Certified IRB Professional Eligibility

Certified IRB Professional Eligibility

The Certified IRB Professional (CIP®) certification program is for individuals whose primary job responsibilities include substantial participation in overseeing, administering, or performing the daily activities of an IRB as part of an HRPP. 
Eligible individuals typically work within an HRPP/IRB office, reviewing IRB submissions, managing the review of IRB materials at IRB meetings, writing IRB minutes, and providing consultation to study teams on IRB submissions.  This includes managing the review of protocol materials submitted to the IRB by research teams, for new approval, modification, continuing review, exemptions, reliance activities, and non-compliance/unanticipated problems.  
Eligible individuals may also be involved in updating the policies and procedures within the HRPP/IRB, providing education to IRB staff and the research community on updates to the federal regulations and guidance documents on human subject protection.

CIP® Eligibility Length of Experience 

All individuals must have at least two years (24 months) of full-time experience (within the past seven years) in executing the job functions that comprise the eligibility guidelines.  

Part-time experience is calculated by the percentage of effort spent on HRPP/IRB administration-related work, based on the following formula:  

1 year of experience x 50% effort in HRPP/IRB administration = 6 months of eligible experience 

CIP® Eligible Experience 

Relevant HRPP experience requires substantial and ongoing performance within the last seven years of IRB administrative functions or duties relevant to an IRB office within a HRPP, which demonstrates a commitment to human subject protection:  

Conducting a review of materials submitted to the IRB—inclusive of completeness and accuracy   
Conducting expedited and exempt determinations  
Developing and providing education to IRB staff and the research community regarding the laws, regulations, and guidance documents on human subject protection  
Managing HRPP policies and procedures  
Managing research protocol approval or reliance process  
Managing review of noncompliance and unanticipated problems on behalf of the HRPP/IRB  
Monitoring and providing regulatory support and expertise during IRB meetings (e.g., monitoring quorum, documenting regulatory determinations, drafting IRB minutes, providing guidance on required determinations)

Please note that ‘managing’ encompasses administering, coordinating, executing and overseeing these tasks.  IRB chairs, members and organizational officials who perform these functions may have experience that meets the definition of relevant IRB experience and may be appropriate candidates to sit for the certification examination. Service as an IRB member is not, in and of itself, sufficient to fulfill the requirements for relevant IRB experience.  

Merely interacting with an IRB office on an occasional or even routine basis (as is common with sponsor personnel and study-site personnel working in study coordinator, study administrator, or investigator positions) does not meet the requirements for relevant HRPP experience for the CIP® certification program. The CIP® designation is not intended to be used as a means of qualification for HRPP related employment for applicants who do not have sufficient HRPP related work experience.  

Candidates must ensure their CV/resumé provides sufficient detail in demonstrating their relevant experience. 

Unsure of Your CIP® Eligibility? 

Candidates who are unsure of their eligibility may send their CV/resumé and their work verification form to certification@primr.org for review by the CIP Council.   

Work Verification Form

I am CIP® Eligible. What's Next? 

If the eligibility requirements are met, a candidate must then: 

Complete and file a CIP® Exam Application including a CV/resumé that clearly reflects responsibilities and experience in administering the core HRPP/IRB functions  and a signed work verification form  
Adhere to the Code of Ethics for Certified IRB Professionals in the CIP® Handbook  
Pay the required fee prior to taking the exam
For further information, please contact PRIM&R by email at certification@primr.org or by telephone at 617.423.4112, ext. 0.  

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