Research Ethics

Question 1

What is the Declaration of Helsinki?

Answer 1

A statement of ethical principles for medical research involving human subjects developed by the WMA

Question 2

What are the regulatory bodies of human research in the UK?

Answer 2

• NHS: National Research Ethics Service (NRES)

- non-NHS: local Research Ethics Committee (REC), in StA its UTREC

Question 3

What is the 4 criteria of consent?

Answer 3

• patient must have capacity
• patient must give consent voluntarily
• patient must be informed
• consent must be continuing

Question 4

What is the first Nuremberg Code?

Answer 4

the voluntary consent of the subject is absolutely essential

Question 5

What does the Declaration of Helsinki add to the first Nuremberg Code?

Answer 5

• each potential subject should be adequately informed of relevant aspects of the study such as aims and methods
• subject should be informed on the right to refuse to participate/withdraw consent at any time
• subject should be informed by physician of which aspects of care are related to research
• informed consent must be sought for research using identifiable human material/data

Question 6

What are things to look out for when taking informed consent?

Answer 6

• the participant feeling pressured into agreeing
• the problem of incentives
• sufficient information
• vulnerable patients

Question 7

What were the ethical issues raised in the Tuskegee Syphilis Trials?

Answer 7

• took advantage of 600 african-american men
• no informed consent - told they were being treated for bad blood
• was meant to be for 6 months but lasted 40 years
• incentives given: free medical exams, meals, burial insurance
• regular examination but none of the subjects were treated for the disease

Question 8

What were the ethical issues raised by the Guatemalan STD trials?

Answer 8

• US gov experimented on 5000+ Guatemalan soldiers, prisoners, people with psychiatric disorders, orphans and prostitutes
• exposed them to gonorrhoea, syphilis or chancroid.
• No evidence consent was sought.

Question 9

What were the ethical issues raised from the Henrietta lacks case?

Answer 9

• cells from Henrietta’s cervix where cultured in vitro
• cells were shipped across the world and used in medical research
• all done without her knowledge/consent

Question 10

Why is there a need for transparency in publication ethics?

Answer 10

• authorship: someone can put their name on research but only contributed very little so now they put names and their role on a paper
• conflict of interest: constitutes a problem when competing interests could unduly influence one’s responsibility in publication process. eg, financial ties, personal relationships, religious or political beliefs etc

Question 11

What are the arguments for/against research using animals?

Answer 11

• benefits
• model (animals are very different from humans)
• sentience (ability for animals to feel and experience emotions)
• value
• moral agency (ability to make moral judgement)
• spiritual/religious potential
• human achievement

Question 12

How does the Home Office determine if they should grant a project licence to test on animals?

Answer 12

• weight the likely adverse effects on the animal against the benefit likely to result of the programme.
• local animal ethics committees review and monitor all eligible research using ASPA/HO guidelines
• Site license
• personal licence
• project licence

Question 13

What are the three principles governing the use of animals in research?

Answer 13

3 Rs:

• replacement: alternative technologies
• reduction: better study design to allow for use of fewer animals
• refinement: eg. better housing, minimise pain, improve welfare