Relevant IRB policies/procedures:
IRO involvement in grant activation
The IRO is responsible for verification that new and competing grants/subawards/contracts have the necessary IRB/IACUC approvals in place prior to award activation.
Step 1 – Grant/Subaward/Contract application review:
For New and Competing applications the PI (grant administrator) submits a copy of Attachment A to OSR. The IRO will review the grant/contract simultaneously with OSR.
There are no additional steps to the Attachment A sign-off process, just include an extra copy of the Attachment A documents when you send through sign-off. OSR will distribute the copy to the IRO.
The IRO is reviewing all new or competing applications for issues surrounding Vertebrate Animals, Human Subjects, and research involving the use of human tissue, data, and cell lines (e.g. Not Human Subjects research). Our goal is to detect potential issues that might delay funding when the grant/subaward/contract is awarded. The pre-award administrator will receive an e-mail from the IRO if there are any issues. No news is good news.
Step 2 - Fundable Score – Get necessary IRB/IACUC approval or Not Human Subjects Determination (NHS): When the Principal Investigator (PI) receives a fundable score, or notice they have been selected for funding, he/she is responsible to submit the appropriate IRB/IACUC application forms (if human subjects, live vertebrate animals, or coded Human Specimens or data are involved). This may involve submitting new applications, or modifying existing files to incorporate the new funding source. For more information on submitting new applications or modifying existing applications please see the requisite IRB/IACUC web sites at https://centernet.fhcrc.org/CN/depts/iro/index.html.
Step 3 – JIT Request – Verification of IRB/IACUC approval: When the PI receives the request from the funding agency for JIT information, complete and submit the Funding Verification and Activation Form to the IRO.
You may recognize that the questions in this form are similar to the questions that were part of the Attachment A form several years ago. Rather than asking these questions on every Attachment A, the process has been streamlined so the PI only needs to submit this form to the IRO for New and Competing grants/subawards/contracts (e.g. once every 5 years for most NIH grants).
This form provides the IRO with the necessary information to confirm all necessary IRB/IACUC approvals or NHS determinations are in place before OSR activates the award. It also provides OSR the information they need to submit JIT information to the granting agency.
Verification that all necessary approvals are in place helps the Center maintain compliance with applicable Human Subject, Vertebrate Animal, and Funding Agency regulations (45 CFR Part 46.118, PHS Policy (IV, D) and NIH Grants Policy (Part II, Terms and Conditions).
Questions? Contact Joshua Clark at email@example.com.
To request the release of funds to initiate activity(ies) that does not involve the use of human subjects and/or live vertebrate animals, the IRO Confirmation of Limited Activity Form must be submitted to the IRO.
Instructions of Submission to IRO:
If you have questions regarding this form and/or process, please contact Karen Hansen at firstname.lastname@example.org or 667-4867.
Simply email Joshua Clark at email@example.com if your funding source receives a No-Cost Extension or if you need to update the support dates for your funding source. You do not need to submit a Modification/Revision Request form.
The animal-related portion of grants supporting an IACUC study must be reviewed by the IACUC in addition to the IACUC application form. This requirement is already in place for human subjects/IRB review and is extended to IACUC activities because of Policy interpretation from the Office of Laboratory Animal Welfare (OLAW) and the American Association for the Accreditation of Laboratory Animal Care (AAALAC). If you have any questions regarding this policy, please contact the IACUC Analyst at 667-5794.
Upon request, the IRO will provide certification of approval. These are typically requested by funding agencies and are in addition to the approval materials provided by the IRO for your regulatory binder. The IRO confirm that the Protection of human Subjects Use regulations requirements have been met before signing any assurance, certification, or declaration forms. These forms include those issued by the government or private agencies (e.g., HHS 310, VA 10 1223, American Cancer Society, March of Dimes, etc).
If you have questions, please contact James Riddle in the Institutional Review Office at (206) 667-6501.
In special circumstances, the Institutional Review Board (IRB) may allow investigators to submit incomplete study materials when a funding agency specifically requests an IRB opinion prior to releasing funds. This type of review is not an “approval”, no human subjects activity may commence until the IRB has formally reviewed and approved the research.
The IRB conducts this type of review in order to satisfy the funding agency’s requirement as well as to meet the needs of our investigators. Investigators are responsible to submit all documents for final review.
Instructions for Submission to the IRB
Please submit the documents in following suggested order:
All documents must be single-sided. Please do not use staples. It is recommended that a complete set of the documents submitted to the IRB be kept for your records.
For Clinical Research Division (CRD) and UW Consortium Investigators: This type of review is only the opinion of the IRB based on draft application materials. If requesting an opinion prior to IRB review, submit your documents directly to the IRO at J6-110. Materials needed for the opinion do not need to to to the Protocol Office.