Which statement best describes evidence about multi-jurisdictional minimal risk research?

Which statement best describes evidence about multi-jurisdictional minimal risk research?

• A. It requires official agreements between institutions.
• B. The single REB review model is mandatory.
• C. Any REB can act as the single reviewing REB.
• D. More REBs always increase participant protections.

Answer: (A)

In multicenter, minimal-risk research, the governance mechanism that makes cross-site ethical review workable is a formal reliance arrangement between participating institutions. These official agreements designate one Research Ethics Board to review the study for all sites, and they spell out how information, consent materials, amendments, and protections are harmonized across jurisdictions. This centralized approach depends on institutions signing and upholding those arrangements, ensuring consistent protections for participants wherever they are. That’s why this option fits best: it captures the requirement for an official agreement to enable a single reviewing REB across institutions. Without such agreements, you can’t reliably appoint one REB to oversee all sites, and other review models may be used only when such arrangements exist. The idea that the single-REB model is mandatory is not accurate, and saying any REB can act as the single reviewer ignores the need for a formal reliance arrangement. Likewise, more REBs do not automatically mean greater participant protections; they can complicate the process and lead to inconsistent protections if not coordinated.

In multicenter, minimal-risk research, the governance mechanism that makes cross-site ethical review workable is a formal reliance arrangement between participating institutions. These official agreements designate one Research Ethics Board to review the study for all sites, and they spell out how information, consent materials, amendments, and protections are harmonized across jurisdictions. This centralized approach depends on institutions signing and upholding those arrangements, ensuring consistent protections for participants wherever they are.

That’s why this option fits best: it captures the requirement for an official agreement to enable a single reviewing REB across institutions. Without such agreements, you can’t reliably appoint one REB to oversee all sites, and other review models may be used only when such arrangements exist. The idea that the single-REB model is mandatory is not accurate, and saying any REB can act as the single reviewer ignores the need for a formal reliance arrangement. Likewise, more REBs do not automatically mean greater participant protections; they can complicate the process and lead to inconsistent protections if not coordinated.