2.2: Evidence in Medicine

Question 1

When carrying out medical trials, why do we need a framework?

Answer 1

To protect those who are taking part in the trial

Question 2

What framework(s) do we follow?

Answer 2

We follow two frameworks:

1. The World Medical Association’s Declaration of Helsinki
2. The Scottish Government Research Governance Framework

Question 3

Describe briefly the Helsinki declaration?

Answer 3

1. Medical research must involve human studies
2. These studies must aim to find out more about diseases and their treatments
3. Must follow ethical standards
4. The importance of new medical knowledge does not take precedence over the individuals’ human rights

Question 4

What are the criteria (in the Governance framework) that a study must fufil before it can go ahead?

Answer 4

1. Answers a question
2. Won’t kill or harm people
3. Won’t allow access to sensitive personal information
4. Won’t collect information that isn’t needed
5. Will be conducted in a professional and appropriate manner

Question 5

What are the principles of data protection?

Answer 5

• Processed fairly and lawfully
• Collected and used for one purpose only
• Adequate and not excessive
• Kept up to date and accurate
• Not kept longer than needed
• Doesn’t breach the rights of the subject
• Protected from unauthorised viewing
• Not sent to countries where it will not be protected

Question 6

Describe the Caldicott Guardian Approval?

Answer 6

This is an appointment person who has responsibility over sensitive data
They can allow people to view this data without individual consent from each person
They must ensure data is being used correctly and patients are anonymous
Eg: Used in fourth year projects

Question 7

Describe non-clinical ethics review?

Requires?

Answer 7

This is for non-NHS subjects
All universities have them for research projects
Requires:
- Study Protocol
- Participant Sheet
- Consent Form

Question 8

Describe a clinical ethics review?

Requires?

Answer 8

This is for NHS subjects
There is a committee who review the submission and consider the project from the point of view of the participants (is it acceptable?)
This review can cover most procedures done to patients
Requires:
- Study Protocol
- Participant Information Sheet
- Consent Form

Question 9

Relevance of this to medical school?

Relevance to future career?

Answer 9

SSCs
Fourth year Project
BMSc
Audits
These may need ethics review
May also require handling of sensitive data
The governance framework is backed up by law - ignoring this could result in jail time