Drug development

Question 1

What is research ethics?

Answer 1

The moral principles that govern how researchers should carry out their work.

Question 2

What are the key

4 ethical issues in research ethics

Answer 2

1) Informed consent
2) Beneficence( do not cause harm)
3) Respecting anonymity and confidentiality
4) Respect for privacy

Question 3

What is clinical ethics?

Answer 3

The reflective practice of making the ‘right’ decisions as a healthcare profession and identifying possible ethical issues before making a decision during clinical practise.

Question 4

What are the 10 ethical issues in clinical ethics?(Name at least 5)

Answer 4

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

Question 5

What is the Declaration of Helsinki ?

Answer 5

It established the ethical principals that should be upheld in a clinical trial involving human participants.

Question 6

What is Good Clinical Practise?

Answer 6

An international standard to which all clinical research is conducted.
(it should be conducted ethically ,scientifically and to a practical standard)

Question 7

What is Good Science ?

Answer 7

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.

Question 8

What does Epistemic mean?

Answer 8

It means its realting to knowledge or the degree of validation

Question 9

What is Publication Ethics?

Answer 9

It ensures a high quality of science is being published so people can trust in it and those involved get credit .

Question 10

How does publication bias occur?

Answer 10

Trials that are unsuccessful are often not published which means only certain positive data comes to light rather than the failed trials data.

Question 11

What is Salami publication ?

Answer 11

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.

Question 12

What does ‘The Animals Act 1986’ cover

Answer 12

1) It regulates the use of lab animals
2) Provides protection of domestic animals, horses and primates
3) Requires an ethics committee in institution.

Question 13

Why are animals used in research?

Answer 13

To understand how the body functions and how diseases or treatments effect us.

Question 14

What are the 3 R’s in regards to animal testing?

Answer 14

Reduce
Replace
Refine

Question 15

Explain the 3 different R’s

Answer 15

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

Question 16

What is Governance?

Answer 16

All the processes that account for ‘governing’ an organisation.

Question 17

Outline the main components of Governance.

Answer 17

1) Systems
2) Strategic planning
3) Performance management
4) Risk management

Question 18

What are stakeholders ?

Answer 18

Any person interested or effected by a organisation or business.

Question 19

Describe the difference between internal and external stakeholders.

Answer 19

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,

Question 20

What is ‘The Human Tissue Act ‘?

Answer 20

Regulate activities concerning the removal, storage, use and disposal of human tissue.

Question 21

What is ‘The Medicines for Human Use(Clinical Trials) Regulations’?

Answer 21

It specifically covers the legal requirements for clinical trials involving an investigational medicinal product.

Question 22

How is governance used to minimise risk?

Answer 22

It allows you to identify risks , evaluate the risks and then identify ways to reduce the risk and finally implement risk reduction procedures.

Question 23

What are the key resources for medicine questions?

Answer 23

BNF , BNF-C , SPC, PIL

Question 24

What is the difference between BNF and BNF-C?

Answer 24

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.

Question 25

What is SPC(summary product characteristics) used for?

Answer 25

It provides info on a medicine to healthcare professionals about how it works , who cant use it etc.

Question 26

What is a PIL?

Answer 26

Patient Information Leaflet found in each medicine box and is compulsory by law to have inside.

Question 27

What is the UKTIS?

Answer 27

The UK Teratology Information service which provides info on medicines and how they effect pregnancy.

Question 28

What is UKDILAS?

Answer 28

A sub group of UKTIS that focuses on medicine and breast feeding.

Question 29

Describe Off-Label medicine use

Answer 29

When medicine not on the SPC is prescribed. However when this is prescribed the doctor or pharmacist have increased responsibility and liability but can be done if there good reasoning.

Question 30

What is an Adverse event? AE

Answer 30

An unexpected occurrence associated with the use of a drug in humans, regardless of casualty.

Question 31

What is an Adverse Drug Reaction(ADR)?

Answer 31

Any unwanted or harmful reactions experienced after the administration of a drug or combo of drugs under normal conditionas of use and is suspected to be related to the drug.

Question 32

What is a Serious Adverse Event ?SAE

Answer 32

Any AE that leads to death, life threatening, long term hospitalisation etc

Question 33

What is a Suspected Unexpected Serious Adverse Reactions (SUSAR)?

Answer 33

Any Serious adverse reaction where the nature or severity is not consistent with the product info hence why its unexpected.