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 Universityclayton.thomason@ht.msu.edu

http://www.msu.edu/~thomaso5

Informed Consent

Exercise:Examining 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?

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.

Elements of Informed Consent

Information Disclosure of information Comprehension of information

Consent Voluntary consent Competence to consent

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

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

Barriers to Patient Comprehension

Problems recalling information Problems evaluating evidence,

probabilities Failure to define jargon, technical

language Reliance on Consent Forms alone

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

Competence or Capacity?

Competence Legal construct Adjudicated by courts Based on clinical assessment

Decision-Making Capacity Clinical construct Assessed by physicians

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

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

Exceptions to Informed Consent

Lack of Decision-making Capacity Emergencies: implied consent

EMTLA Therapeutic Privilege

When disclosure would severely harm patient Waiver

Summary - Informed consent:

Process? i.e., shared decision-making

or Product? i.e., signed consent form

Promoting a Shared Decision-Making Process

Encourage patient to play active role in decision-making Elicit patient’s perspective about the illness Interpret alternatives in light of patient’s goals

Ensure that patients are informed Provide comprehensible information Try to frame issues without bias Check that patients have understood information

Protect the patient’s 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.

Truth-telling and Nondisclosure of Errors

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 don’t want

to be told

Resolving Dilemmas about Deception and Non-disclosure

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?

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 2001:164(4);509.

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; 19:569-589.

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 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. Make a clinically sound treatment decision.2. Accurately identify the legal risk in the case.3. Evaluate the risk by estimating potential costs

of the claim in time, anxiety, money.4. Discount that risk calculation by the

unlikelihood of its occurrence and the potential claim’s defensibility.

5. Evaluate the cost to the patient and society of potential defensive measures.

Deville, supra, at 582.

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; 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

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

“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.

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.

Records, Confidentiality, & Privilege

Records & Record Keeping Duty of Confidentiality Consent for release of information

Written Valid Specific Time-limited Right to revoke

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

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)

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.

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