Certification Process

Corresponding study leads to the IRB Management Certification Examination. In order to qualify for the corresponding course, certification examination, the candidate must have some college experience. Candidates
wishing to take the exam with less than one year of IRB or human research management experience and/or less than an accredited college degree but has recognized experience must submit two letters of recommendation with
application for certification. The application and certification exam score is confidential. The deadline for registration for the certification examination is May 30th and December 15th. The material will be mailed June
and December 15th, with an August 1st and February 1st completion date. Certification results will be released in the months of September and February. The certification package will not replace the experience gained from attending this conference. Upon successful completing the credentialing process, the applicant is awarded the title of Certified IRB Manager, (CIM).

The National Association of IRB Managers, (NAIM) has offered the IRB Management Certification Examination since 1995. The organization has certified managers in 28 states with several certified managers in most of the same states. The primary purpose of the examination is to measure the candidate’s competency beyond the program where he or she is presently employed.

Scores in the 70-79 range are interpreted as being in the limited skill area. For re-certification in the third year, the candidate may send approved continuing education evidence or retake the examination to remove a lower score.

NAIM interpret scores in the 80 percentile to indicate general competency regardless of the IRB, institution, or state where the manager is employed or will become employed.

Less than 25 percent of the certified IRB managers scored in the 90 percentile. The highest scores came from managers in special, or extremely large programs with one exception in the footnotes. Scores in the 90 percentile are interpreted as an exceptionally high skill level, regardless of where the manager practices.

The examination has ten categories with an uneven number of questions in the given areas. The subjects are: management, research assistant, legal consent, general knowledge, basic knowledge, abstracting and chart review, administration, special category IRB, records management, medical ethics, and general management. The candidate may use 21 CFR, Parts 50 and 56, and Title 45 OPRR, Part 50 for answering about 80 percent of the questions. Twenty percent of the questions may be answered with resources in the medical library.

Six weeks are authorized for taking the examination. To reduce anxiety and prevent another candidate’s score from being delayed, it is important that each candidate for certification return the examination results as scheduled. No scores may be issued until all examinations have been received and scored.

Candidates are assigned an overall raw score or number of total correct responses. This score is used to measure the overall level of competency. Scores are assigned for individual areas to show strengths and or area weaknesses.

This examination has about 26 true and false questions and 95 multiple choice questions. There are two bodies of information with 11 and eight questions that pertain to the information.

Footnote: A delegation at the first convention in 1995 was selected to write an examination with national influence by critiquing the proposed certification tool. Exceptionally high scores were assigned to the individuals who critiqued each question on the examination and offered CFR or other support for response.

	Chairman, IRB, Madigan Army Medical Center, Tacoma, Washington, Physician
	Chairman, IRB, Children’s Hospital, Orange County, California, Physician
	Chairwoman, IRB, Deborah Heart of the Lung Center, Brownsmill, New Jersey, Physician
	President, Community IRB of Tarrant County, Fort Worth, Texas
	Administrator for the Atlantic Institute of Clinical Research, Daytona Beach, Florida.

This committee developed a very successful testing tool that was used in 1996. The tool will undergo change and revision each year.

Recommendation: The certification process may offer the greatest benefit to the person who does the day-to-day work of the IRB as well as the person who takes responsibility for the program.

Certification ends three years from the year it is awarded, with one exception. The winter class is assigned certification numbers from the summer class that has just passed. This means the winter class has certification for two and one-half years instead of the usual three years. The reason for this is because all certification must end on the same day each year. Therefore, technically, the December class is a late part of the class from the previous summer and the certification numbers are continued from the pervious summer class. The first 01 number for any new certification year is assigned in July.

If certification is about to end and the credentialed member has earned continuing education over the last three years, a copy of the continuing education transcript from the professional meeting or college of attendance must be sent to NAIM with the re-certification fee of $75.00. Re-certification letters and certificates are mailed twice each year, and are released with new letters and certificates in either September or March. (Note: The re-certification application may be sent at any time during the year, but the certificate is only mailed at the prescribed times.)

Continuing education credit may be earned any time between the date certification is awarded and the date it is

renewed. A list of approved continuing education organizations is shown in this newsletter under the heading of "Re-certification Application." If a credentialed member has not been able to earn continuing education, she/he may retake the current year certification exam for continuing education credit. The exam fee will be at the rate of $125.00, the same as for new candidates. If a credentialed member fails the exam when taking it to re-certify, the earlier or highest exam score will remain on the record.

This re-certification information is in the Fall newsletter. Recent certification letters and certificates each have an expiration date. Certificates from the classes of 1995 and 1996 did not show an expiration date, however, the letters for those years did. When the association honored an expired certificate in 2000, it was re-issued for two years, the certification had been expired for a year when the credentialed member applied for re-certification. This is because the minimum continuing education requirement cannot be waived. One goal of our program is to encourage objective continuing education among NAIM members.