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@ht.msu.edu
http://www.msu.edu/~thomaso5
Informed Consent
Exercise:
Examining Informed Consent Document
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Reading the document before you:
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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?
Why Care about telling the truth,
informed consent, confidentiality?
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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.
Elements of Informed Consent
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Information
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Disclosure of information
Comprehension of information
Consent
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Voluntary consent
Competence to consent
Information to Disclose/Discuss
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Medical condition, prognosis, and nature
of the test or treatment
The proposed intervention
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Benefits, risks, and consequences
Alternatives
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Benefits, risks, and consequences
Legal Standards for Disclosure
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Professionals are held to a standard of care,
judged by either:
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Professional Standard: a reasonable & prudent
physician of ordinary skill (majority of states)
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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
Barriers to Patient
Comprehension
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Problems recalling information
Problems evaluating evidence,
probabilities
Failure to define jargon, technical
language
Reliance on Consent Forms alone
Voluntariness
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Respects patient autonomy
Avoids
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Fraud
Coercion
Manipulation
May still persuade patients
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May enhance autonomy by promoting understanding
May dissuade from decisions against their best
interests
Competence or Capacity?
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Competence
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Legal construct
Adjudicated by courts
Based on clinical assessment
Decision-Making Capacity
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Clinical construct
Assessed by physicians
Competent to do What?
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Global Competence?
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Overall ability to function in life
Medical diagnosis, general mental functioning,
appearance
Competence with regard to particular task
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Competence to give informed consent
Consider prognosis, nature of Tx, alternatives,
risks and benefits, probable consequences
Decision-Making Capacity
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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
Exceptions to Informed Consent
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Lack of Decision-making Capacity
Emergencies: implied consent
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Therapeutic Privilege
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EMTLA
When disclosure would severely harm patient
Waiver
Summary - Informed consent:
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Process?
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i.e., shared decision-making
or Product?
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i.e., signed consent form
Promoting a Shared DecisionMaking Process
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Encourage patient to play active role in decisionmaking
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Ensure that patients are informed
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Elicit patient’s perspective about the illness
Interpret alternatives in light of patient’s goals
Provide comprehensible information
Try to frame issues without bias
Check that patients have understood information
Protect the patient’s best interests
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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.
Truth-telling and
Nondisclosure of Errors
Why tell the truth?
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Reasons For
Disclosure
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Lying is wrong
Pts want to know
Pts need information
More good than harm
Deception requires
further deception
Deception may be
impossible
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Reasons Against
disclosure
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Prevent harm to Pts
Not culturally
appropriate
When Pts don’t want
to be told
Resolving Dilemmas about
Deception and Non-disclosure
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Anticipate problems with disclosure
Determine what the patient wants
Elicit the family’s 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.
Disclosure of Mistakes:
Mistake or Negligence?
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Medical Error = “preventable adverse
medical events”
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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 2001:164(4);509.
Defensive Medicine
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AMA (1985):
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“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; 19:569-589.
Ethics of Defensive Medicine
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A range of practices that subject the patient to:
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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 patient’s anxiety, or other
harms
Significantly increased physical, psychological, and
financial risks, or infringe on important personal
rights.
Deville, supra, at 577.
Avoiding Inappropriate Defensive
Practice
1.
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5.
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
claim’s defensibility.
Evaluate the cost to the patient and society of
potential defensive measures.
Deville, supra, at 582.
Approaches to Disclosing Error in
Practice . . .
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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; don’t 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.
. . . in Practice
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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 2001:164(4);509
Confidentiality
The Duty to Maintain
Confidentiality
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“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.”
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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
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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.”
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American Medical Association, Code of Ethics, Section 9.
Reasons for Maintaining
Confidentiality
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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.
Records, Confidentiality, &
Privilege
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Records & Record Keeping
Duty of Confidentiality
Consent for release of information
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Written
Valid
Specific
Time-limited
Right to revoke
Records, Confidentiality, &
Privilege II
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Patient access to medical records
Privileged Communication
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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)
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Consent v. Authorization
Confidentiality Exceptions
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Disclosure mandated by statute
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e.g., adult or child abuse
Disclosures necessary to prevent harm
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to self
to others
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duty to inform victims/other reasonable steps to
avert foreseeable harm if pt. threatens to harm or
kill (Tarasoff)
Situations in which Overriding
Confidentiality is Warranted
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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.
Summary
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You can respect patients & build trust by:
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Treating Shared Decision-making as a
process
Disclosing information appropriately and
thoughtfully
Has more beneficial than harmful consequences
 Avoiding defensive practice
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Maintaining confidences and protecting
privacy to the greatest extent possible