Clinical Researcher—December 2020 (Volume 34, Issue 10)
IRB INSIGHTS (PART 1)
Gary W. Cramer
Consolidation has been the ongoing trend of the past decade or more where the providers of goods and services tied to the clinical research enterprise are concerned. One need look no further than the institutional review board (IRB) sector in recent years to see heavy levels of restructuring activity as firms vie to remain competitive in the face of many economic, regulatory, and societal challenges affecting research review and oversight.
Whereas some of the “giants” of the for-profit IRB world have grown by leaps and bounds—broadening their offerings nationally and internationally—through strategic mergers with and acquisitions of former rivals, other boards have remained independent and focused on more personalized services to a smaller client base. Such is the case at Principal IRB in Florida, as explained by Freddie Hughes, RN, CIM, Managing Partner, Operations, and Debra Reed, Managing Partner, Marketing, in the following Q&A.
ACRP: Can you share some details about the career path that brought you into the world of IRBs?
Freddie Hughes: For me, I see IRB work as a natural extension of my healthcare experience, and research as a branch on the tree of healthcare. Therefore as a registered nurse, it is understandable that more than a decade ago I developed a passion for the work of protecting individuals who are willing to participate in clinical trials. Research is a vital part of medical innovation, and the people who participate deserve to have an organization like Principal IRB helping to ensure that protections are in place.
ACRP: You call your company a “boutique IRB.” What does this mean in terms of your areas of specialization, and how rare is your business model in today’s IRB environment?
Debra Reed: The boutique IRB size and specialization allows us to be more responsive and personal in our client interactions. Because we are smaller, we can offer more hospitality and better site relationships. Our competitive advantage is our ability to invest more in the vision and goals of our clients. Our target market is start-ups and small to mid-size pharmaceutical and biotechnology companies. Our therapeutic areas of specialization are oncology, cardiology, and neurology, but we have 15 years of experience reviewing most areas of Phase I–IV research.
Attracting our target market has been key to creating a positive work relationship, as well as to retaining sponsors for future work. In a highly competitive market, it is essential that we demonstrate a real understanding of our prospective clients’ needs and their pain points. While the two large private equity group–owned IRBs may dominate our industry by offering one-stop-shop services, a niche company like ours still has a place.
Principal IRB is a totally electronic IRB. Our digital platform, LAUNCH, is compliant with 21 CFR Part 11 of the Code of Federal Regulations and is a critical component in our strategy to streamline the operations of our clinical study sites. We were set up to work electronically long before COVID-19, and that has been a huge asset to us as the industry shifts toward more virtual visits and trial design. This is a very unique part of our smaller IRB.
ACRP: Your company is female and minority owned. How does this impact your perspectives on the kinds of studies you are asked to review?
Hughes: Diversity is not only reflected in our ownership structure, but we also make sure that it is a part of the review committee composition. We believe that there is immense benefit in the collective experiences and opinions from a group that represents more than a single gender, race, and ethnicity. We see the importance of this time and time again when reviewing studies involving diverse research participant populations.
Reed: Principal IRB is a diverse workplace which pulls from a larger range of experiences and sources. Diversity brings new insights to problem solving. Diversity increases innovation, creativity, and strategic thinking, leading to improved results for our company.
ACRP: Can you share some quick details about how accreditation for IRBs works, and what advantages come from achieving accreditation the way you have?
Reed: The primary purpose of having accreditation through the Association for the Accreditation of Human Research Protection Programs (AAHRPP) is to strengthen protections for research participants. AAHRPP instills trust among research partners and sponsors. AAHRPP-accredited organizations often insist that accreditation status be a determining factor in decisions on external IRB review. Virtually all sponsors require all independent IRBs to be AAHRPP-accredited.
Becoming accredited was a rigorous, two-year process for Principal IRB, but it is the gold seal of approval in our industry. Accreditation signifies that we have built the necessary infrastructure for a quality human research protection program that reduces the risks of noncompliance. AAHRPP accreditation also enhances our standing with U.S. federal agencies, which are more likely to target non-accredited IRBs for inspections.
ACRP: What major trend or trends do you see shaping the world of IRBs as we head farther into the 2020s?
Hughes: In the age of COVID-19, we have seen an acceleration in telemedicine. Physical and mental health appointments are being conducted using video and wearable health technology. I think the future will bring an explosion in what I call teleresearch, with a rise in development of health device technology and clinical researchers normalizing remote assessment and monitoring. Principal IRB is prepared for this shift. The company has been virtual from the start. We embraced a fully electronic model in 2017, which is why we were able to continue without interruption during the spring shutdown and to accomplish full AAHRPP accreditation in September 2020.
Gary W. Cramer (gcramer@acrpnet.org) is Managing Editor for ACRP.
