Drug development Flashcards
(33 cards)
What is research ethics?
The moral principles that govern how researchers should carry out their work.
What are the key
4 ethical issues in research ethics
1) Informed consent
2) Beneficence( do not cause harm)
3) Respecting anonymity and confidentiality
4) Respect for privacy
What is clinical ethics?
The reflective practice of making the ‘right’ decisions as a healthcare profession and identifying possible ethical issues before making a decision during clinical practise.
What are the 10 ethical issues in clinical ethics?(Name at least 5)
1) Patients rights
2) Equity of resources
3) Confidentiality of the patients
4) Patients safety
5) Conflicts of interest
6) Ethics of privatisation
7) Informed consent
8) Dealing with the opposite sex
9) Beginning and end of life
10) Healthcare team ethics
What is the Declaration of Helsinki ?
It established the ethical principals that should be upheld in a clinical trial involving human participants.
What is Good Clinical Practise?
An international standard to which all clinical research is conducted.
(it should be conducted ethically ,scientifically and to a practical standard)
What is Good Science ?
Good science is where the work is both ethical and epistemic.
It is very important as both together means it follows the rules and accepted ways of society and also works with the knowledge that you have.
What does Epistemic mean?
It means its realting to knowledge or the degree of validation
What is Publication Ethics?
It ensures a high quality of science is being published so people can trust in it and those involved get credit .
How does publication bias occur?
Trials that are unsuccessful are often not published which means only certain positive data comes to light rather than the failed trials data.
What is Salami publication ?
Roughly defined as a publication of 2 or more articles from 1 single study. This could potentially give scientist more credit as they now have 3 articles rather than 1.
What does ‘The Animals Act 1986’ cover
1) It regulates the use of lab animals
2) Provides protection of domestic animals, horses and primates
3) Requires an ethics committee in institution.
Why are animals used in research?
To understand how the body functions and how diseases or treatments effect us.
What are the 3 R’s in regards to animal testing?
Reduce
Replace
Refine
Explain the 3 different R’s
REDUCE the amount of animals used
REPLACE animals and find alternative methods
REFINE to cause the least amount of pain or distress caused to the animal
What is Governance?
All the processes that account for ‘governing’ an organisation.
Outline the main components of Governance.
1) Systems
2) Strategic planning
3) Performance management
4) Risk management
What are stakeholders ?
Any person interested or effected by a organisation or business.
Describe the difference between internal and external stakeholders.
Internal stakeholders are part of the organisation e.g employees, managers and executives.
External stakeholders are not part of the organisation but are effected or interested in the organisation e.g customers, the local community,
What is ‘The Human Tissue Act ‘?
Regulate activities concerning the removal, storage, use and disposal of human tissue.
What is ‘The Medicines for Human Use(Clinical Trials) Regulations’?
It specifically covers the legal requirements for clinical trials involving an investigational medicinal product.
How is governance used to minimise risk?
It allows you to identify risks , evaluate the risks and then identify ways to reduce the risk and finally implement risk reduction procedures.
What are the key resources for medicine questions?
BNF , BNF-C , SPC, PIL
What is the difference between BNF and BNF-C?
BNF-C is the British national formulary for kids which provides info on medicines used more commonly on children and the effects on a child specifically.
