As IRB professionals increasingly invest in their careers and seek certification, they sometimes find that taking the certification test can be stressful and all-consuming.

Although studying for the Certified IRB Professional (CIP) test can be challenging and nerve-wracking, the worry can be mitigated by a cross-institution study group program, suggests Sarah Marie Huban, MA, CIP, CHRC, human protections program and research regulatory affairs manager at Children’s Healthcare of Atlanta.

“I think taking the test is stressful,” says Sarah Clark-Worley, MPH, CIP, senior IRB coordination manager of the research compliance office at Stanford University in Palo Alto, CA.

“Depending on the institution where you work, everyone’s motivation for becoming certified is different,” Clark-Worley notes. “Some do it for professional enrichment; for others, it’s a requirement for their job, and others have different pressure.”

Clark-Worley and Huban worked to reduce stress and improve CIP passing rates by developing a study group program for taking the CIP test. The new program helped to raise the CIP passing rate among their pilot groups taking the test.

Study with other institutions

The key to success for the study group program was to include IRB staff from more than one institution. “We saw a big increase from our average passing rate from a study group at a single institution versus a study group with lots of different folks,” Huban says.

For instance, the first study group, which had attendees from only one organization, had a passing rate of 67%. The combined study group, including people from three institutions, had a passing rate of 83%.1

As IRBs and research institutions increasingly encourage or require staff to obtain CIP certification, pressure builds among IRB staff. Plus, the time and resources invested in certification can make the process very stressful and result in lower than expected passing rates, Huban and Clark-Worley say.

After months of studying, IRB professionals might become burned out by the time they take the exam. Or they might focus on the wrong areas and not pass it the first time around, Huban says.

The CIP program was created in 1999 as part of a grassroots effort by IRB professionals and policymakers. More than 2,000 people have received their CIP certification. Professionals taking the CIP must have a bachelor’s degree and two years of relevant human research protection program experience, or three years of HRPP experience. The certification is valid for three years and can be renewed.

“We worked together on the programs as colleagues from Emory University IRB in Atlanta,” Clark-Worley says. “We overlapped for three years, and then Sarah went to the Children’s Healthcare center and we still worked together.”

The collaboration ended when Clark-Worley moved to Stanford University, but she’s continued to hold CIP study groups at her new institution.

It proved to be an enormous advantage to have people from different institutions studying together, because IRB members can challenge each other on the perceived regulations, she says.

“When you’re working at a particular institution, you get so focused on institutional policy and how that institution interprets regulations,” Clark-Worley explains. “But when you work with someone from another institution, you remove the institutional goggles and think about it in the broader sense and apply the regulation to how it applies to everyone without getting bogged down in the details.”

Huban saw the institutional bias effect occur when she started her first certification study group with a few people from the same institution.

“I realized that if you’re teaching to one institution’s policies and procedures, then those might go beyond what the regulations require,” she says.

For example, if an IRB’s quorum requires 10 attending members, the IRB professional might not realize that 45CFR, Part 46 regulations require IRBs to have at least five members, Huban explains.

“There are lots of little nuances where you think your policies and your institution’s requirements are the answer, when those are not the regulations but just the way your institution has interpreted it,” Huban says. “Having the perspective of another institution was huge for us.”

The following are some multi-institutional certification study group strategies:

Build camaraderie. The first session introduces the various IRB professionals and talks about why it’s important to incorporate multiple institutions. Generally, the IRB staff were excited to meet colleagues from other human research protection programs, Huban notes.

“Then we went over the schedule, talking about which chapters we’d cover each week and what we expect them to do,” she adds. “We say, ‘Here’s what it will take to be successful when you take the exam.’”

Build incentives. The multi-institution study group met on Friday mornings. Clark-Worley and Huban would bring in bagels or some kind of breakfast.

“We also had one or two celebratory lunches,” Clark-Worley says.

Provide structure and handouts. The group met for 11 weeks, and the meetings lasted about an hour, with the expectation that attendees would spend additional time studying and preparing each week. The group leaders shared supplemental documents and created slideshow presentations. There also were case studies.

They gave attendees only enough materials to complement that week’s assignment.

“We could have given them the handout right at the beginning, but we chose to wait and hand them out each week, thinking it would be overwhelming to receive a giant binder of regulations,” Huban says. “We’d say, ‘You need to read these chapters,’ and they were typically two chapters a week.”

At the end of each session, they suggest what participants can read and do to prepare for the next session, and they give them a chapter quiz.

Make it fun. They used online toolkits to create interesting games for studying. One is a Jeopardy!-type game. Another uses 102 flash cards to make studying more interesting.

For example, on one side of a card would be the words “social harm,” and the opposite side would read: “Decreases in quality of life that result from information being created or used in a way that is damaging to the individual in question — a result of the creation or transfer of information in a way that may negatively affect the research subject.”

Instruct with case studies. They created a cooperative learning environment with less focus on teaching and more of an emphasis on an open dialogue, sharing information. The case studies helped to facilitate discussions, Clark-Worley says.

“We created case studies and worked through them together,” she adds. “We found it was tremendously helpful in the exam as it helped them think critically and work through issues.”


  1. Huban SM, Clark-Worley S. Stronger together: creating a certified IRB professional (CIP) study group that incorporates multiple institutions. Poster presented at the 2014 Advancing Ethical Research Conference, held Dec. 5-7, 2014 in Baltimore, MD: Poster 7.