We recommend use of WIRB's "smart form" online submission tool. Click on the "WIRBNet LOGIN" button in the upper right corner of this screen to establish an account and start using it.

Submitting via the smart form can significantly reduce the number of questions you have to answer about your submission. It also features a safe and secure process for uploading your submission documents, and provides general guidance about what type of documentation is required for various types of review requests.

Users who complete their submission online receive an e-mailed confirmation that WIRB has received their submission. It includes a reference number that will facilitate discussions of the submission with WIRB staff. The confirmation e-mail also serves as an official WIRB acknowledgement of receipt.

Materials required for initial review

The following is a general list of items required by WIRB to begin the review process for a research study.

Items required for all initial review requests

*Materials marked with an asterisk may be omitted if WIRB is already in receipt of a current version. This may include a WIRB-approved consent form for a previously approved protocol, as well as recruitment and other subject materials.

• WIRB Initial Review Submission Form available as a smart form or as a paper form on the download forms page.
• Protocol*
• Current professional license for Principal Investigator, showing the expiration date*
• Curriculum Vitae (CV) for Principal Investigator and each Sub-Investigator*
• Consent form* -- in Word, if possible. For multi-center protocols, it is likely that a consent form has already been approved for the research. You may contact us to verify this, or to ask for a copy of the currently approved version to preview.
• Other materials to be provided to the subjects which are not included in the protocol, such as advertisements, questionnaires, subject diaries, etc.* (Any commercially available validated instruments cited in the protocol that are used without modification are not listed individually on the Certificate of Approval; however, approval of the protocol does extend to the uses of such industry standard forms as described in the approved protocol.)

• For drugs or biologics
  Provide a copy of each of the following:
• Investigator's Drug Brochure*
• Background Information for Food Supplements*
• FDA Form 1572 (if applicable)
• Canadian Qualified Investigator Undertaking Form (Canadian sites)
• Documentation from sponsor or FDA verifying the IND (Investigational New Drug) number, if one is required for the research*
• A request for WIRB Institutional Biosafety Committee (IBC) review or the IBC approval information from the review of your study, if applicable. (Gene Transfer Protocols)


• If a DEVICE study, provide device manual and ONE of the following:
• FDA Letter granting the Investigational Device Exemption (IDE);* OR
• Letter from sponsor stating that the study is a non-significant risk device study;* OR
• Letter explaining why the investigation is exempt from the IDE requirements under 21CFR 812.2(c) or otherwise exempt. *

WIRB does not use the expedited review process for the initial review of research. All initial review of research, even for protocols which fit the expedited categories, are reviewed at convened meetings.

Sending the request to WIRB

back to top of page