Seminar - Ethics

Question 1

outline one historical event which proves ethical regulations are needed

Answer 1

• syphillis study in alabama 1932-1972 - gave syphilis injection to 400 patients without telling them and withheld treatment from them even when penicillin became widely available
• Nazi doctors in WW2 - unethical medical research on prisoners of war

Question 2

why are ethical considerations needed generally?

Answer 2

genetics research
use of hazardous materials
conflicts of interest
and due to increase in number of researchers self-policing is not practicla

Question 3

what was the Nuremerg code in 1947

Answer 3

voluntary participation is needed and risk of harm should be weighed against benefit to society
- blueprint to todays principals

Question 4

when was the first ethics comittee set up in the Uk

Answer 4

1966

Question 5

what is the declaration at Helsinki 1964

Answer 5

guided physicians of biomedical research in using human subjects
lead to first Uk ethics comittee

Question 6

what is audit

Answer 6

does not involve anything being done to patients which would not have been part of their normal routine management
this does not require ethical approval

Question 7

what are some ethical principles

Answer 7

• every individual has the right to determine what happens to them - CONSENT
• no individual shall be placed at risk unless risk is reasonable in relation to anticipated benefit
• risk and benefit should not be unjustly distributed
• special protection to vulnerable subjects

Question 8

what is the purpose of ethical review

Answer 8

protect the dignity rights, safety and well being of research participants
in addition to legal framework

Question 9

what does the legal framework for research include

Answer 9

data protection act - confidentiality of data
mental capacity act

Question 10

outline the ethical application process

Answer 10

HRA (health research authority) - for all NHS research
- assesses governance and legal compliance and research ethic review
sponsor reviews application, has to call central booking service to book appointment, and then its submitted and validated

Question 11

who may be involved during application process

Answer 11

research ethics comittee
give opinion and meetings

Question 12

who is part of the research ethics comittee

Answer 12

mixture of experts and lay persons
- experts - GP, nurse, allied health professional, epidemiologist, statistician

Question 13

what are the issues of interest to the REC

Answer 13

purpose of research
scientific justification
how will it affect routine care
potential for harm/benefit of research participants
funding
compensation
informed consent

Question 14

what should informed consent include in the patient information sheet (PIS)?

Answer 14

purpose
what will happen
likely risks and benefits
protection of privacy

Question 15

what does section 251 of the health and social care act 2006 state

Answer 15

allows patient identifiable data to be used for medical research without consent of patients when it is not possible to use anon info
but REC and confidentiality advisory group (CAG) approval is needed

Question 16

what is a Caldicott guardian

Answer 16

collection use and transfer of patient related info must be approved by the trusts caldicott guardian
- covers all databases and record systems containing clinical information

Question 17

what are the caldicott principles

Answer 17

1. justify the purpose
2. patient identifiable data not to be used if there is an alternative
3. use minimum necessary patient identifiable info
4. access restricted to those who need it

Question 18

what are the principles of the GDPR 2018

Answer 18

data must be fairly and lawfully processed, for specific limited purposes
data minimisation - relevant only
accurate and legible - kept to date
storage limitation - not kept longer than neeeded
security and confidentiality