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.
What You Need to Know? 👇
How does the Supreme Court’s Windsor decision impact FDA regulations for medical device companies?
The Windsor decision requires FDA to include same-sex spouses in regulations using “spouse” or “family” terms. This affects clinical investigator financial disclosures, IRB composition requirements, and human subject protections, ensuring equal treatment regardless of marriage type.
What financial disclosure requirements apply to same-sex spouses of clinical investigators?
Under 21 CFR 54.2(d), clinical investigators must disclose financial interests and arrangements involving their same-sex spouses, just like opposite-sex spouses. This ensures comprehensive conflict of interest identification in clinical trials for medical devices.
Do same-sex married couples need to live in marriage-legal states for FDA regulations to apply?
No. FDA recognizes same-sex marriages valid where performed or where the couple currently lives. This “place of celebration” approach ensures consistent regulatory application regardless of current residence state’s marriage laws.
How does the Windsor decision affect IRB membership requirements for medical device studies?
IRBs must have at least one unaffiliated member who isn’t part of the “immediate family” of institution-affiliated persons. This now includes same-sex spouses, ensuring proper independence and avoiding conflicts of interest in research oversight.
What informed consent protections exist for same-sex spouses in emergency medical device research?
When informed consent isn’t feasible, investigators must attempt to contact family members, including same-sex spouses, about research participation objections. Same-sex spouses can also discontinue participation and must be informed about ongoing studies.
Which specific FDA regulations are affected by the expanded definition of “spouse” and “family”?
Six regulation parts are affected: FOIA expedited processing, human subject protections, clinical investigator financial disclosures, IRB composition, animal drug expert panels, and mammography consumer complaint systems. All now include same-sex spouses equally.
What You Need to Do 👇
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): Content and Organization
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 ID: 3810b7ff3d1ef4d2a0c018c388bb109b