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Navigating Local Considerations When Developing sIRB Reliance Policies

In recent years, the use of single institutional review board (sIRB) review has gained significant traction in the world of research ethics and compliance. sIRBs are intended to streamline the ethical review process for multisite research studies, ensuring research is conducted safely and efficiently.

However, implementing an sIRB reliance model involves important local considerations researchers and institutions must carefully address. In this blog, we explore these local considerations to help research teams navigate the complexities of sIRB implementation successfully.

What is an sIRB?

Before delving into the local considerations, it’s essential to understand what an sIRB is and why it’s used in research. An sIRB is a single ethics review board assuming responsibility for reviewing research protocols, and ensuring ongoing IRB oversight, across multiple institutions or sites engaged in human subjects research.

The primary goals of utilizing sIRBs are to simplify the ethical review process, reduce redundancy and administrative burden, and ensure the same ethical standards are applied consistently across all participating sites.

Local Considerations in sIRB Implementation

Local context, expertise, compliance, and collaboration are all critical factors to sIRB success. By carefully addressing these considerations, research institutions can effectively implement sIRB policies while respecting their local research environments’ unique characteristics and ensuring the highest ethical standards in their studies.

“Local context” is a concept mentioned in regulatory guidance but lacking an official definition. However, the research community generally agrees local context covers key site-level requirements and other local considerations an sIRB must include as part of its review.

Communication and Coordination

Effective communication and coordination are critical when implementing an sIRB policy. Additionally, the National Institutes of Health (NIH) requires grant applicants to provide a communication plan for sIRB reliance.

To ensure the review process runs smoothly, sites should work with the sIRB to establish clear lines of communication. This may involve establishing key contacts at both organizations, regular meetings, updates on protocol changes, and a transparent process for addressing questions or concerns. At the site, local communications should be organized to include the HRPP as well as the research team.

Consent Form Local Requirements

Many institutions have unique consent requirements related to the community they serve as well as state, local, or other organizational needs. This may include birth control language for institutions with religious affiliations or compensation for injury verbiage.

When developing your institution’s consent language for sIRB use, consider what is truly necessary and limit your requirements to just those protecting participants or meeting other local requirements. Establishing clear and reasonable local consent requirements helps ensure the sIRB appropriately addresses local needs while preserving sIRB efficiencies. Avoid the temptation to rewrite the entire informed consent or reword portions for editorial purposes, as this detracts from the purpose of sIRB and delays review timelines.

Local IRB Engagement/Transition Plan

Engage your local human research protections program (HRPP) in evolving the sIRB process. Even though the sIRB is responsible for IRB oversight of the overall protocol, the local HRPP staff will likely still have responsibilities, such as providing local informed consent requirements, reviewing sIRB applications, and ensuring local ancillary reviews (e.g., conflict of interest, feasibility, pharmacy, etc.) are completed as required.

Local HRPPs can provide valuable input in ensuring the sIRB understands local risk factors and respects community values and norms. The ceding institution (i.e., the institutional site giving up local IRB oversight and relying on an sIRB’s review) should be prepared to provide any relevant local context information to the reviewing IRB; for example, some communities may have long standing mistrust of researchers related to historical context not known to the reviewing IRB.

This essential information may inform the IRB review of the study and should be communicated as a part of the local context information. Institutions should consider developing a dedicated sIRB local context resource, perhaps a single document outlining the unique specifics that is shared with sIRBs periodically and whenever there is a revision.

Researcher Training

In developing institutional policies, ensure you include a process for training investigators and study teams on local requirements for ceding IRB review. Researchers and other stakeholders should be trained on the sIRB process, local considerations, and institutional expectations for sIRB research. This should include both initial requirements to cede review, and any requirements for ongoing updates and reporting to the local HRPP.

Researchers should also be aware of the unique ethical, cultural, and regulatory aspects of conducting research in their region so they can appropriately include such details in the sIRB submission process. They should also be familiar with the technology required for sIRB submission, including the sIRB’s platform and any local tools involved in the process.

Equip stakeholders with any special institutional sIRB submission requirements, process details for relying on an sIRB, and any other local elements potentially impacting sIRB review. For example, some institutions may require investigators to complete a reliance form prior to ceding review to an sIRB.

Finally, ensure stakeholders are made aware of and can easily find information regarding ongoing local requirements; for example, do researchers need local approval for a principal investigator (PI) change, and how is local approval obtained? Are study teams required to submit annual reports, or does the local HRPP only need updates if certain changes are made to the research? Are there local reporting requirements for unanticipated events that are in addition to and/or differ from sIRB requirements?

Institutional Culture and Policies

Each research institution has its own unique culture, policies, standards of care, and community expectations affecting how they approach research ethics. When relying on an sIRB, it is crucial to consider how the sIRB process aligns with the institution’s local culture and policies.

Consider what local processes and reviews (e.g., conflict of interest review, radiation safety committee review, etc.) must take place in conjunction with the sIRB review process. From there, think about how these local activities may impact sIRB review timelines. It may be valuable to assess which local processes have minimal impact on sIRB review. This proactive assessment then, can be done in parallel with the sIRB review, instead of waiting to submit until all ancillary reviews are completed.

Engaging an independent third party’s perspective could prove indispensable in assessing current processes and developing new approaches that capitalize on the efficiencies inherent to sIRB review.

Regulatory Compliance

Different communities and regions may have distinct regulatory requirements governing research ethics. Researchers and institutions must ensure the sIRB is aware of local requirements, state laws and statutes, and other regulations governing regulatory compliance.

This includes addressing any differences in informed consent procedures, reporting requirements, and other ethical considerations varying by location (e.g., reporting for-cause FDA or OHRP audits to the sIRB). For example, consent requirements for minors and the age of majority may vary by state. Additionally, it’s critical to notify the sIRB whether the institution has “checked the box” on its Federalwide Assurance (FWA).

Local Expertise

In some cases, local expertise may be required to provide insights into specific cultural or contextual nuances potentially impacting research ethics. Institutions should alert the sIRB regarding local researchers, ethicists, or community representatives whose perspectives may be necessary to the review process.

Data Privacy and Security

Local data privacy and security regulations may vary, and the institution should inform the sIRB of data handling compliance. This may involve encrypting data, obtaining specific permissions, or adhering to local data storage requirements.

Budget and Resource Allocation

Implementing an sIRB process may require additional resources, including financial support, administrative staff, and training. Institutions should carefully consider the budgetary and resource implications of sIRB implementation to ensure the process is sustainable.

Some institutional IRBs may decide to act as an sIRB in certain situations. While this might be easier for the local investigator, many operational considerations must also be made (e.g., local resources, technology, etc.). To do this sIRB work, institutional IRBs charge fees for their services, but many do so arbitrarily, without a clear understanding of their actual operating costs. This lack of cost clarity is a common shortcoming among many HRPPs . It may be valuable to assess this cost to help inform budget considerations for grant applications, to advocate for increased staffing, and other metrics.

Successfully Implementing an sIRB Process

While implementing an sIRB process can significantly streamline the ethical review process for multisite research studies, it’s essential to navigate the local considerations thoughtfully.

By acknowledging and addressing the unique cultural, regulatory, and logistical aspects of each participating institution, and establishing a consistent process for ceding IRB oversight, researchers and institutions can ensure the sIRB process is both efficient and ethically sound.

Effective communication, collaboration, and flexibility are key to successfully implementing an sIRB model designed to benefit all stakeholders involved in research.

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