Research Ethics

Question 1

Learning outcomes

Answer 1

Recognize the importance of the Declaration of Helsinki (2013) in human research
Identify the different ethical issues raised by the Tuskegee Syphilis trial, the Guatemalan STD trial, and the case of Henrietta Lacks
Explain why informed consent is important in research and some of the difficulties that can arise in the process
Debate the need for transparency in publication authorship and declaration of conflicts of interest
Outline the regulatory role of the Home Office in animal research, and the National Research Ethics Service (NRES) & local ethics committees in human research
Outline the key arguments often cited for/against the use of animals in research
Explain the three principles governing the use of animals in research (from the Home Office policy)

Question 2

What is the Nuremberg Code (1947)

Answer 2

A code by which ethical research on humans may take place, basically:
Voluntary consent of subject is essential
Experiments should only be done for results unobtainable by other means and which will better mankind
Experiments should be based off of the results of animal research
Experiments should be designed to minimise harm to the research subjects
Experiments should not be done if there is reason to believe death or debilitating injury will occur
The degree of risk must not exceed the possible benefits from the research to society
Proper preparations must be made in order to protect the subjects
Experiments should only be done by qualified researchers
Subjects must be free to terminate their participation in the experiment at any time
Researchers must be prepared to terminate the experiment at any time if they have reason to believe that it puts the subject in danger of death or debilitating injury

Question 3

What is the Declaration of Helsinki

Answer 3

(latest version 2013)
“The World Medical Association (WMA) has developed the Declaration of Helsinki as 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 4

What is the regulation in the UK on human research?

Answer 4

‘Human’ – participants, data, tissue
If involving NHS staff, patients or premises: National Research Ethics Service (NRES)
Local level: NHS Research Ethics Committee (NREC)
If not involving NHS, then:
Local level: Research Ethics Committee (REC) E.g. here at St Andrews, UTREC: https://www.st-andrews.ac.uk/utrec/

Policy framework for health and social care research (October 2017): http://beta.hra.nhs.uk/planning-and-improving-research/policies- standards-legislation/uk-policy-framework-health-social-care-research/

Question 5

What are the four criteria for valid consent in clinical practice?

Answer 5

Patient must have capacity

Patient must give consent voluntarily

Patient must be informed

Consent must be continuing