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Oversight responsibilities in multisite projects: Problems of multiple reviews

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What role does each IRB have to play in review of multi-sites studies, assuming ... The current model is that all IRBs act in isolation and the PI is left with ... – PowerPoint PPT presentation

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Title: Oversight responsibilities in multisite projects: Problems of multiple reviews


1
Oversight responsibilities in multi-site
projects Problems of multiple reviews
  • Washington DC,
  • April 8 9, 2004

2
Issue 1
  • What role does each IRB have to play in review of
    multi-sites studies, assuming that the study has
    been approved by the lead centers IRB? E.g., how
    much can they revise the consent (revisions that
    are not related to local culture)? Can they
    revise the protocol?

3
Issue 2
  • Are there different responsibilities dependent
    upon the involvement of their investigators and
    risks to subjects at their facility? Could there
    be a different type of review dependent on the
    local involvement?

4
Issue 3
  • How can IRBs work collaboratively? The current
    model is that all IRBs act in isolation and the
    PI is left with having to reconcile competing
    requests.

5
Issue 4
  • The current system is also iterative, I.e.,
    reviews come in one at a time and there is no
    mechanism to put all the reviews together for a
    single, coherent response.

6
Issue 5
  • IRBs are often willing to address issues in ways
    that protect human subjects, while facilitating
    research, but often do not because of fears of
    reprisal. How can these fears of reprisal be
    addressed?
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