Research Ethics

Question 1

What is the declaration of Helsinki?

Answer 1

Statement developed by the world medical association for the ethical principles for medical research involving human subjects

Question 2

Describe the regulation of human research in the UK

Answer 2

If it is involving NHS - National Research Ethics Service (NRES)
If it is not involving the NHS then at a local level the regulations in St Andrews - Research Ethics Committee

Question 3

What is the four criteria for informed consent?

Answer 3

1) Patient must have capacity,
2) Patient must give consent voluntarily,
3) Patient must be informed,
4) Consent must be continuing

Question 4

What does the first principle of Declaration of Helsinski say about consent?

Answer 4

No individual capable of giving informed consent should be enrolled in a research study unless they freely agree.

Question 5

What does the Declaration of Helsinki say about consent

Answer 5

• Participants must be informed of the right to refuse to participate in study or to withdraw consent to participate at any time.
• Physician must inform patient which aspects of their care are related to the research.

Question 6

In regards to informed consent what must you be alert to?

Answer 6

• Participants feeling pressured into agreeing.
• The problem of incentives,
• Sufficient information
• Vulnerable patients

Question 7

What were the ethical issues raised by the Tuskegee syphilis trials?

Answer 7

• Took advantage of 600 african-american men.
• No informed consent (told they were being treated for bad blood)
• It was meant to last 6 months but lasted 40 years
• Incentives; Free medical exams, free meals, free burial insurance.
• They were examined regularly but not 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 and 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 without her knowledge. The cells were shipped across the world and used in all kind of medical research. NO knowledge was ever shared or consent sought

Question 10

Debate the need for transparency in publication authorship and declaration of conflicts of interest

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

Outline the key arguments often cited for/against the use of animals in research

Answer 11

• Benefits,
• Model
• Sentience (ability to feel),
• Value,
• Moral agency,
• 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 accrue as result of programme. They are then granted: Site license, personal licence and project licence

Question 13

Explain 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 (better housing, minimise pain, improve welfare)