|FROM:||Principal Deputy Director, Indian Health Service|
|SUBJECT:||IHS Health Care Providers Compliance with IHS 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. 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 prior to 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 health care providers are required to obtain informed consent from patients before providing a medical or surgical procedure or treatment in accordance with applicable law; the following IHS policies: Indian Health Manual Part 3, Chapter 3, Section 13, Consents to Medical and Surgical Procedures and Chapter 26, Patient Self-Determination and Advance Directives; and a local facility’s applicable policies and procedures.
Obtaining informed consent
With limited exceptions, prior to providing a medical or surgical procedure or treatments, IHS health care providers must give the patient information about the treatment or procedure to be performed, associated benefits, risks and alternatives, and information about their diagnosis when applicable, answer any questions, and ask for consent, i.e., permission to provide treatment or perform any procedures. Patients usually indicate their consent by signing 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, 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 is unable to give consent, and it is not feasible to contact the patient’s next of kin, then the law does allow 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 guardian before providing medical or surgical procedure or treatment to the 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 health care 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. The circumstances under which a minor patient may give their own consent is usually dictated by the law of the state where the minor will receive treatment.1 In many states, minors may give 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 and surgical procedure or treatment. However, the provision of informed consent by emancipated minors is state specific. Utilizing appropriate chain of command, IHS medical providers should consult with their respective Area Chief Medical Officer (CMO) when questions arise as to state-specific laws.
Special circumstances related to law enforcement
There may be circumstances where local law enforcement officials ask IHS staff to perform a medical procedure or treatment on an IHS patient. This issue may arise when local law enforcement 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 patient rights to provide or withhold their consent. Even when law enforcement officers request that a medical procedure 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 guardian. 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 procedure or treatment. Should an IHS provider find himself or herself in a situation where a law enforcement officer is requesting or directing that IHS perform a medical 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
IHS staff must confer with the respective Area CMO, Service Unit risk manager, clinical leadership, when questions arise regarding informed consent, including the Office of the General Counsel as needed regarding applicable state laws and other legal matters related to informed consent.
This SGM becomes effective on the date signed.
/Michael D. Weahkee/
RADM Michael D. Weahkee, MBA, MHSA
Assistant Surgeon General, U.S. Public Health Service
Principal Deputy Director
Indian Health Service
1 This is one of the limited times when IHS complies with the laws of the state where the patient is located. If a lawsuit is filed against the United States, which becomes the defendant in a medical negligence suit involving an IHS medical provider, the law of the state where the tort occurs will apply. Also, if it were alleged that an IHS provider committed a crime of medical assault or battery, the law of the state where the alleged crime occurred would apply as well.