1PURPOSE
This document describes the HSD/IRB procedure for the assessment of anexternal grant application. The purpose of the assessment is to:
1.1Comply with the federal requirement for IRB review of federal grants (45 CFR 46.103(f)).
1.2Ensure that the IRB and PI have the same understanding about what has received IRB approval.
1.3Ensure that all human subjects research described in the grant application has received (or will receive) IRB approval before it is conducted.
2APPLICABILITY
2.1HSDapplies this assessmentto all externalfunding. However, the regulatory requirement (see 1.1, above) applies only to federal grants for which the UW is the prime recipient.
2.2The assessment is not conducted for external grants that do not contain a description of specific human subjects research (i.e., grants that qualify for a DOHR determination).
3GUIDANCE about the regulatory requirement (45 CFR 46.103(f))
3.1Historical context. This regulation was written at a time when grant applications were required to obtain IRB approval before the grant was submitted to a federal agency. This meant that many unnecessary IRB applications were prepared by PIs and reviewed by IRBs – that is, unnecessary because the grant application was unsuccessful and the research was never funded or conducted.
3.1.1Just-in-Time.About 10-15 years ago, federal agencies changed to a Just-in-Time approach. This means that the PI and the PI’s institution provide some elements of a grant application after the federal agency has approved the grant application for funding. This includes IRB approval. Now PIs need to prepare IRB applications only when they know that the funding will be awarded and the research will be conducted.
3.1.2OHRP guidance document.The guidance about this regulation (reference 2) was not updated when the Just-in-Time approach was adopted.
3.1.3Revised Common Rule.This regulation will be eliminated as of January 19, 2018 with the expected implementation of the revised Common Rule.
3.1.4HSD interpretation.This guidance describes HSD’s interpretation of the regulation, based on several email/phone conversations between the federal Office of Human Research Protections (OHRP) and HSD management.
3.2The criteria for considering a federal grant application to have IRB approval are:
3.2.1Plan for IRB approval.There is an acceptable plan for obtaining IRB approval for all of the human subjects activities that are described in the grant application.
3.2.1.1For example: a PI submits an IRB application to the UW IRB for research activities described as Phase 1 in the grant, and the PI states that Phase 2 will be submitted later as a modification or a separate IRB application.
3.2.1.2This does not mean that HSD must obtain copies of the IRB approvals, if other IRBs are doing the reviews. Instead, it means that the PI has provided information about which IRBs will review the human subjects activities not reviewed by the UW IRB and that we are satisfied that appropriate IRBs will review all human subjects activities described in the grant.
3.2.2UW IRB approval.Any UW IRB application connected to the grant has been approved.
3.2.3Inconsistencies.Any inconsistencies between the grant application and any UW IRB application in the following areas have been identified and resolved. This criterion is irrelevant if the UW IRB is not reviewing any of the activities described in the grant.
3.2.3.1Which protected or vulnerable populations (if any) will be studied
3.2.3.2Which institutions are engaged in the research
3.2.3.3Inconsistencies that would result in a “higher” level of UW IRB review
3.2.3.4Inconsistencies that would likely have a negative impact on the UW IRB’s determination that the criteria for approval have been met
3.2.3.5For UW-reviewed clinical trials, any inconsistencies in: (a) the number of intervention groups; (b) the nature of the intervention; (c) drug dosages; or (d) inclusion/exclusion criteria for subjects.
3.3Financial issues.The regulatory review does not assess the adequacy of the budget or resources, or whether specific human subjects-related costs are included in the budget.
3.4Funding dates.The regulatory review does not resolve inconsistencies in the funding dates.
4PROCEDURE: A new UW IRB application with external funding
4.1Pre-review. The HSD pre-reviewer (who is also an IRB member designated to do expedited IRB reviews)assesses the provided grant materials as follows.
4.1.1Complete submission. All relevant materials have been provided, as described in the WORKSHEET Preview: Initial.
4.1.2Plan for IRB review. When the grant describes activities that are not described in the IRB application: The pre-reviewer asks the researcher about how/when IRB approval will be obtained for those activities (if the information is not already provided).
4.1.2.1If the UW is the prime recipientfor the grant: this requirement applies to all human subjects research described in the grant
4.1.2.2If the UW is not the prime recipient: this requirement applies to all UW human subjects research that is described in the grant.
4.1.3Inconsistencies. The pre-reviewer identifies any inconsistencies between the grant application and the IRB application as described above (section 3.2.3). Inconsistencies are resolved with the researcher so that it is clear what activities the IRB is approving and which activities are not being approved.
4.1.4Special case: The UW is engaged only because it is the prime recipient of a federal grant. Consult with an Assistant Director of Operations.
4.2IRB review.The regulatory review is considered completed when the review of the UW IRB application has been completed.
4.3IRB approval of the grantis communicated in the IRB application approval letter.
4.4Certification to funding agencyis provided as follows (if required):
4.4.1The Office of Sponsored Programs confirms the existence of a current IRB approval or exempt status linked to the funding award in the HSD database, and then provides certification to the funding agency; AND/OR
4.4.2HSD staff complete a “310” certification form and provide it to the researcher.
5MATERIALS
5.1Office of Human Research Protections, Optional Form 310. Protection of Human Subjects: Assurance Identification/Certification/Declaration of Exemption.
6REFERENCES
6.145 CFR 46.103(f)
6.2OHRP Guidance, “IRB Review of Application for HHS Support”, May 31, 2000.
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