Medical ethics week 12

Question 1

Name the 2 core values in medical research

Answer 1

• Knowledge
  -Beneficience

Question 2

What is a clinical trial

Answer 2

It is a scientific study testing a medical intervention in humabs

Question 3

What is the purpose of clinical trials- to determine what

Answer 3

To determine the effectiveness an saftery of a treatment

Question 4

In clinical trials what does the experimental group get and what does the control group get
+ what is the purpose of the control grp

Answer 4

• Experimental group gets the treatment
  -Control group dosent get the treatmner

-So u can see the true effects

Question 5

Name 2 types of control groups
-What do they get
-1. What is it used to tes
2. What is comared to this

Answer 5

• PLacebo controlled - They get a fake treatment . used to test if imporvemnts are due to placebo effect

-Active controlled - Thy get a standard treatment that i sknown to work.
The new treatment is compared to this

Question 6

In blinding in clinical trials:
who is blinded- unaware of the treatment in :
-single blind
-double blind

Answer 6

single blind- Patient only is blinf

Double blind- Both doctor and patient

Question 7

What is randomisation

Answer 7

When the participants are randoml assigned to groups

Question 8

Name the phases of the clinical trials and purpose
-Group size + what they check(3- confrims)4- what does it study after approval

Answer 8

Phase 1 :small group, checks saftey and sife effects
Phase 2 : larger group: checks effectivness + saftey
Phase 3 : large group, confrims if the treatment reall works
Phase 4: After approval studies long term effects

Question 9

What are features of the gold standard trisl

Answer 9

it is :
randomized
controlled
placebo tested
blinded

Question 10

What type of stydy/clinical trial produces the most reliable and trustworthy resuls

Answer 10

Gold standard clinical trial

Question 11

Name the ethical criteria for research

Answer 11

1.Social and clinical value
2.-Scientific validity
3.-Fair sampling method
4.-Minimisation of risks
5.-Independent review
6-infromed consent
7.respect for participants

Question 12

Explain the social and clinical value as the criteria for research:
- What mus the research aim to do

Answer 12

Research must aim to benefit society

Question 13

Explain the scientific valdiity criteria for research- what must the study be

Answer 13

-Study must be well planned and methodological

Question 14

Explain the infromed consent criteria:
- the participat must agree knowing what

Answer 14

Must agree knowing the :
-purpose, method, risks,side effects and
that they have the rigth to withdrawl at any time

Question 15

Explain the respect for participants criteria- what does it entsil

Answer 15

Potecting privacy
Keeping them imformed
let them withdraw any time

Question 16

What are ethical problems with infromed consent

Answer 16

-Too complex to understan
-Desperation bias
-Therapeutic misconception

Question 17

Name the 3 fundemental ethical principles

Answer 17

• Respect for peross
  -Beneficence
  -Justive

Question 18

Name the 3 types of justice+ breif description
1. Fair share of what
2. ….
3. What should i have acess to

Answer 18

• Distributive justice- fair share of risks and benefits
  -Compensatory justice- proper care+ compensation for research reletad harm
  -Reciprocal justice- participants should have earlier acces to benefical treatments

Question 19

What does the decleration of Helsinki state
-When is research only ehthicsl

Answer 19

Only ethical if particpants have a reasonable chance of benefiting