Post

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.

  1. Review and update all institutional policies and procedures to ensure inclusion of same-sex spouses in definitions of “spouse” and “family”
  2. Update clinical investigation documentation and procedures to include same-sex spouses in informed consent processes
  3. Revise financial disclosure forms and procedures for clinical investigators to include same-sex spouse interests
  4. Update IRB membership criteria and documentation to reflect the inclusion of same-sex spouses
  5. Modify FOIA request processing procedures to include same-sex spouses for expedited processing
  6. Update consumer complaint handling procedures in mammography facilities to include same-sex spouses
  7. 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


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
This post is licensed under CC BY 4.0 by the author.