The SMART IRB Agreement
Learn more about the nation's premier reliance agreement
SMART IRB Agreement V3.0: Revisions to the SMART IRB Agreement
- Background on SMART IRB Agreement V3.0
- Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement V3.0 necessary?
- How did SMART IRB Agreement v2.0 allow NIH to collaborate with extramural organizations?
- If my institution has already joined SMART IRB Agreement V1.0 or V2.0, can my institution continue to use that Version of the Agreement?
- My institution is not serving as a Reviewing IRB for the NIH nor is it ceding IRB review to the NIH Intramural Research Program IRB. Does my institution need to sign SMART IRB Agreement V3.0?
- Administrative Issues: If my institution serves as a Reviewing IRB for the NIH engaged and for other institutions engaged in the Research, would all of the institutions engaged in that Research need to sign SMART IRB Agreement v2.0?
Scope of Covered Research
- What types of research can be reviewed under SMART IRB?
- Can SMART IRB be used for exempt studies?
- Is the SMART IRB Agreement in compliance with the revised Common Rule, including the cooperative research provision (45 CFR 46.114(b))?
- Can SMART IRB Participating Institutions participate in other IRB reliance agreements?
- How do institutions determine which studies will use the Agreement?
- Are institutions required to cede review or serve as a Reviewing IRB?
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?
SOPs
Local Considerations
HIPAA Privacy Rule
Conflicts of Interest
- How are conflicts of interest of Research Personnel from federal Relying Institutions addressed under the SMART IRB Agreement?
- 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?
- How are conflicts of interest of Research Personnel from non-federal Relying Institutions addressed under the SMART IRB Agreement?
- How do the changes in the conflict of interest provisions reflected in SMART IRB Agreement v2.0 affect institutions that are not collaborating with a federal agency?
Federal Grant Congruency Review
- Why does SMART IRB Agreement v2.0 include the potential for the Reviewing IRB to review the congruence of a grant application/proposal with a research protocol?
- Why does the SMART IRB Agreement v1.0 require the Reviewing IRB to perform federal grant congruency review?
- Congruence of Grant Applications/Contract Proposals: Why does SMART IRB Agreement v2.0 retain Section 5.15, Congruence of Grant Applications/Contract Proposals?
Insurance and Indemnification
- Are local, state, or federal agencies subject to the insurance provision in the SMART IRB Agreement?
- Guidance Regarding Scope of Review Provision of the Trial Innovation Network (TIN) Letter of Indemnification (LOI)
- Does the SMART IRB Agreement contain any "representations and warranties" by the parties or, disclaimers of representations and warranties?
- Why doesn’t the SMART IRB Agreement require Participating Institutions to carry specific types or amounts of insurance coverage?
- Can NIH provide additional detail specifying which people affiliated with NIH are (or are not) covered under NIH’s federal liability coverage?
- How does the addition of the footnote in SMART IRB Agreeemnt v2.0, Section 4.10, Insurance, affect the Agreement’s insurance provision?
Subject Complaints and Injuries
- What constitutes a significant subject complaint that must be reported to the Reviewing IRB?
- Who is responsible for addressing a subject's complaint?
- Why does the SMART IRB Agreement require Relying Institutions to report research-related injuries if the events do not also represent unanticipated problems?
- Why is the Relying Institution responsible for ensuring consistency in financial coverage for research-related injuries between the approved protocol and consent form and the provisions of a grant or contract?
- Why does the SMART IRB Agreement require Site Investigators to notify the Reviewing IRB of any subject complaints and any subject injuries?
- What is a "significant" subject complaint as contemplated by the Agreement?