avoid unnecessary delays when processing new studies, continuing reviews, and modifications to add new KSP. 

  • Education and training requirements must be completed prior to submitting new studies, continuing reviews, and annual check-ins to the IRB. 
  • Education and training requirements must be completed prior to adding new KSP to a study. 
  • For research involving Non-OU Collaborators, investigators must upload and attach a copy of the collaborator's human subject protection training certificate before submitting to the IRB. 

 

Good Clinical Practice (GCP)

Investigators have access to three different GCP courses in CITI:

  • Good Clinical Practice 
  • GCP - Social/Behavioral Research Best Practices for Clinical Research
  • GCP for Clinical Investigations of Devices

This training is not required by the IRB in order to satisfy the IRB training requirements. 

However, investigators and their study team may be required to complete GCP training by a funding agency or sponsor. 

Individuals who complete a GCP course must maintain their own documentation related to the training. The OUHSC HRPP does not monitor GCP training compliance. 

If you would like instructions for to access the GCP training in CITI, please contact the OUHSC HRPP/IRB Office at 405-271-2045 or sent\d an email to irb@ouhsc.edu. 

Non-OU Collaborators

Non-OU Collaborators engaged in human research under the oversight of the OUHSC IRB must provide a current copy (ex: within 3 years) of their CITI human research or other equivalent human research protection training  as required by their institution. 

NOTE: Conflict of Interest, HIPAA, Good Clinical Practice, and Responsible Conduct of Research alone will not suffice as human research protection training. 

IMPORTANT: OU investigators/study contacts must upload and submit a copy of the Non-OU Collaborator's current training with their IRB submission. 

Faculty/Staff Training Requests

The HRPP/IRB Office also offers the following training opportunities:

  • Departmental Training during scheduled faculty/staff meetings for IRB topics including, but not limited to: IRB submission process, informed consent requirements, general IRB updates, and more. We can customize presentations to meet the specific needs upon request. 
  • Classroom Training: Informational training regarding either the IRB submission process, Determination of Research, or Informed Consent. These offerings can also be customized to meet the needs of the course and students upon request. 
  • One-on-One Training: Topics vary from the IRB submission process to iRIS. These are ideal for new staff and can be conducted at your location or in the IRB Office. 

Please contact the HRPP/IRB Office at 405-271-2045 or send an email to irb@ouhsc.edu to schedule a training session. 

OUHSC Contact

865 Research Parkway, Suite 400
Oklahoma City, OK 73104

ph: (405) 271-2045
fax: (405) 271-1677

Email Us: irb@ouhsc.edu

Norman Contact

Five Partners Place
201 Stephenson Parkway, Suite 4200
Norman, OK 73019

ph: (405) 325-8110

Email Us: irb@ou.edu