WIRB now offers an online submission tool, available
here. The online submission feature makes it possible to upload documents
to WIRB through a safe and secure process. It also provides general guidance about
what type of documentation is required for various types of review requests.
Users who complete the online submission process receive an e-mailed confirmation
that WIRB has received and can begin processing the 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
- WIRB Initial Review Submission Form (available
on 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*
- 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. *
*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 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
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Street Address:
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3535 Seventh Avenue SW
Olympia, Washington 98502-5010
USA
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Mailing Address:
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P.O. Box 12029
Olympia, Washington 98508-2029
USA
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FAX:
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360-252-2498
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E-Mail:
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clientservices@wirb.com
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