VULNERABLE PARTICIPANTS AND HIGH RISK ISSUES 23/09/16

Question 1

What do ethics do in a research project?

Answer 1

ensures that risks are minimised and benefits are maximised

Question 2

What does governance ensure in a research project?

Answer 2

ensures that projects have appropriate permission

Question 3

What does consent ensure in a research project?

Answer 3

• ensures partcipation is voluntary and at no cost

Question 4

What are considered high risk ethical issues? (13)

Answer 4

1. vulnerable study participants
2. covert data collection
3. sensitive topics
4. drug/food/fluid administration
5. potentially harmful/painful procedures
6. collection of biological body materials
7. psychological stress
8. prolonged or repetitive testing
9. material or financial participation incentives
10. data transfer outwit the EU
11. conflicts of interest
12. potential risks to researchers, non-participants or the environment
13. animals, human tissues and data protection acts

Question 5

What types of projects do not require formal ethical approval? (3)

Answer 5

1. secondary research
   - already published
2. non-humna research
3. audit/service evaluation

Question 6

What types of projects do require formal ethical approval? (4)

Answer 6

1. non-human subjects
   - covered by animals act 1986
2. service evaluation involving vulnerable participants or ethically sensitive topics
3. experimental research
   - involving a new intervention
4. non-experimental research
   - new information collection on more than one existing service delivery

Question 7

What are the key principles of ethical research, audit and service evaluation? (2)

Answer 7

1. project is conducted in compliance with an explicit protocol
2. it has been authorised

Question 8

When should further ethics committee approval required? (2)

Answer 8

1. there are any substantial changes to the project protocol

2. the project has any unexpected deleterious effects

Question 9

What should a project protocol aim to explicitly describe? (3)

Answer 9

1. why the project is necessary
2. what the project will involve
3. how key ethical, legal and governance issues will be addressed

Question 10

Who should the project protocol provide sufficient information to? (3)

Answer 10

1. team member
2. particpants
3. research committee members

Question 11

Which committees are considered to provide authorisation and ethics approval?

Answer 11

1. instituitional research ethics committees

2. government agency ethics committees