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To Consent, or Not to Consent, That Is the Question

Ethical Issues of Informed Consent for the Use of Donor Human Milk in the NICU Setting

McGlothen-Bell, Kelly PhD, RN, IBCLC; Cleveland, Lisa PhD, PNP-BC, IBCLC, FAAN; Pados, Britt Frisk PhD, RN, NNP-BC

Section Editor(s): Parker, Leslie A.

doi: 10.1097/ANC.0000000000000651
Human Milk Science: Special Series

Background: Evidence supports the superiority of mother's own milk (MOM) in reducing the comorbidities common to prematurity and very low birth weight. In situations where an insufficient amount of MOM is available or maternal contraindications prevent its use, pasteurized donor human milk (DHM) is a viable substitution. When DHM is deemed best, a common practice in many neonatal intensive care units (NICUs) is for parents to provide their consent. However, no universal mandate for informed consent exists. Often, healthcare providers present and obtain the consent for DHM use prior to delivery or shortly after birth and this consent may be “bundled” along with other standardized NICU treatment consents. This approach is likely less than ideal since it provides insufficient time for decision making and often precedes the mother's ability to initiate the expression of her own milk.

Purpose: To review the history of DHM use and the ethics surrounding the consenting process including the ethical principles involved in infant feeding decision making. We argue for the standardization and consistent use of informed consent for DHM in the NICU and offer clinical practice implications.

Findings/Results/Implications for Practice and Research: Providers face several challenges in the consenting process for the use of DHM in the NICU setting. These include limited time to support parents and educate them appropriately during the decision-making process. Standardized and consistent use of informed consent is essential to address the ethical concerns surrounding the use of DHM in the NICU setting.

School of Nursing, University of Texas Health Science Center at San Antonio (Drs McGlothen-Bell and Cleveland); and Connell School of Nursing, Boston College, Chestnut Hill, Massachusetts (Dr Pados).

Correspondence: Kelly McGlothen-Bell, PhD, RN, IBCLC, School of Nursing, UT Health San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229 (

This work was funded by the NIDA T32 Postdoctoral Training Program (T32DA031115) at University of Texas Health Science Center, San Antonio, Texas.

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Evidence supports the superiority of mother's own milk (MOM) in reducing the comorbidities common to preterm birth and very low birth-weight infants, including necrotizing enterocolitis, chronic lung disease, retinopathy of prematurity, late-onset sepsis, hospital readmission, and neurodevelopmental problems in early childhood.1 In situations where a sufficient amount of MOM is not readily available or maternal factors contraindicate its use, pasteurized donor human milk (DHM) is a viable option for the nutritional management of many high-risk infants.2 Several organizations provide recommendations for the use of DHM when MOM is inadequate or unavailable.3 These organizations include the National Association of Neonatal Nurses,4 the World Health Organization,5 the US Department of Health and Human Services,6 and the American Academy of Pediatrics.7 Their recommendations have led to an increased use of DHM in the neonatal intensive care unit (NICU).3

When DHM is to be used, it is common practice in many NICUs for a parent to provide consent.3 In the NICU, decisions regarding the use of DHM are similar to other treatment decisions, as they are most often guided by evidence-based practice, clinical experience, and family-centered care practices.8 However, there is no universal mandate for informed consent when using DHM in the NICU. In many cases, healthcare providers present and obtain the consent for DHM prior to delivery or shortly after birth. Often the consent is included as a “bundle” along with other standardized NICU treatment consents.9

Findings from previous studies suggest that bundling DHM consent with other consents is less than ideal because it provides insufficient time for decision making and often precedes the mother's ability to initiate the expression of her own milk.3 As such, for many parents, the DHM informed consent process may be inadequate as parents are concerned that they are not receiving sufficient amounts of information or given enough time to process it.3 As little is known about informed consent for the use of DHM in the NICU, in this article, we highlight the ethical principles surrounding this common dilemma. Furthermore, we argue for the standardization and consistent use of informed consent for DHM in the NICU.

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The discussion surrounding ethical decision-making is generally based on several principles including (1) nonmaleficence, (2) beneficence, (3) justice, and (4) autonomy.10 Nonmaleficence equates to doing no harm or at least causing minimal suffering to an individual. Beneficence is the act of doing all that is possible, to the best of one's abilities, in terms of preserving life and alleviating suffering. Justice means being fair and giving all infants an equal chance at achieving desired outcomes. Finally, autonomy, in the context of neonatal care, is the right of the parents to make decisions about their child's care. Each of the 4 principles is discussed in the context of the use of DHM in the NICU setting and informed consent.

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DHM and Nonmaleficence

The ethical principle of nonmaleficence requires that the use of DHM does no harm to the infant who receives it. There is a historical context for concerns about potential harms of DHM, which is important to consider in conversations with parents about its use, but there is also more recent research to support its safety.

The use of DHM has steadily increased for high-risk infants, particularly for those born premature or of very low birth weight. Although both informal and formal milk sharing has persisted for centuries, human milk banking was not introduced until 1909 in Vienna.11 The United States and Europe followed suit during the 20th century11; however, in the 1980s, concerns over a new infectious disease, human immunodeficiency virus (HIV) infection, precluded the use of DHM.8 With technological advancement and more robust screening procedures, the World Health Organization and the United Nations Children's Fund (UNICEF) instituted a statement in 1980 supporting the use of DHM when MOM was not available, and human milk banking increased in popularity.11

This renewed interest in human milk banking spurred the development of a system of individual, nonprofit human milk banks.8 In 1985, the Human Milk Banking Association of North America (HMBANA) was developed, and it continues to oversee the safety standards for milk banks across the United States today.8,12 The guidelines developed by HMBANA provide recommendations on the expression, storage, and handling of human milk.12

DHM is considered safe when appropriate measures are taken to ensure the cleanliness and quality of collection, storage, pasteurization, and administration.1 Several methods exist for pasteurization, or the partial sterilization of DHM, thereby making it safe for consumption.8 The Holder method, a pasteurization method used by HMBANA milk banks, includes rapid heating of the milk, then the maintenance of a constant temperature, followed by rapid cooling.13 While Holder pasteurization is the recommended method for DHM use, other methods of pasteurization are currently in development in the hope of improving the integrity of biologically active compounds found in human milk.13

The act of pasteurization of DHM is an example of nonmaleficence in the care of infants. Nonmaleficence promotes the reduction of harm inflicted upon an individual, and the level of care taken to ensure the safety of DHM demonstrates this principle. While the process of DHM pasteurization is highly effective in removing infectious agents, it results in the loss of biological compounds such as immunoglobulins, enzymes, cytokines, and hormones, which must be considered in the context of providing informed consent and promoting beneficence.2

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DHM and Beneficence

The ethical principle of beneficence posits that decisions around the use of DHM must promote the well-being and prevent suffering of the infant. There are advantages of MOM over DHM. To act with beneficence, these benefits must be recognized, discussed, and promoted during discussions with parents.

One of the potential advantages of MOM over DHM is improved infant growth.2 Early research that suggested the use of DHM for low birth-weight and premature infants resulted in slower growth when compared to MOM.1 However, with additional research, the science behind DHM has evolved and growth outcomes are improving. This is likely due to the practice of adding human milk fortifiers to DHM to boost caloric and nutritional content and support infant growth.1

Pasteurization of DHM also reduces levels of important immune cells and bioactive components including lactoferrin and immunoglobulins.2 Furthermore, pasteurization virtually eliminates the protective microbes found in MOM.2 Although DHM and MOM are often considered interchangeable, evidence continues to suggest the superiority of MOM over DHM.14 Without this knowledge, parents are unable to make a truly informed decision regarding the use of DHM, thus undermining the ethics of parental decision-making. When considering available nutritional options for infants, it is important to attempt to maximize clinical benefits. In the absence of MOM, DHM is a superior alternative to formula for very vulnerable infants.7 Utilization of a combination of evidence-based guidelines and consideration of the individual needs of the infant and family should inform shared decision-making between the provider and the parent(s).

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DHM and Justice

Despite the increasing use of DHM in the NICU setting, the limited availability of DHM to the most vulnerable of infants reinforces the importance of promoting the use of MOM. The ethical principle of justice highlights the concept that every infant should have the right to the most nutritious and acceptable form of nutrition, which is MOM. Mothers should be supported in their efforts to maintain lactation and provide MOM to their infant.

Moreover, literature suggests that disparities may exist in the provision of MOM in the NICU setting, making the principle of justice relevant. While non-Hispanic black women are at an increased risk for preterm birth, they are also at greater risk for not breastfeeding.1 Several factors may account for differences in human milk use across NICUs by racial composition. These factors include a lack of consistent hospital policies supporting breastfeeding in the NICU setting, discrepancies between mothers' knowledge and access to education, and healthcare and community support for breastfeeding.1,3 The basic human right to optimal nutrition should be supported across populations.

When MOM is unavailable, the principle of justice is still significant as the access to DHM is also an issue of equity. Limitations in the use of DHM include the costs associated with providing DHM to facilities, which may leave compromised infants at risk of not receiving DHM.2 For this reason, the use of DHM is often reserved for infants born less than 1500 g birth weight.1,2 When appropriate, the use of DHM should not be limited by a hospital or family's ability to pay. Policies ensuring the principle of justice are necessary to provide high-risk infants equitable access to DHM.2

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DHM and Autonomy

Informed consent is derived from the ethical principle of autonomy10 and postulates that, in the case of neonatal care, parents should have the freedom to decide what is and what is not acceptable in the care of their infant, including when DHM is used. After efforts have been made to support mothers in the preservation of lactation, if MOM is unavailable, healthcare providers should ensure full disclosure of all information related to the current state of knowledge regarding DHM. Additional facts, including the purpose and process of DHM use, its risks, and probable consequences, the risks associated with artificial nutrition (commercial infant formula), and an indication of the parent's understanding of these concepts should be well documented.15 These standards are in keeping with the concept of informed consent.

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Informed consent is a concept with a controversial history, particularly as it relates to healthcare. Defined as a healthcare provider's legal obligation to disclose information to his or her patient, informed consent is foundational in the patient–provider relationship.10 Informed consent originated in the early 1900s following the appellate decisions of several tort cases involving the alleged battery (nonconsensual and offensive touching) of a patient by a physician.10 Concerns over the presence or absence of formal consent, regardless of treatment outcome, marked these cases and set the standard for what is now considered standard informed consent practices.10

As aforementioned, informed consent ensures a patient's autonomy and the right to self-govern what happens to his or her own body.15 As such, patients should be the final decision makers regarding whether a test, procedure, or surgery is performed.9 In addition, patients have the right to gather as much information as needed to fully understand a procedure, the risks, and the potential benefits.

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While not ideal, there are reasons why informed consent for DHM use may not always be most appropriate. Table 1 illustrates the pros and cons of informed consent for the use of DHM in the NICU setting. The critical nature of a NICU may lead to less autonomous decision-making for parents of infants in the NICU. Thus, the use of DHM may be subject to the authority of the healthcare provider and/or the surrogate decision maker who make decisions about the infant's care on behalf of the parents. For example, if mothers experience birth complications and are unable to make medical decisions, or if the parents are otherwise unavailable following the birth of an infant, a surrogate decision maker may need to make medical decisions. When this occurs, the act of consenting for DHM may have lasting implications, particularly when the parent's wishes are unknown.



Healthcare providers need to consider the risks and benefits of decisions using their best judgment. Decisions for the use of DHM should be based on the potential future quality of life for the infant and family. This approach can be helpful in assisting not only parents but also surrogate decision makers with the decision-making process.9

DHM is the standard of care for infants when MOM is not available. In keeping with the ethical principle of nonmaleficence, steps must be taken to ensure that the desire for informed consent does not delay the early provision of feedings for already compromised infants. For these reasons, we encourage continuous dialogue between staff (not limited to physicians, nurses, lactation consultants, and therapists) regarding the management of the mother–infant dyad. Open communication can help ensure that mothers' infant feeding decisions are well-communicated and incorporated into care plans, while safeguarding the early provision of infant nutrition.

Conversations should begin throughout the pregnancy regarding the various options for infant feeding, including the use of DHM. These messages should be communicated across the healthcare team to reduce the need for rapid care decisions or the delay of early feedings. Mothers and their support persons should be given sufficient time to make decisions regarding the use of DHM.

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Taking the importance of ethical considerations into account, we argue for a standardized consistent use of informed consent for DHM in the NICU. Table 2 highlights several considerations for the development of informed consent guidelines associated with the relevant ethical principle.



Esquerra-Zwiers et al3 suggest several talking points when consenting for the use of DHM: maternal emotions, the quality of DHM, paternal hesitations, and sufficient MOM volume. Validation of both maternal and paternal emotions and hesitations regarding DHM is also important. The healthcare team should address any questions parents may have. Anticipatory guidance should be given, and contingency plans should be developed should there be issues in attaining MOM. These concepts are particularly important for women at risk of preterm labor and should be addressed prenatally.

When discussing DHM with parents, language should be used that addresses the superiority of MOM over DHM. In addition, steps should be taken to help the mother in providing her own milk. However, mothers and healthcare providers should discuss a contingency plan if MOM volume is insufficient.

Mothers and their partners should be well informed of all precautions taken with the use of DHM including the process of human milk banking and its use in NICUs. Importantly, the mother's emotions regarding her ability or inability to provide her infant with MOM should be taken into consideration. The time needed to ensure the proper delivery of informed consent is an important consideration. Informed consent should be viewed as a continual process. This allows mothers the time needed to assess their beliefs and values regarding the information provided to them by NICU providers.3

Literature suggests that the availability of DHM may be associated with decreased use of MOM, suggesting that education regarding DHM is lacking even when consent is obtained.3 Ethically, one must respect a parent's autonomous decision-making and ensure that their decisions are upheld. Should a parent decline the use of DHM, through the process of informed refusal, the healthcare team will need to ensure that parents fully understand the associated potential negative health outcomes. This will also help ensure that parental refusal is not due to a failure in communication or lack of education.3 Working in collaboration with parents, NICU healthcare providers must offer information in an unbiased and nonjudgmental manner. Regardless of the outcome, NICU families should feel supported in their use of information to make their healthcare decisions.

Nurses are well positioned to advocate for the wishes of the parents concerning their desired infant feeding method and can act as mediators between parents and other members of the healthcare team. The trusting relationships that nurses often develop with NICU families can be leveraged to support parental decisions and ensure the process of parent self-determination and informed consent is aligned with ethical principles. Not only will this approach likely improve the quality of care for NICU infants but it may also enhance parental satisfaction with the NICU experience.

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DHM obtained from established milk banks is a safe alternative to MOM and offers benefits for preterm and low birth-weight infants that artificial nutrition is unable to provide. However, DHM is a biological product and parents need to be offered the opportunity for truly informed consent in the use of DHM for their infant. Parents should understand both the potential benefits and limitations to DHM when compared with MOM or artificial nutrition sources and need to have the opportunity to have their questions and concerns addressed appropriately. This conversation should be separate from the bundled consent for NICU care, and parent understanding should be well documented.

Use of the ethical principles can further inform the use of informed consent for DHM in the NICU. The availability of DHM and informed consent for its use, however, does not preclude the need for early and frequent lactation support to build and sustain maternal milk supply. MOM, except in rare cases, should be viewed as the optimal source of nutrition for the infant, with DHM being viewed as an alternative option when parents are able to provide informed consent. Standardized and consistent use of informed consent for DHM will help ensure that all infants and parents, in collaboration with their healthcare provider, have access to the beneficence, nonmaleficence, justice, and autonomy they deserve.

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donor human milk; ethics; human milk; informed consent; neonatal intensive care unit; parental autonomy

© 2019 by The National Association of Neonatal Nurses