NUMBER / DATE / APPROVED BY / PAGE
HRP-092 / 01/24/2018 / IRB OFFICE / 1 of 5
1PURPOSE
1.1The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for utilization of anExternal Institutional Review Board. The procedures outlined below delineate the process, for the Northwestern University (NU) IRB Reliance on Independent IRBs and IRBs of other academic institutions. The NU IRB reserves the right to determine on an individual study basis whether or not to accept the External IRB review.Please note: Investigators are encouraged to engage the NU IRB prior to submitting the new study application in eIRB+. You may contact the Reliance Agreement Team at with questions regarding the reliance process for External IRB’s.(If Reliance on an External IRB is being requested for an NIH grant submission, please contact to request a letter of support).
1.2The use of anExternal IRBmay be warranted when one or more of the following have been met:
1.2.1When the Northwestern University site is sub-contracted and IRB approval has already been processed by the non-affiliated higher education IRB or Independent IRB.
1.2.2When mandated by the funding agency per Single IRB Requirements (i.e. NIH Single IRB Policy).
1.2.3Enhance the protection of study participants by providing consistent expert IRB review at the national level.
1.2.4Improve access to clinical trials for potential study participants by establishing procedures for the Northwestern University (NU) IRB to use an External IRB.
1.3An External IRBmay not be used for any instances as determined by the NU IRB Executive Director or designee.
1.4NU IRB acknowledgement of the new study application must be received prior to conducting any study procedures.
2POLICY
2.1The NU IRB Office willcedereview and approval to an External IRB when there is a fully executedIRB Authorization Agreement (IAA).
2.1.1Criteria for use of the External IRB mechanism (one or more of the following must be met):
2.1.1.1Multi-center study with Northwestern University IRB not being the IRB of record.
2.1.1.2Phase I - IV or registration trials that have required FDA review.
2.1.1.3Follow-up or extension study for a trial that has been previously approved under the ExternalIRB review mechanism (This includes NIH grant renewals for multi-site research that meet the Single IRB policy requirements).
2.1.1.4Approval to proceed with Independent IRB processing has been received from the NU IRB prior to submitting to an external IRB.
2.1.1.5All documentsmust be prepared by atrained study team member.The consent (when consenting of participants will take place at NU) must include when applicable, the NU HIPAA Authorization language, research injury,costs and conflict of interest language from the NU consent template.
3RESPONSIBILITIES
3.1Investigator: To move forward with processing of an External IRB study, the Investigator conducting the study is responsible for:
3.1.1Reviewing and submittingthe NU New Study application in eIRB+ and providing the NU IRB with the information necessary in order to assess whether or not it will accept anExternal IRB as IRB of Record for the study (For NIH grants that meet the requirements for the Single IRB policy, the decision to rely upon an External IRB would occur at time of grant submission).
3.1.2Ensuring that the External IRB approval and NU IRB acknowledgement for the study is received prior to any procedures/amended procedures being implemented at NU.
3.1.3Complying with applicable local Illinois laws, regulations, and NU policies surrounding research. Please see the Human Subject Protection Program Plan (HRP-101) and Investigator Manual (HRP-103).
3.1.4Ensuring that all researchers and staff are appropriately qualified and have been trained to conduct the study per the protocol.
3.1.5Notifying the External IRB and NU IRB of any Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs), termination or suspension of the study. The NU IRB should be notified following the required timelines as when the NU IRB is the IRB of record.(Please reference: Procedures for submitting RNI’s can be found in section 4.3.
3.1.6Ensuring that only currently approvedand valid consent forms and HIPAA authorization forms (when applicable) are used to enroll subjects into NU protocols.
3.1.7Retainingall approved documents and consent forms pursuant to good clinical practice and confidentiality and security standards.
3.1.8Establishing record-keeping and storage procedures for ExternalIRB files (documents, emails, notifications, etc).
Industry Sponsored studies only: Ensuring that the IRB fees are paid.Note: When the NU IRB has agreed to defer to anExternalIRB, the study will still be charged the standard NU IRB fees in addition to the External IRB fees.
3.2ExternalIRB: If the ExternalIRB’s review is accepted, the External IRB becomes the IRB of Record for the study and is responsible for the following:
3.2.1Reviewing modifications, continuing reviews,unanticipated problems involving risks to subjects or others (UPIRSO) or any serious or continuing noncompliance, and information intended for use by current or prospective study participants.
3.2.2Notifying the NU Investigatorof any termination or suspension of the study.
3.2.3Incorporating in its review any applicable local Illinois laws, regulations, and NU policies, as provided by the NU IRB.
3.2.4Acknowledgment of any applicable COI management plans provided by the NU IRB.
3.2.5Reporting any unanticipated problems involving risks to subjects or others (UPIRSO) or any serious or continuing noncompliance to federal department agencies as required.
3.2.6Following the requirements set forth in the signed IRB Authorization Agreement (IAA).
3.3NU IRB: If the External IRB’s review is accepted,the NU IRB will assume the local oversight responsibility and perform local context functions in compliance with federal regulations and University policy. These responsibilities include, but are not limited to:
3.3.1Apre-review of the initial application will be conducted by The Reliance Agreement Team Lead or designee.The pre- review includes verification that the criteria of section 3.1 have been met in the application.
3.3.2Conducting review of any Reportable New Information (RNIs) that involve subjects enrolled at NU or its affiliate sites and any updates to the External IRB status.
3.3.3Reviewing potential study related Conflicts of Interestand providing any applicable COI management plans to the External IRB.
3.3.4Ensuring Human Subject Protections training is maintained per the institutional requirement.
3.3.5Ensuring that apost-approval monitoring process is in place and prepared to conduct a directed review of the study records. (This may include monitoring of the consent process if applicable.) Correspondence regarding any findings will be forwarded to the External IRB.
4PROCEDURE
4.1PROCEDURE FOR INITIAL REVIEW:The following steps should be followed when submitting the study to the NU IRB:
4.1.1The investigator or staff should upload the following documents in the appropriate sections(Please note that “(xIRB)” should be placed at the beginning of the short and full study title):
4.1.1.1A draft IAA with the required sections completed (The IAA template for when the NU IRB is not the IRB of record should be downloaded from the NU IRB website).
4.1.1.2The study protocol and draft consent form.
4.1.1.3Investigator’s brochure (if applicable).
4.1.1.4Any other pertinent information which would aid the Reliance Agreement Team Leador designee in determining whether or not NU is willing to review the study under the External IRB reviewmechanism. (i.e. Data Management Plan, Study Sites, etc.)
4.1.1.5The IRB Office will assign the study in eIRB+ tothe Reliance Agreement Team Lead or designeefor pre-reviewto ensure that the submission is complete and all requirements have been met for External IRB processing.
4.1.2When pre-review is complete and the NU IRB Executive Director or designeeagrees to defer to an External IRB, notification will be sent to the investigator viaeIRB+by completing the following:
4.1.2.1Signing the draft IAA form.
4.1.2.2Uploading the IAA form in eIRB+ and returning the submission via the request for changes mechanism to the PI and Submission Preparer for signature by the External IRB.
4.1.3Upon receipt of the partially executed IAA, the study team should complete the ExternalIRB submission process (for other higher education IRBs this may include being added as an active site). Once External IRB approval has been received, the eIRB+ submission for the study should be updated by the PI or study team with all finalized approved documents listed on the External IRB approval letter.(Please note the submission should also include a Local Protocol Addendum which outlines the NU site-specific information for the study)
4.1.4Once the eIRB+ submission is updated and the PI or designee forwards the submission back to the NU IRB in eIRB+, the following will occur:
4.1.4.1The IRB Analyst assigned to the study will administratively review the submission and ensure all required language (if applicable) is included in the consent form(s). This will includeverifying that all approved documents listed on the External IRB approval letter have been included in the submission.
4.1.4.2Prior to processing the External IRB acknowledgement, the IRB Analystshould also ensure that COI review is completed and the study team Human Subject Protections training is up to date per the institutional requirement.Note: the expiration date set in eIRB+ will be the External IRB expiration date.
4.1.5If the NU IRB Executive Directoror designeedetermines upon review of the finalized study documents that the IRBcannotagree to defer to the ExternalIRB, the assigned IRB Analystwilldo the following:
4.1.5.1Return the submission to the Investigator with the statement that the IRB Executive Director or designee determined that it would not agree to defer to the External IRB.
4.1.5.2The Investigator will have the following choices:
4.1.5.2.1Withdraw the study in eIRB+ and the study will not proceed at NU, or
4.1.5.2.2Pursue approval to the NU IRB for standard review by creating a new study submission indicating the study is a “Single Site”.
4.2PROCEDURE FOR CONTINUING REVIEW and MODIFICATIONS
4.2.1The Investigator and ExternalIRB are responsible for ensuring that continuing reviewand modifications to research are conducted in accordance with the federal regulations.
4.2.1.1The NU IRB should be informed immediately of all modifications of updated study team members and consent form(s) approved by the External IRB. The approved modifications should be submitted using the Modification function on the site submission for the studyeIRB+.
4.2.1.2The Modification will be assigned to an IRB analyst for administrative review of the External IRB approved documents or new/updated study team members. Once it is confirmed that all NU local requirements have been met, the Modification will be acknowledged.
4.2.1.3The NU IRB should be informed of any other modificationsapproved by the External IRB not meeting the requirements mentioned above at the time of continuing review via the “Modification” function.
4.2.2In the event that the Investigator has failed to renew the study with the ExternalIRB by the expiration date, the Investigator mustnotify the NU IRB in writing within 24 hours after the study has expired.
4.2.3Once the ExternalIRB has approved the continuing review, the Investigator/primary contact should updateeIRB+via the “Modification” function. The Investigator or primary contact should attach all applicable, ExternalIRB forms, approval letters, and approved consent forms.
4.3PROCEDURE FOR REPORTABLE NEW INFORMATION (RNI)SUBMISSIONS
4.3.1Unanticipated problems that do not involve NU or its affiliates’study participants do not need to be submitted to the NU IRB Office.
4.3.2The Investigator should submit the following to the NU IRB Office via the Reportable New Information form in eIRB+:
4.3.2.1NU specific events should be submitted to the NU IRB in accordance with IRB reporting requirements as outlined in the submission and on the NU IRB website ( and in parallel with submission to the External IRB.
4.4PROCEDURES FOR STUDY TERMINATION
4.4.1Closure of a study is considered a change in status and should be reported to the NU IRB via an update of the “Modification” functioneIRB+.
4.4.2When completing, the following should be provided:
4.4.2.1The Investigator/primary contact should select “yes” to the question of whether the External IRB has closed the study.
4.4.2.2The Investigator or designee should upload a copy of the ExternalIRB’s termination letter.
4.4.2.3When the form is completed, the Investigator should submit the form in eIRB+.
4.5TRANSFER OF STUDIES CURRENTLY APPROVED BY THE NU IRB TO ANExternal IRB
4.5.1Studies currently approved by the NU IRB may be transferred to an ExternalIRB. A modification should be submitted for each applicable study. The modification should request the transfer of the study to the ExternalIRB and include the information as outlined in section 5.1 of this SOP.
5MATERIALS
None.
6REFERENCES
Investigator Manual (HRP-103)
Human Subject Protection Program Plan (HRP-101)