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Comments on IRB Modeling Reflecting on Todays Discussion Comparing IRB Models for Multisite Pediatri

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Title: Comments on IRB Modeling Reflecting on Todays Discussion Comparing IRB Models for Multisite Pediatri


1
Comments on IRB ModelingReflecting on Todays
DiscussionComparing IRB Models for Multisite
Pediatric StudiesNational Center for Research
ResourcesNational Institute of Child Health
Human Development NIH Campus, Bethesda, MD,
USA23 April 2009
  • Francis P. CrawleyGood Clinical Practice
    Alliance EuropeStrategic Initiative for
    Developing Capacity in Ethical Review
    fpc_at_gcpalliance.org

1
2
The Vantage Point
  • Chair WG, Guidelines and Recommendations for
    European Ethics Committees (Brussels 1995, 1997)
  • Chair WG, Operational Guidelines for Ethics
    Committees That Review Biomedical Research (WHO,
    2000)
  • Past member UNAIDS ERC
  • Member, EORTC IRB Chair, INCTR IRB
  • Co-founder, Strategic Initiative for Developing
    Capacity in Ethical Review (SIDCER)EC Forums in
    Asia, Africa, Central Eastern Europe, Latin
    America (and national sub-forums)
  • Member, Ethics Working Group, European Academy of
    Paediatrics

3
An Appreciation of IRBs
  • 60 year history? the institutionalization of
    ethics
  • IRBs / Ethics Committees found in every country
    in the world today
  • IRB / ethical review practices around the world
    largely at the same level of development,
    regardless of the individual previous history
  • IRB /ethical review is a national practice?
    intimately related to other aspects of society

4
Modeling IRB Practices
  • A systematic national approach to (ethical)
    review is what is important at a certain point
    for the improvement of (ethical) review practices
  • Improving IRB practices within institutions and
    boards becomes increasingly limited without the
    development of a national system

5
IRB Roles Responsibilities
  • to assure the protection of human subjects? as
    a support to the integrity of the researcher
  • to provide public assurance of this protection
  • to provide institutional oversight and assurance
    of researchIRB ? Ethics Committee a need to
    develop alternative means within institutions to
    meet this requirement (see OHRP 5 March
    questions)
  • to facilitate / promote health research? 1st
    responsibility?

6
Transparency the Public
  • Transparency makes (health) research public and
    publicly accountable
  • NLM/FDA Public Meeting, NIH Campus, 20 April
    2009, on FDAAA and the development of the US
    clinical trials database (www.clinicaltrials.gov)
    for CT registration results publication?
    similar to the EU EudraCT other countries
    discussions

7
IRBs Public Research
  • A need to identify the role and responsibilities
    of IRBs in relation to www.clinicaltrials.gov(res
    earch registration results publication)
  • A need to limit the responsibilities of IRBs

8
A European Survey of EC Practices for Paediatric
Studies
  • Developed by the Good Clinical Practice Alliance
    Europe within RESPECT and in cooperation with
    TEDDY
  • The survey and its results will be shared with
    the NIH

9
Wherefore IRBsin Pediatric Research?
fpc_at_gcpalliance.org
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