Council for Certification of IRB Professionals (CCIP)

1. Columbia University 2010 Institutional Review Board Annual Educational Conference - April 20, 2010 A Gathering for those Interested in Exploring the Certified IRB Professional (CIP) Credential: Your Chance to Ask Us About the Certification and Recertification Processes Susan J. Delano, CIP (Chair, CCIP)Corinne Rogers, MS, CIP

2. Certified IRB Professional (CIP)An Initiative of Public Responsibility in Medicine and Research (PRIMR)Currently 1,250 CIPshttp://www.ptcny.com/clients/CCIP/

3. 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

4. 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

5. 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

6. CIP ELIGIBILITY CRITERIAEducation and Experience • Bachelorsdegree or higher • 2 years “Relevant IRB Experience” within the past 7 years • If 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)

7. “Relevant IRB Experience” • Substantial and ongoing • Represents commitment to human subjects protection • Performance 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

8. Certification - what it is • Component 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

9. Certification - what it isn’t • An endorsement of a particular individual • A guarantee of the person’s qualifications to do a particular job

10. 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

11. 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 Findings http://www.hhs.gov/ohrp/compliance/

12. How Can You Benefit? • Encourages personal development • Promotes confidence in your knowledge and understanding of requirements • Required or desired job qualification for initial hire and/or promotion and/or pay increase • Become part of a community of CIPs

13. 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 questions • Can be found in the CIP Handbook at www.ptcny.com

14. Body of Knowledge • Foundations and Concepts of IRB Practice (25%) • Organizational and Personnel Knowledge (12%) • IRB Functions and Operations (45%) IV. Records and Reports (18%)

15. (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

16. (II): Organizational and Personnel Knowledge (12%) • IRB Committee Organization • IRB Office Organization • Institutional Considerations • Educational Programs

17. (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

18. (IV): Records and Reports (18%) • 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

19. Testing News • Currently 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.

20. Test Format • Approximately 250 multiple choice questions • Choose one answer - the correct or best answer • Questions vary in difficulty • Considerable effort is made to ensure that the questions are clear, relevant and current • There are no “trick” questions • All the information you need is in the question

21. Types of Questions • Direct questions, e.g. ethics, historical background, regulatory requirements • Questions 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.

22. Remember • The 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.

23. 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”.

24. 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.

25. 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

26. 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.

27. RE-CERTIFICATION • Certification is valid for 3 years • Re-certification by • Re-examination • 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

28. 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

29. 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

30. 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.

31. 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: ptcny@ptcny.com Web: www.ptcny.com