New companies using cutting-edge technology can enter the research arena, but they might lack resources and a knowledge base that academic research organizations take for granted.
IRBs can help companies fill some of those knowledge and experience gaps by forming a collaborative relationship and working with them from the beginning of the study design process.
According to a recent study, IRBs can improve their relationships with researchers, leading to a more effective and balanced approach to protecting human subjects.1 For example, a biomedical engineering company has found that working with an independent IRB is a tremendous asset when it comes to protocol development, subject safety, and adverse events.
“We communicate with the IRB on a very regular basis,” says Chelsea Frank, manager of clinical trials for Masimo Corporation in Irvine, CA. Masimo manufactures noninvasive medical devices. Masimo research staff call their IRB weekly. “They take our calls at any time, and they provide us with any sort of advice,” Frank says. “They feel like an extension of our team.”
IRBs might find that it improves their customer service and value to the research community by providing start-to-submission guidance and services. “It’s a way of doing business,” says Leslie Wilson, CIP, director of operations at Ethical & Independent Review Services (E&I) in Independence, MO. “We feel it’s very important to have a working relationship with our clients to ensure they have the guidance they need to keep their research programs on track. In working with investigators and sponsors, as we do, there is an experience that occurs where they recognize they can reach in and begin asking questions early.”
Wilson, Frank, and other experts suggest these methods of improving communication between IRBs, sponsors, and investigators, particularly with new research enterprises:
• Take time to develop trust. An IRB should be willing to dedicate the time necessary to develop a trusting relationship with investigators and sponsors, Wilson says.
IRBs can offer help in the early stages of study design, including information about regulatory compliance and writing informed consent forms.
Some research institutions use research advisory groups, where the IRB is part of a larger framework, says Erica Heath, CIP, partner at E&I. “The IRB director could say to researchers, ‘We welcome early discussion of problematic issues,’” she adds.
Trust takes time for everyone involved in research. “Traditionally, IRBs were very suspicious of the motives of sponsors,” Heath says. “The traditional IRB often would not talk with the people who developed the protocol.” IRBs would talk with investigators when there was a protocol problem, she adds.
Start-up technology companies often work with limited staff and resources when building a research program, Heath notes. “What we try to urge is that they talk with us when building their models,” she says. “They can talk with an IRB, the experts, to try to understand what is their business and what is their research.”
IRBs can keep in mind that start-ups will need time to adjust as they work toward developing human research protection principles.
“It’s not a quick process,” says Katie Huber, PhD, CIP, research ethics consultant at 23andMe in Sunnyvale, CA. “You don’t understand something new and different overnight. You need time to think about it and come back to it multiple times before you understand all implications of it.”
When IRB staff provide above-and-beyond help, such as making calls to regulatory agencies or other experts to consult on behalf of researchers, they help build trust and confidence in the human research protection process, Frank says.
“When you start to recognize that the IRB is an advocate for you, and they’re on your team, then you really start to reap the benefits of what they can provide,” Frank says. “If you treat them as a vendor and someone to just move your goals forward, then you miss out on that.”
Trust is a two-way street. “It’s important for not only us to have trust in the IRB, but for the IRB to have trust in us, as well,” she adds. “That’s the relationship we’ve developed over the years.”
• Keep lines of communication wide open. “An open line of communication helps to develop our relationship,” Frank says.
When Masimo Corporation is developing a protocol for a clinical study and is unsure about where some aspects of the study fall within regulations, or effect informed consent, the IRB can be helpful in navigating this uncertainty, she says.
“They’re really open to brainstorming with us and kind of playing devil’s advocate, helping us look from all different perspectives,” Frank explains. “The IRB can help us develop not only the safest protocol, but a protocol that makes the most sense.”
Part of an IRB’s role in communicating with researchers is sending information about regulatory changes, including the latest advisories from the FDA, she adds.
IRB staff can give researchers advice based on their previous experience, and share their wealth of knowledge about study protocols and human research protection. They also can call investigators to show they are comfortable with direct communication.
“It seems like a simple solution, but in an age where electronic communication is the norm, I think it’s less frequent that conference calls occur, where people are speaking directly with the IRB,” Wilson says.
“For us, what’s challenging is a lot of IRBs are more focused on pharmaceutical studies,” Frank adds. For device companies, it is helpful to work with IRBs that have experience with those types of studies, she adds.
“When we enter into a new, breakthrough area or new device or protocol that we haven’t had any experience with, the IRB is the first one we call to try to develop those things,” Frank says.
One of the best ways an IRB can improve communication between its office and the research office is remaining available for discussions before, during, and after protocol submission. Day-to-day and week-to-week interactions help build that relationship, Frank notes.
• Ask research participants what they want. Participant feedback can help a research organization and IRB better understand research participants’ issues and concerns. The feedback can help provide a more effective review and strengthen human subject protection.1
There are many ways researchers can seek participant input, including holding focus groups, conducting one-on-one interviews, surveys, and providing online test/survey scenarios with a prototype of the study followed by questions about what people see, Huber says.
Questions for participants might focus on basic comprehension issues to ensure people will understand what a particular study is about, says Michelle Agee, MSc, CIP, manager of regulatory science at 23andMe.
“We try to describe risks and benefits,” she adds. “Did we catch all of the risks, or are there other things participants are thinking about that we missed?”
Talking with potential participants is especially important in research that is not clinical in nature, Huber notes.
“With data research, the risks are much more subjective,” Huber says. “There are some privacy risks that come with the use of data, but how dangerous do we think they are?”
The risk level is subjective, depending on an individual’s own level of comfort and privacy, she adds.
- Bullis E, Agee MAD, Wilson L, et al. We’re in this together: Enabling stronger participant protections through collaboration. Presented at the 2019 PRIM&R Advancing Ethical Research Conference, Nov. 17-20, 2019, Boston. Poster: 15.