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Conversations in Ethics:

Ethical Challenges with Informed Consent September 27, 2019

12:00 p.m. — 1:00 p.m. HH Auditorium

Video conferenced to: BHM 5 MCVI Side A, MH Exec Conf. Rm., SMH CL E, and Live Webcast

Speaker:

Christina Edozie, MSN, RN, CCRN Bioethics & Patient Rights Coordinator

Shamma Legrand, MSN Clinical Risk Manager

Conference Director: Ana Viamonte-Ros, M.D. MPH

Medical Director, Palliative Care & Bioethics Baptist Health South Florida

9/25/2019

The Ethical Challenges with Informed Consent

Christina Edozie MSN, RN, CCRN Bioethics & Patient Rights Coordinator HH & WKBH

Shamma Legrand, MSN, RN, CNL, SCRN, CCRN-CSC Clinical Risk Manager & Patient Safety Officer

Disclaimer

The case presentations are based on actual cases. However, to remain in compliance with HIPAA Privacy Rules, the content has been modified.

Baptist Health South Florida

Objectives

• Definition of Informed Consent (IC) • Process • Ethical & Legal challenges • Case scenarios • Outcomes • Summary

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Case #1

CM is a 40 year old woman who seeks advice from a surgeon about a lump in her left breast. The surgeon presents her with her biopsy results and diagnosis of cancer. He explains all the different treatment options including chemotherapy and a mastectomy. He provides her with material on this and recommends she have a mastectomy. He answers all her questions and schedules her to come back in a week after she discusses options with her family. A week later, she returns with her husband and informs the surgeon she has decided on the mastectomy. The surgeon then discusses what he will be doing during surgery. She is referred to the breast clinic for further education. At the clinic, the nurse gives her additional information about what the scar will look like and what to expect after surgery. The morning of the surgery, she is examined and interviewed by the anesthesiologist and is asked to sign the consent for the surgery.

Baptist Health South Florida

Case #2

TL is a 62 year old man transported to a large hospital for evaluation and treatment of a possible cerebral aneurysm. The neurosurgeon informs the patient that he will need a cerebral arteriogram. The radiologist who will be performing the procedure discusses the procedure, the risks, and the benefits in moderate detail. He asks the patient if he has any questions. The patient, who has just heard a lot of information, is overwhelmed and does not ask any questions. Shortly before the procedure, a resident asks the patient to read and sign the standard consent form.

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What is Informed Consent

IC-Consent voluntarily given by a person after a sufficient explanation and disclosure of the subject matter involved, to enable that person to have a general understanding of the treatment or procedure and the medically acceptable alternatives, including the substantial risks and hazards inherent in the proposed treatment and making a knowing health care decision without coercion or undue influence.

Pon. SlatUlps FI.A. STAT. 5751101.

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Elements of Informed Consent

• Threshold Elements I. Capacity II. Voluntariness

• Information Elements I. Disclosure II. Recommendation III. Understanding

• Consent Elements I. Decision II. Authorization

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Why obtain Informed Consent

• Promotes communication between the patient and the healthcare provider(s).

• Patient is informed by his/her physician, ARNP, or PA of the risks, benefits, and alternatives to the operation, invasive, or other procedures.

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What is the process

• Patient must have capacity

• Patient must be informed by the physician, ARNP, PA as appropriate

• Nursing staff or other qualified medical personnel to present the informed consent form to the patient or legal representative for signature

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Vulnerable Populations

• Patients with Disabilities:

— Assistance will be provided as needed for patients with physical, visual, and/or learning disabilities (e.g. sign language services)

— Illiterate Patients may give verbal permission, witnessed by two persons. The entire form must be read to the patient. Those signing with an "X" should have the mark witnessed.

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Who Can Give Consent

• Capacitated Patients • Incapacitated/Incompetent Patients

— Health Care Surrogate — Proxy — Legal Hierarchy FL. Statute 765

Baptist Health South Florida

Case Scenario #3

• Patient is AA0x4 • Hx of hydrocephalus & spina bifida • Patient is on disability • Family like to sign all his paperwork • Family want to sign his consent forms • Pre-op nurse replies, "that's fine but in

order to do that, first fill out the healthcare surrogate form"

Baptist Health South Florida

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Ethical Principles Cases & Outcomes

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Autonomy: Self Determination

RT was a patient with a uterine growth. She gave consent for an examination under anesthesia, but specifically refused to authorize any additional surgery. When the physician found a tumor, he removed it without the patient's consent. Infection followed after surgery, gangrene set in, and the patient eventually suffered serious long-term morbidity. RT sued.

Baptist Health South Florida

Paternalism: For Patient's "good"

Arato V. Avedon The Supreme Court of California ruled that physicians were not obligated to disclose statistical life-expectancy information to patients with pancreatic cancer. In recommending a course of chemotherapy and radiation treatment, none of the treating physicians specifically disclosed the high mortality rate for this type of cancer. The patient ultimately died. The physicians justified the nondisclosure on the grounds that it was medically inappropriate given the patient's anxiety, the risk of depriving any hope of cure, and the problem of predictive data when applied to a specific patient. The patient had been informed that the type of cancer he had was usually fatal.

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Exceptions to the Requirements for Informed Consent

- Emergency • Incapacity

• Patient Waiver - National/ State Waivers

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Veracity: Truth Telling

A patient had frequently asserted that he would immediately die by suicide if he were ever diagnosed with Alzheimer's disease. He had said this multiple times and his physician believed he was serious. The patient said that living with Alzheimer's disease was antithetical to everything he valued in life. The patient was ultimately diagnosed with Alzheimer's disease but the physician lied to the patient about his diagnosis. She lied because she believed that a premature death was incompatible with the patient's best interest

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Legal Challenges Case Scenario

- Legal Scenario

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Requirement for completed consents (Do's)

• Name of provider performing the procedure

• Write legibly (include site/side) and no abbreviations

• No blanks or unused space • Signature of patient/ Surrogate/ Proxy • Witness signature • Date & Time • Patient identification label

Baptist Health South Florida

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Questions

• Patient is scheduled for a tracheostomy today. Consent was obtained two months ago. Is that consent still valid?

• Patient wants surgery cancelled. What should be done with the form?

• Patient with Down's Syndrome is pregnant. Her parents provide you with guardianship court paper. Can they sign the consent for termination of pregnancy?

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Summary

• The hospital personnel act only as a witness to the patient's signature and checks for completion and accuracy of the consent form.

• If specific questions are raised regarding the nature of the procedure, alternatives to it, potential risks or complications, etc., the form should not be signed, notify the provider, and document.

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Steps to improving informed consent process at HH

• Admitting and Registration circles back to complete Consent to Treat forms that were documented as "unable to sign" in ED.

• Admitting and Registration refers these cases to Case Management.

• If patient lacks capacity, Physician documents in medical record

• Legal decision maker is identified

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Resources

• Risk Management/Patient Safety • Bioethics • Consent to Treatment and Informed

Consent — Administrative Policy HH-20400-74200-1201

• Leadership

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Questions and Discussion

References

Beauchamp, T.L., & Childress, J.F.(2013). Principles of Biomedical Ethics (7th ed.). New York, NY. Oxford University Press

Degrazia, D., Mappes, TA., & Ballard, J.B. (2015). Biomedical Ethics (7th ed.). New York, NY. McGraw Hill Fletcher,J., Lombardo, P., & Spencer, E.(2005). Fletcher's Introduction to Clinical Ethics (3rd ed.). Hagerstown, MD: University Publishing Group

Florida Statutes. FLA. STAT. § 765.101. Menikoff, J. (2011). Law and Bioethics (2nd ed.). Washington, D.C. Georgetown University Press

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