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Ethics Exam > Ethics in Medical research > Flashcards

Ethics in Medical research Flashcards

1
Q

When looking at ethics in medical research, we must look at it differently/separately than in clinical care. Why?

A
  1. research and care have different goals
  2. medical research costs a lot of money (possibility of corruption)
  3. past harms
  4. You may care for a patient who is also a research volunteer
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2
Q

what is the goal of clinical care and what is the goal of medical research

A
  • Clinical care goal = patient outcomes, cure patients, make them comfortable
  • Medical research goal = knowledge, finding cures etc.
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3
Q

Possibility of corruption in medical research

A

when drug trials aren’t effective, it is possible companies will skew their results to have better outcomes so they can rekindle some of the profits invested

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4
Q

past harms

A

prima facie duties: restitution

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5
Q

caring for a patient who is also a research volunteer

A
  • Patients may be participants in clinical trials
  • Nurses may or may not know, patients may or may not know (involuntary patients)
  • Nurses may also be involved in a clinical trial
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6
Q

what does REB stand for

A

Research ethics board

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7
Q

what is the purpose of the REB

A

all federally funded research in Canada must get approval before proceeding

To protect participants, not researchers

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8
Q

true or false the REB is made up of researchers

A

false, it is made up with people who are experts in ethics

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9
Q

what is the gold standard for testing medications

A

Randomized Controlled Trial:

Comparing variables [patient outcomes] (e.g., people who got ACL surgery and people who just got cut open as part of the study)

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10
Q

Options for comparison in medical research

A
  • Investigational treatments: used to be called experimental drugs
  • Existing medication
  • Placebo
  • No intervention (observation): used when there typically isn’t an existing medication
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11
Q

Comparisons referred to as?

A

an “arm”
2 arm = comparing 2
3 arm = comparing 3
4 arm = comparing all 4

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12
Q

what are the 4 phases of clinical trials

A
  1. dosage
  2. safety
  3. efficacy
  4. post-marketing
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13
Q

describe phase 1 trials

A

dosage:
- how we find out how much of a drug should be given (and can be tolerated) and when it becomes toxic
- small number of people (healthy people; usually 180lb male)
- placebo
- Start with small amount of medication on small group of people, increase amount on new group of people

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14
Q

describe phase 2 trials

A

safety:
- Slightly larger trial
- Still using healthy volunteers
- Still able to have a placebo
- Making sure no one is having a SAE – serious adverse event (i.e., death or near death)
- Usually longer than phase I trials
- Making sure there are no long-lasting side effects
- repurposed drugs get a pass on phase 2

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15
Q

describe phase 3 trials

A

efficacy:

  • Sometimes this phase is combined with phase II
  • Not quite the same as the meaning of “effective”
    ** Efficacy is a statistical measurement not how effective something is
  • As big as possible
    ** no longer testing it on “healthy” people
    ** using sick participants only (testing drug on the condition)
  • no placebo (selection criteria may include not being on an existing medication of the same kind)
    *** placebo means leaving sick people unmedicated (which would be unethical)
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16
Q

define efficacy

A

Efficacy is a statistical measurement not how effective something is

17
Q

why are there no placebos in phase 3 trials

A

using sick participants only (testing drug on the condition)
having a placebo means leaving sick people unmedicated (which would be unethical)

18
Q

describe phase 4 clinical trials

A

post-marketing:

  • not a formal part of a clinical trial
  • drug is out there, doctors are prescribing it, people are taking it
  • more people are taking the drug, therefore theres more potential for side effects to appear
    *** not all side effects are going to show up in smaller clinical trials
  • working with the side effects
19
Q

what’s supposed to happen in phase 4 trials?

A

when people report side effects to their doctors, doctors are supposed to inform health Canada about them – however, consumers can now report side effects to the Canada Vigilance Program

20
Q

Any participant can drop-out from the research at any time for any reason

A

liberty right – therefore, as long as the patient is not involuntary

21
Q

randomized

A
  • how researchers decide which arm the participants will participate in
  • patients need to understand that their doctors will not assign them to a particular arm based on what will benefit them
  • they will be assigned at random
22
Q

therapeutic misconception

A

patients misunderstanding what randomized means, patients believe they are getting given something therapeutic

23
Q

why must experiments be randomized

A

otherwise the data won’t be accurate

24
Q

what is a “double-blind” clinical trial

A

double-anonymized: neither the researcher nor the participant know who got which drug

25
Q

the only time it is okay for the RPN to not know what is administered to the patient

A

RPNs should not know during randomized clinical trials

26
Q

what are the 6 ethical care principles

A
  1. Beneficence
  2. Non-maleficence
  3. Autonomy
  4. Truthfulness
  5. Confidentiality
  6. Justice
27
Q

beneficence in care vs. medical research

A

care providers do what benefits the patient

researchers and future patients get the benefits (not a therapeutic benefit for existing patient)

28
Q

non-maleficence in care vs. medical research

A

do no harm; moral duty to keep your patient from harm

in research we work hard to protect patients as much as possible, but we don’t know what the harms are yet – research involves unknowns, including unknown risks

29
Q

autonomy in care vs medical research

A

respect the patients right to be self-determining (voluntary informed choice)

no guarantee of benefit and there is a risk of harm, because of this, we need to take extra care so the people getting involved in the research truly know what they are getting involved in. (Consent forms are very long and very dense)

30
Q

truthfulness in care vs. medical research

A

truthfulness should always be the go-to position (but there are times when you cant)

researchers: we have to lie to you, but we’re going to ask you ahead of time if you’re okay with us lying to you, so if you agree we have permission to lie. We need to lie to have meaningful research

31
Q

confidentiality in care vs. medical research

A

patients medical files are private

patients medical files become evidence and thus will be shared with all types of people outside of the research team; still anonymized but nonetheless out there to strangers

32
Q

justice in care vs. medical research

A

money

recruitment (who participates in clinical trials – who takes the risk so we can take the benefits) in the past the recruitment has been unjust (e.g., poor people, racial minorities, cognitive disabled, prisoners)

33
Q

reasons why women are kept out of clinical trials

A
  • birth control / chances of getting pregnant / birth defects
  • “women’s hormones” – researchers: “irregular hormone cycles will mess up our data” – this endangers women
34
Q

vulnerable people in medical research

A
  • women
  • Not enough protection in place for prisoners
  • Not enough protection for children and elderly people
35
Q

If someone is nearing death, should they even been asked to participate in a clinical trial?

A
  • Relational ethics/virtue ethics: you have the chance to contribute to knowledge / do something heroic: someone with the same condition can benefit from the volunteering to participate in a clinical trial
  • Respect autonomy – if that’s what the patient wants, that’s what we should provide the patient

Ethics Exam (7 decks)

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