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