Exam 2 Flashcards
Clinical Trials
Scientific study that is designed to test medical treatments in humans
Goal of Clinical Trials
Knowledge (May result in more health)
Examples of Clinical Trials that were studied
- Polio vaccine trials on children
- WWII experiments
- Tuskegee syphilis
- Willowbrook hepatitis testing
- Vanderbilt testing radiation on pregnant women
- MIT oatmeal
4 phases of research for clinical trials
- Pre-trial
- Phase I
- Phase II
- Phase III
FDA APPROVAL - Phase IV
Pre-trial clinical trials
Animal trials
Phase I clinical trials
- Testing side effects and safe dosage
- 20 to 100 people
- Several months long
Phase II clinical trials
- Testing if it is safe and effective
- 100 to 300 people
- Several months to 2 years
Phase III clinical trials
- Tests effectiveness and side effects again
- 300 to 3000 people
- 1 to 4 years
If passed the first 3 phases for clinical trials
FDA approval
Phase IV
- Long term follow up
- less than 10% of trials get here and move on
Problems with clinical trials
- Sponsors
- Researchers
- Participants
Problem 1 with clinical trials: Sponsors
- Conflict of interest
Problem 2 with clinical trials: Researchers
- Healer vs Researcher
- Are you doing harm?
Problem 3 with clinical trials: Participants
- Individual vs. Communal good
- Is it okay to let an individual suffer to benefit many
Proposed solutions to Conflicts of interest in clinical trials
- Double-blind experiments
- disclosing conflicts of interest
Proposed solutions to Healer vs Researcher
- In the control group, you give them the currently accepted most effective treatment
DDE and Experimentation
Intention: Cannot deliberately infect patients
Means to end: Always has to be met
Proportionality: Side effects cannot be worse than the cure
Intrinsic wrong: Have to have informed consent and privacy has to be preserved
How to stay true to Proportionality (experimentation)
- Well-designed experiments
- Minimize risks to patients
- Permanent records
- Public records
How to stay true to Informed consent (experimentation)
- No huge incentives
- No Authority pressures
- Identify sponsors (known, unknown, disclosed)
Paternalism
Overriding someones decision making for there own good
Strong Paternalism
Overriding a persons actions or choices even though they are substantially autonomous
Weak Paternalism
Overriding someones decision who cannot act autonomously or whose autonomy is greatly diminished
Limitations of paternalism
- Cognitive: mental disabilities
- Social: parental pressures, authority pressures
- Psychological: denial, depression, and fear
Reasons to be paternalistic
- Patients are not sound of mind
- Autonomy is enabled when patients make the best choices
- Patients are happier when choices are made for them
Autonomy
Rational capacity for self-government
Against Paternalism
- Physicians make bad decisions
- People have a right to their own bodies/ a right to freedom
Standard for intervention
1) Harm principle
2) Best interest principle
Harm principle
- Do whatever results in the least harm to the patients
Best Interest principle
- Do whatever results in the best interest of the patient in all health fields
Conflict of the best interest principle
How do you weigh the values?
- physicians have to be pretty sure to overrule parents
3 parts of truth-telling
- Informing
- Lying
- Whole truth
Truth-telling: Informing
- Tell the patient what they want to hear
- Tell the patient what the hospital wants them to hear
- Tell the patient what is best for them
Truth-telling: Lying
Never lie to the patient because they have a right to the truth and because they need to trust you
Informed consent
Affirmation of permission
Privacy
Right to have information protected that has not been made public and which the person would reasonably not want to be disclosed
Why is privacy important
- Allows you to establish relationships
Privacy right
The right to be left alone with respect to the information and is not all information it needs to meet two conditions
Two conditions to the privacy right
- Would reasonably not want info disclosed
- If they were entirely reasonable would they want this information disclosed?
Defendants: Therapists
- Right to privacy
- Frustrate treatment
- If privacy not maintained violence increases
Plaintiffs: Tarasoffs
- physicians have a duty to warn
- protective privilege ends where public peril begins
Standard intervention
when you
Conditions for Informed consent
- Patient is competent to decide
- Physician discloses info adequately
- Patient understands the situation
- Patient has to decide voluntarily
- Explicitly assents to treatment
What are rights issues raised for the patients in clinical trials?
Issues of informed consent or confidentiality
Best interest principle
Value based
