Recent regulations and policies have ushered in the era of mandated single IRB (sIRB) review. Designating a central sIRB for multisite research helps ensure consistent protections for participants, reduces administrative burden, and is more efficient than the practice of multiple local IRBs overseeing a single study. Now that it’s required to use an sIRB, many institutions must now establish policies and processes for working with an external sIRB.
Your best bet for sIRB success is to start early: determine the rules of the working relationship before you ever send your first IRB submission. By establishing expectations and communication plans in advance, you create a solid foundation for every future sIRB interaction. That helps ensure that research participants are appropriately protected, your local requirements are properly addressed, and your research program is more competitive and productive.
Start With the Reliance Agreement
If you know in advance that you’ll be working with an external sIRB, get a reliance agreement in place as soon as possible. In addition to formalizing the reliance relationship, the agreement can also define responsibilities for the relying institution (you) and the IRB of record (the sIRB).
The sIRB is responsible for protecting the rights and welfare of research participants. This relieves the institution of those specific IRB duties, but the institution is still responsible for the research being conducted by its researchers at its facilities. Things like feasibility assessments, research education training, and reporting issues to the IRB can only be done by the institution. There may also be responsibilities shared between the sIRB and the institution, like conflict of interest management.
Consider your local processes and requirements and how they might help or hinder sIRB efficiencies. Often investigators must submit information both to the sIRB as well as to their local IRB or research office. Avoid having your investigators duplicate work—instead of requiring a full local IRB submission in addition to a separate sIRB submission, you might consider developing an abbreviated local form that covers only local requirements. Some institutions use a cover letter to confirm that all local requirements have been addressed prior to sIRB submission.
The reliance agreement might be your first opportunity to get to know the sIRB. Find out how you’ll be interacting with them, and ask questions like:
- Will you have a single point of contact, or do they take a team approach to support?
- Do they have an online submission portal, or does the IRB prefer emailed submissions?
- When does the IRB meet, and what timelines and deadlines should you be aware of?
- What does the IRB’s review process look like?
If the sIRB has worked with many institutions and local IRBs (like Advarra, for example), ask them about best practices for relying organizations. Find out what has worked well for other institutions and how you can use the sIRB relationship to maximize efficiencies for your research program.
Communication Is Key
Establishing a communication plan is one of the most important things you can do to set up your institution for sIRB success. This plan may develop naturally during your reliance agreement conversation.
The sIRB relationship is really a collaborative partnership: the sIRB and the institution both have a stake in doing things the right way and maintaining compliance, and open communications help you both avoid any missteps. Say your institutional compliance team is auditing an investigator who is conducting research overseen by the sIRB—if the audit uncovers any issues, that’s important information for both the institution and the sIRB. The sIRB and the institution may want to develop a plan to work with the investigator to ensure she stays in compliance.
Think about what communication scenarios make sense for your organization. If you’re only relying on the sIRB for one study, you may only need to be in touch as study milestones are reached and other issues arise. If you work with the sIRB frequently, you may want to establish regular communication pathways, like quarterly meetings, to ensure things are going smoothly with all studies the sIRB oversees.
Consider appointing an sIRB “point person” who is familiar with the sIRB processes and knows which institutional studies the sIRB oversees. This might be someone in your research administration office or HRPP who works closely with the sIRB and with local research staff to make sure everyone is on the same page.
If you’re ever unsure about something, don’t be afraid to ask the sIRB about it. This may be before the sIRB ever reviews something—maybe you’ve got a high-risk protocol and you want to make sure the sIRB covers certain considerations—or it may be to clarify something following the sIRB’s review. If seeing the meeting minutes would be helpful, ask for them. This is a collaboration, so make sure the institution and the sIRB understand each other.
The sIRB oversees participant protections for your institution and so wants to do things the right way for your institution and community. They need the institution’s help to understand that local context. While the term “local context” appears in the regulations, it is not defined. Based on our conversations with institutions and local IRB personnel, at Advarra we’ve come to understand local context to mean those unique institutional, local, and regional requirements and other items that the reviewing IRB should know about. Some things to consider:
- How will your institutional policies, procedures, and review process impact the sIRB’s review process?
- What institutional committee requirements must be completed before research can commence?
- Are there state laws that might impact the research?
- Does your local community have unique features or needs that the sIRB should know about?
- Do you require a cover sheet for sIRB submissions, or do you have special language to include in every informed consent form (ICF)?
One of the biggest challenges with shifting from local IRB review to external sIRB review that we’ve encountered is the ICF. Centralizing the IRB review process means there is just one ICF for use across all participating sites. Each site’s ICF will be customized to include the site’s unique information (e.g., contact information, special compensation for injury language, etc.).
To keep the sIRB review efficient, it’s important to only provide the sIRB with your institution’s required consent language. If the content doesn’t add value for human subject protections, ask if it really needs to be included. Keep it straightforward, and avoid the temptation to wordsmith the ICF—as the study progresses and modifications are made to the ICF, it becomes more and more difficult for the sIRB to retain complicated or subjective institutional edits.
Training (aka Internal Communications)
Once you’ve established the details of your sIRB working relationship, it’s time to share that information with the institution’s research team. Make sure your investigators and the research support staff understand the sIRB submission process as well as your institution’s local requirements and procedures. Clearly communicating these requirements can reduce unnecessary administrative back-and-forth during the submission process and helps maintain a solid, efficient sIRB working relationship.
Continuous sIRB education is important—make sure new staff receive the same sIRB information as the rest of the team. If you have a local intranet or other internal resource, consider posting sIRB instructions online for easy access by anyone who needs it. You might also ask sIRB if they can provide training information on working with the sIRB.
Don’t let the sIRB mandates catch your institution off guard. By starting your sIRB planning early and engaging with your sIRB partners regularly, you’ll be able to take full advantage of sIRB efficiencies (and save yourself and your colleagues a lot of headaches).
In need of an sIRB partner? Advarra has served as sIRB for thousands of industry-sponsored and federally funded multisite studies and works with over 3,200 institutions and hospital systems. Benefit from our existing processes, procedures, and resources, including budget planning support for grant applications. Contact us to get started.