Certified IRB Manager Examination

The IRB Manager Certification is designed specifically for individuals who are responsible for the oversight and management of Human Subjects’ Protection Programs. IRB Managers and IRB Administrators 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 Manager Examination, applicants must meet the following requirements:

  • Must currently be employed in the area of Research Compliance
  • Must have a Bachelor’s Degree and 2 years of relevant IRB Management experience within the last 5 years.
    OR
  • An Associates Degree from a two year college or technical school and 2 years of relevant IRB Management experience within the last 5 years.
    OR
  • A High School Diploma equivalent with 3 years of relevant IRB management experience within the last 5 years.

IRB Manager Experience

The experience of the IRB Manager must reflect an ongoing commitment to the protection of human subjects and research ethics. The IRB Manager experience could include a combination of any of the following:

  • Responsible for the oversight of the Human Subjects’ Protection Program or Research Program.
  • Serves as a resource for Federal and State Regulations, Institutional Policies and regulatory compliance issues as they relate to human subjects research.
  • Attends IRB Meetings.
  • Manages professional and administrative IRB staff.
  • Organizes and presents training and educational activities.
  • Develops and implements new policies and procedures.

Examination Development

The Certified IRB Manager 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 CIM® Examination?

  • The CIM® Certification Examination is administered online.
  • 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 Manager Examination click here and complete the Application Form online.

Recertification

  • The CIM® 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 CIM® examination consists of 150 questions presented in a multiple choice and true or false format.
  • Questions on the examination test knowledge and practical application of regulations and guidance documents.
  • The examination is open book. You may use your 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
  • IRB Management
  • 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.