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Human Subject ResearchTown Hall
Georgia Regents University
January 16, 2013
Michael P. Diamond, MDAssociate Dean for Research, Medical College of Georgia
Vice President for Clinical and Translational Sciences
Agenda
1. GRU IRB Development & Highlights
2. Human Subject Research – Challenges
3. Human Subject Research Vision
4. Human Subject Research Initiatives - 2014
5. WIRB-Copernicus Group -
Dr. Stuart Horowitz, MBA, PhD
President Institutions and Institutional Services
6. GRU WIRB & IRBNET Highlights
7. GRU IRB Office – Improvements & Highlights –
Ivy Tillman, Director, GRU IRB Office
8. New GRU IRB Policies
9. Contact Information
2011 2012 2013 2014
Human Subject Research - Past Changes
1. eIRB
2011 2012 2013 2014
Human Subject Research - Past Changes
1. NEW IRB C - Cancer
1. eIRB
2011 2012 2013 2014
Human Subject Research– “Present” Changes
1. IRB B – Social Behavioral2. Office of Human Research Protection Renamed
to IRB Office 3. IRB Office - Staff Restructure4. Creation of Division of Clinical and Translational
Sciences5. Selection of new IRB electronic portal6. WIRB-Copernicus Agreement7. IRB Policies & Procedures
• Administrative Changes • Pre-review process• Many New & Revised Policies
1. NEW IRB C - Cancer
1. eIRB
Human Subject Research – Challenges
Human Subject Research – Challenges
1. IRBA. eIRB –
• Early version product - manufacturer marketed new product within 10 months of GRU’s purchase
• Not metric drivenB. Submission process is burdensome & time consuming
2. Rigorous” Policies3. Ancillary Approvals4. Unclear Research Initiation Process5. Clinical Trial Oversight, Budget Development, and Billing
2014
Human Subject Research – Future
Human Subject Research – Future
To Foster a Culture Conducive to, and Supportive of,
Research
2011 2012 2013 2014
Human Subject Research - Future
1. WIRB 2. IRBNet3. IRB Policies & Procedures4. Expedited Review Process5. Consent Language 6. Streamlined Research Initiation Process7. Locations for Research8. Clinical Trial Data Management System, Registry System9. Billing10.Research Website
WIRB & IRBNET
Stuart Horowitz, PhD MBAPresident, Institutions & Institutional Services
WIRB– Highlights
GRU has joined the National Research Network through the WIRB-Copernicus Group (WCG)
• Western Institutional Review Board (WIRB) • Copernicus Group IRB (CGIRB), • IRBNet, the top research compliance software supporting institutions.
WCG is the world's largest provider of regulatory and ethical review services for human research.
• 8 individual AAHRPP-accredited panels• 100+ experienced board members• 60+ years of combined experience in protocol and study-related review• Only ISO 9001:2008 Certified IRB
WCG can serve as the GRU IRB of record for commercially sponsored trials.
The nation's leading independent
institutional review boards
Site Visibility & Selection
AAHRPP Accreditation
Services
WCG Academy
Online Education Services
E-Consent
IRBNet
More than an IRB…A comprehensive ethical review solution
World-Class IRB Review
Services
UL- ComplianceWireLeading FDA
Online Courses
WIRB – At a Glance
• Founded in 1968 (first independent IRB)
• Network of nearly 750 leading research institutions that rely on WIRB review
• Currently managing over 10,000 protocols
• Over 125,000 protocols reviewed to date
• Only independent IRB with an international fellows program—trained over 120 fellows in 16 countries in partnership with WHO
• Ethical Review Clearinghouse for ex-US Research
• First independent IRB to earn AAHRPP accreditation
• Industry leading expertise – On staff
- 40 Certified IRB Professionals (CIP)
- 14 Regulatory Attorneys & Analysts
- 13 Physicians
“Single Review Solution”Providing the Industry’s Only Single Review Solution (SRS)
Our Approach – “SRS” CRO/Sponsor
CentralIRB
Local IRB Sites
Central IRB Sites
WIRB – Copernicus Group
The Usual ApproachCRO/
Sponsor
CentralIRB
Local IRB Sites
Central IRB Sites
CRO
Coordination
WIRB– Value Added
GRU has committed to utilize WIRB exclusively for Industry-sponsored clinical trials
Efficiency • Innovative “Single Review Solution”• Approximate 5 day approval time when full complete submission provided
Access• GRU will be provided the opportunity to connect with the world’s leading
sponsors and CROs and to expand our repertoire of industry sponsored clinical trials.
• Access to private funding through the top industry sponsors and CRO’s
Oversight• 1 IRB-portal for managing, reviewing, submitting human subject research for
WIRB (industry sponsored clinical trials) and IRB A, IRB B, and IRB C.
GRU TRANSITION TO WIRB & IRBNET
WIRB - External IRB Existing/Active Industry Sponsored Trials
Existing and Active Studies for which Chesapeake IRB (CIRB) is the IRB of record will be transferred to WIRB unless:
• The study is schedule to close within the next ~3 months
• The sponsor explicitly refuses to transfer the protocolGRU Industry Sponsored Clinical Trials at Chesapeake IRB
CIRB & GRU APPROVED
CIRB Approved, GRU Ancillary
Approvals Pending
Submitted to CIRB TOTAL
Previously Reviewed by WIRB
41 9 1 51
New to WIRB 7 1 0 8TOTAL 48 10 1 59
WIRB - External IRB Existing/ Active Industry Sponsored Trials
Process for Transferring Studies• Telephone contact with Sponsor/CRO to discuss this change • Letter to Sponsor/CRO to notify of change and requesting response
- Telephone scripts, and letter templates are available, please contact EXTERNAL_IRB@GRU.EDU for templates and support with process.
• Individual training / support to the Study Team to assist with transfer Individual Protocol Submission Form
WIRB Multi-site application – 51 studies WIRB New Study application – 8 studies
IRB submission and current status information submitted to Chesapeake IRB
Support staff are available to support and facilitate transition!
WIRB - External IRB New Industry Sponsored Trials
All New IRB Submissions for Industry Sponsored Clinical Trials will be submitted to WIRB via IRBNet
Training on WIRB Processes• Commenced Jan 15th • January 22nd 3:00 p.m. – 5:00 p.m. – Greenblatt Library• January 29th 3:00 p.m. – 5:00 p.m. – Greenblatt Library• Individual training will be offered on a continuing basis
by contacting GRU IRB Office at EXTERNAL_IRB@GRU.EDU
WIRB Fees• New fee structure• Sponsor will be billed directly from WIRB• Competitive and may be cheaper particularly for multi-
center trials.
GRU IRB Office • Will continue to provide Education, Training and
Compliance services. • Fee for this service is being reviewed• On-site resource for WIRB
WIRB - External IRB New Industry Sponsored Trials
GRU IRB Office - IRB A, B, C
IRBNet • Will replace eIRB - Goal: March Go Live! • Training commencing in February 2014• Single portal for submitting to WIRB & GRU IRB A, B, and C• Single Sign-On• Website hosted – accessible anywhere! – www.irbnet.org• Simple for external collaborators and new users via
-“Create your account”• Integrated tracking of CITI training• Streamlined submission process• Same “look and feel” for GRU IRB Submissions and WIRB
submissions• Metrics Friendly
• Existing protocols will be migrated into IRBNET
GRU IRB Office - IRB A, B, C
GRU IRB Office will continue to provide • Education• Training • Compliance services• Support for IRB Committees A, B, and C• New - Expedited Review Process
IRB Name Submission Deadline
Meeting Date
IRB A – Biomedical Feb 26 March 12March 19 April 2
IRB B –Social, Behavioral, and Educational
Feb 18 March 4March 18 April 1
IRB C - Cancer Feb 28 March 19April 2 April 16
GRU IRB Office - IRB A, B, C Submission Dates
GRU IRB Office - IRB A, B, C Submission Dates
Last Day for access to eIRB – Wednesday in February/March at 5 pm.
First Day for access to IRBNET – following Monday, March at 8 am.
Specific transition dates will be communicated.
Emergency issues during the transition time sent directly to the IRB Office at:
email: IRB@GRU.EDU phone: 706-721-3110
GRU IRB OFFICEPolicy Updates
Ivy Tillman, MSDirector
Institutional Review Board (IRB) OfficeGeorgia Regents University
GRU IRB Office - Changes to IRB Office
Changes to IRB Office
IRB A (Biomedical) Administrator- Rebecca Miller
IRB B (Social/Behavioral) Administrator- Casey Glover
IRB C (Cancer) Senior Administrator- Angela Toole
External IRB and VA IRB Administrator- Michelle Harper-
Meriwether
GRU IRB Office - Changes to Submission Process
Changes to IRB Submission Process
1. Administrative Changes• Misspellings• Punctuation • Formatting • Witness/LAR signature line removal• Enterprise name changes
2. Pre-review process simplified
3. Expedited Review Process
New Policies
1. Guideline for Roles of Non-Faculty, Non-Georgia Licensed
Physicians
2. Clinical Trials Registration
3. GRU Research Studies Involving Investigational Agents at Non-
Georgia Regents Medical Center Sites
4. Department Chair Responsibilities
GRU IRB Office - New Policies
Revised Policies1. Reportable Events
2. Engagement in Human Subjects Research
3. IRB Operations
4. Investigational Drugs
5. Exempt protocols
6. Research Conducted at the Charlie Norwood VA Medical Center
7. Study Coordinator Responsibilities
8. Continuing Review
GRU IRB Office - Revised Policies
Questions?
Michael P. Diamond, MDAssociate Dean for Research, Medical College of Georgia
Vice President for Clinical and Translational Sciencesmichael.diamond@gru.edu or CTS@gru.edu
706-721-6395
Ivy Tillman, MSDirector
Institutional Review Board (IRB) Office706-721-3110
itillman@gru.edu or IRB@GRU.EDU
Michelle Harper-MeriwetherExternal IRB and VA IRB Administrator
mharpermeriwethe@gru.edu706-721-1478
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