The SMART IRB Agreement

SMART IRB Agreement v2.0: NIH Revisions to the SMART IRB Agreement

• Background on SMART IRB Agreement v2.0
• Background: Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement v2.0 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?

See all 22 articles

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?

See all 31 articles

SOPs

• Is my institution required to use the SMART IRB SOPs?
• What are the SMART IRB Standard Operating Procedures?

Termination of Participation in SMART IRB

• If an institution terminates participation in SMART IRB, are there any ongoing rights and obligations?
• Can an institution’s participation in SMART IRB be terminated by another Participating Institution?
• How do we terminate our participation in SMART IRB?

Amendments

• If there are changes to the SMART IRB Agreement, do we need to re-execute the Joinder Agreement?
• Who is notified about updates to the SMART IRB Agreement?
• Can the SMART IRB Agreement be amended?

Insurance and Indemnification

• Are 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 have an indemnification provision?
• Why doesn’t the SMART IRB Agreement obligate Participating Institutions to carry specific types or amounts of insurance coverage?

IRB Fees

• Can my institution charge fees in connection with review activities conducted under SMART IRB?

Reporting

• Who reports unanticipated problems, serious/continuing noncompliance, and suspension/termination of IRB approval to sponsors and oversight agencies?

Investigations of Noncompliance

• Who investigates if there is a problem or noncompliance in research covered under the SMART IRB Agreement?

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?

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?

Local Considerations

• What laws and regulations must the Reviewing IRB consider?
• How do other “local considerations” (aka “local context” issues) get addressed under the SMART IRB Agreement?

Conflicts of Interest

• How are conflicts of interest of Research Personnel from federal Relying Institutions addressed under the SMART IRB Agreement?
• How are conflicts of interest of Research Personnel from non-federal Relying Institutions addressed under the SMART IRB Agreement?

HIPAA Privacy Rule

• Can a non-Covered Entity serve as Reviewing IRB for a Covered Entity?
• How does the SMART IRB Agreement handle HIPAA Privacy Rule determinations?

Investigator Compliance

• How does a Relying Institution ensure that its Research Personnel comply with the Relying Institution's obligations and the Reviewing IRB’s requirements and determinations?