Information Matters: Informed Consent, Truthtelling, and Confidentiality

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Information Matters Informed Consent,
Truth-telling, and Confidentiality

• Clayton L. Thomason, J.D., M.Div.
• Asst. Professor
• Dept. of Family Practice and
• Center for Ethics Humanities in the Life
  Sciences
• Adjunct Professor, MSU-DCL College of Law
• Michigan State University
• clayton.thomason_at_ht.msu.edu
• http//www.msu.edu/thomaso5

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Informed Consent
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ExerciseExamining Informed Consent Document

• Reading the document before you
• Would you consent to this treatment, based on the
  information documented here?
• What else would you want to know?
• What conversation might need to take place before
  and after this documentation?

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Why Care about telling the truth, informed
consent, confidentiality?

• Promote patient autonomy
• Protect patients (and subjects)
• Avoid fraud duress
• Encourage self-scrutiny by medical professionals
• Promote rational decisions
• Reduce risks to patients physicians

cf., Capron A. Informed consent in catastrophic
disease and treatment. U Penn Law Review 123
(Dec. 1974)364-76.
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Elements of Informed Consent

• Information
• Disclosure of information
• Comprehension of information
• Consent
• Voluntary consent
• Competence to consent

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Information to Disclose/Discuss

• Medical condition, prognosis, and nature of the
  test or treatment
• The proposed intervention
• Benefits, risks, and consequences
• Alternatives
• Benefits, risks, and consequences

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Legal Standards for Disclosure

• Professionals are held to a standard of care,
  judged by either
• Professional Standard a reasonable prudent
  physician of ordinary skill (majority of states)
• MI minimum acceptable standard of care
• Reasonable Patient Standard what a reasonable
  patient in similar situation would expect
• Individual Patient Standard what this patient
  expects
• Usually determined by court (case law) relying on
  expert testimony

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Barriers to Patient Comprehension

• Problems recalling information
• Problems evaluating evidence, probabilities
• Failure to define jargon, technical language
• Reliance on Consent Forms alone

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Voluntariness

• Respects patient autonomy
• Avoids
• Fraud
• Coercion
• Manipulation
• May still persuade patients
• May enhance autonomy by promoting understanding
• May dissuade from decisions against their best
  interests

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Competence or Capacity?

• Competence
• Legal construct
• Adjudicated by courts
• Based on clinical assessment
• Decision-Making Capacity
• Clinical construct
• Assessed by physicians

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Competent to do What?

• Global Competence?
• Overall ability to function in life
• Medical diagnosis, general mental functioning,
  appearance
• Competence with regard to particular task
• Competence to give informed consent
• Consider prognosis, nature of Tx, alternatives,
  risks and benefits, probable consequences

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Decision-Making Capacity

• Capacity to make specific decisions about Medical
  Care
• Standard Patient should have the ability to give
  informed consent (or refusal) to the proposed
  test or treatment
• Balance Protecting patient from harm with Respect
  for Autonomy
• Sliding scale depending on risk of harm

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Exceptions to Informed Consent

• Lack of Decision-making Capacity
• Emergencies implied consent
• EMTLA
• Therapeutic Privilege
• When disclosure would severely harm patient
• Waiver

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Summary - Informed consent

• Process?
• i.e., shared decision-making
• or Product?
• i.e., signed consent form

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Promoting a Shared Decision-Making Process

• Encourage patient to play active role in
  decision-making
• Elicit patients perspective about the illness
• Interpret alternatives in light of patients
  goals
• Ensure that patients are informed
• Provide comprehensible information
• Try to frame issues without bias
• Check that patients have understood information
• Protect the patients best interests
• Make a recommendation
• Try to persuade patients (avoiding coercion)

Lo B. Resolving Ethical Dilemmas A Guide for
Clinicians, 2d ed. 2000. Baltimore Lippincott
Williams Wilkins. 26.
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Truth-telling and Nondisclosure of Errors
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Why tell the truth?

• Reasons For Disclosure
• Lying is wrong
• Pts want to know
• Pts need information
• More good than harm
• Deception requires further deception
• Deception may be impossible

• Reasons Against disclosure
• Prevent harm to Pts
• Not culturally appropriate
• When Pts dont want to be told

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Resolving Dilemmas about Deception and
Non-disclosure

• Anticipate problems with disclosure
• Determine what the patient wants
• Elicit the familys concerns
• Focus on how (not whether) to tell the diagnosis
• If withholding information, plan for future
  contingencies

Lo B. Resolving Ethical Dilemmas A Guide for
Clinicians, supra at 55.
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Disclosure of MistakesMistake or Negligence?

• Medical Error preventable adverse medical
  events
• Errors of omission or commission
• Honest Mistakes
• Negligent Actions preventable, harmful actions
  that fall below the standard of care

Hebert PC, Levin AV, Robertson G. Bioethics for
clinicians 23. Disclosure of medical error. CMAJ
2001164(4)509.
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Defensive Medicine

• AMA (1985)
• performance of diagnostic tests and treatments
  which, but for the threat of a malpractice action
  would not have been done.
• A clinical decision or action motivated in whole
  or in part by the desire to protect oneself from
  a malpractice suit or to serve as a reliable
  defense is such as suit occurs.

Deville K. Act first and look up the law
afterward? Medical malpractice and the ethics of
defensive medicine. Th Med Bioethics 1998
19569-589.
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Ethics of Defensive Medicine

• A range of practices that subject the patient to
• No additional physical or emotional risk
  financial costs minimal or offset by benefits of
  the practice
• Virtually no risk or pain, but impose additional
  financial costs, increase patients anxiety, or
  other harms
• Significantly increased physical, psychological,
  and financial risks, or infringe on important
  personal rights.

Deville, supra, at 577.
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Avoiding Inappropriate Defensive Practice

• Make a clinically sound treatment decision.
• Accurately identify the legal risk in the case.
• Evaluate the risk by estimating potential costs
  of the claim in time, anxiety, money.
• Discount that risk calculation by the
  unlikelihood of its occurrence and the potential
  claims defensibility.
• Evaluate the cost to the patient and society of
  potential defensive measures.

Deville, supra, at 582.
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Approaches to Disclosing Error in Practice . . .

• Report/Resolve conflicts as close to the
  bedside as possible.
• Keep accurate, contemporaneous records of all
  clinical activities.
• Notify insurer and seek assistance from others
  who can help (e.g., risk manager).
• Take the lead in disclosure dont wait for
  patient to ask.
• Outline a plan of care to rectify the harm and
  prevent recurrence.
• Offer to get prompt second opinions where
  appropriate.

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. . . in Practice

• Offer the option of family meetings, get
  professional help to conduct them.
• Offer the option of follow-up meetings.
• Document important discussions.
• Be prepared for strong emotions.
• Accept responsibility for outcomes, but avoid
  attribution of blame.
• Apologies and expressions of sorrow are
  appropriate.

Cf., Hebert, et al., supra, CMAJ 2001164(4)509
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Confidentiality
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The Duty to Maintain Confidentiality

• What I may see or hear in the course of the
  treatment . . . which on no account one must
  spread abroad, I will keep to myself, holding
  such things shameful to be spoken about.
• Hippocratic Oath
• A physician may not reveal the confidences
  entrusted to him in the course of medical
  attendance,or the deficiencies he may observe in
  the character of his patients, unless
• he is required to do so by law
• or unless it becomes necessary in order to
  protect the welfare of the individual or the
  community.
• American Medical Association, Code of Ethics,
  Section 9.

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Reasons for Maintaining Confidentiality

• Respects patient privacy
• Encourages patients to seek medical care
• Fosters trust in the doctor-patient relationship
• Prevents discrimination based on illness
• Expected by patients

Lo B. Resolving Ethical Dilemmas A Guide for
Clinicians, 1995. Baltimore Williams Wilkins.
45.
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Records, Confidentiality, Privilege

• Records Record Keeping
• Duty of Confidentiality
• Consent for release of information
• Written
• Valid
• Specific
• Time-limited
• Right to revoke

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Records, Confidentiality, Privilege II

• Patient access to medical records
• Privileged Communication
• Only in legal proceedings
• Dr./Pt. communications in course of treatment
• Privilege belongs to Patient
• If not asserted by pt. waived
• Health Insurance Portability and Accountability
  Act (HIPAA)
• Consent v. Authorization

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Confidentiality Exceptions

• Disclosure mandated by statute
• e.g., adult or child abuse
• Disclosures necessary to prevent harm
• to self
• to others
• duty to inform victims/other reasonable steps to
  avert foreseeable harm if pt. threatens to harm
  or kill (Tarasoff)

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Situations in which Overriding Confidentiality is
Warranted

• The potential harm to 3rd parties is serious
• The likelihood of harm is high
• No less-invasive alternative means exist to warn
  or protect those at risk
• Third party can take steps to prevent harm
• Harms resulting from the breach of
  confidentiality are minimized and acceptable

Lo B. Resolving Ethical Dilemmas A Guide for
Clinicians, 1995. Baltimore Williams Wilkins.
48.
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Summary

• You can respect patients build trust by
• Treating Shared Decision-making as a process
• Disclosing information appropriately and
  thoughtfully
• Has more beneficial than harmful consequences
• Avoiding defensive practice
• Maintaining confidences and protecting privacy to
  the greatest extent possible