Ethics Flashcards
What is the Nuremberg code?
voluntary consent of human subject
What is the difference between shall and should?
mandatory vs guidance
What is the overarching legislation of ethics?
Canadian Charter
What are the three core principles of ethics?
respect for persons
concern for welfare
justice
What falls under respect for persons?
autonomy
What falls under concern for welfare?
quality of a person’s life
social determinants
group wellfare- research has to benefit that community
What falls under justice?
treat fairly and equitably
limit power imbalance=
What example is power imbalance?
doctor recruiting patients
Who reviews the ethics of studies?
REB
What research REQUIRES REB approval?
living humans
human biological materials from living AND deceased
What doesnt need REB approval?
no for information legally accessible to public,
How many members on REB and what roles are they?
5 members
2 have expertise in field in question
1 that knows ethics
1 that knows relevant law
1 community member
What conditions apply to consent?
-voluntary
can be withdrawn at any time
if withdraw they can also request withdrawl of data and bio materials
- informed
With regards to finding what must be done?
obligated to disclose to participants
When do you not need consent?
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
What parameter covers fair inclusion of vulnerable populations?
justcie
What are all the elements of consent?
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
What is clinical trials?
form of research involving participants and evaluates effects of health interventions
What is duty of care?
duty to act in best interest balanced with gaining new knowledge
What is therapeutic misconception?
participants do not know that trial is to get new knowledge not to benefit them
What are the ethical concerns in each phase of trials?
1= safety in humans
2=safety in risk population
3= safety in random assignment
4= marketing
When are placebo trials ok?
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
What are the main concerns with pharmaceutical trials?
risk vs benefit
minimize risk
minimize therapeutic misconception
If collecting biological materials what is needed?
consent- theirs or third party
How is secondary use of identifiable materials controlled?
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
With regards to materials involved in reproduction what rules apply?
no unless there is no other way to study
cannot pay or exhange services for the material
With regards to genetic research what applies?
plan to manage info that may be revealed
submit to REB
advise participants on how to manage info revealed
For genetic counselling what parameter does this involve?
justice- because need consent and involvements from groups/families
What is the example of the genetic research done in class?
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)
What is the distinction of a p value of 0.051 and 0.049 and 0.001?
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
How do you calculate NNT/NNH?
1/ARD
What is the difference between absolute and relative risk?
risk of pop compared to healthy= absolute
risk of population compared to risk of same population with NO intervention= relative
