Step 2: Prepare for IRB Application & Approval
What Is an IRB?
Institutional Review Boards (IRBs) or Human Subjects Review Boards (HSRBs) monitor research performed on human subjects. IRB oversight prevents research abuses by protecting the well-being of research participants.
IRBs govern whether—and through what protocol—a study may be executed. Researchers apply for IRB approval to validate both the scientific merit of their study plan and the ethical treatment of participants.
Almost all institutions who participate in the MSL have a local IRB. However, if your institution does not have an IRB, please contact your School Coordinator so that we may assist you with this process.
Identify Your IRB Needs
Please work with your administration to determine whether IRB review is required. If your institution decides that the MSL does not need local IRB approval, a “No IRB” Letter must be submitted.
All schools must submit one of the following three documents before data collection starts:
· "No IRB" Letter
· IRB Approval Letter
· IRB Exemption Letter
If you have declared as a Standard Data School and your local IRB and/or school policy does not require you to submit a local IRB review, you must submit a "No IRB" Letter. Download a "No IRB" justification template letter to use. Copy the template onto your letterhead, edit the highlighted areas, sign it, and then forward the document to your MSL School Coordinator.
Submit Your IRB Application
It is important to explore your institution's IRB approval process early and apply as soon as possible, especially if you wish to use the ID Link Approved school option. IRBs may need time to process approvals or may request that an application be revised. Starting the process early contributes to the likelihood that an approval will be granted for your preferred data collection launch date.
The deadline for IRB approval will fall approximately two weeks before your launch date. Please inform your Study Coordinator when your IRB application has been submitted.
Important documents typically required by IRBs
IRB content for Standard Data schools or for ID Link Approved schools (Content from this document can be copied and pasted into your local IRB application.)
IRB Approval Details
If your IRB grants conditional approval and requests further information, please inform your School Coordinator, and provide the conditional approval documents to SoundRocket. Often Conditional IRB approvals include requirements to change elements of the protocol, consent form, etc. The School Coordinator will work with you to update any relevant details to ensure that your IRB package is re-submitted appropriately, and the updates are accurately reflected in our system. If your school has selected the ID Link protocol, please make sure that your IRB conditional approval specifies that it is for the ID Link protocol.
ID Link IRB Approval Denied/Delayed
If your IRB denies your request for ID Link IRB approval, you must proceed with Standard Data IRB approval. If you have already submitted ID Link Approved templates for the consent form, etc., to SoundRocket, you will be asked to resubmit new approvals for the Standard Data materials. Please notify SoundRocket as soon as possible, as this may cause a delay in your launch if it is done late in the process.
Please contact your Study Coordinator if, for any reason, you must change your ID Link status after it has been declared.
If your school intends to participate in the MSL as an ID Link Approved school, and you have not received Conditional IRB Approval three weeks prior to launch, please contact your School Coordinator and discuss your options. If we have not received communications that demonstrate an ID Link Approved status is likely two weeks prior to launch, SoundRocket reserves the right to change your status to a Standard Data School. If this happens, you will be notified by your Study Coordinator.
Submit IRB Approval or Exemption Letter to SoundRocket
If your IRB grants approval or declares the MSL exempt from review, submit your IRB Approval Letter or IRB Exemption Letter to your SoundRocket School Coordinator. If your school has selected ID Link status, your IRB Approval document must include reference to the current "MSL ID Link Protocol". A standard letter that simply approves the "MSL" is not acceptable to demonstrate that the ID Link protocol has been reviewed and approved.
After submitting IRB documentation to SoundRocket
Once you submit your “No IRB” Letter, IRB Approval Letter, or IRB Exemption Letter to SoundRocket, this document must be reviewed and approved by the MSL Research Team.
After approval by the MSL Research Team, you will be notified that your IRB process is complete.