Informed Consent and Assent

Although the need to obtain informed consent prior to proceeding with a procedure or operation is assumed to be a routine part of patient care, this is a relatively new concept when considering the scope of medical history. The current concept of informed consent has roots in both ethical theory and law, and the phrase ‘informed consent’ is adopted verbatim from an amicus curiae brief filed by the American College of Surgeons in Salgo vs Leland Stanford Jr University Board of Trustees in 1957: ‘A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent … In discussing the element of risk, a certain amount of discretion must be employed consistent with the full disclosure of facts necessary for an informed consent.’⁶ The ethical roots of informed consent lie within the principle of autonomy.

In the practice of pediatric surgery, most discussions regarding the direction of care are three sided, and involve the physician, the patient, and the patient’s surrogate(s). Most commonly, the parent(s) will act as the patient’s surrogate decision-maker with the understanding that parents know their child’s interests better than others, and will be deeply committed to pursuing care that fulfills their child’s best interests. Additionally, there is a general understanding of the importance of family autonomy and privacy, allowing medical decision-making within broad ethical boundaries that reflect family values. A parent’s medical decision-making for their child can be framed as a responsibility, rather than a right, with the focus remaining on the child’s best interests, rather than the parent’s(s’) assertion of autonomy. This focus may help to minimize conflict during the process of difficult medical decision-making. While other surrogates will be able to use substituted judgment in medical decision-making for adults who no longer have the capacity to consent for their own care, parental decision-making for the child is based on a broad vision of the best interest standard, incorporating the child’s emotional, social, and medical concerns, as well as the interests of the child’s family.

The elements associated with the process of informed consent are fairly constant, and help create a framework for our conversations with families and patients. Informed consent discussions must include:

These discussions regarding medical decision-making should be understood as a longitudinal process over time, recognizing that many decisions are made throughout the medical course as new information emerges.

An often overlooked, but important issue is the need for patient assent. The value of involving children and adolescents in their own medical decision-making is being increasingly recognized.⁷ The respect owed children as medical decision-makers is dependent on several factors, including their cognitive abilities, maturity of judgment, and the general respect owed a moral agent. Although many minors reach the formal operational stage of cognitive development that allows abstract thinking by mid-adolescence, newer insight into brain structure and function demonstrates slower development of executive function and judgment.^8–10 Executive function is key to the ability to balance risks and benefits and plan for long-term goals, skills that are necessary for meaningful informed consent discussions. While this cognitive control system which promotes self-regulation and impulse control develops during young adulthood, reward seeking behavior is prominent during adolescence, resulting in the risky behavior often seen in this age group. There is increasing evidence that, in general, adolescents make decisions differently than adults, and this slow neuromaturation may limit the adolescent’s medical decision-making ability, despite good cognitive skills.11,12

Despite these concerns, it is very important to include children and adolescents in discussions regarding their medical care. Assent from children as young as 7 years for medical and surgical interventions can foster moral growth and developing autonomy in young patients, contributing to empowerment and potentially even compliance with the treatment plan.¹³ Assent includes helping the patient achieve a developmentally appropriate awareness of the nature of his/her condition, telling the patient what he/she can expect regarding tests and treatments, making an assessment of the patient’s understanding of the situation, and soliciting an expression of the patient’s willingness to accept the proposed care.

Throughout this process, it is very important that the child is not deceived. Although information should be provided, one should not attempt to solicit the child’s assent if the treatment is required. Within these limitations, a child should still be given as much control over the actual treatments as possible. Dissent from the child should carry increased weight when the proposed intervention is not essential and/or can be deferred without substantial risk. In situations with a poor prognosis, and interventions associated with significant risk and discomfort, more consideration should be given to the adolescent’s opportunity to provide assent or refusal.

There are special circumstances under which an adolescent can legally provide his/her own consent for health care. The opportunity for adolescents to legally consent generally involves health care issues related to sexual activity. While all states allow adolescents to consent for treatment for sexually transmitted infections, protection of the adolescent’s confidentiality is less widespread. The majority of states allow at least some access to contraceptive services, but there can be great variation.¹⁴ There is similar variability among the states regarding adolescents’ access to mental health and substance abuse prevention and treatment services. These statutes do not reflect acceptance of the adolescent’s decision-making skills. Rather, allowing adolescents the opportunity to access this care is a public health decision, recognizing the concern that adolescents may not seek care for these issues if they are required to involve their parents for consent.

Another area sometimes encountered by the pediatric surgeon is the issue of the adolescent parent. While there are significant limitations on the adolescent’s legal right to consent for medical care, all states presume adolescent parents to be the appropriate surrogate decision-makers for their children, and allow them to give informed consent for their child’s medical care. This right reflects the adolescent’s status as a parent, rather than maturity of their decision-making abilities. At the same time, there is clearly significant concern in having an adolescent take responsibility for complex medical decision-making for their child while, in general, they are protected and guided in their own medical decision-making.

Withdrawing and Withholding Care

While decisions to withdraw or withhold care are extremely difficult for patients, families and care providers, most children who die in a hospital in the USA die following the withdrawal or withholding of clinical interventions.15,16 Although many clinicians feel uncomfortable discontinuing life-sustaining treatments that are already in place, there is no true legal or ethical distinction between withholding a treatment and withdrawing a treatment. This is important as refusal to withdraw already existing interventions may have negative outcomes. In this situation, patients may be forced to endure continued treatment, with its associated discomfort, despite demonstration that it fails to provide the anticipated benefit. Additionally, concern regarding the withdrawal of previously instituted interventions may make the clinician reluctant to offer a trial of therapy that may provide benefit to the patient, due to the fear of being committed to the technology.

When discussing potential medical interventions with families and patients, it is important that the pediatric surgeon has an understanding of their goals of care. A discussion of the goals of care should have the family and patient contributing their understanding of their illness and their personal values. The surgeon should contribute information on the diagnosis, benefits, burdens of the proposed and alternative therapies, and anticipated prognosis. Discussions that proceed from an understanding of the overall goals of care are more likely to result in a thoughtful, coherent care plan as opposed to episodic discussions of individual interventions. The appropriateness of a medical intervention should not be assessed in a vacuum, but should be evaluated as to how it promotes the goals of care.

Adults with the capacity to make their own medical decisions have the opportunity to accept or refuse all medical interventions, including life-saving medical treatments (LSMT). Additionally, adults are encouraged to create documentation, with the assistance of their physicians and family, that clarifies their preferences regarding their care and choice of surrogate decision-maker in the event that they lose the capacity to make their own health care decisions. In this situation, the surrogate is expected to make medical decisions utilizing a substituted judgment standard: striving to make the same decisions that the patient would have made. Children and their parents are generally not offered such a robust autonomy, especially regarding medical decision-making surrounding LSMT. Parents are expected to approach medical decision-making for their children from a best interest standard. The best interest standard should be considered broadly and includes not only prolongation of life, but also improved quality of life, such as reduction of pain, ability to interact with others, and ability to participate in pleasurable activities. It is very important to recognize that quality of life should be assessed utilizing the patient and family’s preferences and values.

Few adolescents are given the opportunity to discuss advance directives that would address their preferences for end of life care. This discussion, although difficult and requiring a great deal of sensitivity, may be appropriate for mature adolescents who have experienced a chronic illness and want to make their preferences known before further deterioration in their health prevents them from taking part in such discussions. In this situation, parents are able to utilize substituted judgment in making decisions regarding LSMT.

Similar to other medical interventions, decision-making surrounding LSMT should seek to balance the benefits and burdens associated with the proposed intervention(s), and their relationship to the overall goals of care. Although LSMT may provide for extension of length of life, this potential benefit must be considered in the light of associated burdens, especially if the prolongation of life results primarily in the continuation of biologic existence without consciousness. Burdens associated with LSMT may include intractable chronic pain, emotional suffering, repeated invasive procedures, prolonged hospitalizations, and the inability to interact with loved ones and participate in pleasurable activities.

Although Hippocrates is quoted as saying that physicians should ‘refuse to treat those who are overmastered by their disease, realizing that in such cases medicine is powerless’, this statement needs some clarification.¹⁷ First, it is important to acknowledge the difficulty in determining that the patient has been ‘overmastered by their disease’. Good ethics is often dependent on good facts. Second opinions or subspecialty consultation may be helpful. Most importantly, medicine should never be considered powerless in providing comfort. While LSMT may be withdrawn or withheld, care is never withdrawn, and comfort measures should be provided. The involvement of an integrated palliative care service is valuable in the transition of the goals to supportive care and comfort.

When consensus has been reached among the physicians, family, and when appropriate, the patient, that the burdens of LSMT outweigh their benefit, it is appropriate to proceed with withdrawal of these interventions, and focus attention on measures that will provide comfort to the patient and family. Many physicians are less familiar with the option of forgoing medically provided nutrition and hydration in children who may not require mechanical ventilation, but in whom a decision has been made to withdraw LSMT. The decision to withdraw or withhold medically provided fluid and nutrition is often controversial and uncomfortable, in large part due to the symbolism associated with feeding and nurturing infants and children. It is critical to distinguish between medically provided fluids and nutrition and feeding a child who is hungry and capable of eating. It has become clear both ethically and legally that the decision-making process surrounding medically provided fluid and nutrition is the same as for other medical interventions: it appears such care can be withheld when the physicians and family agree that the burdens of care outweigh the potential benefits.¹⁸

Medically provided fluids and nutrition are medical interventions with associated risks. These risks include, but are not limited to the potential for complications, the adverse effects of fluid overload including dyspnea and skin breakdown, systemic infection, and the need for frequent monitoring for fluid and electrolyte imbalance. Infants and children, in whom it may be reasonable to consider the withdrawal of medically provided fluids and nutrition, may include those in a persistent vegetative state and those with congenital central nervous system (CNS) malformations or perinatal CNS injury where a poor prognosis has been established and there is no capacity for conscious awareness or the ability to feed orally. Infants with a severe gastrointestinal injury or a disease that results in the destruction of a large portion of the small intestine, leading to total intestinal failure, are another population in whom the withdrawal of hydration and nutrition may be discussed. Although total parenteral nutrition may provide support for years, the associated morbidities, especially in the absence of any intestinal function, are significant, even in the current era of intestinal transplantation.

Difficult decisions are best made when there is consensus between the family, the patient when appropriate, and the health care providers. As with other LSMT, parents have the responsibility regarding medical decision-making, and they may choose to continue hydration and nutrition with the goal of continued survival. When a decision has been made to withdraw hydration and nutrition, it is important to involve the services of an integrated palliative care team to minimize suffering and provide comfort measures within a broader palliative care plan.

Issues Involved in Donation after Circulatory Determination of Death

The opportunity for organ recovery is one of the many issues that needs to be addressed with patients and families during discussions centered on end of life care. An opportunity to provide organs may offer comfort for a family grieving the death of their child. With increased social awareness, many adolescents have had an opportunity to consider this opportunity prior to their illness or injury, and may have shared their interest in being an organ donor.

The ethical issues related to organ transplantation are well described, and this discussion will focus on donation after circulatory determination of death (DCDD). DCDD serves at least two major purposes: to expand the pool of potential organ donors, and to provide an opportunity for families to proceed with organ donation in those situations where a decision has been made to withdraw LSMT but the child does not make the criteria for brain death. DCDD had been the initial form of deceased organ donation prior to the development of brain death criteria by an ad hoc committee at the Harvard Medical School in 1968.¹⁹ With the publication of a 1981 report on a whole brain determination of death by the Presidential Commission,²⁰ and the passage of the Uniform Determination of Death act,²¹ brain death became a widely accepted definition of death, and patients meeting these criteria became the most utilized source of organ donation, in significant part due to their physiologic stability providing improved organ function after transplantation.

Both the increasing disparity between the number of patients awaiting organ transplantation and the organs available for transplant, and an increased understanding of the need for broadened discussion regarding end of life care have increased attention on DCDD. This increased attention has resulted in regulatory policy regarding DCDD by both the Joint Commission and United Network for Organ Sharing (UNOS). The Joint Commission mandates that while hospitals may not offer DCDD, they must have policies that address it.²² UNOS/OPTN requires that transplant hospitals must develop DCDD recovery protocols that include the model elements as developed by UNOS/OPTN.²³ It is therefore important that all health care providers, especially pediatric surgeons, develop a working knowledge of DCDD and its associated ethical concerns.

There is a significant difference between the recovery of organs from a patient who has met brain death criteria, and one for whom a decision has been made to proceed with DCDD. With controlled DCDD, the patient is generally brought to the operating room and all LSMT are removed, and the patient is monitored until asystole is documented. Most protocols require the use of an echocardiogram or central arterial tracing to confirm asystole. There is variation, generally between two and five minutes, in the length of time required following asystole for determination of death at which point the transplant team is allowed to proceed with organ recovery.

While it is important that families have the opportunity to proceed with DCDD if they wish, it is also important that there be no coercion or pressure applied to their decision. The decision to withdraw LSMT must be prior to and separate from any consideration of proceeding with DCDD. Sometimes, hospital policy on DCDD will include a mandatory ethics consult to allow for independent evaluation of separation of these two decisions, and to help ensure that the family is able to come to this decision without coercion. The goal is to avoid a decision to proceed with withdrawal of LSMT for the purpose of providing organs for recovery. It is ethically critical that the decision to proceed with withdrawal of LSMT is made to further the patient’s best interests, because the interventions no longer provide benefit in the family’s judgment, and not to serve a utilitarian goal of organ recovery.

Proceeding with DCDD is likely to alter the family’s opportunity to be with the child at the time of death. Most often, the patient is moved to the operating room prior to the removal of LSMT to allow for rapid recovery of organs following determination of death. Although withdrawal of LSMT is deferred until the patient is moved to the operating room in the anticipation that asystole and death will occur shortly after, this is not entirely predictable. Most DCDD policies anticipate this problem, and limit the amount of time spent waiting for asystole following removal of LSMT to between 30 and 60 minutes. Families should be prepared for the potential that the patient will be returned to the intensive care unit (ICU), where comfort care will continue until death ensues.

There are additional ethical issues concerning DCDD that significantly impact the health care provider. The concept of DCDD, and the creation of a policy supporting its use, is dependent on a specific understanding and definition of death, which is not universally shared among physicians. Certainly a shorter period of observation following the onset of asystole may increase the concern as to whether the patient is dead prior to the organ recovery. These concerns are due to both the potential for autoresuscitation following the onset of asystole and the fear that the patient is actually in the process of dying, but is not yet dead. It is critical that the patient is dead prior to proceeding with organ recovery as cadaveric organ transplantation operates under the dead donor rule. This rule can be conceptualized two ways: organ recovery must not cause the donor’s death, and the donor must be dead prior to proceeding with the recovery of organs.²⁴ Clearly, providing assurance that the donor is dead is critical to an ethical approach to organ recovery as it minimizes the risk of using patients as a means to an end, and it supports public trust in organ donation and transplantation. While there has been general acceptance by the Institute of Medicine, critical care societies, and UNOS/OPTN regarding the determination of death under DCDD criteria, individual practitioners may have valid concerns about this management. Hospitals should have a process that allows for individual practitioners to decline to support DCDD care, while still providing this service to families that request it.

A related ethical issue is the need for the physicians involved to avoid a conflict of interest in the patient’s care. The attending physician for a patient undergoing removal of LSMT and proceeding with DCDD should not be involved in the organ recovery or transplantation. The transplant surgeons/organ recovery team should have no contact with the patient until after the determination of death. There are other interesting issues surrounding DCDD, including the place of extracorporeal membrane oxygenation (ECMO) in stabilization for DCDD, and social justice issues concerning uncontrolled DCDD, but these concerns go beyond the scope of this chapter.

Conscientious Objection

Conscientious objection among health care professionals has become the subject of increasing attention in the ethics literature as well as the courts and legislature. Conscientious objection refers to health care professionals who may object to or even refuse to provide an otherwise legally available medical treatment within the scope of their practice based on a moral objection to the treatment or procedure. Circumcision is an example in pediatric surgery that may raise concerns in the realm of conscientious objection. Circumcision is well within the scope of practice of the pediatric surgeon, yet there may be reasonable objection to performing circumcision without medical indication on infants and children too young to provide meaningful assent to the procedure. Decisions surrounding end of life care and the conflicts surrounding DCDD are other areas within pediatric surgery where issues of conscientious objection arise.

Conscientious objection is an interesting and important ethical dilemma, as it requires balancing the competing ethical claims of the physician and the patient. There are morally important reasons to protect the health care professional’s exercise of conscience.²⁵ Requiring a health care professional to provide a therapy or perform a procedure that violates their conscience may undermine their sense of integrity and self-respect, and result in a negative effect on their professional persona. Protection of rights of conscience is important in allowing health care professionals to maintain a sense of self, and protects basic religious freedom by allowing the individual to live according to their innermost values.

Issues of conscientious objection reflect an objection based on personal or religious morality rather than commonly accepted professional ethics. While the practice of conscientious objection is important and legally protected, the patient’s right to care must also be respected and protected. Conflicts occur when claims of conscientious objection interfere with access to medical care. Generally, claims of conscience, and refusal to provide a specific medical treatment or intervention, are acceptable as long as the patient is not put at risk and referral is made in a timely fashion to another skilled practitioner who will provide the contested care. A problem arises if the health care provider not only refuses to provide the morally objectionable care, but also refuses to refer the patient to another provider on the grounds of complicity. Complicity is concerned not only with the performance of an act, but also with the facilitation of another’s performance of an act that one finds morally objectionable. This may seriously limit the patient’s right to medical care.²⁶

An understanding of informed consent is critical in considering the ethical conflicts raised by conscientious objection. Providing the information and counseling required for an informed consent is a basic professional ethical and legal requirement so that patients and their surrogates can make an informed judgment regarding their choice of care. This includes information on treatments that the health care practitioner does not provide and/or finds morally objectionable. Informed consent seeks in part to provide adequate information so that the patient and family can match treatment options with their own deeply held values, even if these differ from the health care provider’s values. This opportunity is seriously compromised if the information provided is significantly filtered by the practitioner’s values and nonmedical judgment.

The discussions surrounding informed consent should support and respect the autonomy of the patient and family, recognizing the diversity of backgrounds and values represented in the patient population. Physicians must understand the significant imbalance in power and knowledge between themselves and the patient. Patients should be able to expect a full disclosure from their physician about their diagnosis and all treatment options. Professional licensure defines a social role that includes special responsibilities. Licensure allows physicians as a professional society the right to regulate the training and education required for entrance into the profession. Licensure also allows physicians as a professional society a monopoly over the provision of medical services. This power and control comes with reciprocal responsibilities, which are voluntarily assumed when physicians enter the medical profession. These professional role expectations include activities that support the ethical principles of beneficence. As part of this professional obligation, it is expected that physicians will place the patient’s needs before their own, and these responsibilities must be considered in balancing the values and needs of the physician and patient. In an effort to balance these competing concerns, it is appropriate to respect a constrained right to conscientious objection, allowing the physician the right to decline to provide a morally objectionable medical intervention as long as information is provided about treatment options with a timely referral to another available skilled practitioner.

Clinical Research

All clinical research in the United States is guided by the principles expressed in the Belmont Report. The Belmont Report (the Ethical Principles and Guidelines for the Protection of Human Subjects of Research) was prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published in 1979.²⁷ This work was undertaken due to public outcry over well publicized ethical lapses in clinical research in the USA despite what should have been learned following the Nuremberg Doctors’ Trial.²⁸ The report first distinguished between accepted clinical practice and research by clarifying that research describes an activity designed to test a hypothesis or contribute to general knowledge. In addition, the report also briefly addresses the issue of innovation, and distinguishes between clinical innovation and research, noting that major innovation should move towards formal research at an early stage. Unfortunately, this is the extent of discussion on innovation in the report, and more work needs to be done with innovation and the safety of patients and research subjects. The report clarifies that all activity considered research should undergo review for the protection of human subjects.

The report identifies three basic ethical principles that are particularly relevant to assessing research involving human subjects: respect for persons, beneficence, and justice. Respect for persons is reflected in the principle of autonomy. The principle of autonomy is demonstrated by respecting individuals as autonomous agents when they have the capacity to provide consent. The report discusses the need for protection of individuals who lack the capacity to function as autonomous agents, recognizing that this capacity may fluctuate over time. The principle of beneficence is incorporated in the obligation to maximize benefits and minimize possible harms. The report emphasizes that investigators should seek to design research protocols that will minimize risks to subjects while maximizing the benefit. The principle of justice reflects a fair distribution of both risks and benefits, with equals being treated equally. Care must be taken to insure that the burdens and risks of participating in research will be distributed fairly among the population.

The report then goes on to demonstrate the applicability of these general principles to the creation of guidelines for the protection of human research subjects. There is an extensive discussion of the need for informed consent, recognizing that this level of informed consent may need to go beyond the more standard consent obtained in the clinical setting. Additionally, the discussion of informed consent in the report strengthens the position of assent by older children and adults with limited capacity, giving these subjects the opportunity to decline to participate in research. This is a much stronger protection of the minor’s right to assent to or decline an intervention than exists in the clinical realm. The requirement that the research protocol demonstrates a favorable risk-benefit analysis is seen as an example of the principle of beneficence. Finally, the principle of justice is manifest in the discussion on the selection of subjects. The report clearly discusses the concern regarding the involvement of vulnerable populations in research, and the risk of further burdening an already burdened class including children, prisoners, and the institutionalized mentally ill.

The USA Department of Health and Human Services (HHS) has applied the ethical principles detailed in the Belmont Report to the development of federal policy regarding the protection of human research subjects. This federal policy, HHS regulation 45 CFR 46, is known as the Common Rule as it is utilized by 15 different federal departments and agencies in guiding regulations regarding research.²⁹ This HHS regulation provides general guidelines regarding oversight for human subjects research including the responsibilities and membership of institutional review boards (IRB) and the requirements for informed consent. Subpart D of this regulation discusses the additional protections for children and the need to seek permission from the child’s surrogate to allow their participation in research.

As a vulnerable population, the risks that children may be exposed to are more constrained than the adult population. Children may participate in research not involving greater than minimal risk, or greater than minimal risk, but presenting the prospect of direct benefit to the individual subject. Also, they may be recruited for research with greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s condition. Research protocols that do not fit any of these three categories, but which present an opportunity to understand, prevent or alleviate a serious problem affecting the welfare of children cannot be approved independently by a local IRB, but require review by a panel of experts at the federal level.

The determination of risk is an area where there may be valid disagreement between IRBs. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical examinations and tests. This definition is most likely intentionally broad, allowing for local interpretation. While the rules are developed to protect the interests of the individual research subject, they place significant limitations on clinical research in children.

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