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Tips to Get Ready for the Common Rule Single IRB requirement

Although single IRB (sIRB) review has long existed as an option for institutions to use for the oversight of human subjects research, most institutions only used sIRB in limited situations, such as when required by a Federal agency (e.g., the National Cancer Institute for many studies supported by that agency), an industry sponsor, or to participate in a federally supported consortium (e.g., StrokeNet and NeuroNEXT). In 2018, the National Institutes of Health (NIH) issued a policy requiring sIRB review for most human subjects research it conducts or supports, which significantly expanded the number of studies requiring sIRB review and anticipated the sIRB requirement under the revised Common Rule (henceforth the 2018 Common Rule).

For many institutions, sIRB review requires significant re-engineering of their human research protection programs (HRPPs) because many local IRBs serve as the gatekeepers for institutional requirements beyond what is required under the regulations for IRBs to perform. Institutions relying on external IRBs must now be able to communicate key information to external Reviewing IRBs, ensure compliance with the determinations of external IRBs, and assist researchers with understanding not only IRB requirements but the other obligations that must be met before their research may begin (e.g., ancillary approvals) and throughout the life of the study. Institutions assuming a new role as a sIRB for external institutions (also known as a Reviewing IRB), will require changes to their processes and the possible addition of resources.

What are the sIRB requirements under the Common Rule?

As of January 20, 2020, the 2018 Common Rule requires most federally supported, non-exempt, human subjects research involving more than one institution to comply with the requirement for a sIRB to review the research. On November 12, 2019 OHRP clarified that the following research is exempt from the single IRB mandate:

  • Cooperative research conducted or supported by HHS agencies other than the NIH, if an IRB approved the research before January 20, 2020; or
  • Cooperative research conducted or supported by NIH if either the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020 or if the NIH exempted the research from its single IRB policy before January 20, 2020.

As of the date of this writing, the Office for Human Research Protections (OHRP) has not formally clarified whether sIRB review will be required for human subjects involving more than one institution and for which an IRB conducted a limited IRB review for the research to qualify for exemption.

What are key differences between the NIH Policy and the Common Rule?

Although the sIRB policy issued by the NIH in 2018 parallels the sIRB requirement introduced in the 2018 Common Rule (i.e., both apply only to domestic human subjects research), researchers and institutions should be aware of key differences between them, including:

  • The NIH policy applies only to human subjects research that the NIH either supports or conducts, while the 2018 Common Rule applies to all research involving human subjects that is conducted, supported, or that is subject to the Common Rule.
  • The NIH policy applies to multi-site studies where each site will conduct the same protocol, but the Common Rule does not include a similar specification.
  • The Common Rule may apply to exempt human subjects research that involves limited IRB review (see above), but the NIH policy only applies to non-exempt human subjects research.
  • Both the NIH policy and the Common Rule refer to potential exceptions from the sIRB requirement, such as cases where laws (e.g., tribal law) prohibit sIRB review. In other cases, the Common Rule appears to allow the potential for a federal department or agency supporting or conducting the research to determine and document that the use of a sIRB is not appropriate for the particular context but does not outline a process for requesting the exception. In contrast, the NIH outlines a process whereby institutions may request exceptions to its sIRB policy.

What are some tips for institutions transitioning to sIRB?

The actions institutions might need to take depend on the roles they assume in a sIRB arrangement. To be ready for sIRB, institutions should at minimum ensure they complete the following assessments of their infrastructure, policies and processes, and resources.

All institutions regardless of role

  • Ensure institutional policies reflect what is required in a reliance arrangement and how such arrangements will be documented.
  • Identify who can make decisions on behalf of the institution to enter into reliance arrangements (either to cede IRB review or serve as a Reviewing IRB) and what information is required to make reliance decisions.
  • Educate research teams on when sIRB is required, their roles and responsibilities related to reliance arrangements (including at the grant writing stage), and the process they need to follow to initiate reliance requests.

Institutions that serve as a Reviewing IRB

  • Ensure policies address when the institution may serve as a Reviewing IRB for external institutions.
  • Assess the capacity of the institution to serve as a Reviewing IRB and any limits on it (e.g., the type of study or number of sites involved).
  • Identify the resources and processes required for the review of multi-site research, including what information is required for IRB review, how information relevant to IRB review will be collected from Relying Institutions and research teams, and how IRB determinations will be communicated to research teams and others.
  • Ensure relevant policies and procedures are available to Relying Institutions and research teams (e.g., event-reporting requirements, expectations for submission of local vs. study-wide amendments, what local context information is required) and reflect that research teams may be external to the Reviewing IRB’s institution.
  • Determine whether fees will be assessed for IRB review.

Institutions that may need to rely on an external IRB (i.e., Relying Institutions)

  • Ensure policies address the potential that the institution may need to rely on an external IRB.
  • Assess whether changes are required to processes and/or systems to collect information about studies that will be ceded to external IRBs, so that the institution can track its research portfolio.
  • Identify point people to communicate with Reviewing IRBs on behalf of the institution (e.g., to provide local context information or regarding information or events that may affect the ceded review) and with research teams regarding the reliance arrangement.
  • Ensure resources are in place to ensure compliance with the terms of a reliance agreement and IRB determinations, which could include personnel who can perform auditing functions.
  • Identify and communicate to research teams any requirements beyond IRB approval that must be met before a study can begin (e.g., ancillary review committee approvals) and what information may need to be communicated to both the Reviewing IRB and to the local institution.

What resources are available to support sIRB?

To assist institutions with the transition to sIRB, an agency within NIH, the National Center for Advancing Translational Science, supports a project called SMART IRB. SMART IRB develops resources to support sIRB that are free to the research community. These resources include:

  • Ongoing training and education opportunities, such as SMART Talk – a monthly webinar series with advice from sIRB experts.
  • SMART IRB Ambassadors who are available to help institutions implement sIRB.
  • A help desk to assist institutions and investigators with questions about using SMART IRB resources.

Other tools, templates, and guidance include:

  • The SMART IRB Agreement – a master reliance agreement, which more than 640 institutions have joined, that allows institutions to forgo the negotiations and legal reviews that often accompanied the implementation of a reliance arrangement.
  • SOP Manual – standard operating procedures (SOPs) for establishing and implementing reliance using the SMART IRB Agreement.
  • The SMART IRB Online Reliance System – an online platform that allows researchers and institutions to request, track, and document reliance arrangements on a study-by-study basis.
  • Resources for Reviewing IRBs
    • Communication Plan for Single IRB Review – a template to document key communication roles, such as submitting initial and continuing reviews, amendments, and reportable events to the Reviewing IRB; providing conflict of interest management plans to the Reviewing IRB; and providing IRB-approved documents.
    • Local Considerations: Institutional Profile – recommended information regarding institutional, local, and state requirements that a Reviewing IRB may need to apply to its review and oversight of studies on behalf of another institution.
    • Local Considerations: Protocol-specific Document – a template that allows a Reviewing IRB to collect variations across participating sites regarding key information about study teams (e.g., training and conflicts of interests) and variations in study conduct (e.g., ancillary reviews required, HIPAA requirements, subject population).
    • Reviewing IRB Instructions for Relying Institution Point(s) of Contact and for Relying Site Study Teams – templates IRBs can use to communicate key information about the reliance arrangement as well as next steps after finalizing the arrangement.
  • Resources for Relying Institutions
    • FAQs for Research Teams – Relying on an External IRB – provides helpful hints for study teams whose institutions have agreed to rely on an external IRB.
    • Institution vs. IRB Responsibilities – a guide to the regulatory purview of a reviewing IRB and the role and responsibilities of Relying Institutions.
    • Webinar: Responsibilities of Relying Institutions – guidance for institutions preparing to serve as a Relying Institution under the SMART IRB Agreement.
  • Resources for Training Study Teams
    • Overall PI (and Lead Study Team) Checklist – to help an Overall Principal Investigator (and Lead Study Team, where applicable) understand and fulfill their responsibilities, particularly for studies using the SMART IRB SOPs, which require identification of a Lead Study Team.
    • Relying Site Investigator Checklist – to help site investigators and study teams understand and fulfill their responsibilities when a study has been ceded to an external institution.
    • sIRB Learning Center (coming soon) – brief informational videos for study teams, links to key resources, and the option to download and customize presentations for local training sessions.

CITI Program Webinar: Preparing for Single IRB (sIRB) under the Common Rule

Add this webinar and have learners listen to Dr. Nichelle Cobb, the Director of SMART IRB Operations and an Ambassador for SMART IRB, provide a detailed review of the sIRB requirement, including a comparison of the Common Rule and NIH Policy.

This webinar recording is a perfect addition to your organization’s Human Subjects Research (HSR) and IRB Administration content offerings. Train your investigators and staff today!

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CITI Program Course: sIRB Use and Administration

Add this course for learners to explore key considerations on external sIRB reliance, setting up and serving as a sIRB, and best practices for drafting, reviewing, and implementing authorization agreements between the sIRB and participating sites in multi-site research. The modules from this course may also be added to your organization’s current Human Subjects Research (HSR) offerings.

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December 2019 Newsletter