The year was 1914. In the landmark case Schloendorff v. Society of New York Hospital, Judge Benjamin Cardozo stated:
Though the term “informed consent” would not appear in medical literature until the 1950s, the idea that patients had a right to make decisions about their own medical care had taken root. The signing of paper patient informed consent forms became common by the 1960s and was standard practice by the late-1970s.
In the wake of COVID-19, yet another paradigm shift is now underway in the healthcare industry. Electronic informed consent forms are increasing in popularity as digital informed consent tools take hold. Hospitals, clinical trial sponsors and research sites throughout the U.S. are turning to eConsent forms as a more standardized and efficient way of obtaining patient consent.
All of this raises some key questions:
This blog will explore the various aspects of the informed consent process with a special focus on the use of patient consent platforms in pediatrics. Specifically, how can parents and providers add the child’s assent to digital informed consent?
Informed consent medical forms help ensure that patients understand and agree to medical treatments or procedures before they happen. Our prior blog on the topic of malpractice risk noted that patient consent platforms should — at a minimum — incorporate all of the following:
While some clinicians and providers see informed consent as “just a form” that needs to be filled out prior to a procedure, they are failing to understand the importance of informed consent. Informed consent is all about ensuring that shared decision-making occurs between the patient and provider, and that the provider communicates all of the appropriate information to the patient.
In another prior Taylor Healthcare blog on the topic, Chad Brouillard, M.A., J.D., explored the concept of informed consent from a legal perspective. He noted that informed patient consent solutions are a win/win for the patient and provider.
A highly nuanced concept, “shared decision-making” is one of the most critical aspects of the informed consent process. Healthcare industry experts sometimes refer to the “4 Cs” of informed consent as the communications standard that ensures a patient is fully informed and able to make autonomous decisions about their care.
Competence
The patient must have the mental capacity to understand the information provided and make a decision. This includes being able to comprehend the nature and consequences of the treatment options.
Clarity
Information must be presented in a clear, understandable way. Medical jargon should be minimized, and the patient should be able to ask questions and receive straightforward answers.
Comprehension
The patient must actually understand the information given. This goes beyond just hearing or reading it. They need to grasp the implications, risks, benefits and alternatives.
Consent
The patient must voluntarily agree to the proposed treatment or procedure without coercion or undue influence.
Informed consent forms have traditionally been printed on paper and then reviewed and signed by a patients on clipboards. However, as noted above, such informed consent medical forms are increasingly being delivered electronically instead of on paper.
These eConsent forms rely on specially engineered patient consent software to digitize the entire process. Electronic consent systems maintain the critical patient informed consent forms and related educational materials in a centralized database. The patient reviews the forms on a digital device — such as a tablet or smartphone — and signs the document electronically. The signed form is then automatically saved to the electronic health record (EHR) of the patient for future reference.
When compared to the use of paper informed consent forms, eConsent forms offer three critical advantages.
Specificity
Out of necessity, paper informed consent forms tend to be more generic and less detailed than those stored in electronic consent systems. It’s a practical impossibility to maintain printed paper forms for the thousands of types of medical procedures that may be performed in a hospital or clinic. By comparison, an infinite number of eConsent forms can easily be kept on file digitally, tailored to the unique aspects of each procedure. This lack of specificity can be a source of malpractice risk.
Standardization
When paper informed consent forms are used, patients are often reviewing and signing obsolete versions of those forms. Here again, it’s a practical impossibility to keep the most up-to-date version of every consent form in every file cabinet at all times. The malpractice risk that results grows as the number of sites of care increases.
Electronic informed consent systems, by comparison, ensure that a single, standardized version of each eConsent form is in use at all times. All physicians at all facilities across an entire health system are able to disclose the same information to all patients — with the flexibility to customize that information as needed. As this level of standardization rises, risk declines.
Digitization
Perhaps the most common problem with paper informed consent medical forms is that they are often lost in a sea of paperwork. An alarming study by Johns Hopkins found that 66% of patients were missing a signed patient informed consent form upon arrival in the preoperative area. These missing consent forms, in turn, caused delays in 14% of operative cases. (Source: Missing Consent Forms in the Preoperative Area; JAMA Surgery, Vol. 148, No. 9)
With an electronic informed consent system, on the other hand, the signed patient informed consent form is stored directly to the patient’s EHR and the risk of lost consent forms is eliminated. Not only does the patient or guardian have the convenience of reviewing and signing detailed informed consent medical forms on a personal mobile device, a permanent record of that decision will always be accessible in the patient’s EHR.
Given this background on informed consent medical forms and electronic informed consent in particular, our focus now turns to the field of pediatrics. Once again, a series of questions results.
When used in children’s hospitals, all of the key advantages of electronic consent software are present. The specificity and standardization of eConsent forms help ensure that a confident, informed decision is made. Likewise, the convenience and permanence benefits of digital informed consent tools apply in a pediatrics environment as well. However, while mature minors and emancipated minors can legally consent to certain treatments (e.g., reproductive health, mental health) in some jurisdictions, there is no such thing as a medical consent form for a minor in most scenarios.
The challenge, of course, lies in the 4 Cs. When trying to explain a medical procedure to a child, it’s generally assumed that Competence and Comprehension are absent. A young child simply cannot grasp the nature and consequences of the treatment options available to them, nor the implications, risks, benefits and alternatives.
This is where the child assent process comes in. More and more, child assent is being added to the informed consent process. Rather than a parent or guardian simply making all decisions on behalf of the child with minimal input by the patient, efforts are being made to ensure that children are appropriately informed of and voluntarily agree to participate in a procedure. The Children’s Hospital of Philadelphia (CHOP) summarizes the process as follows:
🔹 1. Assess the Child’s Capacity
The healthcare provider evaluates whether the child is capable of providing assent based on age (typically 7 to 17 years of age), maturity and psychological state.
🔹 2. Provide Age-Appropriate Information
The child is given a simplified explanation of:
🔹 3. Solicit Affirmative Agreement
Assent must be affirmative — the child must actively agree to participate. Silence or lack of objection is not enough to constitute assent.
🔹 4. Obtain Parental Permission
Even if a child assents, parental or guardian consent is still legally required.
🔹 5. Document the Assent
Documentation methods for child assent vary, such as:
To be clear, the child assent process is about gaining the child’s willingness to participate in a proposed medical intervention. Though Institutional Review Boards (IRBs) often require a child’s assent before conducting medical research involving minors, the child’s assent does not carry the legal authority of an informed consent medical form. A parent or guardian must still provide formal consent for the procedure to occur.
However, it respects the developing autonomy of the child and encourages their involvement in decisions affecting them. Adding a child’s assent to digital informed consent processes helps to ensure the child is informed and agrees with the decisions to the extent they are capable. In fact, if a child refuses to assent to a procedure — particularly in non-emergency situations — their dissent may be respected by the provider even if the parent consents. In those moments, the lessons of Schloendorff v. Society of New York Hospital in 1914 come full circle.
Taylor Healthcare has been serving the healthcare industry for nearly a century. We specialize in printed and digital tools that enhance patient-provider communication — tools like iMedConsent™.
iMedConsent is a proprietary informed patient consent solution that standardizes and digitizes the informed consent process. More than 250 health systems ranging from children’s hospitals to the U.S. Department of Veterans Affairs have adopted electronic consent forms, powered by Taylor Healthcare’s iMedConsent. At its core lies iMedContent, a curated content library that provides consent forms and educational information on more than 5,000 treatments and procedures in dozens of clinical specialties.
iMedConsent is just one component of iMedHealth, an entire suite of cloud-based, EHR-integrated technology solutions that enhance the informed consent process, streamline downtime operations, and bolster patient education and engagement. Contact your Taylor Healthcare representative to learn more about iMedHealth and iMedConsent.