Local Considerations and Other Considerations

Applies to: Agreement V3.0

The Reviewing IRB reviews to federal human subjects rules. The Relying Institution supplies everything else. That division of labor is the heart of the Agreement, and Version 3.0 sharpened it.

What the Reviewing IRB is responsible for. Reviewing the study in accordance with the Common Rule, FDA regulations, and any other federal human subjects protection regulations that apply to the study. The Reviewing IRB must take into account any local requirements the Relying Institution communicates to it, but it is not responsible for identifying or interpreting those requirements. Reviewing IRBs are expected to be familiar with the Common Rule and FDA regulations — not with every state law or federal program rule that might touch a study.

What the Relying Institution is responsible for (§6.6). Identifying, interpreting, and communicating to the Reviewing IRB — before review and throughout the study — two categories of requirements that would affect the conduct or approval of the research at its site:

• Local Considerations: state and local laws and regulations, institutional policies and standards, local ancillary reviews, restrictions on the use and disclosure of PHI, and other local factors. (Definition: Exhibit A.)
• Other Considerations (new term in Version 3.0): requirements of federal laws, regulations, departments, or agencies that are not readily apparent from the IRB submission or that are specific to the Relying Institution — for example, 42 CFR Part 2 on substance use disorder treatment records, or a federal funder's department-specific consent requirements. HIPAA is handled separately and is not an "Other Consideration."

The Relying Institution ultimately determines whether the research, as reviewed and approved by the Reviewing IRB, meets its local requirements. Relying Institutions should make sure these requirements are communicated by people who know them — typically the Point of Contact working with the local study team, compliance office, or counsel.

How to communicate them. In the Reliance System, sites attach local considerations (free text and PDFs) when they indicate willingness to rely; the Reviewing IRB receives them by email. Institution-wide, standing requirements belong in your Institutional Profile. The Harmonization Steering Committee's Recommendations for the Harmonization of Local Considerations and Study-Specific Document give a common format.

Consent language. When a Relying Institution needs specific consent language to comply with a legal, regulatory, federal agency-specific, or institutional requirement, it provides that language to the Reviewing IRB, which must consider the request (§5.6). See Consent documents: templates and site-specific language.

HIPAA. Handled by the Relying Institution under Version 3.0 — see How HIPAA works under Version 3.0.

See also - Document local considerations in a request - Submit or update your Institutional Profile - Amendments and personnel changes