Institutional Review Board (IRB)

Federalwide Assurance Number

An FWA is an assurance of compliance submitted to the Office for Human Research Protections (OHRP) by an institution that is engaged in nonexempt human subjects research conducted or supported by the Department of Health and Human Services (HHS) or another U.S. Department or Agency that uses OHRP’s FWA. Renewal is required every 5 years.

• William & Mary FWA: FWA00008186
• William & Mary Expiration Date: 7/22/2030

Looking for another institution's FWA? Use the OHRP search tool to find it.

IRB Name & Registration Number

The HHS regulations at 45 CFR part 46, subpart E, require all IRBs to register with HHS if they will review human subjects research conducted or supported by HHS and are to be designated under an assurance of compliance approved for federalwide use (i.e., an FWA) by OHRP. Renewal is required every 3 years. Any updates made to the IRB registration begin a new 3-year registration period. 

• IRB Name: William & Mary IRB #1
• IRB number: IRB00004701
• Expiration Date: 02/04/2029

IORG Number

The Institution or Organization (IORG) number is a unique number assigned by OHRP to an institution or organization the first time an institution or organization registers an IRB.

William & Mary IORG Number: IORG0003966

(0) What is the IRB?

Research protocols that involve human participants are required to be submitted to the IRB (Institutional Review Board) using the SPARCS product/module “Human Ethics.” The federal oversight body is the Office of Human Research Protections.

(1) How many weeks does the committee need to review my protocol?

The committee requests that exempt and expedited submissions (whether initial or renewal) be submitted 4 weeks prior to the anticipated start date or expiration date of your study. The review will not always take 4 weeks to complete, but we want to make sure the reviewers have enough time to process the review.

If you have a tight deadline, please notify the Research Compliance office. Full Board protocols must be submitted 6 weeks in advance of the intended meeting date. 

(2) I'm just analyzing the data I collected. Does my protocol need to stay open/be renewed?

Active protocols must be maintained if the data being analyzed can identify the participants. Protocols analyzing de-identified or coded data (with the link destroyed) can be submitted for closure. Learn more about submission types.

(3) My protocol was previously approved in the compliance.wm.edu system, but it has expired. How do I do renew my protocol?

Protocols from the “legacy” system (compliance.wm.edu) were not transferred over to SPARCS. To renew your study, you will need to submit the protocol via SPARCS by using the "+new study" feature since the protocol is technically "new" to SPARCS. You can copy over the text from the existing protocol in the compliance.wm.edu to the relevant sections of the SPARCS protocol form along with any attachments you included in the original submission. The SPARCS form does have additional questions that were not included on the compliance.wm.edu form.

Please do not reference the previously approved study in your submission. 

(4) What are the available personnel roles in the system?

Under the “W&M Study Personnel” section, you have the option to add a principal investigator, student investigator, primary contact, co-PI, and all other W&M study personnel. Please refer to the guidance, Roles of Students and Other Personnel on IRB Studies/Submissions to learn more.

(5) Exempt, Expedited, or Full Board. How do I determine which review type and category my study falls under?

In the “Getting Started” section of your submission, you will be asked to self-determine which level of review and subsequent category to applies to your protocol. There are three levels of review: exempt, expedited, and full committee review. 

To learn more, review the following W&M IRB procedures:

• Procedure about Exemptions
• Procedure about Expedited Review

Resources:

• OHRP | Presentation about Exempt Categories
• UCR | Quick Summary of Expedited Categories with Examples
• Lafayette | Detailed Descriptions of Types of Review

(6) I am using an IAA where W&M is the relying institution. How do I enter my protocol?

In the first section, “Type of Review,” you will select “Request to Rely on External IRB.” Once that is selected, additional sections will appear. Please visit W&M’s information page about “IRB Authorization Agreements (IAAs)” to learn more about additional requirements.

(7) I want to make a change to a "participant-facing" document (e.g. consent, survey, etc.) that has already been approved. Do I have to submit the change to the IRB?

(8) Can I request an administrative extension without submitting a protocol?

No. The IRB is the only authority that can extend the expiration period of a study. The IO cannot extend research beyond the expiration date of the study for expedited and full board studies. Exempt and expedited studies do not require ongoing approval/monitoring by the IRB, so they are not subject to expiration dates (only applies if the study was approved in SPARCS).

If PIs with full board studies consistently do not follow the renewal/expiration dates for their study, they can be reported to the IRB for continuing noncompliance. IOs have the authority to suspend or terminate approval of research if it is determined necessary.  

(9) Do I need to attach my training certificates to the submission? What do I do if My CITI training isn't loading into SPARCS?

You do not need to attach CITI certificates of W&M faculty, staff, or students. CITI certificates should be attached for any non-W&M research personnel.

If your training is not automatically syncing into SPARCS, please contact sparcs@wm.edu to let us know that the trainings are not loading into your account. You can still submit the protocol without the trainings appearing.

(10) My project is an Oral History. Does it require IRB oversight?

It depends. William & Mary does not allow researchers to "self-exempt" from the IRB review. If you do not submit your study to the IRB, and it is determined later that your project does meet the definition of "human subject research (HSR)," IRB approval cannot be retroactively sought.

Review the Guidance about Oral Histories for more information. 

(11) My project is a secondary analysis of publicly available data. What do I need to do?

Studies using de-identified, publicly available data most likely do not meet the federal definition of "human subject research (HSR)." Researchers must submit an "oversight determination" in SPARCS if an official determination letter from the IRB is needed. 

(12) I am collaborating with another researcher who is not associated with William & Mary. What do I need to do?

For exempt projects, each institution often requests that researchers should submit a protocol to each institution. W&M allows for "Acceptance of Exemption Determination." 

More information about collaborators and the IRB can be found the Procedure about Cooperative Research and our guidance about Reliance Agreements.