Instead, the HLC IRB will perform IRB review, if required. PDF SOP: Establishing Authorization Agreements - Northwestern University Ann Intern Med. Under the policy, multi-site is defined as two or more sites. SMART IRB leadership and representatives from the NIH National Center for Advancing Translational Sciences reviewed and incorporated feedback from the community and finalized SMART IRB Agreement v2.0 on October 1, 2020. CHOP has entered into a master reliance agreement with Columbia University (CU) for NAMDC research studies. Multiple, separate Cooperative Updates can be active at once. The system includes functionality like document tracking and dedicated tools to assist with processing and communication between investigators and the IRB. Peer reviewers may note if the plan to comply with the NIH single IRB policy is not included in the application/proposal but this will not impact the score. Further explanation of these changes and of the implications for Participating Institutions are provided in the cover memo and accompanying FAQs below. Stark et al. The relying PI will receive an email with either stipulations (if there are any) or the link to the site-specific approval letter. When Stanfords IRB relies on a sIRB, it retains responsibility to: Stanford's IRB also bears responsibility for the local conduct of sIRB studies, including managing noncompliance and unanticipated problems, ensuring training, study monitoring, local ancillary requirements, managing reliance agreements, and handling study specific issues. However, some IRBs do not have an standard Reliance Agreement. Investigators should be aware that reliance arrangements frequently require additional work on the part of the local study team, including submission to the Penn State HRPP and the external IRB, as well as managing communication between these offices. Have a reliance related question? Penn State Global ORCiD ID Portal Applies to all NIH funded multi-site studies conducting the same research at each site. If the PSU HRPP agrees to serve as the Reviewing IRB and sIRB fees apply, a letter of support will be provided, which provides a direct cost estimate (included as line item in budget) for the sIRB review fees to be charged to your award over the life of the project. HIPAA and injury compensation language), and CHOP Ancillary Committees may need to review and approve the study (e.g. Reliance Agreement: A formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution. DOC A New Process for filing Single IRB Exception applications REQUESTING RELIANCE HARVARD LMA SCHOOL as sIRB sIRB review is more than just an IRB review. This webpage is designed to serve as a resource for those interested in learning more about the Harvard Longwood Campus IRB reliance process. The JHM IRB routinely serves as the single IRB, but there are also cases where Johns Hopkins will be asked to rely on an external IRB. The CHOP IRB has created a toolkit for CHOP investigators, which includes all the information about the process. The CHIRP application asks relying sites to "Confirm that all study team members are in compliance with local institutional training requirements for human subjects research. HIPAA and injury compensation language), and CHOP Ancillary Committees may need to review and approve the study (e.g. The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: An SciVal & Funding Institutional Quick Guides, Privacy |Non-discrimination |Equal Opportunity |Accessibility |Copyright Reliance | Rutgers Research Requests for the PSU IRB to serve as the Reviewing IRB should be submitted well in advance of any funding applications where a single IRB plan is needed. Study teams should consider allocating additional resources for administrative staff support in their grant applications. Office Contacts It is the preference of HLC IRB to use the SMARTIRB agreement as the basis of reliance for all studies where we rely on an external IRB or serve as the sIRB. Master Agreements may be reciprocal in that signatory institutions can act as the site providing IRB review and oversight or the site relying. Academic Departments, Divisions and Centers. Authorizations agreements do not replace the need for IRB approval, and all human subjects research protocols still require a submission in CATS IRB, regardless of who may serve as the reviewing IRB. N Engl J Med. Materials Research Institute The PSU study team must ensure that the relying sites are familiar with Penn State policy, such as RNI reporting timelines. Changes that impact local considerations must await PSU HRPP acknowledgement prior to their implementation, Changes in study team members (for a training status check), Changes in the financial interest of study team member(s) including the PI, Changes that impact institutional requirements (e.g., ancillary reviews, EIM form, HRP-880, HRP-598), The Pennsylvania State University [covers University Park and all other campus locations except the Penn State College of Medicine]. 101 Technology Center, University Park, PA 16802 www.smartirb.org . Investigators are advised to visit the Resources section of the SMART IRB website for template documents that may be useful in the reliance process, including templates for the sIRB section of a grant application: https://smartirb.org/resources/. An agreement is needed with each site that will rely on CHOP. JMH IRB uses the SMART IRB agreement as the basis for all Single IRB studies. SMART IRB Agreement v2.0 incorporates revisions to the original SMART IRB Agreement that enable the NIH to participate in the Agreement. Reliance Agreements | It's Your Yale NIH Single IRB (sIRB) Policy, (NIH) Accelerating Clinical Research by Streamlining Multi-Site Review of Human Subjects Research, Frequently Asked Questions about the NIH policy on use of a single IRB, NIH Policy On Single-IRB review A New Era in Multicenter Studies, The initial submission, consent requirements and cooperative updates for CHOP investigators who want to conduct research study that involves relying on an outside IRB (, The process when CHOP is the reviewing IRB. The requirement for single IRB review for cooperative research took effect January 20, 2020. SMART IRB (the Streamlined, Multisite, and Accelerated Resources for Trials IRB Reliance platform) Agreement is a Master IRB Reliance Agreement designed to harmonize and streamline the IRB review process for multisite studies and supports IRB reliance across the nation. Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation. For minimal risk research, review times for external IRB protocols can exceed review times for minimal risk projects approved by a local IRB. Protocols Qualifying for CIRB Review When a Reliance Request involves a SmartIRB participating institution, an additional application is required through theSmartIRB Online Reliance System. conflict of interest, education requirements, state law, institutional policy, ancillary office review). Master Reliance Agreements (MRA) can be utilized when multiple studies are ceding review to a specific external IRB for non-Exempt research. Reliance Agreements FAQ - Lurie Children's Hospital The consent form approved by the Reviewing IRB for the main site must be adapted for use at CHOP and must conform to institutional requirements (e.g. Under the policy, multi-site is defined as two or more sites. Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number 3UL1TR002541-04S2. Multi-site studies use thesame research procedures(i.e., protocol) outlined in a single protocol that is carried out at multiple institutions. To speed up the process, CHOP has entered into several Master Reliance agreements. Investigators requesting a reliance determination should complete a Reliance Request Form. Revise the Consent Form for Use at CHOP Consent Form Requirements when Relying on an External IRB, CHOP Consent Form Requirements: Instructions for the Investigators and the Reviewing IRB (2017), Penn IRB | Reliance Agreement Guidance - Requirements for External Consent Templates, Submitting Updates During the Study: Amendments, Continuing Reviews, and Reportable Events, Principal Investigator Oversight of Multicenter Research, CHIRP Portal Continuing Review User Guide, Research Conducted at both the University of Pennsylvania and CHOP, Research Conducted at both Drexel University and CHOP, Research reviewed by the NCI Pediatric Central IRB (CIRB), CIRB-CHOP Institutional Authorization Agreement and Division of Responsibilities, Columbia University Central IRB Agreement: North American Mitochondrial Disease Consortium (NAMDC), NAMDC Columbia University Central IRB Agreement Determination Form, Final NIH Policy on the Use of a Single Institutional Review Board for Multi- Site Research, Final Rule: Federal Policy for the Protection of Human Subjects, OHRP webpage - Use of a Central Institutional Review Board, FDA Guidance: Using a Central IRB Review Process in Multicenter Clinical Trials. The policy was originally scheduled to take effect as of May 25, 2017 but NIH has issued an extension of the date for implementation which moved the effective date back to January 25, 2018 (the policy is now in effect). For questions about Penn Staterequirements or CATS IRB submissions please reach out the appropriate HRPP staff. Dilts et al. This language can be found in HRP-109 -Consent Language Document. The external IRB submission will be reviewed and returned to you with instruction to submit to the reviewing IRB. HLC IRB RELIANCE POLICY SMART IRB was created to streamline the IRB reliance agreement process between institutions and is funded by the National Center for Advancing Translational Sciences (NCATS). IRB Reliance Requirements - Research SMART IRB Agreement: A national platform sponsored by the NIH, which provides a streamlined process for ceding or accepting authorization for IRB . Participating institutions may cede review of human subjects research to any other participating institution's IRB under this agreement. The relying PI then needs to provide site-specific information for the study in CHIRP and submit it to the CHOP IRB. SMART IRB (the Streamlined, Multisite, and Accelerated Resources for Trials IRB Reliance platform) Agreement is a Master IRB Reliance Agreement designed to harmonize and streamline the IRB review process for multisite studies and supports IRB reliance across the nation. See here for additional Relying PI responsibilities. Collaborator Under the SMART IRB Master Reliance Agreement (Updated 02/10/2022) SMART IRB is not an IRB. The CHOP investigator is required to complete an abbreviated eIRB application (check "Research Study involving CHOP reliance on an outside reviewing IRB") that includes amongst other things, a listing of study personnel, study funding, required ancillary committees (e.g., Pharmacy, Radiology, etc. UIC is a participating institution under the SMART IRB Master Agreement. For individual studies under such a master reliance agreement, the reviewing IRB and relying institution can then agree that the agreement applies to that specific study (rather than negotiating an agreement for every single study). CITI training and/or other institution specific training)". Schedule a meeting here: calendly.com/jchamberlin-reliance, HELPFUL DEFINITIONS Stanford's IRB may agree to rely on a single IRB (sIRB) for multisite studies to provide initial and ongoing regulatory reviews. Once CHOP has accepted the reliance on an outside IRB, amendment changes can be implemented as soon as the reviewing IRB has approved the amendment. The agreements describe each organization's responsibilities regarding IRB review, reporting, and research oversight. Using the SMART IRB Agreement as the Reliance Agreement is an option if the other Participating Institutions have signed on and also agree to use the SMART IRB Agreement for a given study. The proposed budget in the grant application/contract proposal should reflect all necessary Single IRB costs without an approved other exception. Menikoff J. Master Reliance Agreement: An IRB Authorization Agreement designed to cover more than one future multisite study involving two or more sites. SMART IRB was funded by the NIH to help facilitate single IRB review to comply with the NIH's mandate. The reliance terms are outlined in an IRB Authorization Agreement (IAA). When a Reliance Request involves a non-SmartIRB participating institution OR only Harvard University and its Schools, only the external IRB application in ESTR is necessary. NIH Guidance of Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114 (b) (, Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (.