wisconsin irb consortium (wic): a model for multi-site irb review nichelle cobb, phd director,...

Wisconsin IRB Consortium (WIC): a model for multi-site IRB review

Nichelle Cobb, PhDDirector, Health Sciences IRBs

University of Wisconsin-Madison

Secretary’s Advisory Committee on Human Research Protections

October 19, 2010

A presentation on behalf of the members of the Wisconsin IRB Consortium by the CTSA

member institutions identified below

• URL: http://ictr.wisc.edu/

• URL: http://www.ctsi.mcw.edu/

WIC Background

• 2007 (January) - consortium development began– Participating WI institutions for first phase

• Aurora Health Care (Milwaukee)• Marshfield Clinic (Marshfield)• Medical College of Wisconsin (Milwaukee)• University of Wisconsin (Madison)

– More than one CTSA recipient involved

• 2009 (April) - single IRB authorization agreement for WIC formalized

WIC Goals

• Provide more effective and efficient oversight of multi-site human subjects research in Wisconsin

• Reduce administrative burden and costs for study teams and IRBs alike by identifying a single IRB of record for eligible studies when possible

• Facilitate collaborative research among partner institutions to increase investigator-initiated research

Progress Since Inception

• Developed SOPs that describe how research teams submit requests to use WIC and required content of requests

• Established point people at each institution to work with requests submitted through WIC

• Established quarterly meetings of founder institutions– Discuss issues that arise with WIC – Develop further SOPs and shared documents, including a draft

of a shared consent and HIPAA authorization form

• Developed a WIC-specific website: http://www.wicshare.com/joomla15/

WIC Volumes & Duplicate Review Reduction Data from April 2009-September 2010

14

11

6

26

7

17

6

29

0

5

10

15

20

25

30

35

Aurora Health Care Marshfield Clinic Medical College ofWisconsin

UW-Madison

# o

f s

tud

ies

Accepted Oversight

Deferred Oversight

Why WIC Worked

• Leadership at institutions involved committed to project

• Inter-institutional trust and flexibility– IRB offices were familiar with one another– Legal counsels able to come to agreement

• Key policies similar across institutions• Knowledgeable, experienced IRB staff who

understand regulatory requirements for multi-site research and sensitive to researcher needs

Challenges/Next Steps

• No additional resources provided to the IRBs for WIC– Protocol review work, SOP development done in addition to

current IRB staff activities – Looking for funding for a full-time position to support WIC

• Teaching research teams how to present multi-site studies to the IRB and setting expectations about multi-site research requirements

• Expansion from the founding group– Need resources to assess policies from institutions that wish to

join in future to ensure they are in line with WIC charter member standards

Acknowledgments

WIC has been an equal partnership amongst the four institutions involved in its inception.

Specific thank you to Linda Jaros at the Marshfield Clinic for compiling the data used in this presentation and to

Rebecca Marnocha at the University of Wisconsin-Madison for her detailed review of this presentation.

All WIC member institutions agreed to support this presentation to SACHRP.