Working With WIRB University of Alabama, Birmingham August 2009 Sherry Felchlin, Account Executive, Business Developme

1. Working With WIRBUniversity of Alabama, Birmingham August 2009 Sherry Felchlin, Account Executive, Business Development

2. History Established 1968 by Dr. Angela Bowen Fee for services began in 1981 First independent IRB to be accredited by AAHRPP in 2003, reaccredited 2006, completed second reaccredidation audit in 2009 Partnered with WHO for international fellows training program in 2003 Oldest, largest, and most experienced independent IRB in the world No financial relationships with sponsorsNo financial relationships with sponsors

3. WIRB LeadershipDr. Stephen Rosenfeld 19 years at NIH Clinical Associate Hematologist Aplastic Anemia clinical trial Viruses and bone marrow failure CIO Associate Director for Clinical Research Information Systems Clinical Research Information System (CRIS) I�ve included slides on my background because the audience can get a sense of the directions in which WIRB will be going by understanding what I �bring to the table.� In particular, I see the IRB as having two distinct parts � the board itself, and support of the board. The latter can be enormously improved by the application of formal process redesign and technology, but the challenges we will face (from both the board members and clients) will be similar to those I�ve faced implementing new technology (particularly EMRs) in other settings. Issues around, and approaches to, medical errors have a direct correspondence in performance of an IRB. Likewise, the medical quality movement has given us tools that we can use to manage change and improve performance in the IRB setting.I�ve included slides on my background because the audience can get a sense of the directions in which WIRB will be going by understanding what I �bring to the table.� In particular, I see the IRB as having two distinct parts � the board itself, and support of the board. The latter can be enormously improved by the application of formal process redesign and technology, but the challenges we will face (from both the board members and clients) will be similar to those I�ve faced implementing new technology (particularly EMRs) in other settings. Issues around, and approaches to, medical errors have a direct correspondence in performance of an IRB. Likewise, the medical quality movement has given us tools that we can use to manage change and improve performance in the IRB setting.

4. WIRB LeadershipDr. Stephen Rosenfeld 2 � years at Maine Health Largest IDN in Maine Incl. 600+ bed academic teaching hospital Physician CIO Community ambulatory EMR selection, implementation, evangelizing Technology adoption in Medicine Clinical/Research processes and �systems�

5. Business BoardExecutive Policy Committee Regulatory Medical Affairs QA / QC Operations IT Institutions Finance Corporate Counsel Board Chair Panel 1 � 14 Chairs Community Members 130 unaffiliated members Physicians 10 WIRB staff physicians Expedited Reviewers 12 reviewers & support staff

6. WIRB Panel Structure All protocols assigned to an individual panel Monday: Panels 1, 7 & 14 Tuesday: Panels 2 & 5 Wednesday: Panels 3, 11 & 14 Thursday: Panels 4, 12, & 13 Friday: Panels 6, 8, & 14 Bi-Weekly: Panel 10 (Canada) Daily � Investigator Focus Meetings Due to volume of the research oversight and to increase consistency of review, all protocols assigned to a specific panel which will review all issues related to the protocol through the life of the protocol. Discuss process of assignment of new protocol: dependent upon date of receipt and when determined to be complete, expertise of the panel members and when possible, related protocols. No initial review conducted through the expedited process. Panel 13 � DOD, EPA Panel 14 - limited to Phase One first in human, healthy volunteer IFM � describe criteria Due to volume of the research oversight and to increase consistency of review, all protocols assigned to a specific panel which will review all issues related to the protocol through the life of the protocol. Discuss process of assignment of new protocol: dependent upon date of receipt and when determined to be complete, expertise of the panel members and when possible, related protocols. No initial review conducted through the expedited process. Panel 13 � DOD, EPA Panel 14 - limited to Phase One first in human, healthy volunteer IFM � describe criteria

7. Institutions Institutions department provides a direct contact with your institution Consent form templates are negotiated to include required language and approved by WIRB Executive Policy Committee (EPC)

8. Submissions Initial Review forms Sponsor/CRO for multi-center protocol PI submitting for multi-center protocol Initial review of protocol and investigator Supplemental forms Waivers (partial waiver for recruitment, HIPAA, consent) Current forms are posted to www.wirb.com NEW � online submissions through smart forms Forms available on-line, can submit on-line or if there is an authenticated user account, submit through the authenticated site. First page of the submission is the check list of required documents Benefit of online submission is automatic acknowledgement of receipt Discuss the approvable review process Forms available on-line, can submit on-line or if there is an authenticated user account, submit through the authenticated site. First page of the submission is the check list of required documents Benefit of online submission is automatic acknowledgement of receipt Discuss the approvable review process

9. Approval Documents Certificate of Approval Board Action Date Panel assignment Site reporting frequency (e.g. semi-annually or quarterly) Continuing review frequency (e.g. annually or semi-annually) Detailed list of approved items Consent Form (s) Red-line of Consent Form Modifications Legend and Board Roster Supplemental Documents Recruitment material If lengthy list of submitted materials were reviewed, the �approval includes� section may carry on to the second pageIf lengthy list of submitted materials were reviewed, the �approval includes� section may carry on to the second page

10. Approval Document Distribution Investigator and all courtesy copy recipients E.g. coordinator, institution, sponsor / CRO Available electronically via e-mail and web portal or traditional paper delivery Sponsor document review prior to release to investigators can be implemented upon request

11. Submissions � After Initial Review On-going Research Change in Research / Subject Recruitment Submission Adverse Events Study Closure Current forms are posted to www.wirb.com

12. Unanticipated Problems WIRB policy considers two types Unanticipated Problems that are Adverse Events Unanticipated Problems that are Not Adverse Events

13. Unanticipated Problems That Are Adverse Events Adverse events are any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom or disease, temporally associated with the subject�s participation in the research. WIRB requires that an investigator report events that are: unanticipated possibly related and place subjects at a greater risk Events that meet this criteria should be reported within 10 days

14. Unanticipated Problems That Are NOT AEs These events still meet the criteria of unexpected, related or possibly related and suggest that the research may place subjects or others at greater risk. However, the events do not meet the criteria of an AE but may still adversely affect the rights, safety or welfare of subjects or significantly impact the integrity of research data. Planned protocol deviations should be reported prior to implementing as a change in research

15. WIRB Website WIRB Website � Home Page Updated announcements in the WIRB News section Current Forms available through �download forms� Secure On-line submissions WIRBNet Authenticated Website Provides a secure, on-line information portal for authenticated users. Confidential access to view organized information, on-line, at any time from anywhere

32. Ongoing Process Improvement Technology Web site redesign Smart forms Improved tele/video-conferencing Webinars Process 6 sigma/Lean evaluation Internal process optimization (ongoing)