IFLG-What-is-Fully-Informed-Consent-for-Egg-Donors

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.

Rich Vaughn
Rich Vaughn
clients@lseo.com

Attorney Rich Vaughn is founder and principal of International Fertility Law Group, one of the world’s largest and best-known law firms focused exclusively on assisted reproductive technology, or ART, including in vitro fertilization (IVF), surrogacy, sperm donation or egg donation. Rich is co-author of the book “Developing A Successful Assisted Reproduction Technology Law Practice,” American Bar Association Publishing, 2017.

Peiya Wang
PEIYA WANG(王培娅)
Paralegal (律师助理)

Peiya Wang joined IFLG as a paralegal in 2015, where she manages surrogacy, egg donation and parental establishment cases and provides translation services for many of IFLG’s international clients. Peiya received her bachelor’s degree from Beijing Technologies and Business University, where she majored in Marketing. She moved to the United States in 2012 to attend Northeast University in Boston, Massachusetts, receiving a Master of Science degree in Global Studies and International Affairs in 2014. Peiya moved to Los Angeles in 2015 and received her paralegal certification from UCLA Extension. When away from the office, Peiya is a dragon boat paddler and a ballroom dancer, where she favors Rumbas and Cha-chas. She is fluent in Mandarin and English.

Luis Sosa
LUIS SOSA
Paralegal

Luis R. Sosa joined IFLG as a paralegal in 2016, where he enjoys pursuing his passion for family and reproductive law. While working toward his bachelor’s degree at Florida International University, Luis worked as a paralegal and legal assistant for family law litigation firms in Miami and Washington, D.C. As a paralegal and case manager for IFLG, Luis, who is bilingual in English and Spanish, manages surrogacy, egg donation and other reproductive law cases. In addition to spending time with husband Randy and dog Marty, Luis enjoys being outdoors and appreciating the arts.

Toni Hughes
TONI HUGES
Paralegal

After receiving her B.S. in Business Management, Toni joined IFLG to pursue her dream of working in the legal field. As a Paralegal with over 10 years of experience in the assisted reproduction technology field, Toni is our Managing Paralegal, responsible for training and managing our paralegal staff. From drafting legal documents to assisting our clients with post-birth matters, Toni embraces the challenge of learning something new in this field each day. Besides spending time with her son, Jordan, Toni enjoys exploring new things, cooking, spending time with family and friends, and serving as a Youth Advisor for “Next Generation.”

Miesha Cowart
MIESHA COWART
Financial Coordinator

Miesha Cowart joined IFLG as a financial specialist in 2014 following a successful career in development and business finance. Miesha previously worked for 10 years in the construction industry as a controller and for 13 years as Development Coordinator for the non-profit U.S. Fund for UNICEF. In her free time, Miesha works with “Next Generation” at her church. “They are my heartbeats!” she says of the youth in her community.

Kim
KIM DEVEREAUX
Paralegal

Kim has over 25 years of experience in the legal field and has worked exclusively in surrogacy and assisted reproduction law since 1999. Kim is a senior case manager of surrogacy and egg donation cases, and is also responsible for managing parental establishment cases and interacting with IFLG’s Of Counsel attorneys across the country. With three children of her own, Kim understands the importance of family and finds working in this area of law a rewarding experience.

Rich Vaughn
RICHARD B. VAUGHN
Founder

Attorney Rich Vaughn combined his personal passion as a father of twin boys born via assisted reproductive technology (ART) with more than 20 years of experience in business and technology law to build International Fertility Law Group. Today IFLG is one of the most successful and best-known law firms in the world focused exclusively on fertility law, helping thousands of intended parents through empathetic listening, compassionate guidance, and unmatched legal expertise. As an advocate for reproductive freedom, Rich also contributes his knowledge and time to improving the understanding and practice of ART law, most recently as a founder of and speaker at the first Cambridge University International Surrogacy Symposium held in June 2019, as immediate past chair of the American Bar Association ART Committee, and as a popular presenter to law schools, faculty and advocacy organizations all over the world.

Elizabeth Tamayo
ELIZABETH TAMAYO
Paralegal

Elizabeth received her Bachelors of Science degree in Criminal Justice from California State University of Los Angeles. Shortly after graduating, she continued her education at the University of California, Los Angeles where she obtained her Paralegal certificate. Elizabeth is fluent in Spanish and has been in the legal field since 2009. She is excited to be a part of the IFLG Team helping families realize their dreams.

Sunny Chien
SUNNY CHIEN
Paralegal

Sunny joined IFLG as a paralegal in 2017, where she manages surrogacy, egg donation and parental establishment cases for many of IFLG’s international clients. She holds a Bachelor of Arts degree in Philosophy from California State University of Los Angeles, where she graduated cum laude. Sunny is bilingual in English and Mandarin and has extensive experience as a legal assistant and paralegal at Los Angeles-area law firms. She is excited to be part of the IFLG team. In her spare time, Sunny enjoys spending time with her family and their dog, going to the beach, cooking, and being outdoors.

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
OFFICES
Los Angeles

5757 Wilshire Blvd., Suite 645

Los Angeles, CA 90036

Phone:  +1 323 331 9343

Email:  info@iflg.net

Website:  www.iflg.net

New York
PGlmcmFtZSBzcmM9Imh0dHBzOi8vd3d3Lmdvb2dsZS5jb20vbWFwcy9lbWJlZD9wYj0hMW0xOCExbTEyITFtMyExZDMwMjIuNDAxMzgzOTYwOTM5ITJkLTczLjk4Mjk0MTg4NDczMTIzITNkNDAuNzUzMTk1Nzc5MzI3NCEybTMhMWYwITJmMCEzZjAhM20yITFpMTAyNCEyaTc2OCE0ZjEzLjEhM20zITFtMiExczB4ODljMjU5MDAzZWU5ZjZmZCUzQTB4NWZkNDM5ZmQ0YjRlNzEwNyEyczUwMSs1dGgrQXZlJTJDK05ldytZb3JrJTJDK05ZKzEwMDE3ITVlMCEzbTIhMXNlbiEyc3VzITR2MTU1OTc2MjQ0OTgzOCE1bTIhMXNlbiEyc3VzIiB3aWR0aD0iNDUwIiBoZWlnaHQ9IjM1MCIgZnJhbWVib3JkZXI9IjAiIHN0eWxlPSJib3JkZXI6MCIgYWxsb3dmdWxsc2NyZWVuPjwvaWZyYW1lPg==

501 Fifth Avenue, Suite 1900

New York, NY 10017

Phone:  +1 844 400 2016

Email:  info@iflg.net

Website:  www.iflg.net

Molly O'Brien
MOLLY O'BRIEN
Partner

Fertility law attorney Molly O’Brien began working in the field of assisted reproduction technology (ART) in 2005, at an egg donation agency and a surrogacy agency where she became familiar with all aspects of in-vitro fertilization, egg donation and the financial aspects of surrogacy. Since becoming an attorney in 2011, Molly has drafted and negotiated surrogacy, egg donation, sperm donation embryo donation agreements for hundreds of her clients all over the world.