Collaborations in research the common irb model
This presentation is the property of its rightful owner.
Sponsored Links
1 / 9

Collaborations in Research: The Common IRB Model PowerPoint PPT Presentation


  • 48 Views
  • Uploaded on
  • Presentation posted in: General

Collaborations in Research: The Common IRB Model. Secretary’s Advisory Committee on Human Research Protections October 19, 2010. Eric C. Mah IRB Director University of California – Davis [email protected] UC DAVIS UNIVERSITY OF CALIFORNIA. The Problem.

Download Presentation

Collaborations in Research: The Common IRB Model

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Collaborations in research the common irb model

Collaborations in Research:The Common IRB Model

Secretary’s Advisory Committee on Human Research Protections

October 19, 2010

Eric C. Mah

IRB Director

University of California – Davis

[email protected]


Collaborations in research the common irb model

  • UC DAVIS

  • UNIVERSITY OF CALIFORNIA


The problem

The Problem

A bureaucratic, regulatory obstacle of double IRB review at local VA & developing HRPP at prominent, neighboring children’s hospital

  • VA Northern California Health Care System

    • Local IRB with limited resources

    • Duplicative review for UC Davis faculty with joint appointments

  • Northern California Shriners Hospitals for Children

    • Lack capacity, expertise for a local IRB

    • Limited resources available for commercial IRB review


Va northern california uc davis

Opportunities

New relationship requires trust, communication

Eliminate a double IRB review

Save researcher, institutional resources

Faster site initiation

Streamline IRB review process

Risks/Threats

Unfamiliar VA structure, policies and bureaucracy

Additional administrative burden on UC Davis

Increased administrative costs for UC Davis

VA Northern California & UC Davis


Va northern california uc davis1

Opportunities

Expand research, collaboration in pediatrics

Support a neighbor institution

Save researcher, institutional resources

Faster site initiation

Risks/Threats

Shriners lacked a clear research compliance program

No COI review, etc.

Some researchers unaffiliated with UC Davis

UC Davis possibly exposed to significant liability

VA Northern California & UC Davis


Uc davis pathway to success

UC Davis’ Pathway to Success

VA

  • Established new workflows and business processes to adapt to local policies, procedures

    • 200+ studies avoid double IRB review

  • Significantly increased VA engaged research

    • Increase in CTSC-VA engaged studies from 5 to 39+

    • Increased VA research funding to $32 M

  • Offered cutting edge research to VA patients

  • Increased accrual to oncology trials for UC Davis NCI-designated cancer center

  • Clinical research resources that would not otherwise be available for both institutions


Uc davis pathway to success1

UC Davis’ Pathway to Success

  • Shriners Hospital

    • Education, conceptualization of a human research protection program

    • Established FWA, MOU with UC Davis

      • UC Davis also performs COIC review, as needed

    • 30+ studies reviewed on behalf of Shriners

  • The UC Davis CTSC played a pivotal role in partnering with VA & Shriners, building regional capacity


Uc davis results

UC Davis Results

  • Increased the number of available trials between the institutions

  • All stakeholders needs addressed through ongoing communication, open channels

    • Designated VA-UC Davis liaison

  • Efficiencies identified, resources preserved

    • Especially true for VA, Shriners, and UC Davis researchers

  • The rights and welfare of research subjects in no way compromised


Uc davis future

UC Davis - Future

  • Ongoing, shared commitment to human subjects protection

  • Identify other institutions and entities for collaboration, expansion

  • Creativity, open-mindedness, and willing to trust--ensures future successes


  • Login