September 5, 2017
For the Record – September 5, 2017 – Clinical Trials Definition
Posted by NIH in early August 2017
The National Institutes of Health (NIH) recently created a new web page focused on NIH’s definition of a clinical trial. It includes: case studies (examples); FAQs; and a decision tree tool. This new guidance suggests that NIH is using a very broad definition of “clinical trial”.
Why is this important for researchers who apply for NIH grants?
- A new NIH requirement, beginning January 25, 2018: All applications involving one or more clinical trials must be submitted through a Funding Opportunity Announcement (FOA) or request for proposal (RFP) that explicitly states it will accept clinical trials.
- See the Full NIH Announcement here.
- All NIH-funded clinical trials must comply with the following requirements:
Why is HSD telling you about this?
HSD is responsible for identifying UW clinical trials that are required to register at ClinicalTrials.gov and for informing researchers about the requirement. We use the information in your IRB application to make this determination while your application is being reviewed. We will now need to include consideration of this NIH guidance when making this determination.
Effective August 15, 2017
The Food and Drug Administration (FDA) released new guidance that for the first time allows IRBs to waive consent for fda-regulated studies that involve no more than minimal risk to the study participants. It also allows IRBs to waive specific elements of consent that are normally required.
This is part of a Congressionally-mandated requirement for federal agencies to “harmonize” the various federal human subjects regulations. It increases regulatory flexibility for FDA-regulated studies.
Don’t know whether your FDA-regulated study needs a waiver? No need to worry, because:
- We stopped asking you about this when we implemented Zipline and the IRB Protocol application form.
- Instead, HSD staff conduct a pre-review assessment of every new application we receive. The assessment includes determining whether your planned procedures require a waiver of consent or consent elements. If yes, the staff inform the IRB so that the IRB can determine whether your study meets the criteria for granting the waiver.
Effective September 5, 2017
Each of our IRB teams now has its own team email. You can use this email if you know which Team works with your academic department/unit. (Use this link to find out.)
Advantages of this new email address:
- It connects you directly with the HSD staff that shepherd your applications through the IRB review process.
- It is consistently monitored during regular business hours – as opposed to emailing a specific person on the team, who might be on vacation or out sick that day.
- It is another route that you can use – like the regularly monitored firstname.lastname@example.org – to obtain answers to your questions, make comments, and give us feedback.
Effective September 5, 2017
Zipline will automatically email you a reminder that action is required from you on your application if 30 days have elapsed without your response to a request. The reminder will be emailed to the Principal Investigator (PI), PI Proxy, and Primary Contact. The Reminder Notifications will be sent every 30 days thereafter, until you have responded, or have discarded the application. This is intended to help you keep track of your application’s status.
Reminders will be sent for actions required on:
- Initial applications
- Status Reports (Continuing Review)
- RNI submissions
If you have any questions about the Reminder Notification you receive, please contact your HSD Team.