JMU HTH 423 Burnett Exam 2 Study Guide

What are the main principles that pertain to truth-telling/confidentiality?

Paternalism, Autonomy, and Beneficence

How does Paternalism pertain to truth-telling/confidentiality?

There is nothing in the Hippocratic Oath that binds a physician to telling the truth

How does Autonomy pertain to truth-telling/confidentiality?

With informed consent and the value of patient autonomy on the rise, strong paternalism is less common

How does Beneficence pertain to truth-telling/confidentiality?

There is an idea that telling a patient the truth could cause more harm than good, especially in the case of more grim diagnoses

What are some criticisms of full disclosure?

- Telling the truth could cause more harm than good

- Patients don't want to know the truth

- Some argue that patients are incapable of fully understanding the diagnosis

What is the historical context of confidentiality?

Traces backt o ancient Greece and was expressed in a long line of medical codes, which were then implemented into the Hippocratic Oath

What is the consequentialist view of confidentiality?

Unless patients have a relationship with their physician, they will be hesitant to tell them the full truth. Without a patient's full disclosure, the physician cannot achieve proper beneficence and the trust is eroded.

What is the non-consequentialist view of confidentiality?

Patients have the right to self-determination -- they have the right to determine what happens to their body, property, and private life. Therefore, they have a right to limit access to their personal information

What is the concept of 'duty to warn'?

Confidentiality can be overridden in cases when a patient poses a serious threat to themselves or others

What are examples of 'duty to warn'?

- A patient vocalizes their intent to harm their significant other

- An HIV-positive individual refuses to disclose their status to their partners

How does Kantian ethics apply to truth-telling and confidentiality?

Truth-telling and confidentiality are required with no exceptions. This includes the 'duty to warn' -- under Kantian ethics, a physician is strictly forbidden from reporting any potential threats

How does Act-utilitarianism apply to truth-telling/confidentiality?

Judged on a case-by-case basis; whatever provides the most benefit for the patient

How does rule utilitarianism apply to truth-telling/confidentiality?

Maximizing the most benefit for the patient would involve creating a rule that is expected to be followed in the case of both truth-telling and confidentiality, unless there is an extreme circumstance

How does virtue ethics apply to truth-telling/confidentiality?

Physicians who value honesty and fidelity are more likely to be truthful with their patients. Those who have empathy will understand why patients value confidentiality

Define Confidentiality.

Pertains to patients sharing information with health care professionals who promise, implicitly or explicitly, not to disclose that information to others

Define Right to Privacy.

The authority of persons to control who can use and possess information about themselves

What are the 5 conditions of informed consent?

1. The patient is competent to decide

2. The patient gets an adequate disclosure of information

3. The patient understands the information

4. The patient decides about the treatment voluntarily

5. The patient consents to treatment

When is a person deemed incompetent?

Cases of intellectual disability, dementia, psychosis, alcoholism, and being a minor (<18 years old) AND in any case where the patient is unable to communicate a decision, explain their decision, or understand disclosed information

What have the courts mandated be disclosed? Provide an example for each.

- The nature of the procedure (ex: how invasive it is, how long it will take)

- The risk of the procedure (ex: seriousness, probability of procedure and when it will occur)

- Alternatives to proposed treatment (ex: no treatment, benefits of each)

- Expected benefits of proposed treatment (extent and likelihood of good outcomes)

What is a waiver?

A patient's voluntary and deliberate giving up of their right to informed consent

What is therapeutic privilege?

The withholding of relevant information when the physician believes disclosure would likely cause harm to the patient

What are the criticisms of therapeutic privilege?

- When overused, can undo consent

- Patients should at least be able to understand relevant information to make a decision

What was determined under Schloendorff v. Society of New York Hospital?

Underscored the value of self-determination and voluntary consent, stating the "every human being of adult years and sound mind has the right to determine what shall be done to his body"

What was determined under Salgo v. Leland Stanford Jr. University Board of Trustees?

Found that physicians "have a duty to disclose any facts which are necessary to form the basis of intelligent consent by a patient for the proposed treatment"

What was determined under Canterbury v. Spence?

Adequacy of disclosure by a physician should not be judged by what the medical profession thinks is appropriate, but by what information the patient finds relevant to his or her decision

What was determined under Cobb v. Grant?

Disclosure must consist of "all information relevant to a meaningful decisional process"

How does Kantian ethics apply to informed consent?

Humans are intrinsically autonomous beings and deserve to be treated with respect. They must be able to voluntarily choose their treatment and by fully/truthfully informed. Therapeutic privilege is NEVER permissible

How does act-utilitarianism apply to informed consent?

Judged on a case-by-case basis. Informed consent may be used more frequently, but it is not a moral requirement

How does rule-utilitarianism apply to informed consent?

Best case scenario would be if there was a rule that physicians were obligated to disclose information, unless there was an extreme circumstance

How does Rawl's ethics apply to informed consent?

Supports equal liberties for all; to manipulate, coerce, or treat without authorization would violate those liberties

Define Competence.

The ability to render decisions about medical interventions

Define Informed Consent

The action of an autonomous, informed person agreeing to submit to medical treatment or experimentation

What is the process of a clinical trial?

Typically separated into two groups -- 1) an experimental group that gets the treatment to be evaluated and 2) a control group that does not get the treatment. The control group will be given a placebo, which is an inactive or sham treatment. For the treatment to be considered effective, the experimental group must show significant improvement

What is Single Blinding?

When subjects are unaware of the treatment they are receiving

What is Double Blinding?

When both the subjects and researchers are unaware of who is getting which treatment

What is randomization?

Randomly assigning subjects to the experimental and control groups

What is Phase 1 of a clinical trial?

Tests the drugs in small groups to ascertain safety, any adverse reactions, and assess safe/unsafe dosages

What is Phase 2 of a clinical trial?

Investigators give the drug to a larger group to get a preliminary indication of its effectiveness and further assess the safety

What is Phase 3 of a clinical trial?

Goal is to finalize effectiveness, compare efficacy to other current treatment options, and learn how to employ it in the safest way

What is Phase 4 of a clinical trial?

Optional step for further testing after the drug is approved to continue testing its safety an any long-term side effects that may occur

What are the 4 premises for a clinical trial to be permissible?

1) Subjects must give their informed and voluntary consent

2) Study must be designed to minimize risk to subjects and offer acceptable balance of risks and benefits

3) Subjects must be chosen fairly to avoid exploiting or unjustly excluding them

4) Research must be reviewed and approved by an independent panel before the trial can begin

What ethical principles apply to Human Research?

Autonomy, Beneficence, and Justice

What are the basics pertaining to research on vulnerable populations?

There is a moral conflict between the duty to shield the vulnerable from abuse and the aspiration to benefit them or society through needed research

What are some past examples of abuse on vulnerable populations?

poor Black men of the Tuskegee study, the children of Willowbrook State School, and the prisoners of Nazi doctors in the Nuremberg Trials

Define Clinical Trial

A scientific study designed to test medical interventions in humans