Explain the concept of informed consent.

Chapter 13

Patient Consent

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

LEARNING OBJECTIVES – I

  • Explain the concept of informed consent.
  • Discuss the difference between verbal, written, and implied consent.
  • Describe the role of the patient, physician, nurse, and hospital in informed consent.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

LEARNING OBJECTIVES – II

  • Explain how consent differs between competent patients, minors, guardians, and incompetent patients.
  • Discuss under what circumstances a patient might refuse treatment.
  • Explain the available defenses for defendants as it relates to informed consent.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Consent

  • Voluntary agreement by a person who possesses sufficient mental capacity to make an intelligent choice to allow something proposed by another to be performed on himself or herself.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Forms of Consent

  • Express consent
  • Verbal
  • Written
  • Implied consent
  • Act or silence raising presumption consent has been authorized
  • e.g., treatment of accident victim

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Informed Consent

  • Legal doctrine where a patient has right to know potential risks, benefits, & alternatives of a proposed procedure.
  • Patient has absolute right to know about & select from available treatment options.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Physicians
Informed Consent

  • Informed consent is predicated on the duty of the physician to disclose sufficient info to enable the patient to evaluate proposed medical or surgical procedures before submitting to them.
  • Physicians expected disclose risks, benefits, & alternatives of recommended procedures.
  • Disclosure: what a reasonable person would consider material to a decision of whether to or not to undergo treatment.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Nurses
Informed Consent

  • Nurses most cases have no duty to
  • advise a patient as to a surgical procedure to be employed
  • may confirm physician has explained the procedure
  • witness patient’s signature on consent form

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Hospitals
Informed Consent

  • Not generally responsible for informing patients as to the risks, benefits and alternatives.
  • Some cases in which hospitals have a duty
  • CT Scans
  • MRI Imaging

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Patients
Informed Consent

  • Patient’s ability to:
  • understand risks, benefits, & alternatives
  • evaluate info provided by the physician
  • express his or her treatment preferences
  • voluntarily make decisions regarding his or her treatment plan

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Course of Treatment
Patient’s Decision – I

Elderly woman living alone fell & fractured her hip. An orthopedic surgeon reviewed the patient’s condition & decided that rather than utilizing a pinning procedure for her hip, it would be better to adopt a conservative course of treatment, bed rest.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Course of Treatment
Patient’s Decision – II

  • Prior to her injury, plaintiff maintained an independent style of living.
  • Expert testimony at trial indicated that bed rest was an inappropriate treatment.
  • Was the patient successful for not being informed as to alternatives courses of treatment?

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Yes!
Court’s Decision

  • Court held that it is necessary to advise a patient when considering alternative courses of treatment. The physician should have explained medically reasonable invasive & noninvasive alternatives, including risks & likely outcomes of those alternatives, even when the chosen course is noninvasive.

−Matthies v. Mastromonaco

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Lack of Consent – I

Patient had multiple medical diagnoses. Her physician, Dr. Sottiurai, ordered bilateral arteriograms to determine cause of the patient’s impaired circulation. De La Ronde Hospital could not accommodate Sottiurai’s request & patient was transferred to Dr. Lang, a radiologist at St. Jude Hospital.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Lack of Consent – II

Lang performed a femoral arteriogram, not the bilateral brachial arteriogram ordered by Sottiurai. The patient was prepared for transfer back to De La Ronde Hospital. Shortly after the ambulance departed, patient suffered a seizure in the ambulance & was returned to St. Jude. Riser’s condition deteriorated & died 11 days later.

  • What did the trial court determine?

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Trial Court Decision

  • The district court ruled for the plaintiffs, awarding damages in the amount of $50,000 for Riser’s pain and suffering and $100,000 to each child. Lang appealed.
  • On appeal, what did the appeals court determine?

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Appeals Court’s Decision

  • The Court of Appeal held that Lang breached the standard of care by subjecting the patient to a procedure that would have no practical benefit to the patient, that Lang failed to obtain informed consent from the patient.

−Riser v. American Medican Intern, Inc.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Information to be Disclosed – I

  • Physician should provide as much information about treatment options as necessary based on a patient’s personal understanding of physician’s explanation of risks of treatment & probable consequences of treatment.
  • Needs of each patient can vary depending on age, maturity, & mental status.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Information to be Disclosed – II

  • Individual responsible for obtaining consent must weigh importance of giving full disclosure to the patient against likelihood such disclosure will adversely affect the patient’s decision.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Information to be Disclosed – III

  • Courts generally utilize an “objective” or “subjective” test
  • to determine if a patient would have refused treatment if the physician had provided adequate information
  • as to the risks, benefits, & alternatives of the procedure.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Objective Test

  • Take into account characteristics of the plaintiff
  • idiosyncrasies, fears, age, medical condition, and religious belief
  • Must show that a “reasonable person” would not have undergone a procedure if properly informed.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Subjective test

  • Relies on credibility of the patient’s testimony
  • Patients must testify & prove they would not have consented to the procedure(s) had they been advised of the risks.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Adequacy of Consent

  • Patient understand risks, benefits, & alternatives
  • Evaluate the information provided
  • Express treatment preferences
  • voluntarily make decisions regarding treatment plan

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Written Consent Describes – I

  • Nature of the patient’s illness
  • Procedure consented to
  • Risks & probable consequences of the procedure
  • Probability that the proposed procedure will be successful

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Written Consent Describes – II

  • Alternative methods of treatment
  • Associated risks & benefits of each
  • Indication the patient understands nature of proposed treatment
  • Signatures dated & signed
  • patient
  • physician
  • witnesses

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Special Forms of Consent

  • Consent for Routine Procedures
  • Consent for Specific Procedures
  • Implied Consent
  • Statutory Consent
  • Judicial Consent

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Statutory Consent

  • Consent generally assumed
  • Ambulance Care
  • Good Samaritan Statutes
  • Emergency Departments
  • When patient clinically unable to give consent

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Judicial Consent

  • May be periodically necessary
  • When alternatives exhausted
  • 2nd opinions by consulting physicians helpful
  • On-call legal advice should be sought

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Who May Consent

  • Competent patients
  • Guardianship
  • Consent for minors
  • Incompetent patients
  • Limited Power of Attorney

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Right to Refuse Treatment

  • For any or no reason
  • Mere whim
  • Religious Beliefs
  • Blood or blood products
  • Impatience
  • Text Case: Good People Bad Decisions

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Release Form

  • Completed release provides documented evidence of a patient’s refusal to consent to a recommended treatment.
  • Patient’s refusal to consent to treatment, for any reason, religious or otherwise, should be noted in the medical record.
  • A release form should be executed.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Informed Consent Defenses

  • Risk not disclosed is commonly known.
  • Patient assured practitioner he would undergo treatment regardless of the risk.
  • Consent not reasonably possible.
  • Patent did not want to know about the risks.
  • Physician disclosed what he considerable reasonable

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

Ethics
Informed Consent

  • Individual Autonomy
  • Informed consent protects the basic right of the patient to make the ultimate informed decision regarding the course of treatment to which he or she knowledgeably consents.

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

REVIEW QUESTIONS – I

1. Who should be responsible for reviewing with the patient the risks, benefits, and alternatives of a proposed diagnostic test or treatment?

2. Describe what information a patient should be provided prior to undergoing a risky procedure in order for consent to be informed.

3. Why is it important to obtain consent from a patient prior to proceeding with a risky procedure?

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

REVIEW QUESTIONS – II

4. Can a patient consent to a procedure and then withdraw it?

5. Can a parent refuse to consent to a lifesaving procedure for his or her child? Discuss your answer.

6. Discuss how much information is sufficient in order for informed consent to be effective (e.g., consider your answer here from both the objective and subjective forms of consent).

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

REVIEW QUESTIONS – III

7. Discuss the implications of the following statement: “Patients are generally persons unlearned in the medical sciences and, therefore, except in rare instances, the knowledge of patient and physician is not in parity.”

© 2014 Jones and Bartlett Publishers

© 2014 Jones and Bartlett Publishers

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