Table of Contents

 

Involving patients or their surrogate decision-makers in their care is an important element of modern medical practice; however, general consent, informed consent, refusal of care, and shared decision-making can be more complex in emergency settings involving pediatric patients, due to the patients’ age, decision-making capacity, guardianship issues, and other special circumstances. It is important for clinicians to understand and apply the general concepts of informed consent, informed refusal, and shared decision-making, as well as to recognize circumstances in which exceptions may apply, depending on state laws or regulations. You will learn:

The difference between a general consent form and the informed consent process

When general consent will suffice and when informed consent is needed

Essential elements of informed consent

The difference between competence and capacity and how these relate to the informed consent process

Recommendations for best practices, such as using the teach-back method to ensure patients or their surrogate decision-makers understand the clinical situation and care plan

How to approach treatment refusal and when children or their parents/guardians can refuse treatment

When to consult institutional legal counsel or social work teams

When shared decision-making can be used

Approaches to involving patients and their surrogates in shared decision-making

How to address special circumstances including management of sexual and mental health conditions, emancipated minors, mature minors, and situations in which custody is unclear

1. Abstract
2. Case Presentations
3. Introduction
4. Critical Appraisal of the Literature
5. General Consent, Informed Consent, Refusal of Care, and Shared Decision-Making in Medical Management Scenarios
   1. General Consent
   2. Informed Consent
      1. Competence and Capacity
      2. The Informed Consent Process
   3. Refusal of Care
      1. Emergent Situations That Threaten Life or Limb
      2. Nonemergent Situations
      3. Situations in Which a Child Refuses Care but the Parent/Guardian Consents
      4. Situations in Which Parents/Guardians Refuse Care
      5. Situations in Which Both the Child and the Parents/Guardians Refuse Care
      6. Additional Considerations
   4. Shared Decision-Making
6. Special Circumstances
   1. Pediatric Assent
   2. Emancipated Minors
   3. Minor Parents
   4. Mature Minors
   5. Reproductive Health, Substance Abuse, and Mental Health Exceptions
   6. Religious Beliefs
   7. Custody Issues: Police, Foster Care, and Child Protective Services
7. Summary
8. Risk Management Pitfalls Involving Consent, Refusal, and Shared Decision-Making for Pediatric Patients
9. Case Conclusions
10. Clinical Pathway for Managing Consent, Refusal, and Shared Decision-Making in Pediatric Patients Without a Life- or Limb-Threatening Emergency
11. Tables, Figures and Appendix
    1. Table 1. Minimum Elements for Informed Consent Forms, According to CMS
    2. Figure 1. Four-Step Framework for Shared Decision-Making in Pediatric Patients
    3. Appendix. Online Resources for Information Regarding Consent, Majority, and Access to Medical Treatment Services
12. References

Abstract

Involving patients or their surrogate decision-makers in their care is an important element of modern medical practice. General consent, informed consent, treatment refusal, and shared decision-making are concepts that are used regularly but can be more complex in pediatric emergency settings. This issue summarizes these concepts and provides case examples that may be encountered. It explains the essential elements of informed consent, the distinction between the informed consent process and the document, how to approach treatment refusal, and approaches to involving patients and their surrogates in shared decision-making. Special circumstances include treatment for sexual and mental health conditions, emancipated minors, mature minors, and situations when custody is unclear. Implementation of these concepts can increase patient satisfaction, resolve conflict, and reduce risk.

Case Presentations

A 5-year-old boy is brought in by EMS after sustaining significant abdominal injuries in a motor vehicle crash...

• On evaluation, the child is determined to have significant abdominal tenderness. You are concerned because of his expanding abdominal girth, hemoglobin of 5 g/dL, and worsening hypotension.
• The trauma team determines emergency blood transfusion is indicated as a life-saving measure as well as an exploratory laparotomy. The boy’s parents are refusing blood transfusion, based on their religious practice.
• You are worried this child will die if not given an emergency blood transfusion. Should you ignore the parent’s wishes and transfuse the child? Will there be legal ramifications if you do?

A 16-year-old boy with hemophilia who is otherwise healthy presents to the ED for significant bleeding from an injury sustained while riding his bike…

• He does not have any home doses of factor VIII and has been actively bleeding for several hours.
• On initial evaluation, he has early signs of hypovolemia and a hemoglobin of 7 g/dL.
• After receiving factor VIII, his hemoglobin is still dropping, and is now 5 g/dL, with worsening signs of hypovolemia. The team is concerned the patient is still actively bleeding despite the factor VIII treatment. You determine a blood transfusion is indicated and discuss this with the adolescent and his family. The patient refuses the transfusion, indicating that he wants to wait to see if the factor VIII will “kick in” soon.
• You are concerned that the boy does not understand the gravity of the situation. How will you address this? Can the child refuse the transfusion?

A 16-year-old girl with diabetes is brought to the ED by her mother with concern for diabetic ketoacidosis...

• The patient lives alone with her 2-year-old child, who is with them in the ED. The 16-year-old girl is refusing treatment for herself. She states that she is an emancipated minor and can manage her illness at home. In addition, she is very worried about her son, who is ill with a cold and not eating well.
• The girl’s blood glucose reads “high” on the glucometer.
• You are concerned that the girl is in diabetic ketoacidosis and that she may have associated cerebral edema that is compromising her capacity to make healthcare decisions. Can this patient refuse treatment? Is she truly emancipated? What measures can you take to treat her in the ED?

A 3-week-old boy with fever is brought to the ED by his parents...

• The boy has a fever to 38.3˚C (100.9˚F). His other vital signs are within normal limits, and he is well-appearing with mild congestion but no other symptoms. He was born full-term, without complications, to an adequately treated group B Streptococcus-positive mother. His 3-year-old sister has symptoms of a cold.
• Your practice for neonates aged <4 weeks with fever is to do a full sepsis workup, including blood culture, urine culture, and lumbar puncture. The parents are nervous about the lumbar puncture because of an adult family member who had a complication with the procedure in the past.
• You wonder how to best involve the family in decision-making regarding the medical care of their child while adhering to practices that meet standard of care and are within your comfort level. What procedures do you need the parents’ consent for? When, if ever, would it be appropriate to proceed without their consent?

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Clinical Pathway for Managing Consent, Refusal, and Shared Decision-Making in Pediatric Patients Without a Life- or Limb-Threatening Emergency

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Tables, Figures and Appendix

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Key References

Following are the most informative references cited in this paper, as determined by the authors.

3. * Committee on Pediatric Emergency Medicine and Committee on Bioethics. Consent for emergency medical services for children and adolescents. Pediatrics. 2011;128(2):427-433. (Policy statement) DOI: 10.1542/peds.2011-1166

5. * Cordasco K. Chapter 39: obtaining informed consent from patients: brief update review. In: Shekelle PG, Wachter RM, Pronovost PJ, et al. Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices. Rockville: Agency for Healthcare Research and Quality (US); 2013:461-471. (Review) 

6. Agency for Healthcare Research and Quality, Abt Associates, The Joint Commission. Making Informed Consent an Informed Choice: Training for Health Care Professionals. Accessed April 15, 2021. (Training module)

7. * Centers for Medicare & Medicaid Services. Revisions to the hospital interpretive guidelines for informed consent. Accessed April 15, 2021. (U.S. government document)

9. * Guttmacher Institute. An overview of minors’ consent law. State policies in brief. Accessed April 15, 2021. (Website)

11. * Weiss EM, Clark JD, Heike CL, et al. Gaps in the implementation of shared decision-making: illustrative cases. Pediatrics. 2019;143(3):e20183055. (Case reports) DOI: 10.1542/peds.2018-3055

13. Agency for Healthcare Research and Quality. Health Literacy. Accessed April 15, 2021. (U.S. government resource)

14. * Garner BA, Black’s Law Dictionary. 9th ed: U.S.A.: West; 2009. (Legal reference)

15. * The Joint Commission, Division of Health Care Improvement. Informed Consent: More than Getting a Signature. Quick Safety. 2016(21). (Advisory article)

16. 42 Code of Federal Regulations § 482. 24 - Condition of participation: Medical record services.  Accessed April 15, 2021. (Legal information)

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Keywords: consent, general consent, informed consent, consent form, informed consent process, refusal, refusal of care, refusal of treatment, shared decision-making, competence, incompetence, capacity, teach-back method, assent, emancipated minor, mature minor