Two independent institutional review boards (IRBs)—each in business for more than 20 years—will soon become one company if a proposed merger is completed.
California-based Independent Review Consulting (IRC) and Missouri-based Ethical Review Committee (ERC) have entered into a preliminary merger agreement and have begun ironing out a deal that will combine the two companies into one: Ethical and Independent Review Services (E&I).
“The IRB world is a very small family of people, so we’ve known each other for some time,” said Erica Heath, president and founder of IRC. “It’s not a new relationship. We’ve had this for many years and, over that time, become friends.”
IRC and ERC are similar in size and philosophy, Heath said. Both companies have fewer than 10 employees (IRC has five, ERC has nine), experience with large multi-site trials and an emphasis on education.
“One of the things that we really both felt strongly about was education and teaching, so that the client understands why the decisions were important and why we do what we do—why are we making this decision,” said Terri Majors, administrator of ERC. “We have found that education is lacking for many, many investigators—even some of the sponsors. Maybe not the people on top, but the people on the staff don’t always understand the ‘why.’”
As one larger company, E&I will have more resources but fewer expenses and redundancies, Majors said. Business will be run out of ERC’s Kansas City, Mo., office, where it is less expensive to conduct business than the San Francisco area where IRC is based. (The California office will remain open and continue to provide client services.)
Although the two organizations are still working out the terms of the merger, E&I is up and running as a limited liability corporation providing management of both organizations, which continue to operate as separate companies. E&I will eventually be led by Majors, Heath and Leslie Moon, ERC’s assistant administrator.
“As far as we know, this is the first real [merger] in the industry,” Heath said. “How we do it is kind of open to whatever we need to do. There’s a lot of detail involved, of course … to make sure that we’re all using the same standards, databases, forms and all of that.”
Both Heath and Majors said the time is right for an IRB merger. Last year brought challenges of many types to the clinical research industry and IRBs specifically. In April 2009, another independent IRB—Coast IRB—was forced to close after an undercover investigation by the Government Accountability Office exposed several serious regulatory violations. Although Coast is not typical of most IRBs, Majors said, the incident brought a lot of negative attention to the IRB industry.
“The industry has changed. That’s one of the reasons we have decided that this is the time to merge,” Majors said. “We’ve been around 21 years. Last year was the first year that we’ve ever done a promo...It was the first year we’ve ever done a trade show. [Before last year], we just had our niche. We had customers that referred us to other customers. We did good work. We kept our overhead low, and just went along for 20 years.”