Ethics, good practise and regulations Flashcards
What are ethics?
Moral Principles governing a person’s behaviour or activity
What are ethics in clinical research?
Moral principles governing all aspects of the research
What are clinical research ethics achieved through? 3
network of research ethics processes, standards for professional practise and system of legal obligations
What are the core values and principles for doctors set by?
GMC
Dates and names of the 4 main ethical guidelines:
1947- Nuremberg code
1964- Declaration of Helsinki
1979- Belmont report
1996- MRC GMC
What is the ICH GCP?
International ethical and scientific quality standards for all aspects of trials that need subjects- provides basis for quality standards
Why do we need ethical guidelines? 4
- Protect rights, safety and dignity of participants 2. same ethical standards for all researchers 3. accountability (prevent misconduct) 4. Quality research
6 Key ethical principles in clinical research:
- Respect for participants
- Fully informed consent
- Favourable risk
- Independent review
- Research excellence
- Fair recruitment and selection
Respect for participants consists of:
protect rights, safety, dignity and wellbeing through autonomy, confidentiality, informing them of results
Favourable risk consists of?
minimise risk and look at benefit for participants too not just societal
Independent review consists of:
Oversight, accountability, assess risk benefit ratio
Research excellence consists of:
quality research with scientific value and adhering to regulations
Fair recruitment and selection consists of:
Don’t just target the underprivileged or vulnerable
What does healthcare research in UK fall under for regulations? Is it just one document?
Research framework for health and social care
many different bodies, refer to all collectively
What should always be considered in clinical research?
Protection of people in all stages
Who is responsible for setting regulations in the UK?
HRA- health research council
What does HRA do? (2)
Works with other organisations responsible, also hosts IRAS
What is IRAS?
single submission point for all the study documents to be reviewed by these partners
Name 3 HRA partners:
MHRA, NHS R and D, Research ethics committees
Role of independent research committees?
Any medical research involving humans must be approved by an independent research committee
4 independent research committees:
NHS REC, Social care REC, Genetic therapy advisory, Confidentiality advisory group
What is a research committee?
Independent research study trained in ethics with experts and lay members
So where should approval be obtained from before a clinical study can begin?5
Scientific experts, funders, sponsors, MHRA, IEC
6 steps of participant recruitment that should be clearly documented and scrutinised are:
- recruitment method, 2. inclusion/exclusion criteria, 3. Participant info sheet, 4. confidentiality/data protection, 5. risk assessment, 6. informed consent form
What is informed consent?
subject voluntarily confirms willing to participate having understood everything - written and signed
Who should the process of informed consent be conducted by?6
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
