Ethics, good practise and regulations

Question 1

What are ethics?

Answer 1

Moral Principles governing a person’s behaviour or activity

Question 2

What are ethics in clinical research?

Answer 2

Moral principles governing all aspects of the research

Question 3

What are clinical research ethics achieved through? 3

Answer 3

network of research ethics processes, standards for professional practise and system of legal obligations

Question 4

What are the core values and principles for doctors set by?

Answer 4

GMC

Question 5

Dates and names of the 4 main ethical guidelines:

Answer 5

1947- Nuremberg code
1964- Declaration of Helsinki
1979- Belmont report
1996- MRC GMC

Question 6

What is the ICH GCP?

Answer 6

International ethical and scientific quality standards for all aspects of trials that need subjects- provides basis for quality standards

Question 7

Why do we need ethical guidelines? 4

Answer 7

1. Protect rights, safety and dignity of participants 2. same ethical standards for all researchers 3. accountability (prevent misconduct) 4. Quality research

Question 8

6 Key ethical principles in clinical research:

Answer 8

1. Respect for participants
2. Fully informed consent
3. Favourable risk
4. Independent review
5. Research excellence
6. Fair recruitment and selection

Question 9

Respect for participants consists of:

Answer 9

protect rights, safety, dignity and wellbeing through autonomy, confidentiality, informing them of results

Question 10

Favourable risk consists of?

Answer 10

minimise risk and look at benefit for participants too not just societal

Question 11

Independent review consists of:

Answer 11

Oversight, accountability, assess risk benefit ratio

Question 12

Research excellence consists of:

Answer 12

quality research with scientific value and adhering to regulations

Question 13

Fair recruitment and selection consists of:

Answer 13

Don’t just target the underprivileged or vulnerable

Question 14

What does healthcare research in UK fall under for regulations? Is it just one document?

Answer 14

Research framework for health and social care

many different bodies, refer to all collectively

Question 15

What should always be considered in clinical research?

Answer 15

Protection of people in all stages

Question 16

Who is responsible for setting regulations in the UK?

Answer 16

HRA- health research council

Question 17

What does HRA do? (2)

Answer 17

Works with other organisations responsible, also hosts IRAS

Question 18

What is IRAS?

Answer 18

single submission point for all the study documents to be reviewed by these partners

Question 19

Name 3 HRA partners:

Answer 19

MHRA, NHS R and D, Research ethics committees

Question 20

Role of independent research committees?

Answer 20

Any medical research involving humans must be approved by an independent research committee

Question 21

4 independent research committees:

Answer 21

NHS REC, Social care REC, Genetic therapy advisory, Confidentiality advisory group

Question 22

What is a research committee?

Answer 22

Independent research study trained in ethics with experts and lay members

Question 23

So where should approval be obtained from before a clinical study can begin?5

Answer 23

Scientific experts, funders, sponsors, MHRA, IEC

Question 24

6 steps of participant recruitment that should be clearly documented and scrutinised are:

Answer 24

1. recruitment method, 2. inclusion/exclusion criteria, 3. Participant info sheet, 4. confidentiality/data protection, 5. risk assessment, 6. informed consent form

Question 25

What is informed consent?

Answer 25

subject voluntarily confirms willing to participate having understood everything - written and signed

Question 26

Who should the process of informed consent be conducted by?6

Answer 26

Members of the study team who are:
trained and competent in taking it
familiar with study
knowledgeable of treatment
provide verbal and written info (PIS)
Can discuss it fully, give time to think, answer patients questions
Understand the participants particular circumstances