Taking informed consent

Question 1

What is the Nuremberg Code?

Answer 1

Set of research ethic principles for human experimentation due to the Nuremberg trials at the end of the Second World War.

Question 2

What is the Declaration of Helsinki?

Answer 2

Prevents human subjects from being mistreated.

Question 3

What is the International conference on harmonisation?

Answer 3

Discusses scientific // technical aspects of pharmaceutical product development.

Question 4

What are the 2 main UK government policies?

Answer 4

• Medicines for Human Use Regulations 2004.
• The UK policy framework for health and social care research 2017.

Question 5

What are the basic principles of informed consent?

Answer 5

Given by a person with capacity.
Voluntarily given with undue influence.
Given by someone who has been adequately informed.
A fair choice.

Question 6

What is Restriction in ‘Informed Consent’?

Answer 6

Type of study non clinical staff are permitted to obtain in order to inform consent.

Question 7

What are the observational studies in informed consent?

Answer 7

All types.

Question 8

What are the interventional studies in informed consent?

Answer 8

Only device studies where the operator (you) carry out the intervention.

Question 9

What are the 2 parts of informing potential participants?

Answer 9

Consultation
Participant Information Sheet (PIS)

Question 10

What does the Consultation phase involve?

Answer 10

Research Team
Independent personnel

Question 11

What does the Participant Information Sheet (PIS) involve?

Answer 11

Support consultation // verbal discussion around consenting for a research study.

Question 12

What is the structure of the PIS?

Answer 12

Purpose of the study.
Why is the participant invited.
Schedule of activities.
Benefits vs Harm and ALTERNATIVE.
Confidentiality.
Insurance and Complaints Procedure.
Contacts.