The SMART IRB Agreement
SMART IRB Agreement v2.0: NIH Revisions to the SMART IRB Agreement
- Background on SMART IRB Agreement V3.0
- Background: Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement V3.0 necessary?
- Background: How will SMART IRB Agreement v2.0 allow NIH to collaborate with extramural organizations?
- Admninistrative Issues: If my institution has already joined SMART IRB Agreement v1.0, can my institution continue to use that Version 1.0?
- Administrative Issues: 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 v2.0?
- 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?
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?
SOPs
Termination of Participation in SMART IRB
Amendments
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?
IRB Fees
Reporting
Investigations of Noncompliance
Subject Complaints and Injuries
- 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?