L 1.5- Research ethics and protocol design

Question 1

Why do we do research?

Answer 1

1. For the good of humanity
2. To benefit patients
3. Cure disease
4. Develop new products
5. Improve services
6. Knowledge is good in and of itself
7. Self-interest
8. To get my degree
9. To help my career
10. To make money/profit

Question 2

When do ethical tensions arise?

Answer 2

1. When the primary reason for conducting health-related research is not the benefit of patients
2. When the means to achieve the research aim places participants at risk of harm- or the researchers

Question 3

At what stages are ethics integral in?

Answer 3

All stages:
1. Deciding what research to do
2. Designing your protocol
3. Delivering your protocol/conducting the research
4. Disseminating your results

Question 4

What are the basic principles of research involving humans?

Answer 4

1. Maximise the benefits
2. Minimise the harms…but not at any cost
3. Participants should be treated with respect i.e consent, confidentiality & dignity
4. Potential participants should be treated fairly i.e avoid exclusion of under represented groups

Question 5

What is the declaration of Helsinki?

Answer 5

It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent

Question 6

What is good clinical practice?

Answer 6

It is a set of internationally recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people

Question 7

What do you do when your research contains poor information?

Answer 7

Ensure adequate provision of information

Question 8

What do you do when you or the participants are being rushed into making a decision?

Answer 8

Give time and space to make a decision

Question 9

What do you do when your participants or researcher are being shamed, humiliated or pressured into agreement

Answer 9

Ask in private and do not put any pressure to agree.

Be free to change one’s mind

Question 10

What do you do when your participants change their mind

Answer 10

Withdraw at any time
Evaluate feasibility and keep participant(s) informed

Question 11

What do you do when your participants cannot afford to take part?

Answer 11

Provision of expenses

Question 12

What do you do when your participants are being induced to take part?

Answer 12

Remove payments or undue rewards

Question 13

What are the types of studies that raise ethical issues?

Answer 13

1. Systematic reviews
2. Analysis of historical records (100+ years)
3. Analysis of anonymous aggregate data

Question 14

How can you minimise risk of harm to participants?

Answer 14

1. Risk assessment prior to commencing study
2. Procedures for monitoring study processes and events
3. Adverse event reporting and management