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1PURPOSE
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1.1
1.2
1.3
Thisprocedureestablishestheprocessto pre-reviewa requestforIRB approval(approvalof new research,humanitarian use device, continuingreviewof research,and modificationto previouslyapprovedresearch)ora determinationwhetheran activityis exemptHumanResearchoris notHumanResearch.
TheprocessbeginswhentheIRBreceivesarequestfor local IRB approval, including requests from other institutions when the Northwestern University IRB serves asthe IRB of record, e.g., for a Collaborative Study or Multi-Site Study.
Theprocessendswhentheinformationhasbeenplacedon theagendaforanIRBmeetingor willbehandledbyNon-CommitteeReview.
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2PREVIOUSVERSION
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2.1
Revised from previous version dated, 1/25/2018
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3POLICY
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3.1 Submissions (i.e., requestsfor IRB approvalordeterminations ofwhetheran activityis exemptHumanResearchoris notHumanResearch) received by the Northwestern University IRB Office are pre-reviewed by IRB Office staff members, before the information is placed on the agenda for an IRB meeting or handled by Non-CommitteeReview.
4RESPONSIBILITIES
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4.1
IRBOffice staffmemberscarryouttheseprocedures.
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5PROCEDURE
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5.1
5.2
5.3
Ifthesubmissionis aresponsetomodificationsrequiredtosecureapprovalreceivedwithin21 calendardaysof theinvestigatorreceivingtheIRBdeterminationletter:
5.1.1Evaluatewhetherthe investigatormadetherequiredmodifications.
5.1.2Iftheinvestigatormadetherequiredmodifications,follow“SOP:Post-Review(HRP-
052)”to issueanapproval.
5.1.3Iftheinvestigatordidnotmaketherequiredmodificationsormadeunrequested modifications,executethe“RequestPre-ReviewClarification”activityfrom the investigator.Offertheinvestigatortheopportunitytocorrectthesubmission.
5.1.3.1Iftheinvestigatorwillcorrectthesubmission,havethe investigatormake changesthenexecutethe“SubmitChanges”activityandstopprocessing thecurrentsubmissionuntilchangesarereceived.
5.1.3.2Iftheinvestigatorwillnotcorrectthesubmission,havethe investigator executethe“SubmitChanges”activitytoresubmitandcontinue processing.
Ifthesubmissionis aresponsetomodificationsrequiredtosecureapprovalreceivedafter21 calendardaysof theinvestigatorreceivingtheIRBdeterminationletter,discusswhether you maycontinueto processthesubmissionwiththeBiomedicalIRBManagerorSocialBehavioral IRBManager.
Forallothersubmissions,completePre-ReviewActivityorreviewthepreviouslycompleted Pre-ReviewActivityandreviseasneeded,consideringthe itemson“WORKSHEET:Pre- Review(HRP-308)”andnoteallremainingcontingenciesinthe“Final Contingencies” section.
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5.3.1 As part of pre-review, the analyst will check past versions of the protocol and consent documents to ensure that the correct version date information is documented and to ensure that no versions of documents are missing.
5.4 Iftheinformationisnotcomplete,contactthe investigatorbyselectingthe“RequestPre- ReviewClarifications”Activity.Offertheinvestigatortheopportunitytoprovideadditional information.
5.4.1 Continueprocessingoncetheinvestigatorrespondsto therequestfor additionalinformation.
5.5 If the request is for an initial approval and principal investigator is Restricted, contact the
investigator. Explain that the investigator is Restricted, give the reason, and indicate that if a new protocol goes to the IRB, the IRB policy is to disapprove the research. Offer the investigator the opportunity to withdraw the submission pending removal of the Restricted status.
5.5.1 If the investigator withdraws the submission, stop processing the current submission.
5.5.2If the investigator will not withdraw the submission, discusswhether you maycontinueto processthesubmissionwiththeBiomedicalIRBManagerorSocialBehavioral IRBManager.
5.6 Evaluate the most likely level of review using “WORKSHEET: Human Research Determination (HRP-310)”, “WORKSHEET: Engagement Determination (HRP-311)”, “WORKSHEET: Exemption Determination (HRP-312)”, “WORKSHEET: Expedited Review (HRP-313)”, and/or “WORKSHEET: Criteria for Approval for HUD (HRP-323)” as referenced:
5.6.1Iftherequestis forastudyclosure,followinstructionsineIRB+toclosethestudy.
5.6.2IftherequestcanbehandledasaNon-CommitteeReviewand the principal investigator is not Restricted, follow“SOP:Non-CommitteeReviewPreparation (HRP-031).”
5.6.3IftherequestcannotbehandledasaNon-CommitteeReview,placetheprotocolon theagendaforaconvenedIRBmeetinginan IRB withappropriatescope.
5.6.4When reviewing a new HUD protocol, these must be reviewed at a convened meeting. When reviewing a continuing review, modification, or off-label use of a HUD, these can handledasaNon-CommitteeReview.
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6MATERIALS
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6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.11
SOP: New Information (HRP-024)
SOP: Non-Committee Review Preparation (HRP-031)
SOP: IRB Meeting Preparation (HRP-040)
SOP: Post-Review (HRP-052)
WORKSHEET:Pre-Review(HRP-308)
WORKSHEET:HumanResearchDetermination(HRP-310)
WORKSHEET:EngagementDetermination(HRP-311)
WORKSHEET:ExemptionDetermination(HRP-312) WORKSHEET:ExpeditedReview(HRP-313)
WORKSHEET:Criteria for Approval for HUD (HRP-323)
HUMAN RESEARCH PROTECTION PROGRAM PLAN (HRP-101)
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7REFERENCES
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7.1
None.