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Certified IRB Professional (CIP) ExamHow to Prepare
Tanna MacReynold, CIPIRO Assistant DirectorFred Hutchinson Cancer Research Center
June 2006
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Background
Bachelors of Science Degree6 Years IRB Experience
IRB AnalystIRB ManagerIRB Assistant Director
Took the CIP Exam March 2005
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Background Cont.
Training:CITIHuman Subjects Lecture (Speaker)Regional & National ConferencesLocal Ethics ClassesIRB Meetings
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Eligibility
Bachelor’s Degree + 2 years IRB experience within the past seven years, or
No Bachelor’s Degree but 4 years IRB experience within the past ten years
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CIP Code of Ethics
Professional conduct (Honesty, integrity)Prime consideration to human subjectsApply Belmont PrinciplesAdhere to laws/regulationsRespect rights and dignity of all (Cultural sensitivity)
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CIP Code of Ethics Cont.
Disclose COINo insider tradingConfidentiality and privacyContinuing educationFacilitate communication (Shared responsibility)
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Certified IRB Professional (CIP) ExamHow to Prepare
Register StudySleep
SacrificeShareTeam-up
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Learning Style
Four General Styles:Visual – Written Format
Note takingNonverbal – Picture or Design FormatKinesthetic – Hands on Activity
Two or more years experience criticalVerbal
Tape record notes
Identify your style:http://www.ldpride.net/learning_style.htmlhttp://www.engr.ncsu.edu/learningstyles/ilsweb.htmlhttp://www.chaminade.org/inspire/learnstl.htm
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Study Tools
Start a study notebook right away - OutlineMake copies of critical information so you do not have to search for it every time you studyOrganize by study focus groups
1. Foundations and Concepts of IRB Practice (25%)2. Organizational and Personnel Knowledge (15%)3. IRB Functions and Operations (45%)4. Records and Reports (15%)Include notes per topicStudy groups
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Identify Your Resources
Ask Management if there are study resourcesIndependent IRB officesResearch Centers & Academic Institutions
Who has taken the test?Pointers on what they studied and what they would do differentlyCan they mentor you – discuss questions & ask you questions Study Groups
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Identify Your Resources Cont.
Take any possible pre-tests to identify areas to work on:
IRB Management Function – ExamCollaborative IRB Training Initiative (CITI) exam or CD Rom exam
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Example Questions
Take 30 minutes and answer the questions
Check your answers – How did you do?
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Foundation & Concepts
HistoryResearch Ethics (Belmont, Professional codes, COI, Research Design Issues)Regulatory Applications and Audits, HIPAARegulatory Definitions
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Organizational & Personnel Knowledge
IRB Committee OrganizationInstitutional ConsiderationsIRB Office OrganizationEducational Programs
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IRB Functions & Operations
IRB Review Requirements
IRB Staff Review
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Records & Reports
RostersAudit/MonitoringPolicies & ProceduresAssurancesDocumentation – File MaintenanceRegulatory ReportsTraining Records
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What are areas to work on?
ChildrenPrisonersHIPAAFDA/non-FDAEquipoise
Emergency TreatmentBehavioral vs. ClinicalCertification of Confidentiality
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Study Focus
Current PracticeReview your policies and procedures
RegulatoryReview and know the regulations
45 CFR 46; 21CFR 11, 50, 54, and 56Review the “Frequently Asked Questions”
GuidanceOHRP Guidance: http://www.hhs.gov/ohrp/policy/index.html#topicsFDA Information Sheets: http://www.fda.gov/oc/ohrt/irbs/
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Study Focus Cont.
Current Practice should comply with Regulations and Guidance
Do not assume that current practice is always correctTest is regulation driven not institution practice driven
Ethical Principles (Read and re-read)Belmont ReportDeclaration of HelsinkiNuremberg Code
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Study Focus Cont.
Know how to APPLY the ethical principles and regulations to specific situationsUnderstand the IRB meeting process (ATTEND the meetings)Understand training requirements of Investigators, Members, and StaffKnow when Policies and Procedures are required to perform the IRB functions
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Set Timelines – 3 Months
Pre – testing
Studying
Testing after study
Prepare for the day of the test
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The Exam
Get plenty of rest the night beforeEat a good breakfastArrive earlyMake SURE to answer ALL of the questions
What is your style of taking a test?
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After the Exam
Second guess every answer – NOTHave an adult beverageAwait the results – two to four weeksScream and shout when you get the results that you passedOr , set a time to take the test a second time as soon as you can and focus your study on the areas where your score was the lowest – No limit to how many times the test can be taken
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Valid CIP Certification
Valid for 3 yearsRe-certification
Re-examination – every six yearsContinuing Education – 30 hours CE every three years or retake test
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A Few Resources
Institutional Review Board – Management and FunctionIRB – Management and Function Study GuideProtecting Study Volunteers in Research: A Manual for Investigative SitesCIP Handbook for Candidates
http://www.ptcny.com/PDF/CCIP2006.pdfBelmont Report, Declaration of Helsinki, and Nuremberg CodeRegulations/Guidance/Interpretations
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A Few Resources Cont.
FDA Information Sheets: http://www.fda.gov/oc/ohrt/irbs/
OHRP Guidance: http://www.hhs.gov/ohrp/policy/index.html#topics
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Questions ?