17 Feb 2010 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.
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.
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:
- The consent forms can have lasting legal consequences. All participants in the treatment should READ them thoroughly and carefully.
- For the same reason, do not sign forms that contain provisions that do not accurately describe your family configuration and your intention.
- 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.
- Pay close attention to any responsibilities imposed on you, such as to provide updated contact information or instructions regarding stored embryos.
- 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.