In an effort to further reduce investigator burden, more closely harmonize with DHHS New Common Rule changes to Expedited reviews, and prepare for a new KC system (possibly later this year), WVU is modifying how it currently reviews and approves Expedited studies. Because of these changes, you may be required to take action.
SUMMARY OF CHANGES/ACTIONS TO BE TAKEN:
1. Expedited studies that are reviewed under federal OHRP regulations will no longer require continuing review as long as they have been updated to follow New Common Rule guidelines.
2. Expedited studies that fall under FDA Expedited Category 1 will still require annual continuing review regardless of whether the study has been updated to follow new Common Rule guidelines.
3. All Expedited studies will automatically terminate 5 years after their initial approval date. This is consistent with the new 5-year approval period for NHSR, Flex, and Exempt. To continue a study after 5 years of its original approval, you will need to resubmit it as a new protocol (read on for exclusions). You will still need to file Amendments and Event Reports.
4. Expedited studies initially approved BEFORE January 21, 2019 (that fall under OHRP regulations) must be resubmitted as new, initial protocols by February 1, 2022. This will require the use of new informed consent templates.
5. FDA Expedited Category 1 studies that are, or will be, 5 years old by March 31, 2022 will be required to be resubmitted as new, initial protocols by February 1, 2022. This will require the use of new informed consent templates.
6. Exclusions to the requirement to resubmit as a new study may include:·
- National/Regional Registries/Repositories
- Studies closed to enrollment and/or only those with subjects in long-term follow up
- Longitudinal studies
- Studies scheduled to be permanently closed no later than March 31, 2022—if your study isn’t closed by this date, and it doesn’t fall into one of the categories excluded from this mandate, it will be automatically closed by the system
- Expedited studies overseen by external/outside IRBs (WIRB, WCG, Advarra, or an institutional IRB other than WVU)
- To determine what action—if any—you need to take on each protocol, go to the Expedited Review Protocol Assessment Tool and answer the questions related to each one of your studies.
- Some studies originally submitted as Expedited prior to January 21, 2019 may now qualify for a different submission type. To find out if your Expedited study qualifies for Flex or Exempt, use the WVU+kc IRB Protocol Type Decision Tool and check before you resubmit a new protocol as Expedited.
- To request an exclusion from the requirement to resubmit a new, initial protocol, contact WVU OHRP at firstname.lastname@example.org if you believe your study qualifies or if you have other circumstances that might prompt an exclusion. You may still be required to make changes to your study to ensure compliance with New Common Rule regulations.
Where do I start?
Use the Expedited Review Protocol Assessment Tool. It will tell you what action you need to take on each study.
Where can I find the initial approval date for my Expedited studies?
Below are screenshots from WVU+kc to help you. Go to WVU+kc > IRB > Active Protocols and look for studies that are listed as Expedited under the Protocol Type heading. The Approval Date heading will provide you with the date of your initial approval. Make sure these studies were INITIALLY approved as Expedited studies.
How do I know if my study is classified as FDA Expedited Category 1?
Open your study protocol in WVU+kc and go to Questionnaire > Expedited Review. You should find the answer there. Will sponsors be billed for these new, initial submissions? We will not bill for new submissions unless they have never been submitted before.
What if my Expedited study just received Continuing Review approval? Do I still have to resubmit a new protocol?
Use the Expedited Review Protocol Assessment Tool to see. It will guide you. If your study was just approved, you have until next year to resubmit a new protocol. However, we would like to encourage you to do this sooner than later. If you do have to resubmit a new protocol, please start your new protocol title with, “Former Protocol [insert number]: [study title]...”
When does this change begin?
New, initial submissions that qualify under OHRP’s federal regulations (and are not FDA studies) are already receiving a 5-year approval.
I have a Continuing Review in the system now, and it appears I will have to submit a new protocol in the coming months. What should I do?
If you started a renewal in the system, but haven’t submitted it yet and you will be required to resubmit the study as a new, initial protocol by February 1, 2022, we suggest you use the Copy to NEW Document function in [kc.wvu.edu] WVU+kc to transfer your existing information to a new, initial application. You will still need to upload your attachments including new consent templates. But using the copy function should save you some effort.
What about amendments?
You will still be required to submit amendments for Expedited studies. You will also be required to submit Event Reports.
I’m still not sure what to do, can I talk to someone?
If you have used the screening tool and you still have questions regarding what you need to do, please contact us at email@example.com. Include the protocol number, PI’s name, study title, and the best way to contact you. Someone from our office will get back to you as soon as possible.