INTRODUCTION TO ETHICAL PRACTICE FOR CLINICAL STUDIES 23/09/16

Question 1

What are the two ethical responsibilities of researchers? (2)

Answer 1

1. do no harm

2. do good

Question 2

What are the potential harm to participants? (4)

Answer 2

1. biological
2. psychological
3. social
   - stigma
4. structural
   - excessive cost

Question 3

What can harms be? (4)

Answer 3

1. immediate
2. distant
3. anticipated
4. unanticipated

Question 4

How do we mitigated risk of harm? (3)

Answer 4

1. sound science
   - Institutional review boards
2. sound ethical principles
   - research ethics committee
3. sound study practices
   - voluntary particpation

Question 5

How is voluntary participation ensured? (6)

Answer 5

1. informed
2. consent
3. reward free
4. freedom to decline
5. freedom to withdraw
6. rights protection

Question 6

Who are the vulnerable groups of people of involuntary participation or harm? (4)

Answer 6

1. limited agency
   - chikdren
2. diminished autonomy
   - dementia
3. with needs
   - poor
   - unwell
4. unable to consent
   - unconscious