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:
- Managing Human Research Protection Program (HRPP) policies and procedures
- Managing pre-review of IRB materials
- Managing review of IRB materials
- Managing exempt study review determinations
- Managing research protocol approval or reliance process
- Managing regulatory documentation
- Managing IRB records and databases
- Facilitating IRB meeting (e.g., ensure quorum, distribute meeting materials)
- Developing and provide education on IRB regulations and processes
- Providing consultation on IRB submission
- Monitoring for changes in federal regulations and guidance
- Managing review of noncompliance and unanticipated problems
- Managing IRB meeting minutes
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.