IRB Protocol Overview
Researchers may use the "Protocol Template" below to draft their protocol submission. Final versions of the protocols must be submitted via SPARCS.
How to Submit Protocols
All protocols are managed in the SPARCS portal. You can view "user guides" on William & Mary's SPARCS webpage to learn about how to submit a protocol.
video: HOW TO SUBMIT A PROTOCOL IN SPARCS
The normal processing time for a protocol that does not require a convened meeting is approximately three to four weeks from the time of submission. A notice of approval will be sent electronically to the PI(s) of record.
Note to researchers: Protocols submitted after 4 PM on Fridays (or on the last business day of the week) will be reviewed by the IRB Analysts the following week. The IRB Analysts make efforts to review submitted protocols within 1 week of them being received.
Required Documents for Protocol Submissions
Before submitting your protocol, be sure to have the following documents prepared to submit along with your protocol.
Review the following topics to learn more information. (Note: Some may not apply to all research protocols.)
Active protocols must be maintained even after data collection has ended, even if the data is identifiable. If the participant cannot be linked in any way to the data, the protocol may be submitted for closure.
If you are renewing a protocol that exists only in the "compliance.wm.edu" system, you must submit a "new study" and then follow the instructions for an "initial submission."
In the protocol, you can include that this is an extension of a previously approved project. A PDF attachment of your original protocol can be included for reference.
Board Review Type
All protocols involving human subjects must be submitted to the IRB at William & Mary for exemption or approval. William & Mary institutional policy does not permit self-exemption.
| Board Type | Description | Length of Approval | Number of Reviewers |
|---|---|---|---|
| Exempt | Research that has minimal to no risk to the participants and falls under one of the HHS categories | No expiration; yearly "check in" | Chair of the IRB or appointee |
| Expedited | Research that is no more than minimal to the participants and falls under one of the HHS categories (45 CFR 46.110) | No expiration; yearly "check in" | Chair of the IRB or appointee |
| Full board | Research that involves more than minimal risk or involves vulnerable populations | 1 year | Voted on at a convened meeting with a quorum of voting members (>50%) + 1 nonscientist |
If the project is to continue beyond the expiration date, please select the "renew" option and carefully review the data that will transfer to the new protocol. All deviations from the original approved protocol must be modified in the new protocol submission. Resubmitted protocols will be reviewed again.
For questions, please email [[researchcompliance]].