Informed consent and refusal for pediatric procedures involves a process in which the provider, child, and parents/guardians participate. In pediatric gastroenterology, many procedures are considered elective and the process generally begins with an office visit and ends with the signing of the consent document. If the process is emergent then this occurs more expeditiously and a formal consent may not be required. Information about the procedure should be shared in a way that allows a decision-making process to occur for both the parent/guardian and the child, if of assenting age.
Key points
- •
Pediatric informed consent is a unique process that involves the provider, the parent/guardian, and the mature adolescent, if appropriate.
- •
Pediatric assent, in particular obtaining permission from an adolescent, is highly recommend for pediatric endoscopy.
- •
Each procedure has a general list of indications, methods, risks, benefits, and alternatives that should be discussed with the decision maker. The provider obtaining consent should evaluate a general sense of understanding from the parent/guardian, as well as from the patient, when appropriate.
- •
Endoscopic providers should be aware of relevant procedural risks and the specific frequencies with which each occur.
Introduction
Procedural or surgical informed consent is the process by which a practitioner obtains permission from an autonomous decision maker to allow a procedure or invasive test to be done on a patient or subject. This concept is used frequently in the practice of pediatric gastroenterology as it is relates to procedures, transfusions, and transplants.
The general concept of informed consent most commonly finds its origins in ideas stemming from the Nuremberg Trials after World War II. The term was greatly expanded subsequently based on laws relating to assault and battery. The 1969 case of Canterbury v. Spence highlights the modern-day concept of informed consent and the more familiar discussion of risks, benefits, alternatives, indications, and methods. The case highlights the failure of Dr Spence to disclose the possible ramifications of back surgery and subsequent paralysis. The patient was not informed of the risk of complications and a lawsuit ensued. Such cases and history highlight the need for practitioners to share information with a rational, informed, and noncoerced decision maker, or else with a surrogate/proxy. This process is known as respect for autonomy.
Informed consent is part of the continual process of shared decision making that encompasses the transfer of information between practitioner and patient or patient surrogate/parents. Informed consent is the finalization and obtaining of permission with probable documentation of the process that leads to a procedure or test. This consent process accompanies the right of that individual to make an informed refusal. Pediatric assent, a unique component to the care of children, is the process by which a consent modality is applied to an adolescent decision maker.
In contrast, variations to this process in an emergent setting allow for deviations from this routine. One such an example is a life-threatening gastrointestinal bleeding event in which the family was not available. Because of the uniqueness of the pediatric setting and the legal interest of protecting children, formal consent is not always needed in emergency circumstances.
Components of Informed Consent
There are several necessary components to informed consent ( Box 1 ). Some of these are implicit or assumed in routine interactions between the provider and family, whereas others must be specifically transferred as information. Assumed components of the informed consent process include assessment of the decision-making capacity of the decision maker, as well as their voluntariness. Decision-making capacity is the ability to understand and process information and come to a decision. Voluntariness is the understanding of a decision maker that they are intended to make a decision that is free from pressure or coercion by the provider. Both assessments are informal and rarely documented. These issues are not as problematic in pediatrics because of the presence of parental proxies, but can play a role in older adolescents or parents of limited mental capacity. Even with the use of parents, comprehension and understanding can still be limited.
Preconditions: provider assessed:
- 1.
Competence: decision-making capacity
- 2.
Voluntariness: free from coercion, pressure
Information elements: provider disclosed:
- 1.
Disclosure
- a.
Indications
- b.
Methods
- c.
Risks
- d.
Benefits
- e.
Alternatives
- a.
- 2.
Recommendation
- 3.
Understanding
Consent achieved
- 1.
Decision by parent/adolescent
- 2.
Authorization/documentation
The transfer of information is the next component with which most providers are familiar, and includes a discussion of the risks, benefits, indications, methods, and alternatives of the procedure. Transfer of information usually contains a clinical recommendation by the provider. In addition, in this component of informed consent, the provider needs to obtain a decision and authorization from the patient, guardian, or proxy.
Pediatric Assent
Pediatric assent is similar to consent as noted earlier, but the presentation and discussion are focused on the nonlegal bound adolescent patient rather than the legal guardian or decision maker. Assent is usually obtained in patients 11 years of age and older, but assessment of maturity level may influence the age at which this is practical. Some states allow adolescents to give informed consent for specific abortion or sexual reproductive health procedures, although not for other standard procedures, such as pediatric endoscopy.
Although assent is not legally binding, it is imperative in pediatrics for the patient to be involved in the consent process. For example, in pediatric gastroenterology the adolescent may not want an elective endoscopy to be performed. If an endoscopy were to be performed against the adolescent’s wishes, this could be considered battery and is neither ethically nor legally recommended. In the case of unsedated or procedures with minimal sedation, for which a cooperative patient is necessary, following the patient’s wishes is absolutely necessary. Examples of such procedures include unsedated transnasal/transoral endoscopy and capsule endoscopy.
Methods of Consent
Regarding methods of consent, there is significant research showing that all methods generally fail to achieve a complete consent. A recent meta-analysis done by Cochrane confirms that further research and new techniques for implementing the consent process are needed urgently. Specifically regarding gastrointestinal endoscopy, studies have shown that there is a general understanding by families and patients of the procedure and basic risks, but there are deficiencies in understanding the voluntariness and alternatives of most procedures. Most of the current research into consent processes focuses on paper-based or electronic form–based techniques, but video, decision-aid assistance, and interactive Web-based methods have also been investigated.
Several companies in the United States sell video or Web-based decision-aid and information videos for endoscopy, although few are pediatric focused. Milwaukee Children’s Hospital recently published an informative video regarding pediatric endoscopy, but it has not been studied specifically as a decision aid for obtaining consent. One commercial video by Epic Systems Inc has been studied and has been shown to improve consent attainment as based on understanding the risks, benefits, alternatives, indications, and methods using the Consent-20 instrument.
Expertise in the Procedure
In order to obtain consent and provide information transfer to families, technical and nontechnical expertise in the procedure being performed is necessary. Individuals obtaining consent should also be familiar with their own expertise, and be able to provide personal information about general past procedural numbers, and their experience with complications if asked by the consenter. This recommendation may present challenges in training environments, in which fellows are learning to engage in procedural consent. In that there is yet to be a method of consent that has shows significant and complete success, it is important to recognize that teaching consent is difficult. Further research is needed to improve education around the process of consenting for pediatric endoscopy.
Individuals obtaining consent and performing transfer of information must also be familiar with both general and unique components of each procedure, including potential outcomes and risks, of various types and categories of pediatric gastrointestinal procedure. Because of a paucity of data on the specific outcomes in pediatric procedures, some of this information is anecdotal and vague. The Endoscopy and Procedure Committee of the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) is currently working on an agenda to better populate information about risks in pediatric procedures. With this agenda ongoing, even the best data are limited by the experience of each endoscopist and should be interpreted with caution. For example, a single-center risk of perforation quoted at 1:10,000 for diagnostic endoscopy may vary by endoscopist and by risk profile of the patient selection (ie, disease process or comorbidity). One physician may have a complication rate of 1:5000, whereas another may be 1:15,000. In addition, the nature and type of procedure may augment risk, as discussed later.
Introduction
Procedural or surgical informed consent is the process by which a practitioner obtains permission from an autonomous decision maker to allow a procedure or invasive test to be done on a patient or subject. This concept is used frequently in the practice of pediatric gastroenterology as it is relates to procedures, transfusions, and transplants.
The general concept of informed consent most commonly finds its origins in ideas stemming from the Nuremberg Trials after World War II. The term was greatly expanded subsequently based on laws relating to assault and battery. The 1969 case of Canterbury v. Spence highlights the modern-day concept of informed consent and the more familiar discussion of risks, benefits, alternatives, indications, and methods. The case highlights the failure of Dr Spence to disclose the possible ramifications of back surgery and subsequent paralysis. The patient was not informed of the risk of complications and a lawsuit ensued. Such cases and history highlight the need for practitioners to share information with a rational, informed, and noncoerced decision maker, or else with a surrogate/proxy. This process is known as respect for autonomy.
Informed consent is part of the continual process of shared decision making that encompasses the transfer of information between practitioner and patient or patient surrogate/parents. Informed consent is the finalization and obtaining of permission with probable documentation of the process that leads to a procedure or test. This consent process accompanies the right of that individual to make an informed refusal. Pediatric assent, a unique component to the care of children, is the process by which a consent modality is applied to an adolescent decision maker.
In contrast, variations to this process in an emergent setting allow for deviations from this routine. One such an example is a life-threatening gastrointestinal bleeding event in which the family was not available. Because of the uniqueness of the pediatric setting and the legal interest of protecting children, formal consent is not always needed in emergency circumstances.
Components of Informed Consent
There are several necessary components to informed consent ( Box 1 ). Some of these are implicit or assumed in routine interactions between the provider and family, whereas others must be specifically transferred as information. Assumed components of the informed consent process include assessment of the decision-making capacity of the decision maker, as well as their voluntariness. Decision-making capacity is the ability to understand and process information and come to a decision. Voluntariness is the understanding of a decision maker that they are intended to make a decision that is free from pressure or coercion by the provider. Both assessments are informal and rarely documented. These issues are not as problematic in pediatrics because of the presence of parental proxies, but can play a role in older adolescents or parents of limited mental capacity. Even with the use of parents, comprehension and understanding can still be limited.
Preconditions: provider assessed:
- 1.
Competence: decision-making capacity
- 2.
Voluntariness: free from coercion, pressure
Information elements: provider disclosed:
- 1.
Disclosure
- a.
Indications
- b.
Methods
- c.
Risks
- d.
Benefits
- e.
Alternatives
- a.
- 2.
Recommendation
- 3.
Understanding
Consent achieved
- 1.
Decision by parent/adolescent
- 2.
Authorization/documentation
The transfer of information is the next component with which most providers are familiar, and includes a discussion of the risks, benefits, indications, methods, and alternatives of the procedure. Transfer of information usually contains a clinical recommendation by the provider. In addition, in this component of informed consent, the provider needs to obtain a decision and authorization from the patient, guardian, or proxy.
Pediatric Assent
Pediatric assent is similar to consent as noted earlier, but the presentation and discussion are focused on the nonlegal bound adolescent patient rather than the legal guardian or decision maker. Assent is usually obtained in patients 11 years of age and older, but assessment of maturity level may influence the age at which this is practical. Some states allow adolescents to give informed consent for specific abortion or sexual reproductive health procedures, although not for other standard procedures, such as pediatric endoscopy.
Although assent is not legally binding, it is imperative in pediatrics for the patient to be involved in the consent process. For example, in pediatric gastroenterology the adolescent may not want an elective endoscopy to be performed. If an endoscopy were to be performed against the adolescent’s wishes, this could be considered battery and is neither ethically nor legally recommended. In the case of unsedated or procedures with minimal sedation, for which a cooperative patient is necessary, following the patient’s wishes is absolutely necessary. Examples of such procedures include unsedated transnasal/transoral endoscopy and capsule endoscopy.
Methods of Consent
Regarding methods of consent, there is significant research showing that all methods generally fail to achieve a complete consent. A recent meta-analysis done by Cochrane confirms that further research and new techniques for implementing the consent process are needed urgently. Specifically regarding gastrointestinal endoscopy, studies have shown that there is a general understanding by families and patients of the procedure and basic risks, but there are deficiencies in understanding the voluntariness and alternatives of most procedures. Most of the current research into consent processes focuses on paper-based or electronic form–based techniques, but video, decision-aid assistance, and interactive Web-based methods have also been investigated.
Several companies in the United States sell video or Web-based decision-aid and information videos for endoscopy, although few are pediatric focused. Milwaukee Children’s Hospital recently published an informative video regarding pediatric endoscopy, but it has not been studied specifically as a decision aid for obtaining consent. One commercial video by Epic Systems Inc has been studied and has been shown to improve consent attainment as based on understanding the risks, benefits, alternatives, indications, and methods using the Consent-20 instrument.
Expertise in the Procedure
In order to obtain consent and provide information transfer to families, technical and nontechnical expertise in the procedure being performed is necessary. Individuals obtaining consent should also be familiar with their own expertise, and be able to provide personal information about general past procedural numbers, and their experience with complications if asked by the consenter. This recommendation may present challenges in training environments, in which fellows are learning to engage in procedural consent. In that there is yet to be a method of consent that has shows significant and complete success, it is important to recognize that teaching consent is difficult. Further research is needed to improve education around the process of consenting for pediatric endoscopy.
Individuals obtaining consent and performing transfer of information must also be familiar with both general and unique components of each procedure, including potential outcomes and risks, of various types and categories of pediatric gastrointestinal procedure. Because of a paucity of data on the specific outcomes in pediatric procedures, some of this information is anecdotal and vague. The Endoscopy and Procedure Committee of the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) is currently working on an agenda to better populate information about risks in pediatric procedures. With this agenda ongoing, even the best data are limited by the experience of each endoscopist and should be interpreted with caution. For example, a single-center risk of perforation quoted at 1:10,000 for diagnostic endoscopy may vary by endoscopist and by risk profile of the patient selection (ie, disease process or comorbidity). One physician may have a complication rate of 1:5000, whereas another may be 1:15,000. In addition, the nature and type of procedure may augment risk, as discussed later.
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