Agreement
SMART IRB Agreement V3.0: Revisions to the SMART IRB Agreement
- Background
- 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?
- Reporting: How will reporting of noncompliance and unanticipated problems be handled by NIH?
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?
SMART IRB Version 3.0
- When did SMART IRB Version 3.0 Reliance Agreement launch?
- Is joining the SMART IRB Version 3.0 Agreement required?
- When did Joinder and Online Reliance System go off-line?
- I want to learn more about Version 3.0. Where should I go to find out more about the new agreement?
- Does my institution need to sign the Version 3.0 indemnification provision to join Version 3.0?
- How do I know if my institution or another institution joined SMART IRB Version 3.0 Agreement and the V3.0 Indemnification Addendum?
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
Optional Indemnification Addendum
- What is indemnification?
- Does my institution need to sign the Version 3.0 indemnification provision to join Version 3.0?
- What will happen to my institution’s existing indemnification agreements under Version 2.0 or 1.0?
- Can my institution be a signatory to the V3.0 Indemnification but limit its scope, i.e. not apply it to a given study?
- Can the limited scope include rendering the V3.0 indemnification addendum a one-way indemnification agreement?
Local Considerations
HIPAA
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?
- Single IRB requirements when the Reviewing IRB cannot rely upon the COI assurances from NIH
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?
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?