Various Regulations over Third Party Assisted Reproduction and Surrogacy

Third party assisted reproduction and surrogacy is an ever evolving area that is regulated at various levels including at a constitutional level, state level, Federal level, and self regulation by organizations that establish best practices. Some regulations are based in the law, while some regulation is self-imposed and voluntary/best practices. This article will touch upon some of the more prominent overarching regulations, both legally binding and best practices, that help establish a cohesive surrogacy program in the United States to protect patients, along with professionals and ART providers.

State Regulation of Surrogacy

Surrogacy laws differ from state to state. Some states like Florida and California have detailed statutory frameworks on how the surrogacy process is governed. Some states like Ohio are silent on surrogacy and some have specific prohibitions on the surrogacy practice like in New York. According to the book I co-authored titled, The ABA Guide to Assisted Reproduction: Techniques, Legal Issues, and Pathways to Success:

Not only is the surrogacy contract process different in each state, but the legal proceedings required keep off or remove the surrogate as the mother from the birth certificate and name the intended parents as the legal parents differs across the country. While court intervention is not necessarily required for gestational surrogacy arrangements, naming the intended parents as the legal parents may need to be established through a court action. Some states allow a prebirth order naming the intended parents as the legal parents so that the birth certificate never lists the surrogate as the birth mother. Some states require postbirth parentage proceedings to issue a new birth certificate removing the surrogate as the legal mother and naming the intended parents as the legal parents, and some states require a form of an adoption proceeding to terminate a surrogate’s parental rights and name the intended parents as the legal parents.

So what law applies to ART? Generally, the law of the state where the child is born is the applicable law. However, when a surrogate, donor, and intended parent(s) are located in different states or even countries, or the IVF procedures occur in different jurisdictions, it is advisable to consider the laws of where the IVF procedures occurred and also consider the state/s where all parties are located to determine if any of the locations raise legal concerns as to confirming the parental rights once the child is born. An articulation in your surrogacy contract is a great way to assert your intention for the law of a certain jurisdiction to govern your case, but that doesn’t necessarily mean that the jurisdiction you choose has jurisdiction over your specific matter...

International Regulation of Surrogacy

Surrogacy laws outside of the United States vary, with many foreign countries either deeming surrogacy as illegal or only recognizing the birth mother (i.e. the surrogate), as the legal mother of the child born via surrogacy. This can result in the child having citizenship issues and problems when the intended parents leave the United States and return to their home country. It is important that before embarking upon surrogacy, that intended parents consult with both a United States attorney AND an attorney in their home country to make sure additional steps and/or proceedings are handled (if any), in the foreign home country to ensure their parental rights are protected once they leave the United States with the child.

Constitutional Regulation of Surrogacy

The constitution places certain limits that impact surrogacy laws across the United States. The main constitutional impacts seen in the surrogacy context include: the right to procreate, the right to bodily autonomy, and Full Faith and Credit. The right to procreate is seen in the context when the Constitution protects a person's right to be a legal parent to a child, even if they did not deliver the child or provide genetic material for the child. For example, the right to procreate came into play in a Florida Supreme Court case when in a lesbian couple, one woman provided her egg to her partner, and the partner delivered the child. The birth mother attempted to preclude the genetic parent from having parental rights and classify her as a donor under Florida's egg donor statute, however, under Constitutional principals, the Florida Supreme Court vested such right as  legal parent in the biological mother along with the birth mother. As to the constitutional right to bodily autonomy, this comes into play in that a surrogate has the sole source of consent when it comes to decisions relating to her body. While a surrogate and intended parents may agree that the surrogate will undergo an abortion should there be a reason to do so, despite a contract in place between the parties providing for same, intended parents cannot force the surrogate to have the abortion if she chooses not to in the actual moment. Monetary remedies may be the only recourse in such a scenario and the intended parents would still be legally obligated to assume parental rights to such child. Lastly, Full Faith and Credit is applicable when a court order of parentage is entered in a state where surrogacy is legal whereby such order should be recognized in thedifferent home state of the intended parents where the laws may different from the state where the court order was entered.

Federal Regulation of Surrogacy

There are a handful of federally established entities that also govern surrogacy such as the Center for Disease Control and the Food and Drug and Administration. –Centers for Disease Control (CDC), legislation passed in 1992 via the Fertility Clinic Success Rate and Certification Act (FCSRCA): (i) requires mandatory reporting of ART cycle data to the which CDC collects/publishes ART data and publishes annual report ( and (ii) developed model program for certificate of IVF laboratories (in 1999)  which establishes quality control standards, inspections and the ability to revoke approval of said certification. The CDC collects date from over 440 fertility clinics in the United States and calculates standardized success rates for each clinic. These reports are accessible to consumers to review the ART data from fertility clinics nationwide. –Food and Drug Administration (FDA): regulation of drugs, biological products, and medical devices (only use of FDA approved devices), and screening and testing of donor tissues since ART involves handling of human tissue (i.e. donor sperm, eggs, embryos).
  • FDA requires screening/testing of donor tissue of donors in the U.S. to test for “relevant communicable disease agents and diseases”
  • FDA inspectors may view complete records of donor cycles
  • FDA requires maintaining donor records for certain periods of time
  • With FDA required testing, a donor or surrogate may be deemed “ineligible” if tests result are positive for a disease on the FDA’s donor-eligibility determination screening, however, FDA allows in certain circulates the ability to move forward with the “ineligible” donor with certain precautions established by FDA and American Society for Reproductive Medicine, including informed consent, proper counseling, and labeling to indicate associated risks and physician using samples are aware of status of results
Clinical Laboratory Improvement Act (CLIA), published in 1991, implemented by the Centers for Medicare and Medicaid Services (CMS): ensures quality over IVF clinic laboratories via laboratory inspections and accreditation. Participating laboratories must register and be surveyed to become certified. –Americans with Disabilities Act (ADA), Equal Employment Opportunity Commission (EEOC), & Family Medical Leave Act : These acts come into play relating to time off from work for both surrogates and intended parents whereby the ability to receive time off from work (or paid time from work), depends on a variety of factors, including the size of employer and company policies regarding paid maternity leave.

Self Regulation Organization For Surrogacy

Certain professionals involved in ART are regulated by governing organizations such as the American Medical Association (for physicians), the American Bar Association (for lawyers), and both of these types of professionals are also regulated by binding state laws which helps protect the public health and safety in ART. The American Psychological Association establishes ethical standards governing psychologist who are involved in the ART process relating to the mental health screening. Guidance, accreditation and best practices are established for professionals by the American Society for Reproductive Medicine (ASRM) and the ASRM affiliate, Society for Assisted Reproductive Technology(SART) establishing practical and ethical ART guideline. Some important partners who represent consumers of ART and provide infertility services such as peer lead infertility support groups, advocacy and ART funding include RESOLVE, Path 2 Parenthood, and Livestrong Fertility.