For Researchers, Clinicians & Providers
Whether you're starting a chart review, preparing a full board submission, or seeking expanded access for a patient, find the right pathway, forms, and deadlines below.
Types of IRB Submissions
Not all IRB submissions are research (for example, expanded access or compassionate-use requests, and clinical uses of humanitarian use devices). All submissions must be made through IRBNet, and all research activities must receive IRB approval before they begin. Each pathway below includes its application forms, supporting documents, and review process. For post-approval issues (amendments, continuing reviews, reportable events, or closures), open the relevant submission type for details.
Case Reports
Case Reports
Single-patient or small-series clinical observations intended for publication or presentation.
- Case Report Consent Form
Retrospective
Chart Review
Retrospective record reviews and dataset applications using existing health information.
- Forms A through F
- Dataset Application
Compassionate Use
Expanded Access
Access to investigational drugs or devices outside of a clinical trial: emergency, single-patient, and intermediate use.
- Emergency Use Application
- Post-Use Report
- EAC Application
Devices
Humanitarian Use Devices
FDA-approved devices for rare conditions affecting fewer than 8,000 patients annually.
- Forms A through F
Expedited
Minimal Risk
Studies presenting no more than minimal risk to participants. Eligible for expedited review.
- Forms A through F
- Informed Consent Video
Greater Than Minimal Risk
Full Board Review
Studies requiring review by the convened IRB: greater than minimal risk or special populations.
- Forms A through G
Not Deemed Research
Quality Improvement Projects
Projects intended to improve local practice or processes that do not meet the federal definition of research. A determination may be requested from the IRB.
Determination
Not Human Subjects Research
Request a formal determination of whether your activity constitutes human-subjects research. If it does not, IRB review may not be required.
Before You Submit
A little prep saves weeks of back-and-forth.
These are the four things every submission needs, regardless of pathway. Getting them lined up before you start the application makes review dramatically faster.
- Current CITI training certificateAll study personnel need active certification. Expires every 3 years.
- Protocol document readyStudy design, methodology, and analysis approach documented in full.
- Data security planHow data will be stored, accessed, and protected throughout the study.
- Conflict of interest disclosuresFinancial and other potential conflicts for every investigator.
Submission Process
Expedited reviews move on a rolling basis. Full board reviews align with the monthly meeting schedule.
Prepare your application
Choose the pathway, gather documents, complete the relevant forms.
Submit by the deadline
Upload your packet at least two weeks before the next board meeting.
Pre-review & assignment
The coordinator screens for completeness and assigns reviewers.
Review & determination
Receive approval, conditional approval, or requested revisions.
Ongoing oversight
Submit continuing reviews, amendments, and adverse events as needed.
External Resources
Federal regulations, registries, and reference materials.
Need help choosing a submission type?
If you're unsure which type applies to your study, contact the IRB office before submitting through IRBNet. Submitting the correct application type helps ensure a smoother, faster review.