Research Governance and Ethics - Methods

Question 1

Define: ‘Research Governance’

Answer 1

‘Broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality across all aspects of healthcare ‘

Basically:

• Good conduct of research for patient benefit
• Good research ethics and ethical review

Question 2

We need to emphasis WHAT about patient care when they are taking part in a research study?

Answer 2

• That participating is NOT affecting their care

Question 3

Which ACT is concerned with capacity and informed consent?

Answer 3

• Mental Capacity Act

Question 4

Identify some recruitment ethical issues that could arise during conduct of research:

Answer 4

1) Vulnerability
2) Power dynamics (authority)
3) Data protection
4) Information

Question 5

Identify some safety and integrity issues that can arise during conduct of research:

Answer 5

1) Confidentiality
2) Safeguarding of info
3) Safeguarding of participants
4) Safeguarding of researchers
5) Manage risks

Question 6

Identify some enrolling issues that can arise during conduct of research:

Answer 6

1) Time to decide
2) Informed consent
3) Capacity to consent

Question 7

Identify some dissemination (result distribution) issues that can arise during conduct of research:

Answer 7

1) To those involved
2) To translate into practice
3) To key stakeholders

Question 8

How do you know if you need ethical approval and what type?

Answer 8

• GAfREC (Government arrangements for Research Ethics Committees) states when review by REC is ethically and legally required
• NHS HRA (NHS Healthcare Research Authority) oversees research matters within the NHS including Research Ethics Review

Question 9

What decision tool can be used to help us understand whether we are conducting research, audit or service evaluation?

Answer 9

HRA decision tool online