Research Ethics

Question 1

Declaration of Helsinki (latest version 2013)

Answer 1

a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data

• Consent (also be aware of coercion)
• Confidentiality (including resulting data)
• Risks and burdens
• Post-trial provision
• Publication

Question 2

if you are doing human research involving the NHS then what committee do you have to go through

Answer 2

Local level: NHS Research Ethics Committee (NREC)

Question 3

if you are doing human research not involving the NHS then what committee do you have to go through

Answer 3

Local level: Research Ethics Committee (REC)

Question 4

: four criteria for valid consent (in clinical practice)

Answer 4

Patient must have capacity
Patient must give consent voluntarily
Patient must be informed
Consent must be continuing

Question 5

can people who lack capacity to give informed consent participate in research studies?

Answer 5

yes as long as the physical or metal condition that causes the lack of capacity Is a necessary characteristic of the research population

Question 6

what to be alert for in informed consent

Answer 6

Participant feeling pressure into agreeing
The problem of incentives
Sufficient information
Vulnerable patients

Question 7

Tuskegee Syphilis Trials

Answer 7

a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks
where incentivised with free medical exams and meals and burial insurance and then denied treatment even when it became available.

Question 8

Guatemalan STD Trials

Answer 8

Exposed 558 soldiers, 486 patients at psychiatric hospital, 219 prisoners, 6 prostitutes, and 39 others to gonorrhoea, syphilis or chancroid

Question 9

Henrietta Lacks

Answer 9

cervical cells stolen without consent then daily not told even after her death

Question 10

Areas where animals are used in research:

Answer 10

Basic research

Applied research – treatments, toxicity

Question 11

aspects people need to consider in animal research

Answer 11

Benefits
Model
Sentience
Value
Moral agency
Spiritual/religious potential
Human achievement

Question 12

Singer

Answer 12

would experimenters be prepared to perform their experiments on orphaned humans with severe and irreversible brain damage if that were the only way to save thousands? if no then they have no justification to use animals in their testing

Question 13

animal cruelty acts

Answer 13

• The Cruelty to Animals Act, 1876 (1st country to do so)

- Animals (Scientific Procedures) Act 1986 (ASPA)

Question 14

Key principles in ASPA: 3 Rs

Answer 14

• replacement
• reduction
• refinement

Question 15

replacement

Answer 15

e.g. alternative technologies (in vitro, biochemical, mathematical & computer models); use lower organisms

Question 16

reduction

Answer 16

e.g. better study design to allow use of fewer animals; better storage of data

Question 17

refinement

Answer 17

e.g. improve housing; minimise pain; improve welfare

Question 18

Home Office

Answer 18

advised by Animal Procedures Inspectorate

Question 19

Each local arena

Answer 19

animal ethics committee (here in St Andrews, AWEC) – review & monitor all eligible research, using ASPA & Home Office guidelines

Question 20

Licenses are granted:

Answer 20

Site licence
Personal license
Project license