28 Aug 2020 What Is Fully Informed Consent for Egg Donors?

While donated eggs are used in tens of thousands of assisted reproduction cycles each year in the United States—24,300 cycles in 2016, according to the U.S. Centers for Disease Control and Prevention (CDC)—there are few laws governing egg donation in many parts of the country. 

The principle of “fully informed consent” is “vitally important” in regard to potential egg donors, as explained in a 2014 article by Naomi Cahn, JD, and Jennifer Collins, JD, for the American Medical Association Journal of Ethics:

“First, state health care and tort law (particularly in the form of medical malpractice law) require informed consent to ensure that patients are involved in their own medical decision making, and physicians face tort liability for a failure to obtain informed consent. While there are problems with informed consent procedures in the United States—for example, the focus is on the physician providing information, rather than ensuring patient understanding—the general principle is to promote patient autonomy.”

Guidelines for Egg Donors

In its guidelines for egg donors and sperm donors, the state of New York provides this statement on the importance of fully informed consent: “But informed consent is more than a form to be signed. It is the process of helping you fully understand and agree to the medical procedures.”

Although federal regulations primarily are focused on safety testing of donated genetic material, including “oocytes,” or eggs, several states have laws on the books relating to egg donor informed consent. California requires fertility clinics and practitioners that advertise financial compensation for donors to comply with guidelines developed by the American Society for Reproductive Medicine (ASRM) or to include a separate disclosure statement advising egg donors of their right to be fully informed about procedures and any potential risks. New York egg donors must be informed of any medical risks from the procedure as well as how the donated eggs may be used (i.e., for research versus reproduction).

Fertility clinics and third-party donor-matching programs typically recruit donors within an age “window” of 20 to 29 years old. In compliance with ASRM guidelines, most require donors to be at minimum of legal adult age in the state, to ensure the donor has the maturity and capacity to comprehend potential risks. Eggs from donors older than 35 carry a higher risk of producing offspring with chromosomal abnormalities such as Down syndrome or lower the odds of a successful pregnancy.

At a minimum, fully informed consent for egg donors should include the following information, as appropriate to the specific agency or situation, according to the ASRM guidelines:

Pre-Screening for Egg Donors

• Donors will be required to complete an extensive, detailed medical questionnaire, including sexual history, substance use history, family disease and psychological history.
• Donors will be subject to a mental health screening and evaluation by a mental health professional, in part to ascertain the donor is capable of understanding and consenting to the procedures. 
• The U.S. Food and Drug Administration (FDA) requires all donors to be screened for infections or diseases that could be transmitted either to the recipient/surrogate or the resulting offspring, including syphilis, hepatitis B and C, human immunodeficiency virus (HIV)-1 and HIV-2, gonorrhea, and chlamydia.
• Donors will be screened for heritable diseases, including for Tay-Sachs disease, cystic fibrosis (CF) mutation, and spinal muscular atrophy.
• Donors of Asian, African, and Mediterranean descent should undergo a hemoglobin electrophoresis as a screen for sickle-cell trait and thalassemias.
• Donors may be tested for other diseases such as Zika or COVID if their medical history indicates.

Egg Donor Medical Procedures

• Donors should be informed about all medical procedures, the experience of the practitioners who will be performing the procedures, and the risks involved with each. 
• Donors should be informed of all medications that will be used during the donor cycle, including self-injected hormones used to stimulate egg production and the anesthesia used in the extraction procedure, as well as any known side effects.
• Donors should be informed of any potential uses of the donated eggs—whether they might be used for research purposes or solely for reproduction.

Other Considerations for Egg Donors and Intended Parents

• Any medical patient, including an egg donor, may decline any treatment at any time, for any reason—even if the donor has already signed a donor agreement. From the New York guidelines: “You can change your mind. You cannot be forced to undergo medical procedures against your will. Many programs acknowledge that a donor may withdraw her consent to participate at any time before retrieval of the eggs. Before consenting to donate eggs, make certain you understand and agree to the program's and/or the broker's policy on withdrawing consent.”
• Any agency donor agreement should clarify that the donor waives any parental rights over any offspring resulting from the donation.
• What costs could result from complications of the procedures, and who will pay for treatment?
• What financial compensation will the donor receive for a completed cycle, or for a cycle that is canceled before egg retrieval for any reason?
• What are the donor’s rights to anonymity, and what is the potential for future contact by offspring? Keep in mind that a growing number of jurisdictions in the U.S. and internationally are requiring that donors remain fully or partly identifiable in the event offspring seek contact or health information in the future.

The New York egg donor guidelines also point to another issue of concern to potential egg donors: “Before starting a cycle, you may be asked to sign a statement that waives your right to sue the program for medical malpractice, pain and suffering, or any other expenses resulting from complications.” The best course would be for the donor to consult her own attorney before signing any such waiver. If that is not possible, donors should be sure they know what questions to ask, and that they have the answers they need to proceed safely and “fully informed.”

Let IFLG Advise You on Egg Donation Law

If you are an intended parent considering starting a family via egg donation and IVF or surrogacy, the experienced surrogacy attorneys and paralegals on our IFLG team can answer your questions and help ensure your new family is legally protected, right from the beginning.