Revised Common Rule Information

Effective Date: 01.21.2019

 

This page is where you can find information about the Revised Common Rule (RCR), including an overview of key changes, which regulations will apply to your research, and how the changes will be implemented at OUHSC. 
 

Check back to this page regularly for updates, guidance for implementation at OUHSC, and future trainings!

 

** IMPORTANT DATES AFFECTING NEW RESEARCH APPLICATIONS & iRIS! **

In preparation of the RCR, the HRPP Office will be placing a freeze on all new research applications! The deadline to submit a new research application for IRB review will be 5:00pm on Thursday, December 20th. See the timeline below for additional information.

Dec. 20, 2018

iRIS will be closed to new study submissions on Dec. 20th at 5:00 p.m.

Continuing reviews, Modifications, Determination Worksheets, and other submissions will continue to be accepted.

Dec. 21, 2018 – Jan. 15, 2019  

Time needed for IRB to review new studies submitted prior to December 20, 2018, get responses for stipulations, and grant final IRB approval.

Jan. 16, 2019      

iRIS will go offline for transition to RCR and testing.

Jan. 22, 2019      

iRIS will come back up to accept all submission types.

 

NOTE: The above schedule should allow enough time for the HRPP / IRB to complete its review of submissions prior to January 21st to remain under the “pre-2018 Rule."
Research approved January 21, 2019 and beyond must meet the updated requirements of the “2018 Rule”, and is subject to the updated consent and exemption requirements.
Exceptions to the above schedule or urgent submissions will be considered for acceptance on a case-by-case basis. Please contact the HRPP Office at 405-271-2045 prior to submitting any new studies in iRIS during the new study “freeze” window.

 

** PLANNED TOWN HALLS FOR THE REVISED COMMON RULE

There are currently 3 town halls planned. Content will be the same at each session, so choose the one that fits your schedule best. 
Videoconference to Tulsa is available and location is listed on the flyer below! 
This will be your opportunity to preview how the changes will be implemented at OUHSC and get questions answered by HRPP staff. 

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Key RCR Changes cropped

 

 

More Details About Key RCR Changes

Continuing Review

Under the revised Common Rule, a continuing review will no longer be required for:

  • Most studies that qualify for the expedited review process (and meet one of the OHRP Expedited Review Categories)
  • Studies that have completed subject intervention/interaction and research activity is limited to analyzing study data or involves only observational follow-up in conjunction with standard clinical care. 


IMPORTANT:

  • Continuing may be required by the IRB on a case-by-case basis for research that meets the criteria above. 
  • FDA-regulated research must still undergo a continuing review at least annually, per FDA regulations. 
  • An administrative check-in form will be required for non-exempt research that is not subject to continuing review requirements. 

NOTE: Ongoing research (approved prior to 1.21.2019) must still undergo a continuing review in 2019. The IRB may or may not transition ongoing research at the time of continuing review. This will be determined on a case-by-case basis. 

Informed Consent 

Under the 2018 Rule (RCR), the requirements for informed consent will change. 
The following requirements will be added:

  • "Key Information" to be presented at the beginning of the consent form. 
  • New consent elements (required statements and additional statements when applicable to your research)
  • Changes to waiver criteria and documentation. 

The intent of the changes is to facilitate the participant's understanding of the proposed research. The new required elements will also ensure that participants understand how their data and biospecimens may be used. 

A new consent template containing RCR requirements has been added to the Researcher's Toolkit. Click here to access the templates page.  

Exempt Categories

The list of exempt categories expands from six to eight under the RCR. The categories have been given their own section in the regulations and can be found at 45 CFR 46.104. 

Click here to access the list of Exempt Categories in the RCR.

Single IRB Review

This requirement affects federally-funded research that does not go into effect until January 2020.  The NIH issued a single IRB review policy for NIH-funded policy, which has been in effect since January 25, 2018.

The HSC HRPP has a single IRB review process in place. Visit the Reliance Agreements page for more information!

Ongoing Research is Grandfathered into the Pre-2018 Regulations


 **As stated in the image above, any plan to allow for transition of ongoing research to the 2018 Rule (revised Common Rule) will be drafted into a policy and the plan will be announced at a future date.