How IRBs Can Keep Up With the Rest Of The Clinical Research Industry

By Julie Blasingim, CEO, Univo IRB

As members of the research community, we’re all aware of instances of suboptimal human patient protection and safety. Fortunately, we also can point to practical evolutions that create better research participant protections and safety procedures — such as the creation of IRBs.

The beginning of human research protections can be traced back to the ethical findings outlined in the Beecher Report, the Nuremberg Code (post-World War II), and the Declaration of Helsinki, but it was the 1974 National Research Act, which formed the National Commission for the Protection of Human Patients of Biomedical and Behavioral Research, that truly set the foundation for IRBs.¹ This Commission created the Belmont Report, which included the ethical principles and pillars for acceptable human patient research: respect for persons, beneficence, and justice. The creation of IRBs soon followed to ensure .that, following the three principles, appropriate steps are taken to protect the rights and welfare of human patients who participate in research.

But where do IRBs stand today? And, how should they evolve to better meet the needs of modern clinical trials while protecting research patients?

Technology And IRBs

Clinical research has been slow to streamline processes that make research easier and more accessible to patients, including adopting new technology. IRBs have been even slower.

For a long time, central and local IRBs were run similarly:                                                

1. Study investigators would mail or even hand deliver documents to the IRBs for review.
2. Within the IRB, a group of individuals would meet at a predetermined interval of time, review the documents, and either approve the documents, require modifications, or deny the submission based on the documentation made available to them.
3. Communication would go back and forth via in-person communications, phone calls, or faxes, and the process was excruciatingly slow.

With the arrival of the internet, email, and online document transferring/storage, communication between IRBs and clinical research stakeholders became quicker and easier. IRBs built online portals to submit and retrieve IRB documentation as well as in-house database systems to track and store data about each submission and IRB determination. But review timelines remained slower than necessary because IRB meetings  were still occurring in person, largely because of habit and no major driver to conduct virtually. If documents were not received in time for the next meeting or the documents were not able to be reviewed during the meeting, they were tabled until the next meeting — causing delays that cost researchers time and money. Furthermore, poor weather or facility issues could disrupt the entire review timeline.

I remember being part of one of the first 100% virtual IRB committee meetings in 2012. It wasn’t until a key member of the IRB was relocating outside of the area that we explored 100% virtual IRB meetings. I remember the countless hours of preparation and planning it took to anticipate technical support needs and adjust the meeting logistics to make sure that we had active participation and the same level of quality review. We had to ensure that IRB members could access the meeting material securely, test videoconferencing bandwidth, and try out several different webcam options to meet our needs. We also had to set new meeting standards and requirements to ensure that all attendees were in a secure area, engaged, and not distracted. The first few runs were a little bumpy as the IRB members adjusted to a new way of interacting with each other and faced new technology challenges. We also quickly learned that we needed business continuity plans for events such as internet outages that were not a consideration when meeting in-person. But after that, they were able to accelerate IRB meetings and expand their membership to include experts from all over the nation, increasing diversity among the IRB staff and IRB committees.

Today, IRBs can expand out of local areas to ensure a true representation of the clinical community and the patient community, thus allowing more voices to be heard while ensuring the appropriate areas of expertise.

Two Ways Next-Generation IRBs Should Use Technology

As the research community faced operational challenges during the COVID-19 pandemic, we had no choice but to lean heavily on virtual tools to communicate with patients and stakeholders. Fortunately, several IRBs had already evolved to leverage videoconference for IRB meetings and were able to continue to meet virtually with little disruption. However, many sites and researchers did not have digital health technologies in place and struggled to communicate with patients and complete research activities.

First, to transform clinical research and the overall patient experience, we must take what we learned during the pandemic and embrace virtual meetings and digital health technologies (DHTs). Virtual communications offer many benefits to investigators, sponsors, and patients, including faster decisions, reduced costs, increased diversity, and improved accessibility. DHTs also can enhance research quality and efficiency by enabling remote monitoring, data collection, and patient engagement. We need to explore the practicality of patients completing study procedures virtually, thereby enabling researchers to go directly to patients, minimizing disruption to the patients’ day-to-day lives, and reducing the inconvenience and out-of-pocket costs that may come with on-site visits.

Second, an IRB’s use of technology should support, not hinder, DHTs and enable more direct-to-patient models. Technology now enables researchers to meet patients where they are, allowing them to be more easily recruited from a wider, diverse pool and providing more accessible clinical research information. By adopting these innovations, we can modernize the way patients participate in clinical research and help bring more patients into research.

We must also continue exploring how modern tools and capabilities, such as AI, can be leveraged in clinical research. Just like any other technology capability in this industry, it needs to be tested to ensure that it meets the requirements for the functions in which it is being used. At Univo, we fully believe that there is a place for AI in clinical research in some administrative tasks, allowing highly skilled professionals to focus on more specialized matters such as patient and customer support.

How To Successfully Implement New IRB Technology

Whether your company is moving to virtual meetings or adding the latest modern technology to its platform, there are four keys to success:

1. Leadership commitment and buy-in
2. Quickly recognizing that the past ways of doing work may not be the best
3. A friendly culture that believes that there is always a better way and supports continuous improvement

Everyone’s voice matters; consider all user types and journeys to develop the optimal user experience

What To Consider When Evaluating Patient-Facing Technology

As technology evolves, it is important to evaluate how to embrace modern tools not only for internal operations but, perhaps more importantly, for patients. Here are a few areas to consider when evaluating new patient-facing tools in clinical research:

1. Will this tool expose the patient to risks that would be greater than those of in-person communication? If so, how can this risk be minimized?
2. Will the tool inadvertently exclude patients?
3. Are there alternatives if a patient does not want to use this tool or if there is a disruption in its availability?
4. Will it cause major inconvenience to the patients?
5. Will there be any additional costs to patients?
6. Will staff and patients need training and support on these tools?
7. Will it ultimately create a better patient experience?

The Future Is What We Make It

We all want to be innovators in clinical research. We all want to see research evolve. As we look to the next generation of human research protection, we need to follow the needs of research patients both as they exist today and where they might go in the future. As Wayne Gretzky, a top scorer in the NHL, said, “I skate to where the puck is going to be, not where it has been.”

Reference:

1. Moon, M. The History and Role of Institutional Review Boards: A Useful Tension. AMA Journal of Ethics. Published 2009 Nov. 4.

About the Author:

Julie Blasingim, CEO of Univo IRB, is a seasoned IRB executive with 20 years of extensive regulatory, operational, and compliance experience in human research protection and site operations of clinical research. She has served in a dozen senior leadership roles across multiple central IRBs, including Independent IRB, Schulman, and Advarra. Routinely consulted for her extensive human research protection regulatory expertise, she has hosted countless FDA inspections at both the IRB and under site operations and has managed multiple accreditations and certifications through AAHRPP and ISO. Julie holds a master’s degree in business administration specializing in leadership.