Non-Medical IRB Umbrella Protocol FAQ
- What is an “umbrella” protocol?
- What review type should I submit for an umbrella protocol?
- What research is not suitable for an umbrella protocol?
- Who can have an umbrella protocol?
- Can students run their independent projects under a lab’s umbrella protocol?
- Should the Personnel Info section of the protocol application include all those working on all studies?
- Is there a limit to the number of studies under an umbrella protocol?
- Do umbrella protocols qualify for the Extended Approval Process (EAP)?
- Can federal funding be used for research under umbrella protocols?
- Does an umbrella protocol need to include all stimuli for experiments, or are sample stimuli sufficient?
- What about surveys, interview questionnaires, or other study materials?
- How should an umbrella protocol address changing experiment lengths?
- Is it acceptable to provide a general hourly pay rate for participants?
- When should a modification be submitted for an umbrella protocol?
- Where can I go if I have more questions?
What is an “umbrella” protocol?
A non-medical umbrella protocol covers multiple studies on the same topic within one lab. These protocols are broader than single-project protocols but must be detailed enough for the IRB to assess risks and understand all procedures. Each study under the umbrella must follow approved ethical guidelines and procedures.
What review type should I submit for an umbrella protocol?
Submit umbrella protocols under the “Expedited” review type, as they are not eligible for Exempt review.
What research is not suitable for an umbrella protocol?
Umbrella protocols may not be suitable for research involving populations with additional protections under federal regulations (45 CFR 46):
- Children: Research involving children may be submitted in an umbrella protocol, but should be kept in a separate protocol from research targeting adults.
- Prisoners: Prisoner research is not eligible to be reviewed under an umbrella protocol. Research involving prisoners should always be submitted using a separate protocol from studies involving non-prisoner populations.
- Stanford Students: Research targeting Stanford students must be reviewed by the Student Data Oversight Committee (SDOC) before IRB review. Contact SDOC at sdoc_review@lists.stanford.edu for submissions or questions. Research using Stanford's student subject pools generally does not need SDOC review.
- Pregnant Women and Fetuses: Consult with IRB staff if enrolling pregnant women. Research involving fetuses always requires a Medical IRB protocol.
In addition, the IRB may determine that an umbrella protocol is not appropriate in certain circumstances and may require that separate protocols be submitted for each project. Before you submit an umbrella protocol, please contact the IRB at irbnonmed@stanford.edu to determine whether or not an umbrella protocol would be appropriate for your work.
- Examples of research that is not appropriate for an umbrella protocol include:
- Protocols meant to cover human subjects research projects conducted individually by students in a particular class.
- Protocols meant to cover all research using a particular method (e.g. all survey studies or all interview studies), on multiple different topics.
Who can have an umbrella protocol?
An umbrella protocol is limited to one faculty member and their lab’s work. Multiple faculty members in the same lab can contribute, but one Principal Investigator (PI) must take ultimate responsibility as the Protocol Director. A single umbrella protocol covering an entire department’s work, or spanning the work of multiple faculty members’ labs would not be appropriate. No School of Medicine personnel, funding, or resources may be used for non-medical umbrella protocols.
Can students run their independent projects under a lab’s umbrella protocol?
Students are encouraged to submit their own IRB protocols for thesis or dissertation projects. If a student's work directly relates to the aims of an umbrella protocol, it can be conducted under the umbrella protocol with close faculty supervision. New protocol aims should not be added for a student project.
Should the Personnel Info section of the protocol application include all those working on all studies?
The Protocol Director should maintain the list of “Personnel Info” to include all “Key Personnel” responsible for the study's design, conduct, data analysis, or reporting. All Key Personnel must be current in CITI training.
Is there a limit to the number of studies under an umbrella protocol?
There is no limit to the number of studies, but the IRB requires annual Continuing Review with status updates for each study and places a five-year limit on umbrella protocols. After five years, submit a new protocol to cover future work and ensure compliance with current policies and requirements.
Do umbrella protocols qualify for the Extended Approval Process (EAP)?
No, umbrella protocols are not eligible for extended approval and are subject to annual Continuing Review. After five years, submit a new protocol, which can be a revised clone of the previous one. The Protocol Director must review the cloned protocol for completeness and accuracy before submission.
Can federal funding be used for research under umbrella protocols?
Federally funded projects should be submitted under their own protocol to meet additional federal agency requirements.
Does an umbrella protocol need to include all stimuli for experiments, or are sample stimuli sufficient?
Sample experimental stimuli (such as images, videos, etc.) are generally sufficient. The samples should provide enough examples for the IRB to understand what participants will see. The IRB may ask for additional examples as needed.
What about surveys, interview questionnaires, or other study materials?
Attach all surveys, interviews, or study materials developed specifically for the proposed research to the protocol for IRB review.
How should an umbrella protocol address changing experiment lengths?
Provide a range for potential participant time involvement in the protocol and consent forms. If the time estimate changes significantly (such as from a single day to a longitudinal timeframe), the protocol should be modified to reflect this.
Is it acceptable to provide a general hourly pay rate for participants?
Providing hourly pay rates or a payment range depending on experiment length is sufficient.
When should a modification be submitted for an umbrella protocol?
Submit a modification for:
- Addition of new study populations (e.g., adding an in-person component to an online protocol).
- Significant changes to study length (e.g., adding a longitudinal study to a protocol with single-day studies).
- Addition of new study procedures (e.g., adding an experimental intervention to an online survey study).
- Any change in study procedures, compensation, time to completion, etc., requiring a revision to the informed consent form.
Where can I go if I have more questions?
For further assistance, contact irbnonmed@stanford.edu or visit our IRB Office Hours every Thursday from 12-1 pm with our IRB Education Specialist.