Giving Informed Consent for Pediatric VCUG

Unsilenced
Jun 7, 2023
6 min read

Updated: 17 hours ago

In this blog, we discuss how the informed consent doctrine affects pediatric VCUG.

A cropped shot of a person completing medical forms.

What Constitutes “Informed Consent” in Healthcare?

The informed consent doctrine ensures that all individuals, including children, retain the legal right be fully informed when making decisions about their medical care. To give informed consent to a healthcare provider, it’s necessary to first have a comprehensive understanding of the risks, benefits, and alternative treatments involved with any medical choice, from routine exams to surgeries to prescription medications.

In the context of pediatric care, informed consent refers to the process of obtaining assent from legal guardians on behalf of their child. Because minors are incapable of giving legal consent, parents must provide informed consent for their child's medical care. For consent to be "informed," providers are responsible for disclosing all pertinent information that may affect the family's decisions for their child's treatment.

This extends to any reasonable information and includes uncommon risks, if it may be potentially relevant to parental decision-making. Common examples of qualifying information include the nature of the proposed treatment, potential risks and benefits, available alternatives, and the implications of not proceeding with the treatment.

No system is perfect, and the informed consent doctrine in pediatrics is no exception, especially given children's lack of legal standing to consent to care in any way. Informed consent violations not only threaten a child's right to dignity and autonomy, but can inflict long-term harm that affects their adult futures.

Are VCUG Conductors Meeting Their Ethical Obligations Under the Law?

To meet their obligations under the informed consent doctrine, providers are responsible for upholding the following elements:

Information disclosure: Healthcare professionals must provide clear and accurate information about the diagnosis, treatment options, anticipated outcomes, and potential risks and benefits. This information should be presented in a manner that is understandable to the parents or legal guardians.
Capacity to understand: Parents must have the ability to comprehend the provided information and its implications. If there are language barriers or cognitive limitations, efforts should be made to ensure effective communication.
Voluntary agreement: Informed consent must be given voluntarily, without coercion or undue influence. Parents or legal guardians should have the opportunity to ask questions, seek additional information, and discuss their concerns before making a decision.
Competence: Healthcare professionals should assess the competency of parents or legal guardians to make decisions on behalf of the child. If concerns arise regarding their decision-making capacity, it may be necessary to involve additional resources, such as legal authorities or ethics committees, to ensure the best interests of the child are considered.

Understanding Physicians' Obligations Under the Informed Consent Doctrine

Pediatricians can only establish legally effective informed consent by disclosing all pertinent medication information that may affect a family's medical decisions for their child. Providers should always disclose the condition being treated, the nature and character of the proposed medical care, expected results of the proposed treatment, recognized forms of alternative treatment that may also be available (including non-treatment), recognized risks, complications, and anticipated benefits.

Various court rulings offer further guidance under the informed consent doctrine, including:

Gates v. Jenson. This 1979 ruling required physicians to disclose personal or economic interests that may influence their judgement.
Jandre v. Physicians Insurance Co of Wisconsin. This 2010 ruling held that all diagnostic tests that may rule out a possible condition are required to be disclosed to obtain informed consent.
Nixdorf v. Hicken. This 1980 ruling determined that physicians must also disclose information that a reasonable person in the patient’s position would find important. In the same vein, physicians are also required to explain any benefits or risks that may be significant to the person consenting to the medical care (or the legal guardian giving consent for a minor’s medical care).
Truman v. Thomas. This 1980 decision ruled that doctors are obligated to disclose the potential risks associated with not seeking treatment.

Exceptions to Informed Consent in Pediatric Care

Like any area of the law, there are some ceratin exceptions to the informed consent doctrine. Some notable exemptions include:

Physicians are not required to disclose risks that lack inherent relevance to the proper performance of the procedure. This means that any risks solely resulting from the improper performance of the procedure aren’t required to be disclosed by doctors to obtain informed consent.
Informed consent may be omitted if the patient is 1) unconscious and incapable of consenting AND 2) the anticipated benefits of the medical treatment outweighs any risks of potential harm. It’s worth noting that even physicians that qualify for this exemption are still obligated to obtain informed consent as soon as the medical circumstances permit it.
Doctors may be exempt from obtaining informed consent if disclosing medical information poses a threat to the patient’s health or safety. This typically applies to patients who suffer extreme trauma, suffer from mental illnesses, or aren’t in an appropriate emotional state to process disclosed information (e.g., if disclosing said information is predicted to result in psychological harm).

Keep in mind that this is NOT an excuse for physicians to withhold the medical information out of fear that the patient will refuse treatment if the information is fully disclosed to them. As described in the AMA Journal of Ethics, “[A] physician must disclose information that a reasonable person would want to have for decision-making, even [if] that information may cause the patient to refuse treatment that the physician believes [to be] in the patient’s best interest.”

[A] physician must disclose information that a reasonable person would want to have for decision-making, even [if] that information may cause the patient to refuse treatment that the physician believes [to be] in the patient’s best interest.” -American Journal of Ethics

One 1972 case, Canterbury v. Spence, forever altered the landscape of informed consent in medical care after a patient sued his physician for failing to disclose the risks of his laminectomy procedure. The pivotal ruling established that all physicians must disclose medical information if it’s reasonable to do so.

“Parents or other surrogates provide ‘informed permission’ for diagnosis and treatment, with the assent of the child as developmentally appropriate,” reads one 2016 article published by the AAP. “However, the goals of the informed consent process (protecting and promoting health-related interests and incorporating the patient and/or the family in health care decision-making) are similar in the pediatric and adult population, and are grounded by the same ethical principles of beneficence, justice, and respect for autonomy.”

How VCUG Conductors Violate the Informed Consent Doctrine

Generations of children have been traumatized (and continue to be traumatized) by VCUG conductors who fail to obtain informed consent prior to the procedure.

Medical negligence, especially the performance of a traumatizing, sexual, and invasive pediatric procedure on children without informed consent from a parent or legal guardian, has already resulted in preventable harm to generations of children.

Below are 3 ways that some providers fail to meet their obligations under the informed consent doctrine:

1: Failing to disclose clear and accurate information about VCUG.

Many VCUG survivors and their families have no memory of receiving any information about alternative treatments or measures of care. While efficacy of alternative methods will vary from case to case, there's no reason for caregivers to be left in the dark about alternative methods (such as ceVUS or renal ultrasound). In actuality, many low-grade cases of VUR may have been resolved just as effectively through use of non-invasive ultrasounds or related techniques.

2: Coercing caregivers to consent to VCUG through false or misleading information.

Voluntary agreement is a foundational element of informed consent in pediatric care, and many survivors’ stories shed important light on some concerning behaviors by providers. From blackmailing parents (e.g., withholding antibiotics unless consent for a subsequent VCUG was given) to refusing to take safe, alternative measures to fear-mongering parents with the threat of their child's death without VCUG, former VCUG patients have testified about the fear tactics weaponized by providers.

Though they are hopefully only few in number, we can only speculate about the ulterior motives behind such efforts. Regardless, surely this warrants an established protocol and renewed commitment and to upholding the informed consent doctrine in pediatrics.

3: Putting profits over people.

According to a resource from the U.S. Department of Health and Human Services (HHS), obtaining legally effective informed consent requires 3 key things from law-abiding physicians:

Disclosing information needed to make an informed decision.
Facilitating the understanding of what has been disclosed.
Promoting the voluntariness of the decision about whether or not to participate in the research.

It’s safe to say there are numerous reasons why VCUG is still considered the “gold standard” diagnostic test for VUR in children, even decades after VCUG patients were used as proxies in child sexual abuse studies. One stands out among the rest: profits over people.

“The vesicoureteral reflux (VUR) market is expected to reach $1.1 billion by the end of 2023,” reads one report by Market Research Future. “It must also be noted that [the] white population and girls are at a higher risk of developing VUR. [The] development of surgical robots will drive the future market, as they are more precise [and] cause less trauma. However, the minimally invasive surgeries are more expensive, which will act as a drag on the market.”

"The VCUG is an invasive procedure that is uncomfortable and distressing for the pediatric patient," says one 2012 article published by the Journal of Urology. "We conclude that a significant number of parents are uninformed about the VCUG, which influences their expectations for the procedure. [It's] important to inform parents about the procedure so they have reasonable expectations.”