Same-Sex Marriage Recognition in Regulatory Definitions of Spouse and Family
This guidance clarifies FDA's interpretation of the terms spouse and family in its regulations following the Supreme Court's ruling in United States v. Windsor, which struck down section 3 of the Defense of Marriage Act (DOMA). The guidance confirms that FDA now includes same-sex spouses in these definitions across all its regulations.
Recommended Actions
- Review and update all institutional policies and procedures to ensure inclusion of same-sex spouses in definitions of “spouse” and “family”
- Update clinical investigation documentation and procedures to include same-sex spouses in informed consent processes
- Revise financial disclosure forms and procedures for clinical investigators to include same-sex spouse interests
- Update IRB membership criteria and documentation to reflect the inclusion of same-sex spouses
- Modify FOIA request processing procedures to include same-sex spouses for expedited processing
- Update consumer complaint handling procedures in mammography facilities to include same-sex spouses
- Revise conflict of interest assessment procedures for expert panels to include same-sex spouse considerations
Key Considerations
Clinical testing
- Informed consent exceptions require attempt to contact family members, including same-sex spouses
- IRBs must ensure procedures to inform family members (including same-sex spouses) about study discontinuation rights
- Clinical investigators must disclose financial interests and arrangements involving their same-sex spouses
Other considerations
- IRB membership requirements: At least one member must not be affiliated with the institution or be immediate family (including same-sex spouse) of an affiliated person
- FOIA requests: Same-sex spouses qualify as family members for expedited processing
- Mammography facilities: Same-sex spouses qualify as family members for consumer complaints
- Expert panels for new animal drugs: Conflict of interest considerations include same-sex spouses
- Marriage validity is based on where the marriage was performed or where the couple lives
Relevant Guidances
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- Written Procedures for Institutional Review Boards (IRBs): Administrative Requirements and Operations
Original guidance
- Same-Sex Marriage Recognition in Regulatory Definitions of “Spouse” and “Family”
- HTML / PDF
- Issue date: 2014-03-31
- Last changed date: 2019-04-20
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Food & Color Additives, Biologics, Cosmetics, Administrative / Procedural
- ReguVirta summary file ID: 3810b7ff3d1ef4d2a0c018c388bb109b
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