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Do you require your sites to submit closure amendments on exempt studies? Or do you approve an exempt study for a certain amount of time? We have so many exempt studies where faculty members have left our institution.
rfasano 25/01/2024 3:24 pm
@ldschaffer Hi Lisa. Interested in this also. Last summer we implemented a process to allow study teams to request to close an exempt project. We’re now working on updating our policy and processes to begin issuing a 3-year expiration on new Exempt approvals.
Curious if others have made this change and how they handled closing out any old, inactive studies.
Courtney Karmelita 06/05/2024 12:12 pm
@ldschaffer We require study closure, even for exempt studies. It is somewhat of an issue as we know there are studies that have concluded that are still open in our system. We’ve started to send email reminders and announcements at the end of each semester. We include exempt studies in our abbreviated audits and through the audits are able to identify some that can be closed.
When our IRB approves an exempt project it automatically moves into an archived state. Investigators therefore do not need to submit closures for exempt projects. Modifications do not need to be submitted for exempt studies so long as the research remains minimal risk and stays within the boundaries of the exemption categories that the IRB found were applicable to the research. If a modification to the study does require submission, they must submit a new project.
silbertl 02/05/2024 2:58 pm
@a-baumgartner That’s an interesting idea! Does your institution use Huron for IRB submissions?
A.Baumgartner 02/05/2024 3:03 pm
Yes, we’re currently on a older version of Huron IRB that is substantially customized by our internal IT developers.
silbertl 02/05/2024 5:20 pm
@a-baumgartner Been there! We switched to the current off-the-shelf product in 2019. Not sure if we can justify the customization for exempt studies to be immediately moved into an archived state, but it’s definitely an enticing way to avoid a lot of administrative work getting them closed out.
At Cedars-Sinai, we review all studies without a continuing review requirement in our submission system (Huron IRB) on an annual basis. We then survey all researchers/study teams with such studies approved >1 year, and require them to comment on the following:
- whether the research is ongoing
- how many subjects/records have been accrued to date
- whether there have been any changes to the protocol that have not yet been submitted to the IRB
- whether there have been any unanticipated problems related to the research
We include information about how to submit a closure if they indicate the research is complete and notify them that if a closure is not submitted by a certain date, we will administratively close out the research based on their response to the survey.
As you might imagine, some researchers/teams do not respond to the survey (although the response rate has improved significantly over the 3 years since we initiated this process). After several follow-up attempts and personalized efforts to track down responsible parties (as you noted, many have left the institution), we send final notifications to non-responders that their studies will be closed administratively by a certain date.
Occasionally, our administrative closure will prompt a researcher/team to reach out and request the study be re-opened. In such cases, we copy the closed submission and ask the researcher/team to re-submit it for IRB review.
I hope this helps!
Best,
Leah Silbert
Pronouns: She, Her, Hers
Manager, Research Compliance & Post Approval Monitoring
Office of Research Compliance &Quality Improvement
leah.silbert@cshs.org
Cedars-Sinai
6500 Wilshire Blvd, Suite 1800 : Los Angeles CA 90048
office 310‐423‐4149 : cedars-sinai.org
LDSchaffer Topic starter
02/05/2024 5:57 pm
@silbertl you do this for exempt studies too? How long do you allow the study team to respond before you close it for good?
LDSchaffer Topic starter
02/05/2024 5:57 pm
@silbertl you do this for exempt studies too? How long do you allow the study team to respond before you close it for good?
silbertl 02/05/2024 6:21 pm
Yes we include any studies that are Approved in our system without an expiration date. The first year was a doozy but since then has become more manageable.
We give researchers/teams plenty of time to respond, and often move that date forward as needed, so it is not a set amount of time. We usually pick an initial response to survey timeframe that is within a couple of weeks and go from there.
I just checked our last review and the total time from the initial survey to the completion of closures was around 5 months. Out of ~1,000 studies identified, we closed around 250 (includes those who closed their own studies as well as those we administratively closed). We copied <5 studies for resubmission after closure.
