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Principles of Medical Research > Deniers and ethics > Flashcards

Deniers and ethics Flashcards

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USMLE® Step 1 flashcards
1
Q

ethics

A

well founded standards of right and wrong that prescribe what humans ought to do, usually in terms or rights, obligations, benefits for society, fairness or specific virtues

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2
Q

there must be a continuous

A

effort of studying our own moral beliefs and our moral conduct, striving to ensure that we and the institutions we help to shape, live up to standards that are reasonable and solidly based

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3
Q

research ethics principles

A

1) justice
2) fidelity
3) respect
4) non-maleficent
5) beneficence

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4
Q

nuremberg code

A

came about after ww2, due to the atrocities that occurred during human experimentation carried out by the nazi’s

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5
Q

main points of nuremberg

A

1) Voluntary consent
2) Fruitful results for the good of society
3) Experiments based on prior animal experimentation- to limit risk
4) Avoid unnecessary pain and suffering
5) No experiment should be conducted if thought to cause harm to subject
6) Degree of risk shouldn’t be more than the determined humanitarian importance
7) Adequate facilities to protect the subject
8) Only be conducted by a scientifically qualified person
9) Subject can end the experiment at any point
10) Scientist in charge must be preprared to end the experiment if it is likely to result in injury, disability

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6
Q

declaration of helsinki

A

1964

  • a set of ethical principles regarding human experimentation developed by WMA. Widely regarded as the cornerstone of human research ethics
  • many doctors thought nuremberg principles only applied to nazis
  • forms basis for subsequent documents
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7
Q

Belmont report

A

Commissioned by the US Government in response to ethical failures in medical research, such as theTuskegee Syphilis Study, the Belmont Report was written by a panel of experts and proposes three principles that should underlying the ethical conduct of research involving human subjects: 1) Respect for persons; 2) Beneficence; and 3) Justice.

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8
Q

respect for persons

A

o Respect for Persons
The Belmont Report argues that respect for persons consists of two distinct principles: individuals should be treated as autonomous and individuals with diminished autonomy should be entitled to additional protections. The principle of respect for persons is interpreted to mean that researchers should, if possible, receive informed consent from participants, and the Belmont Report identifies three elements of informed consent: information, comprehension, and voluntariness. That is, respect for persons implies that participants should be presented with relevant information in a comprehensible format and then should voluntarily agree to participate.

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9
Q

beneficence

A

o Beneficence
Beneficence can roughly be understood to mean having the interests of research participants in mind. The principle of beneficence is behind efforts by researchers to minimize risks to participants and maximize benefits to participants and society. For example, when considering a research design, the principle of beneficence should cause us to ask if there is another way that we could obtain the same knowledge but with lower risks to participants.

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10
Q

justice

A

o Justice
The principle of justice addresses the distribution of the burdens and benefits of research. That is, it should not be the case that one group in society bears the costs of research while another group reaps its benefits. Issues of justice arise most strongly around questions about the selection of participants.

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11
Q

tuskegee syphilis trial (1931-1972)

A
  • study involving untreated syphilis in black men in Tuskegee university
  • lasted 40 years, told the men they had bad blood
  • undue influence- free meals, healthcare and burial
  • never treated with penicillin even after it was proven to work
  • caused deaths, congenital syphilis and transmission to females
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12
Q

alder why tissue scandal (1988-1995)

A
  • tissue obtained and stored from children who had died without parents consent
  • were not even being used
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13
Q

scientific validity

A

use of acceptable scientific principles and methods and competent investigators, to produce relabel and valid data

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14
Q

fair subject sleection

A

selection so that vulnerable pops. are not targeted for risky research and the rich and socially powerful are not favoured for potentially beneficial research

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15
Q

favourable risk-benefit ratio

A

minimize risks, enhance potential benefits, risk are proportionate to the benefits to the subject or society

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16
Q

respect for subjects

A

subjects should have their privacy protected, the opportunity to withdraw, their well-being monitored and maintained, be informed of new info concerning research and compensated for injury

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17
Q

informed consent

A

provide adequate info for subject so that they can make voluntary decisions

18
Q

independent review

A

view of the above individuals unaffiliated with the research

19
Q

ethics approval committees

A

every application for medical research involving animals, people or human tissue has to satisfy an ethics committee

  • comprise a cross-section society
  • institutional ethics panels as well
20
Q

andrew wakefield

A

author of paper suggesting link between MMR and autism

- struck off for fraud

21
Q

wakefield hypothesis

A

MMR gives you autism

22
Q

why was wakefield struck off

A

strong conclusions were made from very weak evidence

- doubts over MMR safety propagated by the media and prevented many children from being vaccinated

23
Q

consequences of Wakefield paper

A

the growing anti-vacciinatio moment is not based on sound scientific evidence and will lead to children dying from preventable ailments

24
Q

what should always be stated on papers

A

conflicts of interests

e.g. wakefield was being payed by a company that would benefit from positive results

25
Q

post modern circus

A
  • no fundamental truths
  • everything is subjective
  • it depends on the individual
  • alternative facts
26
Q

Peter Duesberg

A

hypothesised that HIV does not cause AIDS. Since HIV does not satisfy Kochs postulates. Believes aids is caused by drug use

BUT
Kochs postulate don’t even hold for cholera
- have been modified t account for viruses

27
Q

Karl Popper

A

tackled the problem of induction. science must be falsifiable

28
Q

induction e.g.

A

all past ravens ever seen are black, therefore all ravens are black. Past perforation is not guide to the future

29
Q

conjecture and refutation

A
  • come up with an idea or hypothesis
  • test it to destruction
  • you cannot prove a hypothesis is true
  • you can corroborate it
  • can prove a hypothesis is false
30
Q

sciences provides

A

falsifiable hypothesis- pseudoscience does not

31
Q

new technology requires

A

new ethical guidelines

32
Q

nazi experimentation

A
  • harm to subjects inevitable
  • no scientific merit
  • forced participation
  • doctors were prosecuted at the trial in nurmebergy
33
Q

basic principles of declaration of helsinki

A

1) safety of human subjects
2) conform to accepted scientific principles
3) protocol
3) ethics committee (independent)
4) clinically competent medical supervisor
5) risk/ benefit analysis
6) respect of privacy
7) informed consent
8) hazards are predictable
9) independent relationship of physician to subject
10) consent from legal guardian
11) protocol reference declaration
12) 2000 update problem with clause on use of placebo

34
Q

placebos

A

unethical in virtually all studies which involve disease with proven treatments. however remains ethical in trials where no proven treatment. revisions due to controversy over use of placebos in attempting to find easy ways to reduce HIV perinatal transmission

35
Q

vulnerable populations which may not have autonomy

A

children, mentally incapacitated, prisoners

36
Q

or those who may be unduly influenced

A
  • students
  • subordinates
  • pregnant women
  • patients
37
Q

jewish chronic disease hospital (1963)

A

cancer cells were injected into patients with chronic debilitating disease.

  • no consent
  • no info
  • no formal reiew
38
Q

willow brook state school (1963-66)

A

new york institution for mentally defective persons

  • admission was contingent on accepting the study
  • children injected with hepatitis
  • no consent
  • most developed hepatitis over time
39
Q

tuskegee syphilis study involved

A
  • 300 black syphilis males and 300 controls
  • 28 deaths
  • 100 cases of disability
  • 19 cases of congenital syphilis
40
Q

the health of my patients will be my first consideration

A

Declaration of helsinki 1963, finland

41
Q

consent is legally required to

A

store and use relevant material from the ling or deceased for the scheduled purpose relating to research

Principles of Medical Research (31 decks)

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