IRB certification becomes industry gold standard
IRB certification becomes industry gold standard
CIP exam hits decade mark this October
When the IRB faced a regulatory crisis period in the late 1990s, research institutions responded by putting more resources into human subjects protection and compliance, and the IRB world responded with the introduction in 2000 of the Certified IRB Professional (CIP) examination by Public Responsibility In Medicine and Research (PRIM&R) of Boston, MA.
In the decade since then, a great deal has changed and evolved in human subjects research. The CIP has grown in stature and reach throughout the industry's highs and lows. Since October, 2000, when the first candidates took the CIP exam, more than 1,200 people have received the credential.
"The certification has always been important, but it's even more important now with so many regulatory requirements out there," says Susan Delano, CIP, deputy managing director of the Research Foundation for Mental Hygiene of Menands, NY. Delano is the chair for the Council for Certification of IRB Professionals.
"The amount of knowledge someone has to have in these roles is extensive," Delano adds. "This is an increasingly professional field, and the certification came about at a time when the role of the IRB director/manager had really changed."
The CIP exam has become an independent measure of a person's knowledge about human subjects research protection.
"Accreditation has become more common for research institutions, and certification and accreditation go hand in hand," Delano says. "As people become accredited, they look at staff training, and the CIP designation is an indication that people are taking this work seriously and they are committed."
The exam has 250 questions that are changed and updated annually. It's available only to people who have two years of relevant experience working for an IRB.
"It's not designed for IRB members or chairs unless they have relevant IRB administrative experience," Delano says. "This is for people engaged in the day-to-day activity of running an IRB or overseeing that function."
The National Association of IRB Managers (NAIM) was the first organization to offer IRB certification with its certified IRB manager (CIM) examination in 1994. But after certifying 800 people in more than a decade, NAIM released certification responsibility at its May 2008 convention and no longer certifies human subject protection employees.
A boon for research
The CIP has been a boon for research organizations and independent IRBs as they seek well-trained and qualified staff, notes David Forster, JD, MA, CIP, chief compliance officer at Western IRB (WIRB) in Olympia, WA.
The 300-employee, independent IRB requires certification for its IRB analysts, staff board members, supervisors, and upper level employees. There are 48 staff members with the CIP designation, including Forster who took the exam with the first group in October 2000.
"The CIP tends to be fairly expensive, so what we've ended up doing is making it voluntary for many positions below supervisor," Forster says. "We allow them to take the CIP if they wish, but if they don't we have an internal exam called Advanced Regulatory Training that they can take."
Also, WIRB provides staff with a 20-session preparation course that helps employees study and train for the CIP or the internal exam. IRB professionals need to study and prepare for the exam because their experience is not enough to ensure a passing score, says Corinne Rogers, MS, CIP, administrator of the institutional review board at New York State Psychiatric Institute in New York City.
"I gave myself three months to prepare, and even before that it was on my mind thinking about it," she says.
Rogers studied with the aid of IRB guides and practice tests.
"I know people who thought they didn't need to study for the exam, and they failed it even after doing IRB work for 10 years," Rogers says.
The certification exam's questions reflect the varied knowledge that's necessary to work in human subjects research protection, including state and federal regulations, as well as local institutional policy, Delano says.
"One thing that's important to understand is we can't measure actual performance on the job," she adds. "We measure whether this person has knowledge of the critical content areas of human subjects research protection."
From the perspective of IRB professionals, the certification can result in better job offers.
"In this tight job market, having the right credentials counts when there's so much competition for jobs," Delano says. "People who hold the CIP credential are now recognized by employers as having the knowledge base necessary to help run IRBs in a compliant manner, and many job postings include a requirement or preference for CIP certification."
People with a CIP credential do demand a higher salary, Forster says.
"It shows they worked at least two years in the IRB setting and were able to pass the test," he adds. "It's a fairly tough test."
The lawyers and physicians hired by WIRB who have taken the exam typically were able to pass without difficulty, but staff with just a high school education had a tougher time of it, Forster notes.
However, the CIP has some requirements that are more stringent than many professional certification processes, including the requirement that IRB professionals take the CIP exam at least every six years. The CIP credential is valid for three years and can be renewed once with specific continuing education requirements. But at the second recertification anniversary, IRB professionals have to take the four-hour exam again.
"The first reaction from lawyers and physicians when they hear this is 'You're kidding!'" Forster says. "It's a harder certification to keep than my law degree."
The CCIP set it up this way because the human research subjects protection field and regulations are continuously evolving and because this prevents the trend of people recertifying based on less- than-optimal continuing educational coursework, Delano says.
"We want this credential to mean something so when someone puts it after their name, people will know that it's a tough certification process," she adds.
When the IRB faced a regulatory crisis period in the late 1990s, research institutions responded by putting more resources into human subjects protection and compliance, and the IRB world responded with the introduction in 2000 of the Certified IRB Professional (CIP) examination by Public Responsibility In Medicine and Research (PRIM&R) of Boston, MA.Subscribe Now for Access
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