Ethics in Medical Research

Question 1

What are the differences between medical research and clinical care?

Answer 1

1. Research and care have different goals
2. medical research costs a lot of money
3. Past harms
4. You may care for a patient who is also a research volunteer

Question 2

Research and care have different goals:

Answer 2

The clinical care goal focuses on patient outcomes, curing patients, and making them comfortable
The medical research goal focuses on knowledge, and finding cures

Question 3

Medical research costs a lot of money:

Answer 3

There is a possibility of corruption*
When drug trials aren’t effective, it is possible companies will alter their results to have better outcomes so they can compensate for the financial loss

Question 4

Past harms:

Answer 4

Falls under restitution, one of the prima facie duties ?

Question 5

You may care 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
• Nurses can also be involved in a clinical trial

Question 6

What is REB?

Answer 6

It is the research ethics board
- It is all federally funded research in Canada must get approval before proceeding with the clinical trial

Question 7

What about privately funded research?

Answer 7

If private research is being trialled in a publicly run facility, it should be approved by an REB

Question 8

What is the “Gold Standard” for testing medications?

Answer 8

Randomized Controlled Trial (RCT)
- It compares variables (patient outcomes)

Question 9

What are the other options for comparison in medical research ?

Answer 9

• Investigational treatments (experimental drugs)
• Existing medications
• Placebo
• No intervention (observations)

Question 10

What are comparisons referred to?

Answer 10

They are called an “arm”
2 arm = compares 2 of the options
3 arm = compares 3 of the options

Question 11

What are the 4 phases of clinical trials?

Answer 11

1. Dosage
2. Safety
3. Efficacy
4. Post-Marketing

Question 12

Phase 1: Dosage

Answer 12

How we find out how much of a drug should be given and when it becomes toxic
- Small number of volunteers that are healthy
- Uses a placebo
- Starts with a small amount of medication on a small group of people, increasing amount on a new group of people

Question 13

Phase 2: Safety

Answer 13

Repurposed drugs get a pass on phase 2
- There is a slightly larger trial that still uses healthy volunteers
- There can still be a placebo
- No SAE (serious adverse event)
- Ensures there are no long lasting side effects*

Question 14

Phase 3: Efficacy

Answer 14

Efficacy is a statistical measurement, not how effective sometime is*
- This trial is as big as possible, and tests on sick participants
- There is no placebo (means leaving sick people unmedicated which is unethical*)

Question 15

Phase 4: Post-Marketing

Answer 15

The drug is out there, Dr.’s are prescribing it, and people are taking it
- There is more potential for side effects to appear in the public because not all side effects are going to show up in smaller clinical trials
- Dr.’s are supposed to inform Health Canada when patients report side effects
- Consumers can report side effects to the Canada Vigilance Program

Question 16

What is randomization in medical research?

Answer 16

This is how researchers decide which “arm” the participants will participate in*
- Patients need to understand that their Dr.’s will not assign them to a particular “arm” that will benefit them
- The experiments must be randomized, or the data won’t be accurate
- Clinical trials are typically double-blind (neither the researcher or participant know who got which drug
- This is the only time it is okay for the RPN to NOT KNOW what you are administering to the patient

Question 17

What is therapeutic misconception?

Answer 17

It is the patient’s misunderstanding of what randomized means, it is when patients believe they are getting something therapeutic

Question 18

Who are the participants for clinical trials?

Answer 18

They are men because women have complications with their hormones and birth control
- Researchers say the irregular hormone cycles will mess up data, which endangers women
- This is sexist because men can have issues with their semen from the chemicals in the drugs

Question 19

Who doesn’t have enough protection ?

Answer 19

There is not enough protection for prisoners, children, and elderly people

Question 20

How is medical research connected to relational ethics/virtue ethics?

Answer 20

Participants have the chance to contribute knowledge and do something heroic because someone else can benefit from the results of the clinical trial

Question 21

Beneficence in ethics vs medical research

Answer 21

Ethical Care:
- HCP do what benefits the patient
Medical Research:
- researchers and future patients get the benefits

Question 22

Non-maleficence in ethics vs medical research

Answer 22

Ethical Care:
- Do no harm, it is our duty to keep the patient from harm
Medical Research:
- Research works hard to protect patients, but research involves unknowns and unknown potential risks

Question 23

Autonomy in ethics vs medical research

Answer 23

Ethical Care:
- To respect the patients right to be self-determining (voluntary informed choice)
Medical Research:
- There is no guarantee of benefit, and there is a risk of harm, participants know what they are getting into with long and dense consent forms, respecting the patient’s decision to participate

Question 24

Truthfulness in ethics vs medical research

Answer 24

Ethical Care:
- It should always be used, but there are occasions when you cannot be truthful
Medical Research:
- Researchers have to lie, but they ask permission to lie. Lying creates meaningful research

Question 25

Confidentiality in ethics vs medical research

Answer 25

Ethical Care:
- Patient’s health information files are kept private
Medical Research:
- Patient’s medical files become evidence and will be shared with multiple people outside of the research team (it is still anonymized, but available to strangers)