NUMBER / DATE / APPROVED BY / PAGE
HRP-093 / 01/23/2018 / IRB OFFICE / 1 of 5
1PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for when the
Northwestern University (NU) IRB will serve as the IRB of record for multi-site research studies.
Multi-site research includes studies that involve collaboration with sites or individuals external to
Northwestern University and affiliates (i.e. Yale, Stanford, etc.). Unless required by the NIH Single
IRB Policy, the NU IRB reserves the right todetermine on an individual study/site basis whether
tobecome the IRB of Record.Please note:it should not be assumed that the NU IRB will serve as
the IRB of Record for multi-site research.Therefore, Investigators are encouraged to engage the
NU IRB during proposal development and/orprior to submitting the new study application in eIRB+.
Federally-funded studies that meet the requirements for the NIH Single IRB Policy should submit a
pre-consultationrequest form at least five weeks prior to proposal submission to receive an
assessment and letter of support for the NU IRB can serve as the IRB of Record for the study if
funded. You may also contact us at with questions regarding the
reliance process for multi-site research.
1.1The request for the NU IRB to serve as the IRB of Recordmay be warranted when one or more of the following have been met:
1.1.1When the Northwestern University site is the lead contracted site.
1.1.2When mandated by the funding agency per Single IRB Requirements.
1.1.3Enhance the protection of study participants by providing consistent expert IRB review.
1.2The NU IRB will not serve as the IRB of Record when:
1.2.1The oversight of multiple sites may not be feasible in relation to the study procedures involved (i.e. Phase I drug/device studies, multiple international sites, etc.). Please see HRP-092 SOP
1.2.2Other instances as determined by the NU IRB Executive Director or designee.
(Please note the NU IRB may seek the services of an Independent IRB if it is determined we cannot be the IRB of record)
2POLICY
2.1The NU IRB Office willbecome the IRB of Record (Reviewing IRB) when there is a signed IRB Authorization Agreement (IAA) between the engaged site(s)and NU.
2.1.1Criteria for use of the NUReviewing IRBmechanism (One or more of the following must be met):
2.1.1.1Multi-center with Northwestern University IRB serving as the IRB of record.
2.1.1.2The Northwestern site is the lead contracted site and other sites are sub-contracted and would like to rely on the NU IRB approval for the study.
2.1.1.3Follow-up or extension study for a clinical trial that has been previously approved under the NU Reviewing IRB mechanism.
2.1.1.4The necessary expertise for oversite at NU.
3RESPONSIBILITIES
3.1NU Investigator: To move forward with the NU IRB serving as the IRB of record for a multi-site study, the NUInvestigator 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 serveas IRB of Record for additional engaged sites involved with the study.(For NIH grants that meet the requirements for the Single IRB policy, the decision to serve as the IRB of Recordwill occur at time of grant submission).
3.1.2Ensuring that all sites receive the NU IRB initially approved study documents and any following modifications to these documents.
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).
3.1.4Notifying the NU IRB of any Reportable New Information (RNI) including, Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO’s), serious or continuing non-compliance, termination or suspension of the study for all sites. The NU IRB should be notified following the required timelines(Please reference: Procedures for submitting RNI’s can be found in section 4.3
3.1.5Ensuring that only currently approvedand valid consent forms and HIPAA authorization forms (when applicable) are used to enroll subjects at all sites.
3.1.6Retainingall approved documents and consent forms pursuant to good clinical and ethical practice and confidentiality and security standards.
3.1.7Establishing record-keeping and storage procedures for files at all sites (documents, emails, notifications, etc).
3.1.8Ensuring that all researchers and staff are appropriately qualified and have been trainedto conduct the study per the protocol.
3.2ExternalSites: If the NU IRB becomes the IRB of Record for an engaged site(s), the external site(s)will assume the local oversight responsibility and perform local context functions in compliance with localstate and federal regulations and any institutional policies to which the external site(s) would normally adhere to when conducting research. These responsibilities include, but are not limited to:
3.2.1Ensuring NU IRB approval has been received for the overall study and site prior to moving forward with any study activities.
3.2.2Retaining all approved documents and consent forms pursuant to good clinical practice and confidentiality and security standards.
3.2.3Notifying the NU Investigator of any serious adverse events (SAE’s) and unanticipated problems involving risks to subjects or others (UPIRSO’s) occurring at the external site.
3.2.4Complying with all NU IRB determinations once the information is provided by the NU Investigator.
3.2.5Maintain all files per the standards established by the NU PI and remain prepared for any possible internal/external compliance audits.
3.2.6The External Site remains responsible for Conflict of Interest review and communicating any management plans to the NU IRB.
3.2.7Ensuring Human Subject Protections training remains valid and meets the NU IRB requirement of being repeated every 3 years.
3.2.8Providing the NU IRB any site specific consent form language or draft consent form(s) for review.
3.2.9Following all the requirements as set forth in the signed IRB Authorization Agreement (IAA).
3.3NU IRB: If the NU IRB becomes the IRB of record for an external engaged site, the NU IRB is responsible for the following:
3.3.1Reviewing the initial submission, modifications, continuing reviews, unanticipated problems involving risks to subjects or others (UPIRSO) or any serious or continuing noncompliance, and any participant facing information intended for use by study participants.
3.3.2Notifying the NU Investigator of any termination or suspension of the study.
3.3.3Reporting to federal agencies or departments any unanticipated problems involving risks to subjects or others (UPIRSO) or any serious or continuing noncompliance.
3.3.4Ensuring that a post 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 is applicable.)
3.3.5Following all the requirements as set forth in the signed IRB Authorization Agreement (IAA).
4PROCEDURE
4.1PROCEDURE FOR INITIAL REVIEW:The following steps should be followed when submitting the study to the NU IRB:
4.1.1The NU Investigator or staff should upload the following documents in the appropriate sections of the eIRB+ application:
4.1.1.1Download a copy of the NU_IRB of Record IAA from the NU IRB website and complete the required sections.
4.1.1.2The NU_IRB of Record IAAshould be completed and signed by the external site.
4.1.1.3The study protocol and drafted consent form for all sites.
4.1.1.4Investigator’s brochure (if applicable).
4.1.1.5The Communication & Responsibilities Worksheet (HRP-830).
4.1.1.6Any other pertinent information which would aid the Reliance Agreement Team Lead or designee in determining whether or not NU is willing to serve as the IRB of Record. (i.e. Data Management Plan, Monitoring Plan for External Sites, etc.)
4.1.1.7The IRB Office will assign the study in eIRB+ toanIRB Analystfor pre-reviewfollowing the usual assignment process.
4.1.2Following pre-review, the IRB Analyst will notify the Reliance Agreement Team Lead or designeeof the request for processing an IAA. (Please note a pSite submission will need to be created for each external site requesting to rely upon the NU IRB.
4.1.3The Reliance Agreement Team Lead or designee will review the study and verify the procedures involved are suitable for requesting the NU IRB serve as the IRB of Record for the study.
4.1.4Once all necessary items have been verified, the IAA will be presented to the NU IRB Executive Director or designeefor signature.
4.1.5Once the IAA form has been signed, it will be either emailed to the study team or uploaded into eIRB+ as a comment to the study team.
4.1.6Upon final approval, the NU Investigator will receive the approval letter along with all applicable approved documents (i.e. protocol, consent form, etc…).
4.1.7Once the study approval has been received by the PI or designee, the following will occur:
4.1.7.1The PI or designee should ensure that all approved study documents have been provided to the approved external site(s) and provided to the corresponding IRB(s) for informational purposes.
4.1.7.2The PI should ensure that approved external site(s) only perform procedures in the currently approved protocol and that the outlined monitoring/oversight procedures for external site(s) is maintained for the life of the study.
4.1.7.3All approved external site(s) must list the NU site(s) IRB expiration date as the expiration date for their individual site(s).
4.1.8If at any point during review it is determined by the NU IRB Executive Director or designee that the NU IRB cannot serve as the IRB of record for an external site(s) or the overall study, the NU PI will be notified via eIRB+ and the external site(s) will need to submit to their institutional IRB(s) per the standard process.
4.2PROCEDURE FOR MODIFICATIONS and CONTINUING REVIEW
4.2.1The NU Investigator is responsible for ensuring that any study modifications and continuing reviewaresubmitted to the NU IRB per the standard process.
4.2.1.1Upon approval of any follow-on submission, the NU Investigator must immediately notify the external site(s) of changes or updated study approval.
4.2.1.2The external site(s) should follow their corresponding institutions IRB(s) requirement for notifications after overall study approval has been received.
4.2.1.2.1Request for approval of new external site(s) should be submitted via a modification. The modification should include information regarding what study procedures will be conducted at the external site.
4.3PROCEDURE FOR REPORTABLE NEW INFORMATION (RNI)SUBMISSIONS
4.3.1Unanticipated problems involving risks to subjects or others (UPIRSO’s) that occur at all site(s) should be submitted to the NU IRB via the Reportable New Information form in eIRB+.
4.3.2Any occurrences should be submitted to the NU IRB in accordance with IRB reporting requirements as outlined in the submission and on the NU IRB website (
4.3.2.1If the UPIRSO occurred at an external site(s), the external site(s) Investigator should also notify their institutional IRB following their specified timelines.
4.4PROCEDURES FOR STUDY TERMINATION
4.4.1Closure of the study should be submitted in eIRB+ following the standard process.
4.4.2Once approval for the study closure is received by the NU Investigator, the following should occur:
4.4.2.1The external site(s) should receive notification that the study is now closed with the NU IRB.
4.4.2.2The external site(s) should notify their corresponding institutional IRB(s) of the study closure and follow any standard process for closing the study at their site.
4.4.2.3The study records should be maintained per the requirements outlined by the protocol and following standards set forth by Northwestern University policies. Please see Investigator Manual (HRP-103).
5MATERIALS
None.
6REFERENCES
Investigator Manual (HRP-103)
HRP-092 SOP (External IRBs)
Human Subject Protection Program Plan (HRP-101)