Document 2593490

Certified IRB Professional (CIP)
An Initiative of Public Responsibility
in Medicine and Research (PRIMR)
Currently 1,250 CIPs
http://www.ptcny.com/clients/CCIP/
Council for Certification of IRB
Professionals (CCIP)
l 11 members (all CIP).
Current Members: Heather Butts, Lynn Bevan,
Gary Chadwick, Susan Delano (Chair), Paul
Goebel, Erica Heath, Moira Keane (Vice-Chair),
Greg Lim, Kathy Schulz, Dan Voss, Wanda
Quezada.
l Staggered terms
l Diverse representation
The mission of the CCIP is to provide
certification of IRB professionals through
its credentialing process and to advance
the quality of human subject protection
programs.
CCIP Mission Statement
Eligibility
 The CIP certification is for individuals participating in
and overseeing the daily activities associated with an
IRB.
 It is not for individuals interacting with an IRB as
sponsor or study site personnel.
 Service as an IRB member is not sufficient to fulfill the
eligibility requirements
CIP ELIGIBILITY CRITERIA
Education and Experience
l Bachelors degree or higher
l 2 years “Relevant IRB Experience” within the
past 7 years
l If no Bachelors degree
l 3 years “Relevant IRB Experience” within the
past 7 years (CHANGE please note: prior to 2010,
examination experience was to be obtained within past 10 years)
“Relevant IRB Experience”
l Substantial and ongoing
l Represents commitment to human subjects
protection
l Performance of broad range of IRB functions –
regulatory compliance, IRB correspondence,
documentation, managing IRB office, training
l IRB chairs and members who also perform these
functions may be eligible
l IRB membership or interacting with IRB is not
sufficient
Certification - what it is
l Component of credentialing process
l Focuses on the individual
l Meets professional experience requirements
l Understanding of a body of knowledge at a level
that meets established standards
l Peer recognition usually issued by a
professional group
Certification - what it isn’t
l An endorsement of a particular individual
l A guarantee of the person’s qualifications to do
a particular job
Why is Certification Important?
l Sets a standard for professional knowledge
l Helps assure adherence to regulatory
requirements, best practices and ethical
principles
l Encourages professional development and
continuing education
How your Institution/Organization
Can Benefit
l A professionally managed IRB can improve
processing and review of applications, regulatory
compliance and documentation.
l For examples of problems that arise in IRB
administration see OHRP: Common Compliance
Oversight Findings
http://www.hhs.gov/ohrp/compliance/
How Can You Benefit?
l Encourages personal development
l Promotes confidence in your knowledge and
understanding of requirements
l Required or desired job qualification for initial hire
and/or promotion and/or pay increase
l Become part of a community of CIPs
What is Tested?
Body of Knowledge (BOK)
l Regulation-based and established practices
l Reviewed by CCIP and revised as needed to
accommodate new laws, regulations, guidelines
l Drives exam questions
l Can be found in the CIP Handbook at
www.ptcny.com
Body of Knowledge
I.
Foundations and Concepts of IRB
(25%)
Practice
II.
Organizational and Personnel
Knowledge (12%)
III.
IRB Functions and Operations (45%)
IV.
Records and Reports (18%)
(I): Foundations and Concepts of IRB
Practice (25%)
l Historical Background
l Research Ethics (Belmont, International codes,
Professional codes, COI, Research Design Issues)
l Regulatory Application and Audits, HIPAA
l Regulatory Definitions
(II): Organizational and Personnel
Knowledge (12%)
l IRB Committee Organization
l IRB Office Organization
l Institutional Considerations
l Educational Programs
(III): IRB Functions and Operations
(45%)
l
Levels / Types of Review
l
Criteria for Approval of Research
l
Emergency Uses /Treatment Uses
l
Human Subject Private Information: Data, Documents, Records,
Specimens
l
Subject Recruitment
l
Special Regulatory Requirements (fetuses, pregnant women, IVF,
prisoners, children, emergency-setting)
l
International Research
l
Data and specimen repositories
l
Staff pre-screening and post-meeting communications/ review
l
Monitoring
(IV): Records and Reports (18%)
l
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l
l
l
l
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Written Policies and Procedures
Assurances and Registration
Regulatory Reports (Internal/External)
Audit Reports, Monitoring and Other
Communications
Meeting Minutes
Document and File Maintenance
Archiving Requirements
Information Management
Training Records
Testing News
l Currently
1,250 CIPs!
l Electronic testing.
l Availability of several hundred test sites reduces
travel and accommodation costs.
l Testing occurs twice a year during two week
windows. (March 6-20 and September 11-25 in
2010). Test takers are able to select a day and time
that is convenient.
l Paper and pencil testing can be arranged to
accommodate special needs.
Test Format
l Approximately 250 multiple choice questions
l Choose one answer - the correct or best answer
l Questions vary in difficulty
l Considerable effort is made to ensure that the
questions are clear, relevant and current
l There are no “trick” questions
l All the information you need is in the question
Types of Questions
l Direct questions, e.g. ethics, historical background,
regulatory requirements
l Questions that require applying regulatory and best
practice requirements
l Questions about the best way to handle a situation
l Brief scenario is presented. More than one question
follows.
Remember
l The examination does not test on additional
institutional/organizational policies and procedures
developed by individual IRBs.
l You may be asked questions based on well established
best practices and federal guidance.
l Don’t “overthink” a question. Any information needed
to answer the question is provided.
l Choose the correct or “best” answer when prompted to
do so.
How
to
Prepare
l Familiarity with the regulatory material referenced in the
Handbook.
l Review of suggested reference materials.
l Test yourself to find out what you don’t know. "Protecting
Study Volunteers in Research" by Dunn and Chadwick has
52 multiple choice questions in the back and a Study Guide
Workbook is available to accompany Bankert and Amdur’s
“Institutional Review Board Management and Function”.
How to Prepare cont.
l Know where your IRB’s policies and procedures or state
laws/regulations impose additional requirements.
l Many candidates have found study groups to be very
helpful.
l Connect with colleagues on networking sites such as
LinkedIn which has a discussion group for CIPs.
l Try the new online practice test.
Web Based Practice
Examination
l Approximately 75 questions - varying difficulty –
immediate “test” results
l Find out which areas you are strong or weak in
l See how questions are constructed
l Cost $50
l Available on the CIP area of the PTC website
http://www.ptcny.com/clients/CCIP/index.html#Dates1
PRIM&R Online Community for CIP
Discussion
l Accessible to PRIM&R members
l A forum to connect with CIPs in your area, set up study groups, discuss
exam preparation
l To access the forum:
l go to Discussion Forums via the PRIM&R home page
l click on 'Human Subjects' from the drop-down list.
l Click on link "PRIM&R's Online Communities"
l Scroll down to "Human Subject Protections" (Members only)
l click on the CIP forum.
RE-CERTIFICATION
l Certification is valid for 3 years
l Re-certification by
l Re-examination
l Continuing Education
 CE may be used for one renewal then the
examination must be taken for the next renewal
 If there is more than a 6 months lapse of
certification you cannot renew by CE and must
take the examination to recertify
Recertification by Continuing
Education

30 documented hours of CE - at least 15 hours carrying
credits from a recognized accrediting body – this
conference counts!

CE must be within the Body of Knowledge (Content
Outline) and generally beyond initial, basic,
fundamental training

CE must be obtained after the date the examination was
passed

Training that you conduct cannot be used
Documentation

You must have documentation of continuing education:
 Obtain certificates of attendance with dates and hours,
keep a copy of the agenda with topics, speakers, hours,
and information about available CE credits.
 If you cannot obtain formal documentation of
participation (e.g., a certificate) you must have a log of
events with supporting documentation to show topics,
speakers, dates, hours, and information about available
CE credits. Advise obtaining witness signature to verify
participation.

Documentation must be kept for at least 3 years after recertification
Having Trouble finding low cost CE?
A suggestion that is free.

NIH Bioethics Webcasts
http://videocast.nih.gov/pastEvents.asp?c=0&s=1




Choose topics that are within the Body of Knowledge (Content Outline),
beyond basic training
Keep information about the topics, speakers, hours, and information about
available CE credits
Keep a log of viewing
Have your supervisor or other appropriate person sign the log entry to
confirm that you viewed the webcast. Include date and hours.
More Information on Certification as an
IRB Professional (CIP)
Professional Testing Corporation
1350 Broadway, 17th Floor
New York, NY 10018
Phone: 212-356-0660
Fax: 212-356-0678
E-mail: [email protected]
Web: www.ptcny.com