Certified IRB Professional (CIP)An Initiative of Public Responsibility in Medicine and Research (PRIMR)

Currently 1,250 CIPshttp://www.ptcny.com/clients/CCIP/

Council for Certification of IRB Professionals (CCIP)

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.

Staggered terms

Diverse representation

CCIP Mission Statement

EligibilityThe 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 CRITERIAEducation and Experience

Bachelors degree or higher 2 years “Relevant IRB Experience”

within the past 7 yearsIf no Bachelors degree

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”Substantial and ongoingRepresents commitment to human

subjects protectionPerformance of broad range of IRB

functions – regulatory compliance, IRB correspondence, documentation, managing IRB office, training

IRB chairs and members who also perform these functions may be eligible

IRB membership or interacting with IRB is not sufficient

Certification - what it isComponent of credentialing process

Focuses on the individual Meets professional experience

requirements Understanding of a body of knowledge at a

level that meets established standards

Peer recognition usually issued by a professional group

Certification - what it isn’t

An endorsement of a particular individual

A guarantee of the person’s qualifications to do a particular job

Why is Certification Important?

Sets a standard for professional knowledge

Helps assure adherence to regulatory requirements, best practices and ethical principles

Encourages professional development and continuing education

How your Institution/Organization Can Benefit

A professionally managed IRB can improve processing and review of applications, regulatory compliance and documentation.

For examples of problems that arise in IRB administration see OHRP: Common Compliance Oversight Findingshttp://www.hhs.gov/ohrp/compliance/

How Can You Benefit? Encourages personal developmentPromotes confidence in your knowledge and

understanding of requirementsRequired or desired job qualification for

initial hire and/or promotion and/or pay increase

Become part of a community of CIPs

What is Tested?Body of Knowledge (BOK)

Regulation-based and established practices

Reviewed by CCIP and revised as needed to accommodate new laws, regulations, guidelines

Drives exam questionsCan be found in the CIP Handbook at

www.ptcny.com

Body of Knowledge I. Foundations and Concepts of IRB

Practice (25%)

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%)

Historical Background

Research Ethics (Belmont, International

codes, Professional codes, COI, Research

Design Issues)

Regulatory Application and Audits, HIPAA

Regulatory Definitions

(II): Organizational and Personnel Knowledge (12%)

IRB Committee Organization

IRB Office Organization

Institutional Considerations

Educational Programs

(III): IRB Functions and Operations (45%)

Levels / Types of Review

Criteria for Approval of Research

Emergency Uses /Treatment Uses

Human Subject Private Information: Data, Documents, Records, Specimens

Subject Recruitment

Special Regulatory Requirements (fetuses, pregnant women, IVF, prisoners, children, emergency-setting)

International Research

Data and specimen repositories

Staff pre-screening and post-meeting communications/ review

Monitoring

(IV): Records and Reports (18%)

Written Policies and ProceduresAssurances and RegistrationRegulatory Reports (Internal/External)Audit Reports, Monitoring and Other

CommunicationsMeeting MinutesDocument and File MaintenanceArchiving RequirementsInformation ManagementTraining Records

Testing NewsCurrently 1,250 CIPs!Electronic testing. Availability of several hundred test sites

reduces travel and accommodation costs. 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.

Paper and pencil testing can be arranged to accommodate special needs.

Test FormatApproximately 250 multiple choice questions

Choose one answer - the correct or best answer

Questions vary in difficultyConsiderable effort is made to ensure that

the questions are clear, relevant and current There are no “trick” questionsAll the information you need is in the

question

Types of Questions Direct questions, e.g. ethics, historical

background, regulatory requirementsQuestions that require applying regulatory

and best practice requirements Questions about the best way to handle a

situation Brief scenario is presented. More than one

question follows.

RememberThe examination does not test on additional

institutional/organizational policies and procedures developed by individual IRBs.

You may be asked questions based on well established best practices and federal guidance.

Don’t “overthink” a question. Any information needed to answer the question is provided.

Choose the correct or “best” answer when prompted to do so.

How to Prepare Familiarity with the regulatory material

referenced in the Handbook.

Review of suggested reference materials.

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. Know where your IRB’s policies and procedures

or state laws/regulations impose additional requirements.

Many candidates have found study groups to be very helpful.

Connect with colleagues on networking sites such as LinkedIn which has a discussion group for CIPs.

Try the new online practice test.

Web Based Practice Examination

Approximately 75 questions - varying difficulty – immediate “test” results

Find out which areas you are strong or weak in See how questions are constructed Cost $50 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 Accessible to PRIM&R members A forum to connect with CIPs in your area, set up study

groups, discuss exam preparation To access the forum:

go to Discussion Forums via the PRIM&R home page click on 'Human Subjects' from the drop-down list. Click on link "PRIM&R's Online Communities" Scroll down to "Human Subject Protections" (Members

only) click on the CIP forum.

RE-CERTIFICATIONCertification is valid for 3 yearsRe-certification by

Re-examinationContinuing 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 re-certification

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 Corporation1350 Broadway, 17th Floor

New York, NY 10018

Phone: 212-356-0660Fax: 212-356-0678

E-mail: ptcny@ptcny.comWeb: www.ptcny.com