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  1. SMART IRB Support Center
  2. The SMART IRB Agreement
  3. Using SMART IRB for a Study

Using SMART IRB for a Study

  • If one of the Relying Institutions does not submit the necessary information for continuing review in advance of the expiration date, will all Relying Institutions be affected?
  • If the Reviewing IRB requests an audit of a study conducted at a Relying Institution, will the Relying Institution receive documentation that the audit was conducted, regardless of the result?
  • What if an amendment could be affected by state law or other local institutional requirements?
  • How is it ensured that all study teams are aware of new amendments and know when the Reviewing IRB has approved them?
  • Does the Relying Institution have a role in the review of amendments (changes of protocol)?
  • How are changes in study personnel handled?
  • What if a change of protocol only affects one or some of the participating sites?
  • Who is responsible for submitting amendments (changes of protocol) to the Reviewing IRB?
  • What if my institution wants to see the minutes for a study we ceded to a Reviewing IRB?
  • If study team members from a non-federal Relying Institution identify potential financial conflict of interests relevant to the research reviewed by the Reviewing IRB, do they have to disclose this information to their local IRB?
  • Who ensures the subject-injury language in a consent document is consistent with language in the grant/contract?
  • When is local language inserted into the consent documents?
  • Can Relying Institutions use their own template consent form?
  • How will any outstanding concerns/requirements and/or local context issues be addressed?
  • To satisfy the SMART IRB eligibility criteria, does my institution need to require IRB review and institutional oversight for exempt human subjects research?
  • Can an institution that has "unchecked the box" on its FWA and agreed to serve as Reviewing IRB for a non-federally funded study apply a flexible approach to the review?
  • Can there be more than one Reviewing IRB for a study under the SMART IRB Agreement?
  • Once oversight of a study has been ceded to the Reviewing IRB, can an institution take back IRB oversight?
  • What if the IRB at the Overall PI's institution declines to serve as the Reviewing IRB?
  • Can an IRB from an institution that is not conducting a particular study be the Reviewing IRB for that study?
  • Is the IRB at the Overall PI’s institution required to be the Reviewing IRB for a study proposed by that PI?
  • How is the IRB of Record (Reviewing IRB) for a study selected?
  • I want to use SMART IRB for a study I am conducting, what do I do?
SMART IRB Support Center