Research governance

Question 1

What is research governance?

Answer 1

Means by which NHS organisations ensure they are delivering high quality research. Involves:

1. Legislation
2. Principles and standards of good practice
3. Mechanisms to monitor and assess practice

Question 2

What is the role of the HRA?

Answer 2

Health Research Authority (HRA)

1. protect and promote the interests of patients and the public health in health and social care research
2. Make sure NHS based research is ethically reviewed and approved
3. Over see research ethics committees
4. Ensure that all research completed in-line with the ethical principles outlined in the declaration of helsinki

Question 3

What is the UK policy for health and social care research?

Answer 3

Policy framework that sets out principles of good practice in the management and conduct of health and social care research in the UK

Question 4

What are the 6 characteristics of good research (UK policy HSCR)?

Answer 4

1. Safe
2. Scientifically and ethically sound
3. legal
4. Has the relevant approval
5. Lets people choose to take part
6. Conducted by competent people who weigh up the risks and benefits

Question 5

What is IRAS?

Answer 5

Integrated Research Application System

HRA provided system
Captures information needed for relevant approval for ethical review bodies

E.g. Social care research ethics committee or Gene therapy advisory committiee

Question 6

What is the human tissue act?

Answer 6

Consent is the fundamental principle of the legislation and underpins the lawful removal, storage, use and disposal of humans bodies, organs and tissues

Allows for anonymous organ donation

Lead to the development of the human tissue authority