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Informed Consent

Overview | Clinical Scenarios | Additional Tips | References
By Deja Williams, MSW, JD and Deborah Giorgi-Guarnieri, JD, MD

OVERVIEW

General Principles 

The concept of informed consent in medicine was introduced in the late 1950s. In the 1970’s, the practice of medicine incorporated informed consent into daily practice.  Today, the main aspects of informed consent include:

  • Information: The patient needs sufficient information in order to give consent. Sufficient information is what the reasonable person would need in order to make the present medical decision, 
  • Competency to Give Informed Consent: A competent patient has adequate mental ability to engage in the process of informed consent and      
  • Voluntariness: A voluntary patient gives consent free of coercion. Coercion may include deterrence, compellence, or brute force, as well as threats, behaviors, or influence.

Informed consent is a medical, legal, and ethical principle supported by medical data, legal standards,  and analytical arguments.

Informed consent arises from a fiduciary duty: a duty that emerges when one person in the contractual relationship has special knowledge and the other person relies on and benefits from that information. The physician owes the patient a fiduciary duty. A physician may fulfill the fiduciary duty (Link: See Key Points page 533) by providing sufficient information regarding treatment, treatment options, and the consequences of treatment refusal.

 Jurisdictional Considerations

  • All United States jurisdictions have adopted some form of the doctrine of informed consent, either by statute (Link: See Figure 1 page 106) or case law. Legal standards of care required to uphold the doctrine of informed consent vary from state to state. 
    • Some jurisdictions use the reasonable person standard or what the patient needs to know (Link: See page 1217). 
    • Other jurisdictions maintain the older standard of the reasonable physician (Link: See page 533). In the 1970s, courts required physicians to disclose information typically disclosed by similarly experienced clinicians.
    • Common law, or case law decisions based on state standards, usually have more detailed requirements.
  • Civil law/ negligence: Physicians can be sued for malpractice if they fail to obtain informed consent.  [See Medical Malpractice]
    • Treatment after inadequate consent is considered negligence or malpractice. 
      • The intentional tort called medical battery occurs when a patient has suffered an unauthorized touching or medical physical intervention without their consent. Absent the presence of a criminal intent to commit offensive or harmful touching, medical battery is a civil intentional tort.
  • Criminal law: Traditional battery in criminal law is the offensive or harmful touching of another person  (Link: See page 1215). 
    • Generally, criminal medical battery occurs when the Physician intends to harm and provides treatment without consent or treatment despite a patient’s objection. 
    • The patient must prove (Link: See page 1214) that the medical physical treatment was without consent. 
    • The elements of proof for a criminal medical battery claim are: 
      • criminal intent 
      • actual cause,
      • proximate cause, 
      • harmful or offensive contact, and 
      • by a medical professional. 
  • Medical battery conducted with criminal intent is considered a crime and an intentional tort.
  • Board actions: The State Medical Board must investigate a failure to obtain an informed consent claim by a patient. If the board determines that the doctor breached the duty, then the board may impose disciplinary actions.
  • The AMA provides guidance about the ethics of informed consent. 

Special Considerations 

  • The incapacitated patient: the incapacitated patient refers to one who cannot provide consent. Some individuals, however, may lack capacity in one area but not another. The clinician must determine the patient’s ability to comprehend and consent to the recommended treatment. Clinicians should be familiar with their state laws and regulations concerning substitute decision-makers. ((Link to Jackie’s DCM Chapter) Clinicians always have the option to seek judicial intervention.
  • The minor patient: Considering the state’s definition of a minor and the situation requiring consent, the person legally responsible for the minor or, when appropriate, the minor should give consent. The consenting process is the same, but the informed consent procedure should involve the parent/guardian and, whenever possible, the minor. (See: Peter’s chapter) 
  • Levels of patient understanding: The level of information should meet the patient or patient representative’s level of understanding (Link: See page 534). If the patient has a limited intellectual capacity, the physician should use language that matches the patient’s ability to comprehend. If the patient is a physician, more detail should be given in order to truly inform the patient.
  • Consent for clinical trials: A consent form specific to the clinical trial and the patient’s participation in the study should be presented, explained, and reviewed with the person. Informed consent is an ongoing process during a clinical trial.
  • Delegation of responsibility for obtaining consent: In hospital settings, obtaining a signature on the informed consent form is often delegated to clinical staff. The delegation of responsibility should be to a licensed professional. The consent process should be performed privately and include a question-and-answer exchange. The consent form should be signed after all questions have been answered by the delegated professional or the physician/psychiatrist. 
  • Emergency situations: Inpatient and outpatient emergencies may not allow for or require informed consent. Emergency situations exist when the person is an imminent danger to self or others, during an involuntary admission, or in a situation that lawfully allows forced medication. Usually, the courts or state laws specify the emergency situations/involuntary treatments and the lengths of time during which consent is not required.
  • Special situations: Additional situations that require informed consent include audio or video recordings, photographs, student presence or participation in treatment, and experimental treatments.

CLINICAL SCENARIOS

Scenario #1: A patient is involuntarily committed to an adult psychiatric unit. How should the clinician obtain informed consent?

  • Consent may not be required in an emergency situation that led to involuntary admission, but attempting to obtain consent may assist in forming a doctor-patient alliance.

Scenario #2: A non-violent, elderly woman with a diagnosis of Dementia, unspecified, is brought to the emergency room by her daughter, who is the patient’s guardian. Earlier that day, the elderly woman began experiencing auditory hallucinations. The evaluation indicates that the patient has a urinary tract infection. The doctor recommends IV haloperidol as a non-emergent treatment for the hallucinations. The daughter refuses IV haloperidol, stating her mother developed a bowel obstruction when she was given one dose of oral haloperidol in the recent past. The emergency room doctor says that IV haloperidol does not cause bowel obstructions. The daughter refuses IV haloperidol again and specifically requests risperidone. The emergency room doctor gives the IV haloperidol. The elderly woman developed a bowel obstruction on the third day of hospitalization for the UTI. Did the emergency room doctor fail to obtain informed consent?

  • The emergency room doctor needs to give correct information about the side effects of IV haloperidol. The doctor’s failure to do so constitutes a lack of informed consent and may lead to a malpractice action. The emergency room doctor also physically treated the elderly woman without the consent of the patient’s authorized representative. The doctor’s treatment is a medical battery in some states.

Scenario #3: Dr. P performs ECT on five patients every Monday, Wednesday, and Friday, except on holidays. One busy Wednesday, Dr. P performed his usual five treatments. Upon completing the fifth treatment, he learned that the hospital staff needed to have Patient 1 sign the consent form earlier that day, and, in addition, Patient 4 was the wrong Janice Smith. Patient 1 had signed consent forms for prior ECT treatments. Patient 4 had signed a consent form to undergo lithotripsy for kidney stones. Did Dr. P commit medical battery?

  • Medical battery exists when a physician executes an unauthorized procedure, even when actual injury does not occur. Dr. P performed unauthorized treatments on Patients 1 and 4, which would be considered medical battery. In the case of Patient 1, the patient had undergone ECT previously, was at the hospital for ECT, and then received ECT. Therefore, it would be difficult to characterize Dr. P’s actions as “harmful or offensive.” In the case of Patient 4, Dr. P likely committed medical battery because actual injury is not necessary in a medical battery case. Whether the medical battery is civil or criminal depends on the state.

ADDITIONAL TIPS 

  • Informed consent, involving a patient and a clinician, has four basic elements: 
    • The patient or patient representative should possess the capacity to make the decision,
    • The clinician discloses sufficient information with enough detail for the patient to make an informed decision, 
    • The patient or patient representative demonstrates understanding of the information or asks appropriate questions and
    • The decision maker clearly authorizes the treatment procedure and plan.
  • Sufficient information includes:
    • The diagnosis,
    • The prognosis, 
    • The planned treatment, 
    • Risks and benefits of the treatment, 
    • Alternative treatments with comparative benefits and risks and 
    • The risks and benefits of refusing treatment.
  • Factors (Link: See page 534-6) that may impact informed consent: 
    • Patient’s ability to comprehend, 
    • The patient’s decision-making process: patient autonomy or delegation of autonomy, 
    • Time demands on the clinician who is required to obtain informed consent and 
    • The physician’s style of communicating the standard informed consent.
  • Off-label treatments: Off-label treatments are common practice. For example, psychiatrists and general practitioners often use trazodone to initiate sleep, although trazodone does not have an FDA-approved indication for insomnia. Off-label treatments usually require more explanation to the patient about why they are being used and the risks and benefits of use. The psychiatrist should provide more information to the patient when the off-label use is uncommon, or little specific information is available to the general public. 

Documentation Tips

  • The consent form should be distinct from the process of obtaining informed consent. Both documentation of the consent process and the consent form should exist in the medical record. The documentation content, not the consent form, is usually the issue in subsequent litigation.
  • Two theories on how to document exist:
    • List all the information that was disclosed or 
    • State generally the risks and benefits, as well as the alternative treatments were discussed
    • Both approaches have shortcomings and may be supplemented with patient education materials. 
    • Check with your malpractice carrier to understand their preference for documentation.
  • The clinician should document the discussion of all black box/boxed warnings.
  • Off-label use of medications should be thoroughly discussed with the patient and documented. The clinician should explain and document the clinical reasons for the off-label use in the medical record, the rationale behind the off-label use, and the patient’s situation initiating the off-label use.

Additional Resources

  1. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972) 
  2. Cobbs v. Grant, 502 P.2d 1, 10 (Cal. 1972)
  3. Informed Consent [Internet]. YouTube. YouTube; 2019 [cited 2022Mar27]. Available from: https://www.youtube.com/watch?v=xTIdmv2VzNs 
  4. Legal and Ethical Aspects of Medicine [Internet]. YouTube. YouTube; 2016 [cited 2022Mar27]. Available from: https://www.youtube.com/watch?v=jKPqP3vImpc 

REFERENCES

  1. About Physician Discipline. Federation of State Medical Boards. 2018. Available from: https://www.fsmb.org/u.s.-medical-regulatory-trends-and-actions/guide-to-medical-regulation-in-the-united-states/about-physician-discipline/#:~:text=When%20a%20board%20receives%20a,,%20public%20reprimands,%20and%20fines.
  2. Battery basics [Internet]. Findlaw. 2018 [cited 2022Mar27]. Available from: https://www.findlaw.com/injury/torts-and-personal-injuries/battery-basics.html#:~:text=A%20battery%20is%20an%20intentional,intent%20need%20not%20be%20present 
  3. Bedigian B. Understanding the Difference Between Medical Malpractice & Medical battery. Gilman & Bedigian. Dec. 15, 2020. Available from: https://www.gilmanbedigian.com/understanding-the-difference-between-medical-malpractice-medical-battery/ 
  4. Biddle TD. Coercion Theory: A Basic Introduction for Practitioners. Texas National Security Review. 2020 3(2):94—109. Available from: http://dx.doi.org/10.26153/tsw/8864
  5. Chmieleski SR, Lamber KM. Informed consent for psychiatrists – american professional [Internet]. American Professional Agency. [cited 2022Mar27]. Available from: https://www.americanprofessional.com/wp-content/uploads/Informed_Consent.pdf
  6. Clinton KL. The Rise of Medical Battery and Informed Consent. Tennessee Bar Association. 2016. 
  7. Dailey L, Gray M, Johnson B, Muhammad S, Sinclair E, Stettin B. Grading the States: An Analysis of U.S. Psychiatric Treatment Laws. Treatment Advocacy Center. Available from: https://www.treatmentadvocacycenter.org/storage/documents/grading-the-states.pdf\
  8. Furey K & Wilkins K. Prescribing “Off-Label”: What Should a Physician Disclose? AMA J Ethics. 2016;18(6):587-593. doi: 10.1001/journalofethics.2016.18.6.ecas3-1606. 
  9. Gutmann Koch V. Eliminating liability for informed consent to medical treatment. SSRN Electronic Journal. 2018; 53:1213–28. https://lawreview.richmond.edu/files/2019/05/Koch-AC-534.pdf
  10. Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment: Figure 1: Canadian Medical Association Journal [Internet]. 2012;184(5):533–40. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307558/ 
  11. Halleck SL. Informed Consent. In: Law in the practice of psychiatry: A handbook for clinicians. New York: Plenum Medical Book Company; 1980. p. 83–109.
  12. In Your State. National Resource Center for Supported Decision-Making. Available from: https://supporteddecisionmaking.org/in-your-state/
  13. Informed consent [Internet]. American Medical Association. [cited 2022Mar27]. Available from: https://www.ama-assn.org/delivering-care/ethics/informed-consent 
  14. Kelly C. The Rise of Medical Battery and Informed Consent. TBA Law Blog. Aug. 1, 2016. Available from: https://www.tba.org/index.cfm?pg=LawBlog&blAction=showEntry&blogEntry=25458 
  15. Kurtz, Sheldon F. “The law of informed consent: From doctor is right to patient has rights.” Syracuse L. Rev. 50 (2000): 1243. https://scholar.google.com/scholar_lookup?title=The+Law+of+Informed+Consent%3A+From+“Doctor+Is+Right”+to+“Patient+Has+Rights”&author=Kurtz+Sheldon+F.&publication+year=2000&journal=SYRACUSE+L.+REV.&volume=50
  16. Mark S. O’Connor & C. Lincoln Combs, Informed Consent 27 – 29 (2015).  
  17. Medical Battery Definition. LegalMatch. Available from: https://www.legalmatch.com/law-library/article/medical-battery.html.
  18. Miller T. Informed consent: A Medical Board analysis. Journal of Medical Regulation. 2010;96(3):16
  19. Morson E. The Women Who Paved the Way for Informed Consent Laws in the U.S.. National Women’s Health Network. Mar. 28, 2023. Available from: https://nwhn.org/informed-consent-blog/
  20. Psychopharmacology: Part II. Rx for Risk. Professional Risk management Services. 2016. Available from: https://www.prms.com/media/1860/rx_for_risk_v24_issue2_digital.pdf
  21. Raab EL. The parameters of Informed Consent. Trans Am Ophthalmic Soc 2004. 102:225—32. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1280103/pdf/tao102pg225.pdf
  22. Rumfelt M. Medical battery definition [Internet]. LegalMatch Law Library. LegalMatch; 2020 [cited 2022Mar27]. Available from: https://www.legalmatch.com/law-library/article/medical-battery.html 
  23. Sabatino C. Capacity to Make Health Care Decision. Mark manual Consumer Version. Sept 2022. Available from: https://www.merckmanuals.com/home/fundamentals/legal-and-ethical-issues/capacity-to-make-health-care-decisions
  24. State Laws on Minor Consent for Routine Medical Care. SchoolHouse Connection. Jun. 5, 2023. Available from: https://schoolhouseconnection.org/state-laws-on-minor-consent-for-routine-medical-care/
  25. Studdert DM, Mello MM, Levy MK, Gruen RL, Dunn EJ, Orav EJ, Brennan TA. Geographic Variation in Informed Consent Law: Two Standards for Disclosure of Treatment Risks. Journal of Empirical Legal Studies 2007:4(1):103—24. Available from: https://law.stanford.edu/wp-content/uploads/sites/default/files/publication/441383/doc/slspublic/4JEmpiricalLegalStud103.pdf 
  26. https://my.clevelandclinic.org/health/treatments/24268-informed-consent
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