IRB Protocol Overview

Protocol Template

Researchers may use the following Protocol Template to draft their protocol submission. Final versions of the protocols must be submitted via SPARCS.

PROTOCOL TEMPLATE (doc)

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

Processing Time

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: Protocols submitted after 4 p.m. 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 one 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. 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.

Exempt

Research that has minimal to no risk to the participants and falls under one of the HHS categories. No expiration; only a yearly "check in."

Expedited

Research that is no more than minimal risk to the participants and falls under one of the HHS categories (45 CFR 46.110). No expiration; only a yearly "check in."

Full Board

Research that involves more than minimal risk or involves vulnerable populations. Voted on at a convened meeting with a quorum of voting members (>50%) + 1 nonscientist. Expires after 1 year and must be submitted for renewal to continue work. Resubmitted protocols will be reviewed again.

Questions?

For questions, please email [[researchcompliance]].