What's New (OUHSC Campus)

New HSC Protocol Outline available, effective 3/12/2019!

• This template is availabe on the Forms & Templates page. Researchers can also access the template in the Help section of iRIS.
• Researchers should save and use this new template when developing investigator-initiated research studies.

New VA Consent Template, Form 10-1086, available on the Forms & Templates page:

• This new template version is effective 1/31/2019 and complies with the 2018 Rule (Revised Common Rule) requirements.

New Board 2 roster now available under Meeting Schedules & IRB Rosters in the 'About Us' section.

Several policies have been updated to reflect changes due to the Revised Common Rule, which went into effect 1/21/2019. The effective date of these policies is 1/21/2019. The Searchable SOP link has also been updated! You can access all of the SOPs on the Policies and Procedures page. 

NEW! Updated HSC IRB Application Version is Live, Effective 1/22/2019:
A new version of the HSC IRB Application has been published. Users MUST convert to the new form version when prompted by iRIS.

Below is a summary of changes. Be sure to address all of the required action items below before submitting your revised application to the IRB. Any missed or incomplete questions will be returned for correction before IRB review of your submission can be completed.

• Section 1230, Waiver of Signed Written Consent: New Category 3 option added for new studies / post-RCR (post-2018 Common Rule) studies only!
  • No action should be required for applications that branch to this section.
  • Check this section and if your answer is erased, select the same category as before. The new option for Category 3 is only allowed for new studies that comply with the 2018 Common Rule (aka, Revised Common Rule), effective 1/21/2019.  
• Section 1240, Waiver of Signed Written Consent:  Replaced question with a new sub-form that is to be completed for ALL studies that branch to this section.
  • ALL ongoing studies (and pending applications) that branch to this section MUST complete the new sub-form before submitting to the IRB.
• Section 1500, Review or Analysis of Records/Data/Biological Specimens: Replaced the 4^th question in this section with a new question to identify whether any member of the study team will use identifiable information as part of the chart review. 
  • ALL ongoing studies (and pending applications) that branch to this section MUST answer this new question.
• Section 1600, Privacy & Confidentiality:  Added a new question before the Certificate of Confidentiality question. It is the 4^th question in this section and the remaining questions have moved down one.
  • ALL ongoing studies (and pending applications) MUST answer this new question before submitting to the IRB.