Certified IRB Coordinator Examination
The IRB Coordinator Certification is designed specifically for individuals involved in coordinating clinical trials.
IRB Coordinators working in academia or community hospital IRBs, Independent IRBs or other institutions or facilities involved in conducting research may be eligible.
Qualifications
To qualify for the Certified IRB Coordinator Examination, applicants must meet the following requirements:
- Must currently be employed in the area of research compliance
- Must have 2 years of relevant IRB Experience within the last 5 years
- Must have a minimum of a High School diploma or equivalent, or an Associates Degree from a two year college or technical school.
IRB Coordinator Experience
The experience of the IRB Coordinator must reflect an ongoing commitment to the
protection of human subjects and research ethics. The IRB Coordinator experience could
include a combination of any of the following:
- Serves as a resource and provides information on Federal and State Regulations and Institutional Policies that relate to human subjects research to investigators, staff and IRB members.
- Coordinates and attends IRB Meetings.
- Reviews new protocol submissions in accordance with OHRP and FDA Regulations.
- Participates in education activities for investigators, staff and IRB members.
Examination Development
The Certified IRB Coordinator Examination was developed by a group of senior individuals all with experience and expertise in the field of human subjects’ protection, research compliance, regulatory affairs, IRB systems, IRB management and HIPAA.
How Do I Sign Up to Take the CIC® Examination?
- The CIC® Certification Examination is administered online the first Monday of every month.
- Applicants will have one week or seven calendar days to complete the examination.
- The number of times you can log in to the examination is unlimited.
To apply for the Certified IRB Coordination Examination click here and complete the Application Form online.
Recertification
- The CIC® Certification must be renewed every 3 years.
- Recertification can be completed by obtaining 30 continuing education credits (CECs).
- The examination must be retaken every 6 years.
- To access Recertification Information click here.
Examination Content
- The CIC® examination consists of 100 questions presented in a multiple choice and true or false format.
- Questions on the examination test knowledge and practical applications of regulations.
- The examination is open book. You may use any available resources to complete the examination.
The examination content includes:
- Regulatory Requirements including Special Categories
- Informed Consent Requirements
- Research History
- Research/Medical Ethics Considerations
- IRB Administration
- Guidance Documents
- FDA and DHHS Regulatory Differences
- HIPAA Requirements
- Common Rule
Examination Resources
Regulations
21 CFR – Parts 50, 56, 312 and 812
http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm
45 CFR – Part 46
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
Ethical Resources
The Belmont Report
http://www.hhs.gov/ohrp/policy/belmont.html
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Nuremberg Code
http://www.hhs.gov/ohrp/archive/nurcode.html
Declaration of Helsinki – Current Version
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Guidance Documents
FDA Information Sheets –
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/…
OHRP IRB Guidebook
http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
HIPAA References
http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html
Management
Bankert, E. A. and Amdur, R.J. (2006). Institutional Review Board: Management and Function. Second Edition.
Sudbury, MA: Jones and Barlett Publishers.