Developing a Sperm Banking Consent Process




© Springer International Publishing AG 2018
Ahmad Majzoub and Ashok Agarwal (eds.)The Complete Guide to Male Fertility Preservationhttps://doi.org/10.1007/978-3-319-42396-8_13


13. Developing a Sperm Banking Consent Process



Lisa Campo-Engelstein  and Nanette Elster1


(1)
Alden March Bioethics Institute and Department of Obstetrics and Gynecology, Albany Medical College, 47 New Scotland Avenue, MC 153, Albany, NY 12208, USA

 



 

Lisa Campo-Engelstein



Keywords
Sperm bankingInformed consentLawEthicsAdultsMinors



Introduction


In the early 1970s commercial sperm banks began to emerge, and men were able to preserve their sperm for future use [1]. As sperm banking continued to evolve so too did the reasons to why a man would choose to store or cryopreserve his sperm. Some reasons, however, might include men undergoing cancer treatment whose fertility may be impacted, men who are going off to war, individuals who are born male but are transgender and undergoing gender affirming surgery, and even men who have concerns about the impact of aging on their future children. To add to the complexity, cryopreservation might also be an option for children and adolescents who are undergoing cancer treatment that might impact future fertility. Because of the varied reasons for preserving sperm, developing an informed consent process that meets the diverse needs and circumstances of those making the decision to cryopreserve sperm is necessary.

In this chapter, we focus exclusively on informed consent in sperm banking only with respect to sperm freezing for autologous use. We consider the necessary legal and ethical elements and individuals to be included in this process. We begin by considering the legal and ethical underpinnings of informed consent. We then explore the elements of consent that are necessary for adults preserving sperm followed by a discussion of the unique components of informed consent when a minor’s sperm is being cryopreserved. The chapter concludes with a list of recommended elements to consider in developing an informed consent process for sperm banking for autologous use.


Background


Informed consent is commonly defined as “an individual’s autonomous authorization of a medical intervention or of participation in research” [2]. The Joint Commission provides an even more detailed definition: “Agreement or permission accompanied by full notice about the … service that is the subject of the consent. A patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course. After receiving this information, the patient then either consents to or refuses such a procedure or treatment” [3].

The process of informed consent has ethical and legal considerations. In both law and ethics, informed consent is much more than a document that must be signed, but rather it is a process. The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research defines the process “rooted in the fundamental recognition—reflected in the legal presumption of competency—that adults are entitled to, accept or reject health care interventions on the basis of their own personal values and in furtherance of their own personal goals” [4]. In fact, the concept of informed consent has a lengthy history, a discussion of which goes well beyond the scope of this chapter.

Dating back to the time of Hippocrates, however, informed consent was not the cornerstone of medicine and healthcare that it is today. “Classic documents in the history of medicine such as the Hippocratic writings (fifth to fourth century B.C.) and Thomas Percival’s Medical Ethics (1803) present an extremely disappointing history from the perspective of the right to give informed consent. The central concern in these writings was how to avoid making disclosures that might harm or upset patients. Physician ethics was traditionally a nondisclosure ethics with virtually no appreciation of a patient’s right to consent” [2].

The legal precedent can be traced back to the 1914 case, Schloendorff v. Society of New York Hospital [5]. In that case, the court held that “Every human being of adult years and sound mind has a right to determine what shall be done with his own body” [3]. Case law and statutory law continued to enforce the need to provide patients with information prior to biomedical intervention. To date, every state has some statutory law and/or case law regarding informed consent. Such laws may define the age of consent [6]; who may consent for whom [7]; penalties for failure to obtain informed consent [8]; and more. The variability between and among states is tremendous and thus necessitates a consideration of jurisdictional issues when developing an informed consent process. In addition to considering state-specific laws and regulations , consideration of any relevant professional society guidelines is also necessary.

The legal mandates regarding informed consent have distilled the process down to “a legally or institutionally effective approval given by a patient,” [2] or essentially a signed form. The form, however, should only serve to memorialize a more interactive and ongoing process. This chapter focuses on the concept of informed consent as an ongoing process rather than the signing of a generic form.

The ethics of informed consent help to flesh out the elements that are necessary for the process to accomplish the goal “to protect and enable meaningful choice” [6]. The key underlying ethical principle at play in informed consent is respect for persons. According to the Belmont Report, respect for persons consists of two components : “first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection” [9]. The principle of respect for persons distinguishes between individuals who have decision-making capacity and those who do not. Individuals with decision-making capacity have the right to autonomy, which includes the right to make their own medical decisions. However, in order to be able to make good and informed decisions, patients need the relevant information. Especially because most patients are not healthcare professionals, it is important for healthcare professionals to provide the relevant medical information in a way that is easy for patients to understand. Furthermore, as previously mentioned, providing this information is not a one-time event. Rather, it is a continuous conversation as time goes by and as new circumstances arise. It also should be thought of as a dialogue with a back-and-forth exchange of questions and answers and an attempt to understand the goals and values of the patient.

Individuals without decision-making capacity (e.g., children, adults with developmental disabilities, individuals who may have a temporary loss of capacity due to illness or injury, and individuals who are not conscious) do not have autonomy rights because they do not have the cognitive ability to make reasoned and rational medical decisions for themselves. In order to respect them as persons, they need protection, which basically translates to having a proxy make decisions for them that uphold their best interests; such a proxy is often referred to as a surrogate decision maker. This will be discussed further below.

Cryopreservation of sperm raises some unique challenges especially with respect to disposition or future use of the previously collected reproductive material. The issues will certainly vary with regard to the age of the participant. In any event, certain factors will need to be discussed and understood including the cost, who may or may not have access to the sperm, and how the sperm can or cannot be used and by whom in the event of the death or future incapacity of the participant. In the following sections, we discuss each of these topics with respect to both adults and minors. The chapter concludes with recommendations of the elements that are necessary for a robust, ethical informed consent process.


Information


One of the essential components of informed consent is the provision of a clear and understandable description of risks, benefits, and alternatives. In the context of consent for sperm banking, certain basic information must be provided to all clients: the actual process , including detailed information about the solution used in preserving the sperm and the mechanism for storage; the cost , including annual storage fees; and duration—the period of time for which sperm will be stored, what happens if the sperm bank goes out of business, is sold to another entity, suffers a power outage, and/or sperm is lost or inadvertently destroyed. In addition to such general information, the informed consent process may also need to be tailored to the age, marital status, and impetus for cryopreservation.


The Process


Discussion of the process of sperm freezing will involve discussion of such basic information as the culture medium used; the type of equipment used; the temperature at which the sperm is stored; risks, if any, to the quality of sperm as a result of the freezing; and what sort of emergency backup if any exists in the event of an equipment failure, power outage, etc. This may be very important given that in 2013, one storage facility faced 40 lawsuits when a cryopreservation tank malfunctioned resulting in the damage or destruction of sperm [10].


The Cost


Cost is another factor that is integral to the informed consent process. For many, insurance will not be available to cover the cost of storage. The consent process should detail whether fees are paid all at once, annually, monthly, etc. as this may be important information to be factored in by those considering banking their sperm. If the sperm bank has options for pre-payment for extended periods of storage, this too should be detailed in the consent process.


The Duration


Those opting for sperm banking will also need to have information about how long their sperm can be maintained. For example, patients may want to know if any data exists regarding the length of time sperm can be frozen before it is no longer viable and whether the facility in which they are storing sperm has a limit on the amount of time the sperm may be frozen. In some countries outside the USA, for example, legislation may exist limiting the period of time that gametes may be stored [11]. Currently no such law exists in the USA; however, this may be a consideration for both the men preserving his sperm and the cryobank.

Included in the information provided about duration would also be identification of any policies that exist that could result in the inability or unwillingness of the storage facility to maintain the sample. For example, identifying those circumstances under which storage may be discontinued by the facility should be communicated to the man. An explanation of how, when, and if notice will be given prior to transfer or destruction of sperm samples is also necessary.


Special Considerations


In addition to general information about the procedural aspects of sperm donation , the informed consent process must also consider the individual who is storing the sperm. The information will differ if an adult is making the decision for himself or if a parent1 is deciding for a child.


Considerations for Adults



Reason for Accessing


In developing the informed consent process for cryopreservation of sperm, understanding the patient’s reasons for pursuing fertility preservation can improve the informed consent process. Is the man undergoing cancer treatment that may impact future fertility? Is he going to be engaged in combat and concerned that he may be injured? Is the individual transgender and undergoing gender-affirming surgery but wants to preserve the ability to have a genetic child?2 Each of these reasons may require provision of different information to the patient. Understanding a patient’s motivation is necessary to attempt to inform him in a way that respects his goals and values. Respect for the individual’s goals and values is a cornerstone of any informed consent process.


Marital Status


Marital status can sometimes factor into individual seeking sperm banking because some healthcare providers refuse in/fertility treatment for unmarried individuals [12]. Additionally, marital status may be a factor in considering disposition of sperm in the future if the patient either loses capacity or dies. For example, if the married patient dies without having documented his wishes for disposition of any remaining sperm as will be discussed below, his spouse may thus have a claim to his sperm.

On the policy side, many insurance companies and state laws regarding insurance coverage of infertility treatment exclude single individuals from coverage for infertility services [13]. Yet, limiting fertility preservation services, such as sperm banking, to married couples ignores the reasons people choose to undergo fertility preservation. Men undergo sperm banking because they want to keep open the possibility of biological children in the future. As Campo-Engelstein argues, “Denying patients fertility preservation because they are unmarried at the time they seek treatment fails to recognize the future-oriented nature of fertility preservation treatment and that patients’ marital status may change by the time they decide to use their reproductive material” [14]. As one’s goals toward marriage do not necessarily equate with one’s goals for parenting, marital status should not be a barrier to cryopreservation. This is especially true given that “the option to use fertility preservation therapies can have positive psychologic effects on cancer survivors” [15]. And, those undergoing fertility preservation in advance of gender-affirming surgery may, in fact, be preserving sperm with a future goal toward marriage and family building, but not yet be married. “This banked spermatozoa can then possibly be used later to inseminate a female partner if the quality is good, or else be used to perform IVF” [16].


Disposition


If a man dies or loses capacity, there are a variety of ways to handle his sperm: it can be destroyed, donated for scientific research, donated for use by an infertile individual or couple, or used to create a child that the man’s family or loved ones will raise. The best way to avoid any conflicts regarding disposition of frozen sperm if the sperm provider dies or becomes incapacitated is for the individual freezing sperm to explicitly document his wishes and update them if his circumstances change. In fact, having men annually update their dispositional choices is a helpful way to avoid future conflict. By clearly documenting what he wants and does not want, there is less possibility for disagreement and conflict should he become unable to make his wishes known due to incapacity or death. Most fertility clinics require individuals creating embryos via IVF to complete a document outlining how to handle extra embryos if the couple who created the embryos separate or one individual dies. According to a survey published in 2003, “In 338 of the 340 responding practices, the patient or couple must sign a consent form before their embryos are frozen” [17]. Additionally, the American Association of Tissue Banks also addresses this in its Standards for Tissue Banking updated in 2011: “In the case of a Client Depositor the Informed Consent Record shall also include details about costs of tissue cryopreservation, storage , distribution and disposition options” [18] (emphasis added) indicating that the same practice should be employed for individuals freezing gametes. This practice should in fact be easier for individuals freezing gametes because the gametes only contain one person’s reproductive material whereas embryos contain reproductive material of two people and therefore two people need to agree on all the stipulations of the directive at all times. Additionally, embryos have a different status in the law than gametes, having a heightened “special status,” somewhere between person and property [19].

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Feb 26, 2018 | Posted by in GYNECOLOGY | Comments Off on Developing a Sperm Banking Consent Process

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