Using SMART IRB for a Study
- What laws and regulations must the Reviewing IRB consider?
- What constitutes a significant subject complaint that must be reported to the Reviewing IRB?
- Who is responsible for addressing a subject's complaint?
- 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?
- Why does the SMART IRB Agreement require Relying Institutions to report research-related injuries if the events do not also represent unanticipated problems?
- Who is informed when the Reviewing IRB makes a determination of serious and/or continuing noncompliance or suspends or terminates a study?
- 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?
- If study team members from a non-federal Relying Institution identify potential financial conflicts of interest after the study has received IRB approval, must they disclose this information to the Reviewing IRB?
- How do study team members from a non-federal Relying Institution communicate potential conflicts of interest and applicable management plans to the Reviewing IRB?
- Whose conflict of interest policies do a non-federal Relying Institution’s Research Personnel members follow?
- 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?
- In order 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?