Agreement

Version 3.0 essentials

• What's new in Version 3.0
• Key dates and the transition from V1.0/V2.0
• V3.0 transition: key dates
• Check an institution's V3.0 status
• Consortia and designated central IRBs
• What research can be reviewed under the Agreement?

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Running a ceded study

• Selecting the Reviewing IRB
• Flexible review when an institution has "unchecked the box"
• Consent documents: templates and site-specific language
• Local Considerations and Other Considerations
• Continuing review and lapses
• Amendments and personnel changes

See all 10 articles

SOPs and policies

• The SMART IRB SOPs: what they are and when they apply
• Default vs. flexible implementation

HIPAA

• How HIPAA works under Version 3.0
• Can a non-Covered Entity serve as Reviewing IRB for a Covered Entity?

Conflicts of Interest

• COI for non-federal Relying Institutions
• COI when a federal agency is a Relying Institution

Grant congruence review

• Grant congruence review under Version 3.0

Insurance and Indemnification

• The optional Indemnification Addendum
• Representations and warranties
• The insurance requirement

Reporting, complaints, and noncompliance

• Noncompliance, investigations, and audits
• Subject complaints and injuries
• Who reports to OHRP, FDA, sponsors, and funders
• Notifying other institutions of federal for-cause investigations

Legal provisions

• Section 8.11: No Violation of Law
• Working together when there is a dispute or breach
• Governing law and venue
• How the Agreement is amended

Ending Participation

• Terminating your institution's participation
• Automatic termination and the grace period
• What survives termination