How to Seek IRB Approval for a Case Series
If your case series requires IRB approval, follow these steps:
1. Identify Your Institution’s IRB Process
- Contact your institution's research office.
- Determine whether the study qualifies for full review, expedited review, or an exemption.
2. Prepare the IRB Application
- Provide a detailed protocol including:
- Study objectives
- Data collection and analysis methods
- Confidentiality and data protection plans
- Potential risks and benefits
- How patient confidentiality will be maintained
3. Include Patient Consent (if applicable)
- If identifiable data is involved, you may need to obtain patient consent.
- If you seek a waiver of consent, justify why consent is not feasible.
4. Submit and Respond to Feedback
- Submit the IRB application.
- Address any comments or revisions from the board.
- Case Reports vs. Research: A case report, by definition, is a description of one or more cases, but it's often not considered research. However, if a case report analyzes more than a few cases, it might be deemed research.
- IRB Review & Approval: If the analysis or reporting of a case (or series of cases) is considered research, it requires IRB review and approval before publishing the research.
- IRB Guidance: Many institutions provide guidance for investigators to determine if a case report constitutes research and requires IRB review. Some journals also require a letter or acknowledgement from an IRB prior to case report publication.
- Patient Consent/HIPAA: If the case report includes identifiable protected health information (PHI), it may require a signed consent form from the patient (or their authorized representative) to comply with HIPAA regulations.
📝 Do I Need an IRB for a Case Series?
When conducting a case series, one of the most common questions researchers face is whether Institutional Review Board (IRB) approval is required. The answer depends on factors like the number of cases, the nature of the data, and how the information will be used.
❓ When is IRB Approval Required?
🔎 1. Case Report vs. Case Series
Understanding the difference between a case report and a case series is crucial in determining whether IRB approval is needed:
| Type | Description | IRB Requirement |
|---|---|---|
| Case Report | Describes a single patient case | IRB usually NOT required if it’s purely descriptive |
| Case Series | Describes multiple similar cases | IRB MAY be required, depending on data handling and analysis |
IRB approval is generally REQUIRED if:
✔️ The data is identifiable and not de-identified.
✔️ The study involves prospective data collection (new patient data).
✔️ The study aims to compare interventions or outcomes.
✔️ The goal is to contribute to generalizable knowledge.
✔️ Any patient intervention or change in care is involved.
👉 Example:
- A case series comparing two surgical techniques for cleft lip repair, involving prospective data collection—IRB REQUIRED
Federal and Institutional Guidelines
According to the U.S. Department of Health and Human Services (HHS) and many institutional guidelines, IRB approval is required if the case series involves:
✔️ Prospective data collection (data gathered specifically for the study)
✔️ Identifiable private health information (PHI)
✔️ Systematic investigation intended to contribute to generalizable knowledge
✔️ Use of patient data in a way that could pose a risk to confidentiality or privacy
🔒 If PHI is involved:
- IRB approval is required.
- A patient consent form or HIPAA waiver may be necessary.
