Informed Consent Documents at the IVF Clinic

The Flood of Forms, by Deborah Forman, Of Counsel to NFLC
The full article may also be found at http://www.theafa.org/library/article/informed_consent_and_the_flood_of_forms/

If you are undergoing fertility treatment or using assisted reproductive technology to create a family, at some point, you will confront a stack of forms provided by your physician.  These forms represent one method by which your physician obtains your informed consent to proceed with treatment.  These forms likely run many pages and contain a mass of medical, legal and other information.  Some forms may require merely your initials and signature; others may require you to consider options and provide instructions regarding your treatment.  In some practices, your physician or a nurse or treatment coordinator may review these forms with you.  In others, you will be handed the packet of forms and asked to review and sign them.  Either way, the task of wading through the mountain of information and making decisions about such important matters as embryo disposition can prove daunting.  To assist you in the process, this article will explain the law of informed consent and provide an overview of the types of information and decisions you are likely to encounter in these forms.  The article concludes with tips to keep in mind before signing the forms.

Informed Consent
The legal doctrine of informed consent is designed to protect the autonomy and self-determination of each of us.  Every state recognizes that the patient has the right, in most circumstances, to determine what will happen with his or her body and whether to accept or reject proposed medical treatment.  Indeed, even the U.S. Supreme Court has recognized this right.  Moreover, a doctor’s failure to obtain the informed consent of his or her patient can subject the doctor to liability.

For many types of treatment, this process consists primarily of a discussion between the physician and patient; no written forms may be involved.  For major treatments, such as surgery, the physician typically requires the patient to sign a number of forms authorizing the procedure and outlining the risks of the proposed procedure, as a supplement to the conversations the physician has with the patient covering the proposed treatment.  The written forms are not a substitute for the patient’s conversation with her doctor, but they are an important part of the process.  While you may see the forms as a tedious obstacle that must be plowed through as fast as possible, in fact, the forms offer you an opportunity to review the information shared by your doctor at your own pace and to formulate questions that need further response.  It can be difficult in an initial discussion to absorb fully all the information provided by your physician.  In addition, it is critically important to understand that the forms can have significant legal consequences.  For that reason alone, it is essential that you read carefully and fully understand the documents before signing them.

Information Disclosed
The legal standards governing the information that must be disclosed to satisfy the requirement of informed consent vary from state to state but fall into one of two categories.  About half the states determine the adequacy of the disclosures based on what other doctors of that type would have disclosed in that situation. Other states determine the adequacy of disclosure by whether the physician has disclosed all information that would be material to a reasonable and intelligent decision by the patient.  In terms of the written consent forms, there is little difference between these two standards.  In addition, your physician’s decision about what information to disclose is likely to be influenced by guidance from professional societies, such as the American Society for Reproductive Medicine (ASRM).

The heart of the informed consent process is the explanation of the procedure and the benefits, risks and alternatives to the proposed treatment.  The forms likely will explain in considerable detail the myriad risks of the treatment, including any medications prescribed, to the patient (or donor or surrogate), as well as to any children resulting from the treatment.  Informed consent does not require your physician to disclose every conceivable risk, no matter how remote or unlikely.  Nor does he or she have to disclose risks that are commonly known, such as the risk of infection from surgery.  But risks of serious adverse outcomes should generally be disclosed.

Unlike forms used by other types of physicians, the forms used by fertility doctors often go way beyond these medical matters and contain information that does not technically fall under the doctrine of informed consent but can have significant legal consequences for you.  For example, a form covering in vitro fertilization using donor eggs may include statements regarding the intentions of the parties as to who will be considered a parent under the law.  Forms authorizing cryopreservation (freezing) of eggs, sperm or embryos will likely seek directions from you regarding future disposition of any unused embryos. In some cases, courts have considered and relied on statements in consent forms to determine parental rights in disputes over children born through assisted reproduction and to decide disputes over embryos in cases of divorce or death.

Unfortunately, clinics do not always have forms that accurately reflect the wide range of family configurations utilizing assisted reproduction, and patients risk future legal difficulties by signing forms that do not correctly identify them, their relationship to their partners and to their future children.  For example, in a California case, K.M. v. E.G. (2005), a lesbian couple initiated IVF treatment to conceive a child.  One of the partners provided the egg; the other partner carried the child to term.  When the relationship ended, the partner who had gestated the child claimed that she never intended for the partner who provided the egg to be considered a legal parent of the child, despite the genetic connection and the fact that they had raised the child together for several years.  The trial court found that the genetic mother was merely an egg donor, with no parental rights, relying in part on the consent form she signed at the time of treatment.  She claimed that she signed the form because that was the only option presented to her, and she and her partner wanted to get going with treatment.  The California Supreme Court ultimately overturned the decision, but the risk remains.  You should not sign a form that does not accurately reflect your intentions as an intended parent, donor or surrogate.

Individuals and couples participating in third party reproduction also need to be aware of potential conflicts between the physician’s consent forms and contracts they may have entered into.  Physicians’ forms cannot possibly address all the specific details and the variations covered in a surrogacy or egg donor contract.  Consequently, if the consent form appears to conflict with your egg donor, surrogacy or other contract, you should discuss the matter with your attorney.  Often the contract will contain a clause that supersedes the language of the consent form.  Without such a clause, the conflicting provision could cause problems if a dispute arises.

Tips for Navigating the Forms

The informed consent requirement aims to protect patients.  Written consent forms are an integral part of that process, especially for patients undergoing fertility treatment, but they are drafted to cover a multitude of situations and with an eye, as well, toward protecting the physician from potential liability.  To get the most out of the forms and to help you avoid future disputes, keep in mind the following key points:

  1. The consent forms can have lasting legal consequences.  All participants in the treatment should READ them thoroughly and carefully.
  2. For the same reason, do not sign forms that contain provisions that do not accurately describe your family configuration and your intention.
  3. Seek the advice of counsel if you are unsure of the meaning or effect of provisions, especially those regarding parentage or embryo disposition.  The added fee for a consultation may be well worth the expense for peace of mind and the opportunity to avoid costly legal disputes in the future.
  4. Pay close attention to any responsibilities imposed on you, such as to provide updated contact information or instructions regarding stored embryos.
  5. Finally, the written forms should be a supplement to—not a substitute for—discussion with your physician.  If you have any questions about information contained in the forms, ask your physician or other knowledgeable health care provider.
Rich Vaughn
Richard Vaughn
rich@iflg.net

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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