Consent and Assent Issues

The requirement to obtain informed consent from a patient or legal guardian before providing medical care is a central feature of health law and ethics. A person may not be touched, treated, or transported without his or her con­sent.

Table 18.1: IRB Criteria for Research Performed Without Informed Consent—FDA Final Rule (FDA Final Rule: 21 CFR Part 50.24. Adapted from the FDA Information Sheet)

• The subject is facing a life-threatening or permanently disabling situation for which the only known therapy is investigational, unproven, or unsatisfactory and the collection of valid scientific evidence is necessary to determine the safety and effectiveness of a particular intervention;

• The child is incapable or unable to provide valid consent and the parents cannot be reached for permission before the time the investigational treatment must be started;

• The experimental treatment has a realistic probability of benefit that equals or exceeds that of standard care;

• The risks of the experimental therapy are reasonable in comparison with the patient's condition and stan­dard therapy;

• There is minimal added risk from participation in the research protocol;

• There is no possibility of obtaining prospective consent from individuals likely to need the experimental therapy;

• The therapeutic window is defined and the principal investigator is committed to attempting to contact legally authorized representative within that narrow window of time;

• Participants and/or parents will be provided with all pertinent information about the study as soon as possible;

• Once the legal surrogate decision maker has been informed of the research, he or she may choose to discon­tinue participation at any time after being fully informed of the consequences of doing so;

• Federal regulations require that input from community representatives be sought about the protocol before IRB approval to gain a form of “community consent” to proceed with the research and that public disclosure of the research and its risks and benefits be made to the community from which potential participants will be enrolled before initiation of the research; and

• Alteration or waiver of consent will not adversely affect the rights and welfare of the subjects.

maker.” Minors (children younger than 18 years) present a special situation, because they do not have the legal authority to give consent, unless emanci­pated or designated as a mature minor.

The emergency exception rule also is known as the doctrine of implied consent. For minors, this doctrine means that transport team members can presume consent and proceed with appropriate treatment and transport if the following 4 conditions are met:

1. The child has an emergency condition that places his or her life or health in danger.

2. The child’s legal guardian is unavailable or unable to provide consent for treatment or transport.

3. Treatment or transport cannot be delayed safely until consent can be obtained.

4. The transport team administers only treatment for emergency conditions that pose an immediate threat to the child.

This emergency exception rule is based on the assumption that reason­able people would consent to emergency care if able to do so and that if the parents or legal guardian knew the severity of the emergency, they would consent to medical treatment of the child. Any time a minor is treated with­out consent, the burden of proof falls on any professional treating or trans­porting the child to justify that the emergency actions were necessary. The transport team must clearly document in the child's record the nature of the medical emergency and the reason the minor required immediate treatment and/or transport.

If possible, interfacility transport team members should contact online medical control for assistance when consent is unclear or unavailable. If the guardian is unavailable and cannot be notified, information about the des­tination emergency department should be provided to the most responsible person on scene with instructions to pass the information on to the minor's legal guardians. As a general rule, when the transport professional's authority to act is in doubt, team members should always do what they believe to be in the best interest of the patient.