As you may know, the Office of Research Integrity Assurance (ORIA) is no longer under the GTRC/GTARC organization, but is now included in the EVPR office. If you are sending email to associates in ORIA, and you are using the GTRI/GTRC mail system, you may find that your messages are not delivered. This is likely due to your mail client cache. If you experience bounced messages when sending to ORIA emails, please clear your auto-complete cache in your local Outlook client (e.g. https://its.unl.edu/emailhome/clear-e-mail-cache). After clearing your cache - resend the message. If you still receive a bounce back or if you do not hear back from ORIA, please contact us via phone or Teams to make sure your message was received.
The IRBs are also authorized to retain consultants when necessary.
These federal resources may be helpful in learning more about regulations that affect protocol applications:
- Health and Human Services Regulations on Protection of Human Subjects (Pre-2018 Common Rule)
- Health and Human Services Regulations on Protection of Human Subjects (Revised 2018 Common Rule) - Effective 01/21/2019
- Food & Drug Administration Regulations
- FDA Information Sheets (Guidance for Institutional Review Boards and Clinical Investigators)
- Federal Office for Human Research Protections/HHS
- Federal HIPAA regulations (Department of Health and Human Services National Standards to Protect the Privacy of Personal Health Information)
- NIH Clinical Trial Requirements (NIH Definition of clinical trial)
- NIH Single IRB Policy (Single IRB Policy for Multi-site Research)
Please see the following resources that pertain to the Revised Common Rule, which went into effect on 01/21/2019:
- The revised 2018 Common Rule
- List of Federal Agencies complying with the 2018 Common Rule
- Revised 2018 Common Rule OHRP Training Videos:
- Additional resources can be found on the CITI site at https://about.citiprogram.org/en/final-rule-resources/#irbimpact and https://about.citiprogram.org/en/final-rule-resources/#overview