Oversight responsibilities in multisite projects: Problems of multiple reviews

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Oversight responsibilities in multi-site
projects Problems of multiple reviews

• Washington DC,
• April 8 9, 2004

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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?

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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?

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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.

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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.

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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?