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TO: | All Indian Health Service Employees |
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FROM: | Director, Indian Health Service |
SUBJECT: | Indian Health Service Healthcare Providers Compliance with Indian Health Service Informed Consent Requirements |
The purpose of this Special General Memorandum (SGM) is to reiterate that patient safety is one of the highest priorities of the Indian Health Service (IHS), and to remind all IHS staff of the requirement to obtain informed consent before medical or surgical procedures or treatment are provided. This SGM supersedes any conflicting IHS policies. As a general rule, patients have a right to consent to having a medical or surgical procedure or the right to refuse such procedure or treatment. Failure to obtain consent before performing a medical or surgical procedure or treatment could result in the provider being accused of negligence, assault, battery, or malpractice.
Applicable IHS Policies
All IHS healthcare providers are required to obtain informed consent from patients before providing a medical or surgical procedure or treatment in accordance with applicable federal law and IHS policies. The IHS is not subject to state law but may choose to follow state-specific consent laws unless such laws conflict with Federal law or policy. The IHS is in no way bound by state laws.
Obtaining Informed Consent
With limited exceptions, before providing a medical or surgical procedure or treatments, IHS healthcare providers must give information to the patient about the treatment or procedure to be performed; the associated benefits, risks, and alternatives; information about the patient’s diagnosis when applicable; answer any questions; and ask for consent, i.e., permission to provide treatment or perform any procedures. Patients usually indicate consent by signing the IHS standard form IHS-515, “The Authorization for Administration of Anesthesia and For Performance of Operations or Other Procedures.” The law holds that the person designated, in writing, to make health decisions on behalf of the patient, whether the next of kin or legal guardian – whichever is applicable, can authorize necessary and reasonable care when the patient is incapable of giving consent because of age, incompetency, or incapacity.
Exceptions to Obtaining Informed Consent
When the need for care is urgent, the patient cannot give consent, and it is not feasible to contact the patient’s next of kin, the law allows the physician to proceed with lifesaving diagnostic and therapeutic procedures without informed consent.
Special Circumstances Related to Minors
Except in very limited circumstances, IHS medical providers must obtain the informed consent of a minor patient’s parent or legal guardian before providing medical or surgical procedures or treatment to a minor. The law holds that the closest available relative or legal guardian can authorize necessary and reasonable care when the patient is incapable of giving consent because of age, incompetency, or incapacity. A healthcare provider, acting on the reasonable belief that a person is the patient’s next of kin, is legally protected if the authorizing person turns out not to be a close relative. There are circumstances under which a minor patient may give their consent. For example, minors may sometimes consent to treatment for sexual assault, sexually transmitted diseases, substance use disorders, birth control, and obstetric care. Emancipated minors may provide informed consent for all medical or surgical procedures or treatments. Utilizing the appropriate chain of command, IHS medical providers should consult with their respective Area Chief Medical Officer (CMO) when questions arise as to specific circumstances.
Special Circumstances Related to Law Enforcement
There may be circumstances where local law enforcement officials ask IHS staff to perform a medical or surgical procedure or treatment on an IHS patient. This issue may arise when local law is seeking to gather evidence from a patient. Law enforcement officers cannot mandate that IHS medical providers perform a medical or surgical procedure or treatment that would violate the law or patients’ rights to provide or withhold their consent. Even when law enforcement officers request that a medical or surgical procedure or treatment be performed on a patient or individual, the IHS must obtain the patient’s informed consent; in the case of a minor, the parent or legal guardian’s consent. If a patient does not consent, the IHS medical provider is not authorized to perform any medical or surgical procedure or treatment on that patient unless the law enforcement officer presents a valid court order or search warrant signed by a Federal judge requiring the medical or surgical procedure or treatment. Should an IHS provider find themselves in a situation where a law enforcement officer is requesting or directing that IHS perform a medical or surgical procedure or treatment on a patient without IHS obtaining the patient’s consent, the IHS provider must immediately notify the Service Unit Chief Executive Officer (CEO). The CEO will then contact the Area Director or CMO for guidance.
Resources to be Used to Address Questions or Concerns
When questions arise regarding informed consent, all IHS staff must confer with the respective Area CMO, Service Unit risk manager, and clinical leadership, including the Office of the General Counsel, as needed regarding applicable laws and other legal matters related to informed consent.
Effective Date
This SGM becomes effective on the date signed.
/Roselyn Tso/
Roselyn Tso
Director
Indian Health Service