The healthcare provider performing the procedure is responsible for discussing the procedure with the child and the family and for obtaining informed consent before implementation of any surgery, research protocol, procedure, or treatment that warrant informed consent.
Informed consent must be obtained from parents/legal guardians and assent obtained from children who are cognitively able in order to respect the right to self-determination in decision making.
Only patients who have appropriate decision-making capacity and legal empowerment can give their informed consent to medical care. In all other situations, parents/legal guardians provide informed permission for diagnosis and treatment of children, with assent of the child whenever appropriate.
Healthcare providers should seek parent/legal guardian permission in most situations. However, they must focus their goal on providing appropriate care and be prepared to seek legal intervention when parent refusal places the child at clear and substantial risk.
Privacy standards as outlined in the Health Insurance Portability Accountability Act of 1996 (HIPAA) must be followed to ensure confidentiality.
The process of informed consent must minimally address the following:
A full explanation of the condition
An explanation of the procedure or therapy to be used in terms appropriate to the parent or child’s level of understanding provided by the person performing the procedure or therapy
A description of alternative treatments or therapies available
A description of benefits to be expected from the treatment or therapy
A description of risks associated with the treatment or therapy
Sufficient time and encouragement to answer the child’s and family’s questions
Discussion that is free from any coercion, unfair persuasions, or other inducements to comply with the treatment being discussed
In emergency care situations when the need for treatment is immediate or the child has lost any decision-making capacity, consent is then implied. Consent is considered with regard to what the child or parents/legal guardians would have wanted to approve had they been present or mentally capable of making the decision.
When the child is a minor, all attempts should be made to attain assent for a procedure or research. Information presented in attaining assent should be limited to the child’s level of understanding. Assent would be the child’s permission to proceed.
Minors are deemed emancipated and treated as adults for all purposes, including informed consent, if the minor is any of the following:
Self-supporting and/or not living at home
Married
Pregnant or a parent
In the military
Declared to be emancipated by a court
In addition, many states give decision-making authority (without the need for parental/legal guardian involvement) to some minors who are otherwise unemancipated but who have decision-making capacity or are seeking treatment for certain medical conditions, such as sexually transmitted infections, pregnancy, and drug or alcohol abuse.
Legal statutes preclude obtaining informed consent from anyone younger than the age of 18 years. Researchers, however, are encouraged by institutional review boards to obtain assent from anyone older than 7 years of age. This legal mandate may need to be adapted for the adolescent who can clearly participate in his or her own decision making.
Consent document if required for the particular procedure. Some procedures are covered by the general consent-to-treat form that is signed upon
admission to a healthcare facility or upon initial treatment.
Indelible ink pen.
Dependent on the procedure or treatment to be discussed, the following may be helpful in aiding the child’s or family’s understanding of care:
Various forms of learning material addressing the child’s and family member’s learning styles and literacy skills (e.g., written pamphlets, videos, picture boards, anatomic models)
Teaching mannequins for the child and family to have a visual hands-on experience
PROCEDUREObtaining Informed Consent
|
KidKare It may be useful to have a doll available for the child to use as a vehicle for pointing concerns out and asking questions.
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
