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Review Services

IRB Services for International Research

Institutional Review Board (IRB)

Key Services

  • Protocol review and approval
  • Advisory review
  • Research oversight
  • Institutional biosafety committee (IBC), data monitoring committee (DMC), and endpoint adjudication committee (EAC) support
  • Global consulting

Comprehensive Review Options

Protocol Review

Advarra offers protocol review when a local ethics committee (EC) has already approved the project. This ensures compliance with U.S. regulations by assessing the protocol, making recommendations to protect participants, and issuing an approval document where applicable. This helps clarify review standards across multiple regions.

Advisory Review

If no local EC approval is available, Advarra provides an advisory review to evaluate your draft protocol. This review answers critical questions about study design, participant protections, and regulatory requirements, ensuring your materials align with U.S. standards and can be helpful to local ethics committees in their assessments.

Centralized Review

Advarra can oversee research in the U.S., Puerto Rico, and Canada, following centralized review models. Research conducted outside North America must be reviewed by local ECs, though Advarra offers resources to ensure U.S. compliance for studies spanning multiple regions, providing a cohesive oversight process.

Specialized Committees

Beyond IRB review, Advarra’s integrated services extend to IBC, DMC, and EAC. These additional services ensure international research complies with both safety and ethical standards through every phase of the study.

Need expert guidance to navigate international research regulations and compliance?

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