Continuing Education Activity

Physicians and medical researchers have a moral and legal obligation to obtain informed consent. Informed consent must include the patient being competent and understanding the options, risks, and benefits. For pediatric patients, parental consent, or consent from a surrogate, must be obtained for medical procedures, treatment, or research. When reasonable, pediatric assent is also a vital part of a positive physician-patient relationship that engages the child in their care. To avoid legal and ethical issues, this activity highlights the role of the interprofessional team in obtaining informed consent from parents.

Objectives:

• Summarize the reasons parental consent should be obtained.
• Describe the historical basis of obtaining informed consent.
• Discuss the common challenging reasons informed parental consent is obtained.
• Review how the healthcare team can work together to obtain parental consent and achieve better outcomes.

Introduction

Physicians and medical researchers have a moral and legal obligation to obtain informed consent.[1] Informed consent must include the patient being competent and understanding the options, risks, and benefits.[1] For pediatric patients, parental consent, or consent from a surrogate, must be obtained for medical procedures, treatment, or research. When reasonable, pediatric assent is also a vital part of a positive physician-patient relationship that engages the child in their care.

The current practice of informed consent stems from ethical theory and the law, most common being the concept of autonomy.[2] This practice allows the patient to guide their care based on their preferences and beliefs. Most pediatric patients, if not all, cannot be autonomous. Parents and guardians, therefore, must protect and promote the child’s health.[2]

Function

Sexually transmitted infections (STI) are relatively common diseases in the adolescent population. All states allow the treatment of adolescents with STIs without parental consent, but there are holes in that policy. These patients may not seek treatment due to fear of their parents finding out. Some states allow providers to notify parents after treatment, billing statements may disclose STI testing and medications provided, and access to the online medical record by parents/guardians all offer opportunities for adolescent privacy to be compromised.[2]

Human Papillomavirus (HPV) is a sexually transmitted infection that causes almost all cervical cancer cases and genital warts. This disease has a significantly effective vaccination that is administered in a 2 or 3 dose series. A patient who receives their first dose before they turn 15 can only get two doses. Studies have shown that the two doses of the HPV vaccine given between the ages of 9 to 14, at least six months apart, provides equal or superior protection. Patients are still able to receive the 3-dose vaccine from ages 15-26. Despite the effective prevention of HPV, a study in Rhode Island found that 27% of female adolescents have not fully received the vaccination.[3] Parental consent is necessary for the more effective 2-dose series. The Family Planning Title X Program provides access to contraception and STI prevention and treatment to teens without permission from guardians. Many people feel that the Title X Program should cover the HPV vaccine to provide adolescents with the best HPV protection exempt from parental consent.[3]

Abortions are a controversial topic for many people, especially adolescent abortions. Most states require patients under 18 years old to involve a parent or guardian before the procedure. One study surveyed 20 teenage patients who stated they chose to obtain an abortion because they felt they could not wholly provide for their child, and a child would limit their futures.[4] The stigma associated with abortions limits patients’ decisions and their social support. Many of the 20 patients surveyed experienced ridicule, shame, and emotional abuse after choosing to obtain an abortion. The fear of disclosing their pregnancy and abortion decision causes emotional distress for adolescents. Lawmakers should consider this harm when amending or making laws that require parental consent or involvement.[4] Others argue that an adolescent’s capacity to make such a complex decision has limitations due to neuroscience. The part of the brain involved in critical decision-making does not fully mature until the patient is in their mid-twenties. Teens are also more likely to be impulsive, and parents may provide an essential advising role for their children in this life-altering decision.[5]

Adults can refuse medical treatment, interventions, and care based on faith and religious values. For example, Jehovah’s witnesses tend to deny blood products even if it would be lifesaving. Christian Scientologists may refuse medical treatment also when faced with severe conditions.[2] In 1944, the United States Supreme Court ruled in Prince v Massachusetts that children should receive treatment, despite parental beliefs, when the refusal of treatment would cause significant disability, substantial harm, or death.[2]

Vaccinations have had one of the most significant impacts on health around the world. Most vaccines are scheduled to be given to children as they grow and mount an immune response to the world around them. The administration of these vaccines is with parental consent, and parents may also refuse them. Many states and schools mandate children to be vaccinated to attend public schooling. However, many private schools will educate children despite their vaccines not being up to date. Parents may home school their unvaccinated children, and there are ways for children to be exempt from needing their vaccines. One study found that 54% of parents were concerned about severe adverse effects associated with vaccines and that 31% felt they should be able to refuse vaccines for their children without repercussions at schools.[6] Most commonly denied are the HPV, varicella, and meningococcal vaccines. Some people also claim religious exceptions to vaccination, stating the vaccines go against God's will or that they have more issues with the way specific vaccines were made.[6] As unvaccinated children grow up, many then wish to obtain their vaccines. Many parents will then agree, but if they do not, this becomes a very controversial situation. Allowing these adolescents to consent to vaccinations against their parent’s wishes promotes their health, poses minimal risk, and increases community protection against preventable diseases. Some believe that states should have laws that allow access to vaccines to minors at least 12 to 14 years of age.[7]

Current guidelines do not address how to care for transgender minor patients when their parents disagree with the gender-affirming treatment. The Journal of Medical Ethics suggests avenues for providing care through this disagreement, those being legal carve-outs to parental consent, the mature minor doctrine, and state intervention for neglect.[8] Transgender is turbulent for the patient and family, but coming to a head at complete disagreement can put the patient at risk of physical and emotional harm. In the absence of parental consent, gender-affirming treatment needs more research and guidelines to best care for these patients and their families.

Research is incredibly beneficial for the medical field. Parental consent is required to be able to use patients younger than 18 years old in research. However, this may result in sampling bias.[9] A meta-analysis of 15 studies with a total patient population of over 100,000 children found that with active parental consent, the response rate was significantly lower when compared to passive consent. Research has also noted that female, younger, and African American patients were most unlikely to participate in research that required active parental consent. One study using passive consent found that patients were more likely to disclose substance abuse compared to those studied with active consent.[9] Active parental consent decreases the validity of pediatric research and leads to bias and misrepresentation. In the future, researchers would benefit from research procedures that protect minors without silencing their responses.[9]  

Issues of Concern

Parental consent improves the relationship between the healthcare provider and those caring for their pediatric patient - this establishes a bond and trusting dialogue that provides a more healing environment in and out of the exam room. Patient consent is then just as essential as the child becomes more involved in their care and control over their bodies. However, there are some situations where parental consent is not required, which may be harmful to involve parents or the provider to do what is in the child's best interest, which may be against the guardian’s wishes. Inability to obtain parental consent, except for emergency conditions or otherwise specified in various jurisdictions, may lead to litigation and claims. Hence, in a healthcare setting, it is deemed essential to obtain parental consent whenever required.

Clinical Significance

Several states have mandated the obtaining informed consent is the duty of the physician.[10] However, in most offices and hospitals, this is a team effort. Often, a physician will educate the patient and parents on the procedure, risks and benefits, and alternative options and obtain verbal consent. They will then send in a nurse, or surrogate, to obtain written consent on a handout authored by the physician, again outlining everything the patient needs to know. After obtaining signed, informed consent, another medical team member then scans the document into the electronic medical record (EMR) for proof. Pennsylvania’s supreme court has ruled physician assistants (PAs) may not obtain informed consent in lieu of a physician. However, many believe that as long as a physician directly oversees a PA, the PA obtaining consent is an extension of the physician-patient relationship.[10]

Parental consent is typically necessary for medical evaluation and treatment. Clinicians and staff need to understand that they must obtain consent before seeing and providing care to pediatric and adolescent patients. However, parental consent is not a requirement in an emergency. The AAP states that a pediatric examination, treatment, and stabilization should take place in an urgent or emergent situation without parental consent. Efforts should be made to obtain consent, but therapy should not delay if parents are not in attendance or unreachable. The Emergency Medical Treatment and Active Labor Act mandates that providers treat patients in emergent medical situations regardless of consent.[2]

Enhancing Healthcare Team Outcomes

It is vital that, as an interprofessional medical team, the entire staff works to ensure that parental consent is obtained and documented correctly. It may be beneficial for organizations to monitor that consent is quickly collected and uploaded to the EMR. Clinicians should also document the discussion and receipt of verbal consent. Even if the signed paper is uploaded to the EMR, it should still be recorded by the clinician. Nurses and allied health professionals can assist in this role by double-checking documentation and making sure the patient and parents understand the consent they are signing. These steps are imperative to providing excellent medical care. 

In an emergency setting without the ability to obtain medical consent, the entire team should be educated on their duty to continue with the minor's care. Staff members are not to hesitate and delay emergency treatment. While the essential team is working with the emergent minor, another team member should be monitoring the ability to locate the parents. It is crucial to ensure that a team member is calling parents or guardians and trying their best to obtain consent and notify the parents of their child's state.