Ethics

Question 1

What is the Nuremberg code?

Answer 1

voluntary consent of human subject

Question 2

What is the difference between shall and should?

Answer 2

mandatory vs guidance

Question 3

What is the overarching legislation of ethics?

Answer 3

Canadian Charter

Question 4

What are the three core principles of ethics?

Answer 4

respect for persons
concern for welfare
justice

Question 5

What falls under respect for persons?

Answer 5

autonomy

Question 6

What falls under concern for welfare?

Answer 6

quality of a person’s life
social determinants
group wellfare- research has to benefit that community

Question 7

What falls under justice?

Answer 7

treat fairly and equitably
limit power imbalance=

Question 8

What example is power imbalance?

Answer 8

doctor recruiting patients

Question 9

Who reviews the ethics of studies?

Answer 9

REB

Question 10

What research REQUIRES REB approval?

Answer 10

living humans
human biological materials from living AND deceased

Question 11

What doesnt need REB approval?

Answer 11

no for information legally accessible to public,

Question 12

How many members on REB and what roles are they?

Answer 12

5 members
2 have expertise in field in question
1 that knows ethics
1 that knows relevant law
1 community member

Question 13

What conditions apply to consent?

Answer 13

-voluntary
can be withdrawn at any time
if withdraw they can also request withdrawl of data and bio materials
- informed

Question 14

With regards to finding what must be done?

Answer 14

obligated to disclose to participants

Question 15

When do you not need consent?

Answer 15

if very minimal risk
lack of consent doesnt adversely affect welfare
impossible to do it if they need consent
debreif
NO therapeutic intervention
Medical emergency of prospective patient
no other standard efficacous care or their best chance
unconscious/lacks capacity
third party cannot be secured in time

Question 16

What parameter covers fair inclusion of vulnerable populations?

Answer 16

justcie

Question 17

What are all the elements of consent?

Answer 17

being invited to participate
purpose of research
what they will do
risk and pros
free to withdrawl
info
commercialization/conflict of interest
debrief
contact info
what will be collected
confidentiality
any reimbursment
stopping rules
and rights to legal recourse

Question 18

What is clinical trials?

Answer 18

form of research involving participants and evaluates effects of health interventions

Question 19

What is duty of care?

Answer 19

duty to act in best interest balanced with gaining new knowledge

Question 20

What is therapeutic misconception?

Answer 20

participants do not know that trial is to get new knowledge not to benefit them

Question 21

What are the ethical concerns in each phase of trials?

Answer 21

1= safety in humans
2=safety in risk population
3= safety in random assignment
4= marketing

Question 22

When are placebo trials ok?

Answer 22

no established effective therapies for that population
new evidence raises doubt of benefit of current therapies
adding new drug to established effective therapies
patients okayed nont getting established and this wont cause irreversible harm

Question 23

What are the main concerns with pharmaceutical trials?

Answer 23

risk vs benefit
minimize risk
minimize therapeutic misconception

Question 24

If collecting biological materials what is needed?

Answer 24

consent- theirs or third party

Question 25

How is secondary use of identifiable materials controlled?

Answer 25

only if essential to research
use without consent is unlikely to adversily effect them
take measures to protecct privacy
comply with previously expressed concerns of their material
seek consent and permission

Question 26

With regards to materials involved in reproduction what rules apply?

Answer 26

no unless there is no other way to study
cannot pay or exhange services for the material

Question 27

With regards to genetic research what applies?

Answer 27

plan to manage info that may be revealed
submit to REB
advise participants on how to manage info revealed

Question 28

For genetic counselling what parameter does this involve?

Answer 28

justice- because need consent and involvements from groups/families

Question 29

What is the example of the genetic research done in class?

Answer 29

havasupai tribe
-misue of the DNA( others used their DNA for indication of inbreeding and alcoholism), lack of informed information given (didn’t know english)

Question 30

What is the distinction of a p value of 0.051 and 0.049 and 0.001?

Answer 30

0.051 COULD be a decent drug but not stat sig
0.049 means it IS a decent drug stat sig
0.001 is WOW this is a good drug
=5.1% this is due to chance

Question 31

How do you calculate NNT/NNH?

Answer 31

1/ARD

Question 32

What is the difference between absolute and relative risk?

Answer 32

risk of pop compared to healthy= absolute
risk of population compared to risk of same population with NO intervention= relative