CIP certification is taking off among IRB staff

Job listings often include CIP as a qualification

Nearly 800 people have worked to earn a certified IRB professional (CIP) designation in the six years since the first CIP exam was given.

The certification program's success has led to increasing numbers of job postings for IRB professionals who have or will soon achieve the CIP designation, says Susan J. Delano, CIP, deputy managing director for the Research Foundation for Mental Hygiene Inc. in Menands, NY. Delano has spoken at national IRB and research conferences about the CIP program.

"One thing that helped CIP launch successfully was the large number of people, who were well established in their IRB careers, saw the need for this," Delano says. "Even though it wouldn't benefit them personally, they took on the exam as a show of support for the field."

Now, the CIP designation is used as a means to gain employment or a promotion within an organization, Delano says.

There are two other reasons the program, which is sponsored by the Council for Certification of IRB Professionals (CCIP), is a success. For one, the program was developed by Public Responsibility in Medicine & Research (PRIM&R) and the Applied Research Ethics National Association (ARENA); and, two, the timing was right, Delano explains.

In recent years there has been a lot of focus on developing IRBs and making them more professional, Delano says.

"CIP was giving credibility and importance to the role of IRB administrators as a key component to strengthening human protection," Delano says.

"Independent IRBs have been a strong participant in this program, and a large number have required their staff to become CIP certified," Delano says. "My perception is that they see that as a way they can demonstrate to a broader community the professionalism and standards within their organization."

Based on a demographic report of the first 700 people who achieved a CIP designation, the following information is known, Delano says:

  • 40% hold a bachelor's degree, 25% have master's degrees, and 17% report having doctorates.
  • More than half had five or more years of experience, and 20% had more than 10 years of experience.
  • Nearly 40% reported being employed by an academic medical center, and 15% were employed by an individual IRB. The remainder reported employment in a variety of institutions, including community hospitals, HMOs, industry, research institutions, and non-medical institutions.
  • Three quarters of those certified were ages 30 years and older, and more than half were 40 years and older.
  • Most of the people certified are women.
  • To be eligible to take the CIP examination, an IRB professional must meet these requirements:
  • must have a bachelor's degree, plus two years of relevant IRB experience within the past seven years, or have four years of relevant IRB experience within the past 10 years;
  • complete and file an application for the certification examination for IRB professionals;
  • pay the required fee.

Relevant experience refers to hands-on IRB management duties and only applies to IRB members or chairs who handle regulatory compliance, IRB correspondence, documentation, IRB office management, and training, Delano says.

"We recommend people look at the regulations and guidances and national best practices," Delano says. Local policies and procedures and state laws are not a part of the exam, so it's important for CIP candidates to know the difference between what's required federally and what's required locally, she adds.

The CIP exam has 250 questions, and it's scheduled twice a year with a two-week testing window, Delano says. The test takes about four hours, and it costs $335 to $435, depending on ARENA membership.

Starting this year, the exam is offered through computerized testing, although some paper and pencil testing will be available based on individual circumstances.

More than 700 cities will host the CIP exam this year, making it cheaper and easier for people to find a test site, Delano says.

Those who have a CIP must recertify every three years, but for the first recertification they are permitted to recertify through continuing education credits. The next time they are required to take the exam again, Delano says.

The exam is kept current and thorough by unpaid volunteers on the certification council, and it's produced by the Professional Testing Corp. of New York, NY, Delano notes.

Each year the council holds an item review session with CIPs in different parts of the country, and together they go over the questions on the exam, Delano says.

"It's a two-day process to review each of those questions and make sure it's a question that should be asked and to make sure the question is clear, the answer is correct," Delano explains.

The council also makes sure the questions are pertinent to the required body of knowledge.

"Each member of the council takes the test, and then as a group we go over the questions on the exam again, to make sure it's a question worth asking and that it's still relevant, and that it hasn't been affected by regulatory changes," Delano says.

When regulatory changes mean some new questions should be asked, then something else will be eliminated, Delano says.

The council also debates how much weight should be given to any particular area on the exam, and the emphasis will be shifted according to the current regulatory climate.