Ethical and Legal Aspects of Care

Ethical concerns may be grouped into a few broad categories. Questions of patient selection (which has the potential for abuse), and principles of non-maleficence, justice and equity may all pertain[3].

Determination of Limitation or Withdrawal of Care
The medical team and the family may legally discontinue overly burdensome treatment [264-266]. Non-initiation or withdrawal of intensive care for high-risk newborns must consider several key areas:

  1. Decisions about non-initiation or withdrawal of intensive care should be made by the health care team usually in collaboration with the parents, who must be well-informed about the condition and prognosis of their infant.
  2. Parents should be active participants in the decision-making process.
  3. Compassionate comfort care should be provided to all infants, including those for whom intensive care is not provided.
  4. It is appropriate to provide intensive care when it is thought to be of benefit to the infant, and not when it is thought to be harmful, or of no benefit, or futile.

The goal for the primary team and subspecialty consulting services is to design a course of action that is in the baby’s best interest. However, there is currently no consensus defining a best interest standard. It may therefore be appropriate to take into account the interests of others, including family and caregivers, but these interests should be given less priority than the baby’s[266].

The Texas Advance Directives Act and its Application to Minors
If an infant is to be transitioned from curative to comfort care and this entails the withholding or withdrawal of life-sustaining treatment, it is important to determine if s/he is a qualified patient under the Texas Advanced Directives Act (TADA). The TADA, also known as the Texas Futile Care Law (1999), states that a qualified patient is one with either an irreversible or a terminal condition. A patient need have only one of the two conditions to qualify for TADA.

An irreversible condition is one that may be treated but is never eliminated, leaves a person unable to care for or make decisions for him or herself, and is fatal without life-sustaining treatment provided in accordance with the prevailing standard of medical care. A terminal condition is an incurable condition caused by injury, disease or illness that according to reasonable medical judgment will produce death within six months, even with available life-sustaining treatment provided in accordance with the prevailing standard of medical care. The baby’s mother, legal father, or legal guardian may sign or verbally agree to an advanced directive, or make treatment decisions for the affected infant. The TADA also empowers the attending physician to invoke an institutional review process if parents persist in demanding interventions that the attending physician believes to be inappropriate[267].

The 1984 “Baby Doe” amendment to the Child Abuse Prevention and Treatment Act (CAPTA) directs Child Protective Services to investigate cases to prevent the withholding of medically indicated treatment from disabled infants with life threatening conditions. The amendment defines treatment as NOT medically indicated if the infant is irreversibly comatose, if it would merely prolong dying, not be effective in ameliorating or correcting all of the life-threatening conditions, if it would be futile in terms of survival, or if it would be virtually futile in terms of survival and be inhumane. Definitions for “life threatening,” “prolong dying” and “virtually futile” are in an appendix to 42 U.S.C. § 5106, do not have the force of law, and have never been enforced in Texas or any other state.

Special Circumstances Surrounding Delivery Room Resuscitation
There is no federal law or Texas state law mandating delivery room resuscitation in all circumstances. According to the Neonatal Resuscitation Program (NRP), it is ethically and legally acceptable to withhold or withdraw resuscitative efforts if the parents and health professionals agree that further medical intervention would be futile, would merely prolong dying, or would not offer sufficient benefit to justify the burdens imposed.

Parents and health care providers must have accurate and current information regarding potential infant survival and outcomes. Joint decision making by both the parents and the physician should be the standard. Given the uncertainties of ultrasound-guided gestational age assessment and fetal weight determination, it will usually be necessary to examine the baby at birth before making firm statements to parents and others regarding providing or withholding resuscitation. However, clinical exams of extremely premature infants have been found to sometimes be inaccurate[268]. The physician’s best clinical judgment should therefore always be used. In specific cases when parents request that all appropriate resuscitative measures be performed in the face of a high or uncertain morbidity and/or mortality risk, it may be appropriate to offer the infant a trial of therapy which may be later discontinued. Alternatively, some parents may not want full resuscitation of their child; the appropriate response in these cases will depend upon the circumstances.

Ethical and legal scholars agree that there is no distinction between withholding and withdrawing life-sustaining treatments[269]. The Born-Alive Infants Protection Act of 2002 ("BAIPA" Pub.L. 107-207, 116 Stat. 926, enacted August 5, 2002, 1 U.S.C. § 8) by Congress extending legal protection to an infant born alive after a failed attempt at induced abortion has never enforced in the case of a periviable infant.

The Option of No Escalation of Care

Parents faced with the prospect of their infant’s death may not be able to join in the decision to discontinue life support altogether. The family should again be informed that despite all available interventions, the known outcome for their infant remains unchanged. The option of continuing current support to give the parents time for memory-making with their baby may be offered as a bridge to the transition to comfort care. However, ultimately the baby’s best interest comes first. If further treatment of the infant is determined to be futile and the parents remain unable to accept this, the primary team should discuss the patient’s case with the medical director and consider a bioethics consult.

Disagreement between the Medical Team and the Family

The infant’s parents serve as legal and moral fiduciaries for their child, and the relationship of parents to children is a responsibility, not a right. Because infants are incapable of making decisions for themselves, their parents become their surrogate decision makers [270-272]. The physician serves as a fiduciary who acts in the best interest of the patient using the most current evidence-based medical information. In this role as an advocate for their patients, physicians oversee parental decisions. Thus, the patient’s best interest standard overrides the doctrine of informed consent and right to refusal of care.

Even in the best of circumstances people of good conscience may disagree. If individual caregivers’ ethical standards conflict with those of the parents or the primary team, the caregiver is free to remove herself or himself from the care of the patient in accordance with hospital and unit policies. In circumstances of disagreement between the family and medical team, other professionals (e.g., social worker, family relations team, and the chaplain) may be of help in further discussions. In both instances, the director of nursing and the medical director should be notified.

If the benefit of providing or withholding a certain treatment or intervention is unclear, the final decision should rest with the parents of the infant.

Bioethics Committee Consultation
If further agreement with the family cannot be reached, a bioethics committee consult should be obtained.  If the parents request full resuscitative measures in direct opposition to the opinion of the medical team and the infant is responsive to those measures, the infant should continue to be supported while the ethics committee’s deliberations are ongoing.

Under the law, the following process must occur if the treatment team and institution wish to take full advantage of the law’s safe harbor provisions:

  1. The family must be given written information concerning hospital policy on the ethics consultation process as well as information about a state-wide referral registry maintained by the Texas Health Care Information Council.
  2. The family must be given 48 hours’ notice and be invited to participate in the ethics consultation process.
  3. Those involved with the ethics consultation process must provide a written report to the family detailing the findings of the ethics review process.
  4. If the ethics consultation process fails to resolve the dispute, the hospital, working with the family, must try to arrange transfer to another physician or institution that is willing to give the treatment requested by the family and refused by the current treatment team.
  5. If after 10 days (measured from the time the family receives the written summary of the ethics consultation process) no such provider can be found, the hospital and physician may unilaterally withhold or withdraw the therapy that has been determined to be futile.
  6. The patient or surrogate may ask a state court judge to grant an extension of time before treatment is withdrawn. This extension is to be granted only if the judge determines that there is a reasonable likelihood of finding a willing provider of the disputed treatment if more time is granted.
  7. If the family does not seek an extension or if the judge fails to grant one, the disputed treatment may be unilaterally withdrawn by the treatment team with immunity from civil or criminal prosecution. (This is the legal “safe harbor” for physicians, institutions, and ethics committees, the first of its kind in the country) [273].

Patients in Child Protective Services Custody
It is the policy of the Texas Department of Family and Protective Services that any decision to withdraw or redirect care of a qualified patient in the custody of CPS must have the concurrence of an ethics committee with knowledge of the patient’s case, and must also be approved by a court.

The attending physician of record should document in the chart the reasons why the patient qualifies for withdrawal or redirection of care, as well as the discussion of these qualifying factors with the surrogate decision maker (see who may execute a directive on behalf of a patient under the age of 18 below; however, in the NICU the surrogate decision maker will almost always be the parents). If the patient is actively dying, there is no need for this documentation to be witnessed. However, if the patient is being electively transitioned to comfort care or withdrawal/limitation of support and adequate time exists, a Directive to Physicians should be utilized. The Directive to Physicians may be verbal or written. If verbal, the conversation between the physician and the surrogate decision maker should be observed by two witnesses unrelated to the family and patient and who have no role in the patient’s medical care (see witness requirements below; these witnesses may be other medical personnel in the NICU who are not directly caring for the infant). The note should document that the surrogate decision maker agrees with the modification of the plan of care and should include the names of the witnesses. A Directive to Physicians may also be signed by the surrogate decision maker and two unrelated witnesses. After the care team discusses the terminal and/or irreversible diagnosis and care plan with the family, a “Do Not Attempt Resuscitation” (DNAR) order should be entered in the patient’s chart. The attending physician should honor the family’s wishes as previously documented when completing this form. If there is any uncertainty as to whether a specific intervention should be withheld, that decision should be discussed further with the family. In the case of the active withdrawal of life sustaining therapy, a DNAR form is not necessary.

Sec. 166.035. EXECUTION OF DIRECTIVE ON BEHALF OF PATIENT YOUNGER THAN 18 YEARS OF AGE. The following persons may execute a directive on behalf of a qualified patient who is younger than 18 years of age:
   1. the patient’s spouse, if the spouse is an adult;
   2. the patient’s parents, or
   3. the patient’s legal guardian.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Renumbered from Sec. 672.006 by Acts 1999, 76th Leg., ch. 450, Sec. 1.03, eff. Sept. 1, 1999.

Sec. 166.003. WITNESSES. In any circumstance in which this chapter requires the execution of an advance directive or the issuance of a nonwritten advance directive to be witnessed:
1. each witness must be a competent adult; and
2. at least one of the witnesses must be a person who is not:

  • a person designated by the declarant to make a treatment decision,
  • a person related to the declarant by blood or marriage,
  • a person entitled to any part of the declarant’s estate after the declarant’s death under a will or codicil executed by the declarant or by operation of law,
  • the attending physician,
  • an employee of the attending physician,
  • an employee of a health care facility in which the declarant is a patient if the employee is providing direct patient care to the declarant or is an officer, director, partner, or business office
  • employee of the health care facility or of any parent organization of the health care facility, or
  • a person who, at the time the written advance directive is executed or, if the directive is a nonwritten directive issued under this chapter, at the time the nonwritten directive is issued, has a
  • claim against any part of the declarant’s estate after the declarant’s death.

Added by Acts 1999, 76th Leg., ch. 450, Sec. 1.02, eff. Sept. 1, 1999.