When it comes to taking your small or medium-sized enterprise (SME) to international levels, research institutes and universities offering innovative medical products may hold more opportunities than you think. But scaling and accessing those opportunities may require a bit of extra planning. One way to streamline your company’s scaling process is to leverage the often-overlooked compliance mechanism known as an agreement with an Institutional Review Board (IRB). With the right approach, you can quickly commercialize research opportunities and, ultimately, save yourself the hassle of navigating the global clinical research landscape. International commercialization can be confusing, but an IRB reliance agreement may help;
An IRB is an independent ethics committee tasked with providing ethical, scientific, and regulatory oversight for research institutions. In the United States, universities and medical research institutions that receive public funding are required to file annual group approval requests with the Department of Health and Human Services (DHHS). These DHHS filings allow small and medium-sized enterprises to conduct medical product research at their academic institutions. Most DMEs and academic medical centers (e.g., hospitals or clinics affiliated with a university) have designated IRBs to oversee their clinical research activities. These IRBs provide a level of ethical and scientific review and evaluation for the studies conducted by their institutions. Generally speaking, IRBs will only evaluate research efforts that offer significant value to their institution’s members and further their mission. However, the IRB may be open to providing their services if you have the right plan in place.
IRB reliance agreements can facilitate the timely review of medicine by allowing you to partner with research institutes that share similar clinical interests. To help convince them that placing their IRB jurisdiction in your hands is the best option, you should address two primary factors in your proposal:
Once you have discussed these concerns, an IRB may offer your organization the chance to avoid lengthy regulatory processes and commercialize faster than you could in isolation. Well-organized IRBs leverage their experience in drug and product evaluation to process commercial research efficiently. They even have international partnerships to help provide oversight for research efforts across borders. An IRB also can streamline patient recruitment by discussing clinical research opportunities with medical students and expanding clinician networks.
IRB reliance agreements can be significantly beneficial to those small and medium-sized businesses with research opportunities concentrated in one location. An IRB can minimize regulatory challenges and support compliance with international regulations that would otherwise be burdensome on small and medium-sized enterprises. For instance, the different countries may have varying forms for clinical research. Some countries may require that clinical research be approved by their own IRBs. This can make is difficult for small and medium-sized enterprises without the budget or resource to navigate the global clinical research landscape. An IRB reliance agreement can be like having a passport, granting SMEs easy entry into new markets. Even if you don’t have a business presence in another country, it may be able to work with you and get you access to networks in those countries.
A 2015 EU regulation governs research involving EU clinical trial sites. Taken together with Part 56 of the FDA’s IND regulations in the United States, compliance with just these two protocols can be a full-time job for a team of lawyers. However, an institutional review board (IRB) that is familiar with both EU and U.S. laws can ensure compliance with both sets of regulations in one process. Complying with both sets of guidelines in one review process streamlines the compliance effort.
New clinical trial regulations should support the development of unified policies for IRB shared submissions. This means that at least, in theory, all IRB-reviewed studies for drugs and biologics should be able to use a centralized institutional review board. Perhaps once these new regulations are in place, the possibility of a practical IRB reliance agreement will present itself.
In an increasing number of industries, SMEs are benefiting from academic support. For example, small- and medium-sized businesses that are developing AI technology to measure the quality of manufactured materials are advancing their product with support from universities and labs. Likewise, big companies might be seeking out unique, customized, or niche products that small businesses and R&D centers can efficiently create. Ultimately, scaling will require efficiency, and small businesses should be attuned to this need when looking for resources.
One of the most exciting characteristics of small and medium-sized businesses is that they are not set in their ways. Entrepreneurs are accustomed to developing and pivoting their processes, allowing them to adapt to changing market fluctuations. In this way, they can play to their strengths by rejecting a standard IRB review process in favor of a shared IRB review process. Businesses that seek to work with IRBs have a unique opportunity to build the terms of their collaboration into the contract. For example, as part of your contract, you can request that the IRB grant you with: In these ways, your reliance agreement can support your international commercialization efforts.
Because you likely will not have the resources to hire an in-house institutional review board, you should keep several factors in mind as you seek an IRB reliance agreement that aligns with your business goals. Here are some of the most important considerations.
If you seek the help of an IRB, you will likely be asked to enter into a reliance agreement, with the first draft coming from the IRB. You may then refine the document as you negotiate the terms of the agreement. In the following sections, we outline some of the most essential clauses to consider.
Finally, it is essential to keep in mind that IRB oversight likely will continue until your Phase 2 trial is complete. Your task will be to review the lot tracking process and the safety reporting process and to offer a revised consent form when necessary.