L5/6: Clinical Ethics Flashcards

1
Q

define ethics

A

branch of philosophy dealing with values pertaining to human conduct

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2
Q

ethical value 1: what is nonmaleficence

A
  • Non-maleficence means to “do no harm.”
  • Physicians must refrain from providing ineffective treatments or acting with malice toward
    patients.
  • This principle, however, offers little useful guidance to physicians since many beneficial therapies also have serious risks.
  • The ethical issue is whether the benefits outweigh the burdens.
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3
Q

ethical value 2: what is beneficence

A
  • an action that is done for the benefit of others.
  • Help, prevent or remove harms or to improve the situation of others.
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4
Q

ethical value 3: what is non exploitation

A

not using humans as data engines

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5
Q

ethical value 4: what is autonomy

A

Physicians must respect a patient’s right to make decisions regarding his medical care.

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6
Q

what are the two other ethical values

A

justice, and respect

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7
Q

what is the goal of clinical research

A
  • Develop generalizable knowledge to increase understanding of human biology and health
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8
Q

what is a key ethical concern of clinical research

A

exploitation of human subjects
- we place people in the risk of harm for the greater good
- ethical requirements aim to minimize exploitation

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9
Q

what are three key sources of guidance on ethical concerns of clinical research. why were these made?

A
  • Several international documents
  • Nuremberg Code
  • The Tuskegee study
  • Declaration of Helsinki
  • Many of these were written in response to certain specific ethical events, and have the purpose of avoiding future scandals
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10
Q

how did the nuremberg code come to be?

A

Nuremberg Code (1947) was part of the judicial
decision condemning the atrocities of the
Nazi physicians.

the concerns they were condemning were:
- forced sterilizations
- killing people with mental illness
- medical experiments that led to 200,000 deaths

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11
Q

what is the Tuskegee study and how was it unethical

A
  • the goal was to study the progression of untreated syphilis in African American men.
  • all participants were poor, illiterate african american men who were deceived and told they were receiving free health care and food, when they were just exploited to discover treatment. they were not told that hey had syphilis.
  • even when penicillin was created to cure the treatment, they were denied the treatment and this experiment went on for decades
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12
Q

what is the declaration of helsinki

A
  • A set of ethical principles and guidelines for conducting medical research involving human subjects.
  • It was adopted by the World Medical Association (WMA) in 1964
  • It fills in the gaps of the nuremberg code (adding independent review and risk-benefits)
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13
Q

what are the 10 points of the nuremberg code

A
  1. require voluntary consent
  2. procedure must be justified as being necessary and should yield results for the good of society
  3. experiment should be proceeded by animal experiments and the history of the study should be considered
  4. avoid unnecessary physical and mental harm
  5. no experiment should cause death, unless, experimental physicians also are the subjects?
  6. degree of risk should be less than how much it will help humanity
  7. proper prep for the experiment
  8. experiment should only be done by scientists
  9. subject should have the right of withdrawal
  10. the scientist should be able to terminate the experiment at any point
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14
Q

what are the 7 guidelines of unified framework (list)

also what is the purpose of the framework

A

Systemic framework for determining whether clinical research is ethical
- meant to be universal

  1. value
  2. scientific validity
  3. fair subject selection
  4. favourable risk benefit ratio
  5. independent review
  6. informed consent
  7. respect for potential and enrolled subjects
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15
Q

1: Value

explanation and justification

A

Explanation:
evaluation of a treatment, intervention of theory that will improve health and well-being or increase knowledge
- should be generalizable, yield unique results, and results that could be implemented

Justification:
scarce resources and non exploitation

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16
Q

2: Scientific validity

explanation and justification

A

explanation:
use of accepted scientific methods and principles to yield reliable and valid data
- include statistical tests to prove objectivity
- must be feasible
- enough sample to have applicable results
- proper method
- has to have a null hypothesis
- scientists must have clinical equipoise (be uncertain if one treatment is better than the other)

justification:
scarce resources and non-exploitation

17
Q

3: Fair subject selection

explanation and justification

A

explanation:
selection of subjects so that stigmatized and vulnerable individuals are not targeted for risky research. opposite for rich people and beneficial research.
- all subjects should be chosen to minimize risk and enhance benefits

justification:
justice

18
Q

4: favorable risk benefit ratio

explanation and justification

A

Explanation:
minimization of risks, enhancement of benefits, risks to the subject are proportionate to the benefits of society. avoid extraneous benefits (financial aid and medical aid)

justification:
non-maleficent, beneficence, and non-exploitation

19
Q

5: Independent Review

explanation and justification

what are Key Components to an REB application

A

explanation:
review of the study design and execution by individuals unaffiliated with the research.
- required for social accountability
- ensures ethical measurements of the subjects
- local level review: Institutional review board (IRB)/ research ethics board (REB)
- Before a clinical trial can start (e.g. at a hospital or clinic), the principal investigator must submit a detailed application to the local REB for approval

Key Components to an REB application
* Recruitment
* Consent
* Balancing risk vs benefit in research
* Confidentiality
* Fairness and equity
* Conflicts of interest

justification:
public accountability, minimizing influence of potential conflicts of interest

20
Q

6: Informed consent

explanation and justification

what should consent forms include?

A

Explanation:
* to ensure that the participants control whether or not they enrol
* to ensure that the participants only participate when the research is consistent with their values and preferences
- consent should be voluntary, informed, and ongoing. REB needs to see this
- consent forms must have: contact info, risks and benefits, statement of voluntary consent, summary, signatures

Justification:
autonomy
* Concerns and extreme caution: children and adults with diminished mental capacity who are unable to make their own decisions about participating in research
– Nonetheless they have interests and values

21
Q

7: respect for potential and enrolled subjects

explanation and justification

A

explanation:
respect by
- allowing withdrawal
- protecting privacy and confidentiality
- informing of new risks or benefits along the way
- informing subjects of results and clinical research
- maintaining welfare of subjects
- subjects contributions should be recognized

justification:
autonomy and welfare