Ethics in Medical research

Question 1

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

Answer 1

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

Question 2

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

Answer 2

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

Question 3

Possibility of corruption in medical research

Answer 3

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

Question 4

past harms

Answer 4

prima facie duties: restitution

Question 5

caring for a patient who is also a research volunteer

Answer 5

• 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

Question 6

what does REB stand for

Answer 6

Research ethics board

Question 7

what is the purpose of the REB

Answer 7

all federally funded research in Canada must get approval before proceeding

To protect participants, not researchers

Question 8

true or false the REB is made up of researchers

Answer 8

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

Question 9

what is the gold standard for testing medications

Answer 9

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)

Question 10

Options for comparison in medical research

Answer 10

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

Question 11

Comparisons referred to as?

Answer 11

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

Question 12

what are the 4 phases of clinical trials

Answer 12

1. dosage
2. safety
3. efficacy
4. post-marketing

Question 13

describe phase 1 trials

Answer 13

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

Question 14

describe phase 2 trials

Answer 14

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

Question 15

describe phase 3 trials

Answer 15

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)

Question 16

define efficacy

Answer 16

Efficacy is a statistical measurement not how effective something is

Question 17

why are there no placebos in phase 3 trials

Answer 17

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

Question 18

describe phase 4 clinical trials

Answer 18

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

Question 19

what’s supposed to happen in phase 4 trials?

Answer 19

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

Question 20

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

Answer 20

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

Question 21

randomized

Answer 21

• 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

Question 22

therapeutic misconception

Answer 22

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

Question 23

why must experiments be randomized

Answer 23

otherwise the data won’t be accurate

Question 24

what is a “double-blind” clinical trial

Answer 24

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

Question 25

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

Answer 25

RPNs should not know during randomized clinical trials

Question 26

what are the 6 ethical care principles

Answer 26

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

Question 27

beneficence in care vs. medical research

Answer 27

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

Question 28

non-maleficence in care vs. medical research

Answer 28

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

Question 29

autonomy in care vs medical research

Answer 29

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)

Question 30

truthfulness in care vs. medical research

Answer 30

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

Question 31

confidentiality in care vs. medical research

Answer 31

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

Question 32

justice in care vs. medical research

Answer 32

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)

Question 33

reasons why women are kept out of clinical trials

Answer 33

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

Question 34

vulnerable people in medical research

Answer 34

- women - Not enough protection in place for prisoners - Not enough protection for children and elderly people

Question 35

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

Answer 35

- 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