What Qualifies as 'Relevant HRPP 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, such as:
- Serving as a regulatory/technical resource during IRB meetings
- Supporting IRB meetings
- Preparing, reviewing and maintaining IRB correspondence and documentation
- Providing required ancillary services to the IRB such as conditions of approval, reconciliations, and tracking consent form changes
- Managing and/or supervising the office that provides support for the operation of the IRB
- Developing and implementing IRB policies and procedures
- Performing IRB directed reviews such as exemption determinations and expedited reviews
- Performing monitoring activities (audits) for/directed by the IRB
- Ongoing training of, and serving as a resource to staff, investigators, and IRB members on issues pertinent to the protection of human subjects
- Performing oversight activities of IRBs for or on behalf of a Common Rule agency.
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/resume provides sufficient detail in demonstrating their relevant experience.