Introduction

The APSA Ethics Committee will provide education for our colleagues and trainees on a variety of ethical issues in pediatric surgery practice.

The Ethics Committee provides education that is relevant to the active practice of pediatric surgery. We specifically aim to address issues that residents and fellows may find challenging as well as ethical issues that confront pediatric surgeons who have completed training. We provide resources for resolution of ethical dilemmas and a forum for discussion of particular cases.

A list of the current Ethics committee members can be found on the Ethics committee page on apsapedsurg.org.

see also the Pediatric Surgery Not a Textbook topic on Ethics

Ethics Position Statement

Vision Statement

Ethics is a dynamic and evolving normative science based in philosophy, spirituality, science and belief. The Ethics Committee will keep the APSA membership up to date regarding ethical challenges and management approaches pertaining to the care of pediatric patients as well as the ethical standards for pediatric surgical practice. The Committee has a role in the promotion of inclusion, equity, diversity and professionalism among the APSA members and leadership. This Committee contributes educational curricula and resources in clinical medical ethics for surgeons in training as well as for those in practice. The Committee will collaborate with other medical societies to promote equitable and ethical advocacy and healthcare policy for children. Collaboration with other APSA committees as well as with national and international organizations will provide opportunities to develop programs, guidelines, research, educational activities and wellness resources with a focus on ethics.

Mission Statement

The APSA Ethics Committee is committed to the fundamental principles of ethics in all aspects of pediatric surgical practice as well as among healthcare professionals. The committee is a resource for APSA members who are seeking ethics education, guidance for ethical challenges in patient management and a voice for the highest quality, equitable healthcare for children.

Videos

video link to the Ethics committee session for the APSA 2020 virtual meeting on Ethics in the COVID-19 Era

Three part series on Moral Distress from the APSA Ethics and Wellness committees

Episode 1 What is moral distress

Episode 2 Moral distress rounds

Episode 3 Strategies for dealing with complications and difficult situations

Ethical Topics in Pediatric Surgery

Conflict Resolutions/Refusal of Treatment

Erica Carlisle, Annie Fecteau

Curricular objectives:

1. To know the ethical, legal and policy justifications for consent and the elements of consent.

2. To understand the substitute decision-making process and recourse with respect to the best interest of the child.

3. To know the basic principles of conflict resolution techniques and hospital resources available to help in conflict situations.

Ethical messages:

1. The best interest of the child is the primordial criteria for decision-making.

2. Familial beliefs need to be respected and explored to help the family reach a consensus decision.

3. Time and open communication are of the essence in conflict resolution.

Pre-workshop readings:

1. American Academy of Pediatrics, Committee on Bioethics. Policy statement: Conflicts between religious or spiritual beliefs and pediatric care: informed refusal, exemptions, and public funding. Pediatrics 2013;132(5):962-965[1]

2. American Academy of Pediatrics, Committee on Bioethics. Policy statement: Informed consent in decision-making in pediatric practice. Pediatrics. 2016;138(2): e20161484[2]

3. AAP Case Based Teaching Guides for Resident Training. https://www.aap.org/en-us/Documents/Bioethics-ReligiousCulturalAndPhilosophicalObjectionsToCare.pdf

Paradigm case: A 2-year-old is diagnosed with a respectable Wilm’s tumor; parents refuse surgery as they believe that God will cure their child.

Teaching modality: Case discussion and then role playing in conflict resolution exercises.

Competencies targeted: Medical expert, Communicator, Collaborator, Professional

Case: George is a 2-year-old male that is brought to an emergency room by his mother after he was vomiting for a few hours. She had been told he had fallen from about 3 feet high onto his abdomen at his childcare center. He cried at the time but seemed to resume his normal play afterward. At the local emergency room, the ER physician has felt a mass on the left side of the abdomen and an ultrasound has revealed an 8 X 9 cm left renal mass. George now has some hematuria and there is a small amount of free fluid in the abdomen.

After much negotiation, the diagnosis of a probable Wilm’s tumor is confirmed by CT scan. The tumor shows recent evidence of intratumoral bleed but no rupture. There is no evidence of tumor in the left renal vein and there is no distal metastasis. You are called to see this child for a nephrectomy but you learn from the emergency pediatrician that the mother who is accompanying the child is refusing any further treatment. Both parents are members of a community who believe that ‘God decides the faith of his children’. The community does not believe in modern medicine, especially with something as aggressive as surgery. The mother wants to leave the emergency room, stating that she needs to go home to take care of the other children. She will pray with her community for the tumor to resolve.

You convince the mother to talk to you a little longer. You learn that she has 4 other children, aged 1 to 9. She has also lost 2 pregnancies in the first trimester. They live in a community setting with their extended family. Her husband is a woodworker and she works in a bakery. The children are cared for at the community childcare center during the day. All her children are otherwise healthy, except for a few minor ailments. None of them have been immunized. The community is led by an elected patriarch who makes all the important decisions for the community. There is no television or telephones in the community, except for one at the patriarch’s house. Members of the community who do not follow the patriarch’s advice are ostracized by the community.

George’s mother is obviously a loving one. She reassured George who is quite frightened by the emergency room setting. George is obviously very attached to his mother. Even though you have built a good rapport with George’s mother, she is still adamant that she has to leave.

Questions for discussion:

1. What should you do in this situation? Who would you contact to help with the situation?

2. Should you allow George to go home?

3. What is in George’s best interest? (Explore the impact of your answer on George and his family in this context).

4. Should you recourse to Children’s Aid/Protection?

5. What are the criteria’s to call Children’s Aid/Protection in your state/province?

6. In your state/province have the courts ruled in favor of parent’s refusal of treatment on the basis of religious beliefs?

7. How can you resolve conflicts with families when involved in their care? Who can help?

Other Relevant articles and resources

[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15]

The Mature Minor

Annie Fecteau

Curricular objectives:

1. To know the concept of the mature minor, their rights and confidentiality issues.

2. To know the meaning of competence and how to assess for it.

3. To know the principle of assent.

4. To understand the concept of an emancipated minor.

5. To know the laws pertaining to consent in minors in your jurisdiction: mature minor and emancipated minor.

Ethical messages:

1. Chronological age is not a criterion from maturity

2. The autonomy of the mature minor should be respected

Pre-workshop readings:

1. Katz AL , Webb SA , Committee on Bioethics. Informed consent in decision-making in pediatric practice; technical report. Pediatrics, 2016; 138: e http://pediatrics.aappublications.org/content/138/2/e20161485[16]

2. English A, Bass L , Boyle AD , Eshragh F. State minor consent Laws a summary, 3rd edition. www.freelists.org/archives/hilac/02-2014/pdftRo8tw89mb.pdf 9 (This is a repository of mature minor laws in all 50 US States)

3. Coughlin KW . Canadian Paediatric Society Position statement. Medical decision-making in pediatrics Infancy to adolescence. Paediatr Child Health 2018; 23: 138-146(Has a table for the mature minor law and age of consent in all Canadian provinces)

4. Kutner TL. Medical decision-making and minors: issues of consent and assent. Adolescence 2003; 38: 343-358.

5. Geist R., Opler SE. A guide for health care practitioners in the assessment of young people’s capacity to consent to treatment. Clinical Pediatrics 2010; 49: 834-839.[17]

Paradigm case: A 16-year-old girl present with fulminant ulcerative colitis failing medical therapy. She refuses the recommended subtotal colectomy and ileostomy.

Teaching modality: Case discussion after interactive presentation

Competencies targeted: Medical expert, Communicator, Collaborator, Professional

Case: Cynthia is a 16-year-old girl who has been hospitalized for three weeks. She presented to the hospital with bleeding per rectum for 2 days. In the previous weeks, she had crampy abdominal pain post-prandially. She lost about 15 pounds. She was admitted to the Gastroenterology service, who diagnosed Cynthia with fulminant ulcerative colitis. She has been started on high dose steroids to which immunosuppressants were added, without much change in the bleeding. Over the last three weeks, Cynthia has received three transfusions of blood and her hemoglobin is now 65. The pediatricians have ordered another 15cc/kg of PRBC. The GI consultants have consulted you for a subtotal colectomy and ileostomy. Cynthia was quite shocked by what she heard and after sobbing uncontrollably for 1 hour, she stated quite adamantly that she will not have the surgery.

Talking to Cynthia, you learn that she is quite an athletic young woman. She swims competitively at the national level and is training in view of making the next Olympic team. Her specialty is the 100-meter backstroke. She also does the backstroke for the 400-medley. Cynthia was training 4 hours a day everyday except Sunday until she was hospitalized. She was away at training camp for most of the summer, living halfway across the country with roommates in a rented apartment.

Cynthia also does some modeling. She has mostly worked at the local level, but she won a contest last September, which gave her a photo shoot with a teen magazine. Since then she has had a few calls from bigger modeling agencies trying to recruit her. The modeling career was put on the back burner with preparations for the next Olympics.

Cynthia is quite upset with her appearance. The steroids have made her gain some weight and she started to get acne. She says that she doesn’t recognize herself in the mirror. Her mother noticed that over the last few days Cynthia is no longer interested in grooming herself.

You spend a long time discussing the indications and the surgery itself, including future J pouch and the possible complications. After all the discussion, Cynthia still refuses surgery. Both parents agree that they want to proceed with the colectomy.

Questions to consider:

1. Who should decide whether Cynthia will undergo the surgery or not?

2. What is the definition of a mature minor in your state or province?

3. What factors should be considered in the decision making and how should these factors be weighed- e.g. Cynthia’s age, maturity, understanding of the procedure and its consequences, etc.?

4. Should you delay surgery in an attempt to allow Cynthia some measure of autonomy? To explore more fully the reasons for Cynthia’s refusal? To allow time for appropriate counseling?

5. How could you assess Cynthia’s capacity? Given the concerns regarding the effects of the steroids and signs of depression, is Cynthia able to make an informed choice?

6. Should the criteria for competency be more or less stringent depending on the type of case (elective vs urgent vs life threatening)?

7. Is there any reason not to respect the minor’s wishes?

8. Please discuss the mature minor and laws pertaining to family planning, pregnancy, STD. HIV status, mental health and substance abuse prevention in your state or province.

9. Please explain the difference between a mature minor and an emancipated minor.

Other Relevant articles and resources

[18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36]

Summary of Adolescent Consent Laws by State

Neonatal end of life care: withdrawal and withholding of treatment

Baddr Shakhsheer, Annie Fecteau

Curricular objectives:

1. To know the key ethical, legal and policy with respect to “futility” cases.

2. To have an approach to the pressing demands for non-medically-warranted life-sustaining treatment

Ethical messages:

1. Good and sensitive end-of-life care is a must.

2. Prolonging death and suffering is not ethical.

3. Future quality of life is an issue that needs to be considered in children.

Pre-workshop readings:

1. Pet GC, McAdams RM, Melzer L, Oron AP, Horslen SP, Goldin A, Javid PJ. Attitudes Surrounding the Management of Neonates with Severe Necrotizing Enterocolitis. J Pediatr. 2018 Aug;199:186-193.e3[37]

2. Feltman DM, Du H, Leuthner SR. Survey of neonatologists’ attitudes toward limiting life-sustaining treatments in the neonatal intensive care unit. J Perinatol. 2012 Nov;32(11):886-92.[38]

3. Cooper TR, Garcia-Prats JA, Brody BA. Managing disagreements in the management of short bowel and hypoplastic left heart syndrome. Pediatrics. 1999 Oct;104(4):e48.[39]

Paradigm case: A 25-week-old baby boy is admitted to the neonatal intensive care unit for perforated enterocolitis. He is also found to have fungal sepsis and a grade III/IV intracranial bleed. The baby is the product of in-vitro fertilization and the parents want to continue full medical treatment.

Teaching modality: Case discussion after interactive presentation.

Competencies targeted: Medical expert, Communicator, Collaborator, Professional

Case: Caroline was born at 25 weeks of gestational age to a 35-year-old woman. Caroline is the result of an IVF treatment. (Caroline’s mother had three previous unsuccessful attempts). Her birth weight was 900 grams. The initial physical examination revealed a tiny female infant with marked bruising. She appeared blue and limp and was gasping for air. Initial resuscitation included endotracheal intubation, mechanical ventilation, volume transfusion and inotropic support to maintain adequate cardiorespiratory function. Caroline was immediately admitted to the NICU. Her primary diagnosis was respiratory distress syndrome. She required fairly high ventilator rates and pressures to maintain adequate oxygenation and ventilation. She required surgical ligation of the patent ductus arteriosus within the first week of life. Cranial ultrasounds performed at day 3 and 14 of life revealed the presence of Grade III bilateral intraventricular hemorrhages.

The parents were kept informed of their daughter’s progress throughout these first weeks of life. They were assured that important decisions would be made only when consensus was reached between them and the health care team. Both parents asked many questions about how the medical staff would know if their daughter was getting worse or perhaps even dying.

On day 17 of life, Caroline started to have increasing residual of her nasogastric feeds. Her abdomen was distended and feeds were stopped. Abdominal x-rays are taken and show diffuse pneumatosis and a little venous portal air. You are called to assess the baby. On physical exam, the baby is not active, the abdomen is red and tender diffusely. She is started back on pressors but her status is unchanged.

You discuss the situation with the parents. You explain to them that you think Caroline needs an operation. She has necrotizing enterocolitis which is likely perforated. You are concerned it involves a long segment of her gut. You are planning a bowel resection +/- stoma. You discuss with them that if too much gut involved is removed, Caroline might suffer from short gut syndrome. You explain to them about TPN and its associated liver injury and the eventuality of small bowel transplant, but that most babies this size do not survive long enough to get an organ.Both parents are upset but understood the gravity of the situation. The mother says that she could not think of her daughter dying. The father expressed that he doesn’t want his daughter to suffer as he thinks she has undergone quite a bit already. He states that he would want bowel resected only if there was a good chance that Caroline will not suffer from short gut syndrome. Hearing this, the mother runs out of the room crying.

Questions for discussion:

1. What would you do at this point? Who would you call upon to help at this point?

In the OR, you find that most of Caroline’s small bowel is necrotic, except for 4 proximal cm. Her colon is also necrotic to the mid-transverse colon.

2. What would you do at this point?

3. What is in the best interest of the child? Should those override those of the mother?

4. Discuss sanctity of life and quality of life in this case.

5. Are there lengths of viable/necrotic bowel that would make you feel that there is no ethical dilemma involved?

The baby is getting more unstable in the OR. You come out to talk to the parents about what you have found at laparotomy and ask the neonatologist to join you. You advise them that you think you should not proceed with resection and keep the baby comfortable as the disease is disseminated. Caroline’s father indicates that he is comfortable with the decision to withhold treatment; he feels that it is wrong to prolong his daughters suffering. In fact, he said that he would have difficulty visiting his daughter if treatment was not withheld and she continued to suffer.Caroline’s mother remains adamant that life is important at all costs. She explained that this belief was rooted in her religious teaching and was not negotiable. She would not expand on the source or the nature of these beliefs.

6. What should the health care team do when parents disagree about holding/withdrawal of life sustaining treatment for their child? Is it morally acceptable to proceed with the consent of one parent?

7. Are there morally defensible limits to parental decision-making?

8. How should the health care team respond to the mother’s claim that her belief are rooted in her religious teaching when she will not (cannot) explain these beliefs? Would it matter if the mother’s beliefs were not rooted in religious teachings but simply were “her beliefs”?

Other Relevant articles and resources

[12][37][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58]

Surgical error: The Ethics of Disclosure

Patrick Javid, Annie Fecteau

Curricular objectives:

1. To know the epidemiology of surgical errors and understand the principles of system errors.

2. To understand the principle of truth telling, justice and trust.

Ethical messages:

1. A blame-free milieu needs to be in place to promote the reporting of errors, foster quality improvement and the implementation of better systems

2. Truth telling preserves patient autonomy and trust.

Pre-workshop readings:

1. Gallagher TH, Mello MM, Levinson W, et al. Talking with patients about other clinicians’ errors. N Engl J Med. 2013;369(18):1752-7.[59]

2. Shaikh SK, Cohen SP. Disclosure of Medical Errors. Pediatr Rev. 2020;41(1):45-47.[60]

3. Tsao K, Browne M. Culture of safety: A foundation for patient care. Semin Pediatr Surg. 2015;24(6):283-7. [61]

4. Wu AW, Cavanaugh TA, McPhee SJ, et al. To tell the truth: ethical and practical issues in disclosing medical mistakes to patients. J Gen Intern Med. 1997;12(12):770-5. [62]

Teaching modality: Case discussion

Competencies targeted: Medical expert, Communicator, Professional

Case 1: Simon, a 3-month old boy, presents to the emergency department one afternoon with an incarcerated right inguinal hernia. Simon was born at term and the mother recently noticed an intermittent bulge in his right groin. His hernia is the size of a golf ball and tender. The skin is red. You are able to reduce the hernia after sedation, but only with difficulty. You explain the details of an inguinal hernia repair to the parent including the risks of the procedure, and the case is added on for the following day. At the time of surgery, the tissues are still very inflamed and after some dissection, you realize that the vas deferens has been cut. You tag the two ends with nonabsorbable monofilament suture and complete the hernia repair.

Discussion questions:

1. What should you tell the parents postoperatively? When should you tell them about the complication? Should you apologize to the family?

2. What are your institutional policies about medical/surgical error?

3. Should this case be peer-reviewed? Are there systems issues associated with this case?

4. Who can you reach out to at your institution if you are experiencing distress about this complication?

Case 2: Marcy is an 18-month-old girl who had a diverting colostomy as a neonate for imperforate anus. She has undergone a successful posterior sagittal anorectoplasty and now presents for colostomy closure. The case proceeded uneventfully, but on post-operative day 3 she has erythema around her incision with a small amount of drainage. She develops fever and emesis on post-operative day 4, and the skin incision appears to be open. On exam, there is a wide dehiscence of the fascia with exposed bowel in the wound. The patient is taken to the OR where the wound is washed out and a vacuum sponge is applied. The fascia could not be re-approximated. The patient will require a prolonged hospital stay and intravenous antibiotics. While reviewing her chart, you notice that she did not receive peri-operative antibiotics for the colostomy closure.

Discussion questions:

1. Are you obligated to tell the family about the lack of preoperative antibiotics?

2. How should you disclose this information to the family? When should you disclose this information?

3. Describe an approach to the disclosure that would minimize conflict with the family.

4. What ethical principles compel you, as the provider, to disclose this error?

5. How would you incorporate error on the systems level in the discussion with the family?

6. How should prevention of this error in the future be addressed in the conversation with the family?

Case 3:You are an attending pediatric surgeon in a small group practice. Your partner is on call tonight but has a fever of 102.0 and a mild cough. She calls the hospital infection prevention hotline, and she is told she must go home immediately. She asks you to cover her call tonight, and you agree as your other partners are on vacation. You have a thoracoscopic lobectomy in a 6-month-old baby boy and an interval appendectomy in a 10-year-old girl on the elective OR schedule the following day. You end up operating all night as you need to perform an ex lap in a neonate for necrotizing enterocolitis and an ECMO cannulation.

Discussion questions:

1. Should you plan to perform your elective cases the following day?

2. What should you disclose to the families of your elective surgical patients?

3. What if, instead of working all night, you were at home taking care of your 4-month-old baby boy who is up all night with mild congestion and a low grade fever?

4. Should fatigue or stress from personal responsibilities outside of the hospital be disclosed to your patients and families? Is the nature of these potential distractions different than those related to professional responsibilities?

Other Relevant articles and resources

[59][60][61][62][63][64][65][66][67][68]

Multiculturalism

Lisa Van Houwelingen, Annie Fecteau

Curricular objectives:

1. To understand the diversity of ethical principles in different cultures

2. To understand the concept of cultural safety, family centered and anti-oppressive medical care.

Ethical messages:

1. Different cultures have different ethical standards, and view the need for autonomy, beneficence and justice differently that need to be respected.

Pre-workshop readings:

1. Starter MB. The ethics consultation and the pediatric surgeon. Semin Pediatrics Surg 2013; 149-53

2. Tervalon M, Murray-Garcia J. Cultural Humility versus Cultural Competence: A Critical Distinction Defining Training Outcomes in Medical Education. Journal of Health Care for the Poor and Underserved 1998; 117-25.[69]

3. Kinsman SB, Sally M, Fox K. Multicultural issues in pediatric practice. Pediatr Rev 1996; 17:349-55[70]

4. Dior is C, Salen K, Ladas E et al. Traditional and Complimentary medicine used with curative intent in childhood cancer: A systematic review. Pediatr Blood and Cancer 2017 e26401.

Paradigm case: Stanislav is an 18-months-old boy with an unresectable hepatoblastoma. The parents refuse a liver transplant and want to try alternative therapies.

Teaching modality: Case related discussion

Competencies targeted: Medical expert, Communicator, Health Advocate, Professional

Case: Stanislav is an 18-month-old boy who presented with abdominal distension for 2-3 months. On ultrasound he was found to have a large central lesion in his liver consistent with hepatoblastoma. On further work up he was found to have an AFP of 7500. Percutaneous biopsy confirmed the diagnosis of hepatoblastoma fetal type. Review of CT reveals a 14 x 8 cm mass from the confluence of both portal veins. The right and left hepatic veins are very close to the tumor and the middle vein is not seen. There is no evidence of metastasis. The tumor is felt to be unresectable.

Stan is started on a regimen of chemotherapy, which he is tolerating well. After 4 cycles of chemo, his tumor has shown some shrinkage but still abuts the portal vein and hepatic veins closely. Because of unresectability, the child is referred for a liver transplant.You meet the child as the liver transplant surgeon. He is the youngest of four. The mother and father are quite informed as far as the hepatoblastoma is concerned. You give them information on liver transplantation, including listing criteria, risk of surgery and long-term outcome.The parents are not prepared to consider transplant. They want to try alternative therapies. The father explains to you that he sees living with a transplanted organ as a life-long problem with too many complications. They would like to try some herbal medication that they have found on the internet. They want to combine Essiac and Yakolife alternative therapy with a strict diet of organic food, deep sea fish and fruit juices. They are confident that it will cure the tumor and avoid the need for transplantation. They are willing to reassess if the tumor starts growing on imaging or the AFP starts rising.

They are from a Slavic country and are first generation immigrants to this country. They have 2 other children who are healthy and Stanislav looks like a very well cared for child. Father owns his own business and the mother stays home with the children. They have no family in Toronto. They have never missed a medical appointment and are very compliant with the therapy. When further questioned, the father tells you his family history of an uncle cured from metastatic disease without chemotherapy and a father who was the only one to come back from an ambush during the war. He feels in his heart that the impossible can happen, his family history proves it. He wants to try everything before “condemning” his son to a transplant.

Discussion Questions (Reflection, Cultural Sensitivity):

1. How do you understand your cultural orientation? Reflect on your culture. – In addition to attitudes, beliefs, values, which social markers also influence your culture (e.g. faith/religion, sexuality, class)? Which cultures do you belong to?

2. In addition to your cultural contexts, you also carry with you a professional one. Reflect on the culture of pediatric surgery. What are its norms, values and beliefs? In the context of your pediatric surgery program, discuss the most frequently encounter multicultural issues.

3. How does your cultural orientation influence your perspectives on patients, illness and healing?

4. Have you witnessed or experienced an encounter where the culture of the physician was (or seemed to be) imposed on you or a patient? What did (or could have) happened?

5. Consider power and privilege. Are there certain universal values that are neutral? How do we decide what is fair and legitimate and a function of autonomy?

Discussion Questions (Skills: Communication)

1. One of the pathways to culture is through language. Thinking about your work with a patient from a culture that is very different from your own, which communication skills will facilitate respectful partnerships?

2. What values/principles are important for cross-cultural communication?

Discussion Questions (Skills: Advocacy) Cultural safety and humility are aligned with anti-oppressive practice. They are predicated on understanding power differentials in health service delivery and redressing these inequities. They are action-oriented and involve creating culturally responsive medical practices/systems.

1. Thinking of the case example of Stanislav and his family, identify key themes that may be critical in moving toward culturally safe medical practice: what do you think is in the best interest of this child?

2. How far do you think the medical team has to go in respecting cultural beliefs of a family?

Other Relevant articles and resources

[28][71][72][73]

Prenatal consultation

Erin Rowel, Annie Fecteau

Curricular objectives:

1. To be able to negotiate a discussion regarding pre-natal and post-natal expectations for a baby with multiple congenital anomalies and genetic disorder with regard to maternal autonomy, reproductive freedom, beneficence, non-maleficence.

2. To be able to negotiate a discussion regarding risks and benefits of prenatal intervention for the fetus and for the pregnant mother with regard to reproductive freedom, beneficence and non-maleficence for the mother versus beneficence and non-maleficence for the fetus.

Ethical messages:

1. Prenatal consultation discussions ought to be non-directive.

2. The mother is the patient during the discussion, and her emotions and decisions regarding the pregnancy ought to be respected.

3. Prenatal interventions may be possible and involves risk to the mother for potential benefit to the fetus.

Pre-Workshop readings:

1. Harris KW, Brelsford KM, Kavanaugh-McHugh A, Clayton, EW. Uncertainty of prenatally diagnosed congenital heart disease: a qualitative study. JAMA Network Open;3(5): 2020.[74]

2. Wolfe ID and Carter BS. Active or passive guidance? Decision-making in fetal health consultation. J Matern Fetal Neonatal Med, 2020 May 4;1-2. Epub ahead of print.[75]

3. Brown SD, Lyerly AD, Little MO, Lantos JD. Paediatrics-based fetal care: unanswered ethical questions. Acta Paediatr;97(12):1617-9, 2008. [76]

4. American College of Obstetricians and Gynecologists, Committee on Ethics; American Academy of Pediatrics, Committee on Bioethics. Maternal-fetal intervention and fetal care centers. Pediatrics; 128(2):e473-8, 2011. [77]

5. Kovler ML and Jelin EB. Fetal intervention for congenital diaphragmatic hernia. Semin Pediatr Surg;28(4):150818, 2019. [78]

6. Antiel RM, Flake AW, Collura CA, Johnson MP, et al. Weighing the social and ethical considerations of maternal-fetal surgery. Pediatrics;140(6):e20170608, 2017.[79]

Paradigm case 1: 30 year-old mother, 21 weeks pregnant with ultrasound diagnosis of probable trisomy 21, double bubble, and AV canal defect. Mother is seeking to confirm the diagnosis, understand the prognosis and determine future of the pregnancy.

Paradigm case 2:35 year-old mother, 20 weeks pregnant with ultrasound diagnosis of left congenital diaphragmatic hernia with liver up. Additional prenatal testing suggests severe CDH defect with option for prenatal intervention with fetal endoscopic tracheal occlusion (FETO).

Teaching modality: Case-related discussion and literature review

Competencies targeted: Medical expert, Communicator, Collaborator. Professionalism

Case 1:You are asked to see Breanna in prenatal consultation. She is 30 years old, single, and is 21 weeks pregnant. At her 20-week ultrasound, her male fetus was found to have an absent nasal bone, double bubble and AV canal defect. Her cell-free DNA was positive for trisomy 21. She comes to the visit with her fiancé who is the father of the fetus. They both work in the restaurant/food industry and have recently each changed jobs. The pregnancy was not planned. Breanna and her partner wish to learn more about the conditions and what effect these will have for their baby.

Discussion Questions:

1. How do you begin this discussion? What are the important findings from the tests that have been done so far?

2. How do you explain what to expect for a baby born with these conditions?

3. Discuss how you will handle uncertainty in the discussion.

4. Who is your patient during this discussion?

5. If Breanna asks about not continuing the pregnancy, how do you respond?

6. How do you handle your own emotional reaction to what the parents may be feeling and considering?

Case 2:You are asked to see Amanda in prenatal consultation. She is 35 years old, married, and is 20 weeks pregnant. She and her husband learned from the 20-week ultrasound that the fetus has a probable left congenital diaphragmatic hernia. They are here for further evaluation and counseling.Amanda and her husband have 2 other children, ages 4 years and 2 years, both born full term by vaginal delivery. Amanda works part-time for a non-profit, and her husband works in information technology. This was a planned pregnancy.

On the day of the visit, Amanda has a level 2 ultrasound which confirms the finding of left congenital diaphragmatic hernia with liver up and lung-head ratio less than 1. A fetal ECHO shows normal cardiac anatomy with dextroposition. A fetal MRI shows a moderate-severe risk left CDH with total lung volume 30% predicted.

Discussion Questions:

1. What do you tell the parents about the findings? What are the facts they need to know at this time?

2. The father of the fetus asks you about options for surgery before the baby is born. What do you tell them about prenatal intervention in this case?

3. How do you frame the ethical considerations of prenatal intervention with respect to the mother?

4. How do you frame the ethical considerations of prenatal intervention with respect to the fetus?

5. What ethical principles do you consider in this discussion with respect to the other children in the family?

6. Discuss how you will handle uncertainty in this case. How do you handle your own emotional reaction to what the parents may be feeling and considering?

Relevant articles and resources

[53][80][81][82][83][84]

Child Abuse and Neglect

Annie Fecteau

Curricular objectives:

1. To understand relevant child protection law and the mechanisms for Children’s Aid Society referrals and involvement.

Ethical messages:

1. The importance of beneficence and non-malfeasance in dealing with suspected cases of child abuse and neglect.

2. Protection of the child while trying to maintain the familial environment is key

Pre-workshop readings:

1. Quiroz HJ., Parreco J., Easwaran L., et al. Identifying populations at risk for child abuse: a nationwide analysis. J Pediatric Surg 2020; 55(1): 135-139[85]

2. Christian CW, committee on child abuse and neglect. The evaluation of suspected child physical abuse. Pediatrics 2015: 135: e1337-1354[86]

3. Tozzo P., Picozzi M., Caenazzo L. Munchausen Syndrome by Proxy: balancing ethical and clinical challenges for healthcare professionals Ethical consideration in factitious disorders. Clin Ter 2018; 169 (3):e129-134. doi: 10.7417/T.2018.206[87]

4. Greenbaum J., Crawford-Jakubiak JE., Committee on child abuse and neglect. Child sex trafficking and commercial exploitation: health care ne

Paradigm case: A 10-year-old boy is admitted to the surgical service after having “impaled” himself on a wine bottle. He comes in 5 days after the trauma because of incontinence.

Teaching modality: Case discussion after interactive presentation then role-playing to practice interviewing and maintaining trust with parents in child abuse cases.

Competencies targeted: Medical expert, Communicator, Collaborator, Health Advocate, Professional

Case: Scott is a 10-year-old boy who is brought to the emergency department because of fecal incontinence. He was first seen in the community hospital that transferred him to the pediatric hospital.According to his mother, Scott has been a well boy until five days ago. He was playing in the backyard with his cousin. It was muddy outside after the rain the day before and when the boys came in their pants were soaked and dirty. Scott’s mother took their pants and threw them in the wash. The boys continued to play in their underwear in the basement. As they were pushing each other, Scott fell on a bottle of wine that was in a case. He felt immediate pain and when he got up there was some stool and blood on the bottle neck. His mother had a look and could see a little bit of blood at the anus but no skin injury. The pain lasted for 30 minutes and then subsided. He did not have any abdominal pain.Scott has had no fever and his appetite is normal. He is quite embarrassed as he is incontinent, soiling his underwear when he passes gas. There is a little bit of blood on the toilet paper when he passes stool.

Discussion:

1. What points in the history would make you suspicious of child abuse? What other questions would you ask? What could you do to verify the story?

2. What are the criteria in your jurisdiction to call Children’s Aid Society/Child protection Agency?

3. Do some role playing around telling the parents that you are getting Children’s Aid Society/ Child Protection Agency involved.

4. Discuss the role of the pediatric surgeon in dealing with cases of child abuse (documentation, testifying, etc.).

5. Discuss the potential clues that a trauma patient could be a victim of child sex trafficking.

Other Relevant articles and resources

[3][86][88][89][90][91][92][93][94][95][96]

AAP Health Initiative on Child Abuse & Neglect

American Academy of Child & Adolescent Psychiatry: Child Abuse Resource Center

American Professional Society on the Abuse of Children

Child Abuse Laws by State

Pediatric surgical research

Oliver Muensterer, Annie Fecteau

Curricular objectives:

1. Develop a framework for understanding ethical issues raised by performing research and implementing innovations in children.

2. Understand the concept of clinical equipoise

3. Understand the concept of assent, consent, and disclosure

4. Understand the procedural requirements for conducting a pediatric clinical research study.

5. Realize the types of potential conflicts of interest in clincal research

Ethical messages:

1. The importance of value and validity, informed consent, risk-benefit ratio, justice in subject selection, protection of the research subject especially vulnerable population in research and innovation.

2.The value of autonomy in clinical trials involving children.

3. Awareness of potential conflicts of interest.

Pre-workshop readings:

1. Laventhal N, Tarini BA, Lantos J. Ethical issues in neonatal and pediatric clinical trials. Pediatric Clinics of North America. 2012;59:1205-20[97]

2. Nwomeh BC, Caniano DA. Emerging ethical issues in pediatric surgery. Pediatr Surg Int 2011;27:555-62[98]

3. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-711[99]

4. Wendler D. Is it possible to protect pediatric research subjects without blocking appropriate research?. J Pediatr 2008;152:467-470[99]

5. London AJ. Equipoise in Research: Integrating Ethics and Science in Human Research. JAMA 2017;317(5):525–526[100]

Paradigm case: Clinical trial: a randomized control trial in premature infants with inguinal hernia, laparoscopic versus open repair.13- year-old who does not want to participate in a study that tests a new method of pain control initiated by the device manufacturer.

Teaching modality: Interactive presentation. The first scenario (A) involves the trainee to take the role as peer reviewer of a study protocol of a randomized controlled trial evaluating laparoscopic versus open inguinal hernia repair in premature infants. The students are asked to discuss the protocol and decided on its acceptability and potential pitfalls. In the second scenario, the trainee is asked to take the role of the pediatric surgeon taking care of a teenager with pectus excavatum who refuses to participate in a clinical study comparing two different methods of postoperative pain management. The students are asked to discuss issues regarding assent, consent and autonomy, as well as the various conflicts of interest that arise.

Competencies targeted: Medical expert, Communicator, Collaborator, Manager, Scholar, Professional

Scenario A: You are a member of your hospital institutional ethical review board and you are asked to review the attached protocol: “A multi-center, prospective randomized trial to evaluate laparoscopic versus open inguinal hernia repair in premature infants”. The investigators would plan to include a total of 10 pediatric surgical centers. From what you know, some of these centers have a reputation for performing advanced minimal-invasive procedures, others don’t. The inclusion criteria for patients are being born premature and having a unilateral or bilateral inguinal hernia on exam. Incarcerated hernias are excluded. The primary outcome variable is recurrence in the first 6 months after the operation. In order to boost participation, the investigative team plans to distribute pamphlets to all parents and caregivers of premature infants born in their institution. After recruitment, the patients are randomized to laparoscopic or open inguinal hernia repair. There are protocols on how the operations should be performed for comparability. Study participants are required to come for follow-up evaluation at 1, 3, and 6 month intervals after the operation.

Discussion Questions:

1. Is there equipoise in this study question?

2. What are your a-priori thoughts on the following requirements for clinical research: ValueScientific validity, Fair subject selection, Favorable risk-benefit ratio, Independent review, Informed consent, Respect for potential and enrolled subjects.

3. From what you know so far, would you recommend approval of this study in your hospital?

4. Would you recommend any changes to the protocol?

Scenario B: Martha is a 13-year-old girl with pectus excavatum who sees you in clinic for possible repair with her parents for repair. You are part of a multicenter trial comparing postoperative analgesia using an epidural to a new method involving cryoablation of the intercostal nerves. The cryoablation device manufacturer is sponsoring the study, provides the devices free of charge. Currently, the device is approved for adults, the company would like to extend the approval to a lower age limit of 12 years. In adults, cryoablation was associated with decreased pain and shorter length of hospital stay.

Both parents have read the consent form carefully and are willing to enroll Martha in the study. They think it is a good educational experience for Martha, teaching her the value of altruism. The research nurse talks to Martha to get her assent. Martha is a rebellious teenager who states that "she does not want to be a guinea pig", and refuses to take part in the study.

The parents are trying to reason with her and are telling her that she will be helping others, and that she may benefit from improved pain control with the new method. Martha still refuses. You have been promised co-authorship in a paper on the outcome of the study if you enroll more than 10 patients. So far you have been successful at including 9 patients.

Discussion Questions:

1. What should you do?

2. Which conflicts of interests do you appreciate in this situation?

3. Is this study protocol ethical?

4. How important is assent in pediatric surgery research?

Other Relevant articles and resources

[101]

Fertility preservation articles

[102][103][104][105][106][107][108]

Novel Surgical Therapies

Oliver Muensterer

Curricular objectives:

1. Understand the spectrum that constitutes variation in practice, surgical innovation, and clinical experimentation.

2. Realize the institutional, legal, and ethical framework that defines and regulates innovation in pediatric surgery.

3. Beware of patient disclosure and informed consent when using innovative surgical techniques.

4. Understand the balance between medical advancement, future collective benefit, and individual patient risk when using novel, innovative methods.

Ethical messages:

1. The case-based development and application of new operations has historically formed the backbone of surgical advancement.

2. Potential for future collective benefit must be weighed carefully against individual risk.

3. Skepticism towards paternalistic practice patterns, as well as an increasingly complex regulatory framework have made it more difficult to implement innovative techniques in recent decades, particularly in pediatric surgery.

Pre-workshop readings:

1. Riskin DJ, Longaker MT, Krummel TM. The ethics of innovation in pediatric surgery. Semin Pediatr Surg 2006;15:319-23[109]

2. Schwartz JA. Innovation in pediatric surgery: the surgical innovation continuum and the ETHICAL model. J Pediatr Surg 2014;49:639-45[110]

3. Brower V. The ethics of innovation. Should innovative surgery be exempt from clinical trials and regulations? EMBO Rep 2003;4:338-40[111]

4. Section on surgery; Committee on bioethics; American Pediatric Surgical Association New Technology Committee. Responsible Innovation in Children’s Surgical Care. Pediatrics 2017;139:e20163437[112]

Paradigm cases: Application of a novel treatment strategy for a rare tumor in a child with poor prognosis. The therapy is associated with substantial morbidity, but may also be the only chance of survival for this patient.Novel use of a therapeutic device that is used for similar indications in adults, but that has not been formally used, tested, or reported in children.

Teaching modality: Interactive presentation. Both scenarios require the student to take the role of the acting surgeon who must balance the risks and benefits of using novel treatment strategies in their patients.

Competencies targeted: Medical expert, Communicator, Collaborator

Cases:

Scenario A: You performed an excisional biopsy of a pelvic tumor in a 7-year-old girl that turned out to be a desmoplastic small round cell tumor. Intraoperatively, she had peritoneal implants and a single liver metastasis in her staging workup. After six cycles of chemotherapy, the pediatric oncologists propose cytoreductive surgery combined with HIPEC (hyperthermic intraperitoneal chemotherapy), quoting reports in the literature with promising results.

You read the reports and realize that there is substantial morbidity from the procedure. HIPEC has been used by the adult oncologic surgeons at your institution, but you have no personal experience with it.

Discussion Questions:
1. Should you offer HIPEC to your patient? If so, should you involve other surgeons and colleagues since you have not used the technique previously?

2. What would be the most appropriate way to talk to the parents of this?

3. Should the child be informed about the procedure?

Scenario B: A patient with complex esophageal atresia developed a large esophageal leak after a recent rather ambitious dilatation. The patient already had undergone several thoracotomies, prompting you to believe that open repair would carry a substantial risk in itself. An adult thoracic surgeon colleague of yours tells you about the possibility of using endoscopic vacuum therapy, which according to her works well in leaks after esophagectomy for cancer in adults. The device she gives you is rather large, but you decide to trim the sponge down to an appropriate size for use in your patient.

Discussion Questions:

1. Should you contact your institutional review board before using the novel therapy?

2. Is formal application for compassionate care warranted?

3. How do you propose the treatment plan to the parents?

4. What type of information should be documented in a written consent form?

5. What risks are involved in modifying a device to make it fit for pediatric patients?

Resources

Ethics committee articles of interest

American Academy of Pediatrics (AAP) Committee on Bioethics Consensus Statements

AAP Bioethics Case-Based Teaching Guides

American Medical Association (AMA) Medical Ethics

AMA Journal of Ethics

American Society for Bioethics and Humanities

bioethics.net

Children’s Mercy Bioethics Center

Ethical Challenges in Short-Term Global Health Training

Ethical Issues in Surgical Care- American College of Surgeons Book and Course Link

The Hastings Center

The MacLean Center for Clinical Medical Ethics

NIH Research Ethics

University of Washington Department of Bioethics and Humanities

References