Ethics in the NICU: Principles, Methods & Application

1. Ethics in the NICU:Principles, Methods& Application Mark R. Mercurio, MD, MA Christy L. Cummings, MD

2. Overview Adequate fellowship training in ethics and professionalism is crucial so that neonatologists may effectively approach and resolve numerous ethical dilemmas that frequently arise in the NICU

3. Assigned Reading • American Academy of Pediatrics, Committee on Bioethics Informed Consent, Parental Permission, and Assent in Pediatric Practice. Pediatrics. 1995;95:314-17. Available at: http://pediatrics.aappublications.org/content/95/2/314.full.pdf • American Academy of Pediatrics, Committee on Bioethics Guidelines on Religious Objection to Medical Care. Pediatrics. 1997;99(2):279 –281. Available at: http://pediatrics.aappublications.org/content/99/2/279.full.pdf • Hardwig, John. “What about the Family? – The Role of Family Interests in Medical Decision Making.” Hastings Center Reports, 20 (March/April) 1990, p. 5-10. Available at: http://web.utk.edu/~jhardwig/family.htm • Mercurio MR. The role of a pediatric ethics committee in the newborn intensive care unit. J Perinatol. 2011;31(1):1-9. Available at: http://www.readcube.com/articles/10.1038/jp.2010.39

4. Learning Objectives • Demonstrate application of various ethical frameworks to approach challenging ethical situations in the NICU. • Principle-based, feminist ethics, case-based, and ethics of care • Recognize limitations and strengths of each • Demonstrate ability to identify appropriate decision-makers when caring for an infant. • Distinguish between informed consent and informed parental permission. • Identify appropriate, practical strategies to resolve ethical conflicts in the NICU. • Understand the role of a pediatric ethics committee

5. Discussion Questions • Who should make medical decisions for an infant and on what basis should he/she decide? • What if there is disagreement between parents or among family regarding the best course of action? • What are some ethical frameworks and perspectives to approach ethical conflicts in the NICU? • What is the difference between informed consent and informed parental permission? • What are the rights of an infant? What are the rights of the parent(s)?

6. Discussion Questions • What are the best interests of the infant? Who determines this? What about the interests of the parents and family? • What if the infant’s parents refuse a recommended treatment? • What if the infant’s parents request a medical intervention not recommended by the physician? • What are some practical approaches to help resolve conflicts between an infant’s parents and the clinical providers?

8. Parental Authority • Traditionally, parents are accorded the right to make decisions on behalf of their children. • This notion of parental authority dates back as early as Ancient Rome • offspring were regarded as actual property or commodities that could be killed, traded or sold by the male head of the family or ‘paterfamilias,’ usually the father. • Under Roman law, this power granted to the father was referred to as ‘Patria Potestas.’ Long G, Dictionary of Greek & Roman Antiquities, 1875.

9. Parental Authority • Common justifications for parental authority include: • “Parents are responsible for bringing up their children, and that responsibility necessarily requires having rights for decision-making; • Apart from the children, parents will be the ones most likely to have to live with the consequences of any decisions made; • Parents know the child best; • Affection and close family ties make parents most likely to reach decisions based on the child’s best interest.”2 • Children generally grow up to share many of their parents’ values. Foreman EN, Ladd RE. Making decisions - whose choice ? 1996.

10. Parental Authority vs Parental Responsibility • Parental authority is still widely recognized today, and extends to medical decision-making as well. • This right is now also balanced by parental responsibility the obligation of parents to care for and support their children • Love, nurturing, care • Basic necessities (food, clothing, home) • Education and guidance AAP COB, Informed Consent, Parental Permission & Assent, Pediatrics, 1995.

11. Limits to Parental Authority “Parents are free to become martyrs themselves. But it does not follow that they are free, in identical circumstances, to make martyrs of their children before they have reached the age of full and legal discretion when they can make that choice for themselves.” Prince v. Massachusetts, 321 US 158 (1944).

12. Limits to Parental Authority Parents generally do not have the right to refuse recommended medical treatment for their children that is clearly opposed to their best interests, or would “likely prevent significant harm, suffering, or death” AAP COB, Guidelines on Religious Objections to Medical Care, Pediatrics, 1997.

13. Surrogate Decision-Maker • Respect for autonomy forms the basis for informed consent • fully informed, competent adults are accorded the right to make medical decisions, including the right to refuse an unwanted therapy, even if this results in serious harm or death • One cannot give “informed consent” for another person • When a patient is unable to given informed consent on his own behalf, a surrogate decision-maker provides informed permission, often parents of a child. • The biological parents may not always be the appropriate decision-makers • An infant may be in the custody of a relative, surrogate or adoptive parent(s), a court-appointed guardian, or the state.

14. Principle-Based Ethics Respect for autonomy Beneficence Nonmaleficence Justice • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009.

15. Respect for Autonomy • ‘Self-rule,’ derived from the Greek auto and nomos • Implies the ability of a person to make meaningful medical decisions for oneself, free from coercion, misinterpretation or other limiting factors • recognizes individual beliefs, opinions and perspectives, and allows an individual the freedom to make informed medical decisions regarding treatment or nontreatment • Forms the basis for informed consent • Irrelevant in the NICU; rely instead on parental authority and parental permission • Is not absolute and should be considered along with other ethical principles and perspectives • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009.

16. Beneficence • This principle dictates that a physician is obligated to ‘do or produce’ good for the benefit of his or her patients, to promote their well-being. • Includes protecting the rights of others and preventing harm, which overlaps with the principle of nonmaleficence. • May at times conflict with autonomy • When a competent decision-maker refuses a treatment that would clearly benefit him or her. • Irrelevant in the NICU as infants are not autonomous. • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009.

17. Nonmaleficence • This principle states that a physician is obligated to ‘do no harm’ (primum non nocere) willingly to his or her patients • In medicine, however, many treatments intended to do good must be weighed against their inherent potential harms. • Ventilators • Antibiotics • Surgery • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009.

18. Justice • This principle broadly implies that equal persons ought to be treated equally. • This concept can be applied at the individual level, at a community level, as well as the societal level • Similar patients ought to be treated equally • Resource allocation across country • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009.

19. Feminist Ethics • Addresses the care of groups that have traditionally experienced oppression, domination and bias • women, minorities and children • Allows for “consideration of a broader notion of autonomy” • includes the relationships and “contexts in which women live, the difficulty they often have in accessing treatment services, and their endurance of systematic oppressions related to ethnicity, socioeconomics, and politics.” • Gilligan C. (1982). In a different voice. • Marcellus L. Feminist ethics must inform practice: Interventions with perinatal substance users. HCWI. 2004. • Tong, R and Williams, N. (May 2009). “Feminist Ethics.” In re: Zalta, EN, (ed.). The Stanford Encyclopedia of Philosophy

20. Virtue Ethics • Virtue ethics emphasizes decision-making based on certain qualities or characteristics thought to be essential to a good person: • truthfulness, fairness, integrity, temperance, compassion and fortitude. • Virtue ethics asks, “What would a virtuous person do?” • action appropriately follows from this admittedly circular approach • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009.

21. Ethic of Care • An ethic of care approach, or care-based ethics, focuses on elements of decision-making that some feel have been historically neglected in medicine: • compassion, care, love, and empathy • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009.

22. Case-based Ethics Case-based approach seeks to identify similar situations or cases and examine ethical approaches used, as well as relevant outcomes, that could provide further direction for the current case • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009.

23. Narrative Ethics Attempts to ground abstract principles and theories Focuses on understanding the patient’s or family’s unique personal story or narrative to form the basis for ethical reflection and decision-making Narrative ethics may also be useful as an informative teaching instrument when educating families or clinicians • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009.

24. Informed Consent vsInformed Parental Permission • Respect for autonomy forms the basis for informed consent • fully informed, competent adults are accorded the right to make medical decisions, including the right to refuse an unwanted therapy, even if this results in serious harm or death • One cannot give “informed consent” for another person • When a patient is unable to given informed consent on his own behalf, a surrogate decision-maker provides informed permission. • Parents typically fill the role of surrogate decision-makers for an infant patient and provide informed parental permission on his or her behalf. AAP COB, Informed Consent, Parental Permission & Assent, Pediatrics, 1995.

25. Best Interests • Determined by the parents or other appointed decision-maker • Parental authority, Subjective • Broader definition recognizes others’ significant interests, such as parents and siblings, and places the child in the context of immediate and extended family • Eg. A mother may be weighing the benefits of continued aggressive life-sustaining treatment for her critically ill premature infant, including possible survival with severe neurologic impairment, with the psychological, physical and financial burdens of extensive chronic medical care and its impact on her husband and other children • The interests of the infant should remain paramount Hardwig, J. “What about the Family? – The Role of Family Interests in Medical Decision Making.” Hastings Center Report, 1990.

26. Best Interests • Best interests of the infant generally include • life and optimal health • In the face of illness, may require a careful benefit/burden analysis • Quality of life may perhaps outweigh quantity of life, depending on prognosis, harm of proposed therapy, and individual values and judgments • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. 2009 • Cummings C, Mercurio M. Ethics for the Pediatrician: Autonomy, Beneficence • and Rights. Pediatr Rev, 2010;31:252-255.

27. Parental Refusal of Therapy • Parents may sometimes decide to pursue a treatment that a physician may not agree with or choose for her own child, but is still within the realm of acceptable treatment options. • Families should be given wide discretion and such decisions should generally be respected • All children have the right to “effective medical treatment that is likely to prevent serious harm, or suffering, or death.” AAP COB, Guidelines on Religious Objections to Medical Care, Pediatrics, 1997.

28. Parental Refusal of Therapy If parents reach a decision that is clearly opposed to the child’s best interests, with likely significant negative consequences, the neonatologist and medical team should first engage in further conversation, time permitting, to understand their rationale and aid them in reaching an alternative decision that is mutually agreed upon. If the parents persist in their decision, the medical team should consider overriding their decision, with court assistance if necessary and if time allows. AAP COB, Guidelines on Religious Objections to Medical Care, Pediatrics, 1997.

29. Parental Request for Therapy The parental right to refuse therapy for their child in certain situations ≠ the right to demand a therapy All appropriate therapies should be offered to parents as indicated, as determined by currently available data and established standards of care, not simply by request. Reasons for denial of such requests should be clearly explained to families Cummings C, Mercurio M. Ethics for the Pediatrician: Autonomy, Beneficence and Rights. Pediatr Rev, 2010;31:252-255.

30. Practical Approaches https://www.youtube.com/watch?v=-4EDhdAHrOg

31. Practical Approaches • Utilize a variety of ethical perspectives and frameworks • Provide a safe environment for discussion and open communication • Promote trust, respect and communication between the medical team and families • Preserve the therapeutic relationship • Maintain trust, provide optimal care, allow for conversation • Aid in the realignment of goals and interests • Recognize physician/medical limitations • Offer opportunity for 2nd opinion • Seek ethics consultation

32. Selected References • American Academy of Pediatrics, Committee on Bioethics Informed Consent, Parental Permission, and Assent in Pediatric Practice. Pediatrics. 1995;95:314-17. Available at: http://pediatrics.aappublications.org/content/95/2/314.full.pdf • American Academy of Pediatrics, Committee on Bioethics Guidelines on Religious Objection to Medical Care. Pediatrics. 1997;99(2):279 –281. Available at: http://pediatrics.aappublications.org/content/99/2/279.full.pdf • Hardwig, John. “What about the Family? – The Role of Family Interests in Medical Decision Making.” Hastings Center Reports, 20 (March/April) 1990, p. 5-10. Available at: http://web.utk.edu/~jhardwig/family.htm • Mercurio MR. The role of a pediatric ethics committee in the newborn intensive care unit. J Perinatol. 2011;31(1):1-9. Available at: http://www.readcube.com/articles/10.1038/jp.2010.39

33. Selected References • George Long, “Patria Potestas”, in William Smith, A Dictionary of Greek and Roman Antiquities London, John Murray, 1875, pp. 873‑875. Available at http://penelope.uchicago.edu/Thayer/E/Roman/Texts/secondary/SMIGRA*/Patria_Potestas.html. Accessed April 2014. • Beauchamp TL and Childress JF. Principles of Biomedical Ethics, 6th Ed. Oxford University Press, Oxford 2009. • Marcellus L. Feminist ethics must inform practice: Interventions with perinatal substance users. Health Care for Women International. 2004;25(8):730-42. • Gilligan C. (1982). In a different voice. Harvard University Press, Cambridge, MA, pp. 100-108, 159-60, 174. • Tong, R and Williams, N. (May 2009). “Feminist Ethics.” In re: Zalta, EN, (ed.). The Stanford Encyclopedia of Philosophy. URL =http://plato.stanford.edu/entries/feminism-ethics/. Accessed March, 2014.

34. Selected References • Hardwig, John. “What about the Family? – The Role of Family Interests in Medical Decision Making.” Hastings Center Reports, 20 (March/April) 1990, p. 5-10. • Cummings C, Mercurio M. Ethics for the Pediatrician: Autonomy, Beneficence and Rights. Pediatr Rev, 2010;31:252-255. • Cummings C, Mercurio M. Autonomy, Beneficence, and the Rights of Parents and Children: Exploring the application of ethical principles in pediatrics. July, 2011. Adams M, Diekema D and Mercurio M (Eds.), AAP Bioethics Curriculum Case-Based Teaching Guides. • Prince v. Massachusetts, 321 US 158 (1944). Accessed April 2014 at: http://supreme.justia.com/us/321/158/case.html#170 • American Academy of Pediatrics Committee on Bioethics. Institutional ethics committees. Pediatrics. 2001;101:205–209. (Reaffirmed Oct 2008). • Mercurio MR. The role of a pediatric ethics committee in the newborn intensive care unit. J Perinatol. 2011;31(1):1-9.