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L4A - Research Ethics
A code of ethics is only a code and carries no…
L4A - Research Ethics
A code of ethics is only a code and carries no legal imperative
- In Australia HRECs review study protocols and protect patients interests
Two Major Dimensions of Ethics in Research
A. Procedural ethics: involves seeking approval from a relevant ethics committee to undertake research involving humans
B. “Ethics in practice” or the everyday ethical issues that arise in the doing of research
Basic Concepts in Medical Ethics
Ethics and morality
- Principles establishing right of conduct rather than actual legality
- Distinguishes between right and wrong
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Morality
Concerned with or derived from the code of behaviour that constitutes what is acceptable in society
Respect for Autonomy
Autnomy refers to the capacity to think, decide and act on one's ow free initiatives
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Relationship between Ethics and Law
- Nuremburg Code
- Declaration of Helsinki (1964)
ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS)
- Ethical values are fluid, and always responding to cultural values
Ethics exists outside of the law
- Ethics are a matter of persoal conscience. - Ethics grows within a social context, therefore their is correspondence between ethics and law.
- Where ethics ad Law conflict, ethics must always prevail
Ethics exists within the Law
- Society's needs and governing laws define ethical behaviour
- What is ethical can never interfere with what is legally required
Nuremburg Code (1946)
- Research Ethics and Principles for human research established after the insights of the Nuremburg trials
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Code
- CONSENT: Required is the voluntary, well-informed, consent of the human subject (or
guardian) in a full legal capacity.
- AIM: The experiment should aim at positive results that cannot be procured in some
other way.
- JUSTIFICATION: be based on previous knowledge (eg, an expectation derived from
animal experiments) that justifies the experiment.
- BEST PRACTISE: be set up in a way that avoids unnecessary physical and mental
suffering and injuries.
- DO NO HARM: should not be conducted when there is reason to believe it could cause
harm.
- RISKS: the risks should be in proportion to (not exceed) the expected humanitarian
benefits.
- PROTECT AGAINST RISKS: preparations and facilities must be provided protect the subjects against risks. that adequately
- QUALIFIED RESEARCHERS: those conducting the experiment must be adequately
qualified.
- FREEDOM TO WITHDRAW FROM THE STUDY: the human subjects must be free to withdraw
- DISCONTINUE: the staff must stop the experiment at any point when it is apparent that
continuation would be dangerous.
Resistance and Mal-Adherence
Resistance to the Code: The ‘Nuremberg Code was useful for barbarians,’ but unnecessary for civilized physicians.
Details
- Involved - 8 months observation followed by interventions with contemporary treatments for Syphilis (many toxic)
=>was toxic treatment beteer than no treatment
- Men were actively prevented from exiting the study or from accessing treatment outside of that which they were being prescribed
- Particpants were illiterate African-Americans from Tusk. Alabama
- Did not give Informed Consent
- Uniformed of the dangers
- Made to agree to an autopsy after death
- Some were denied treatment n order to observe natural development of the disease
By 1947 Penicillin had become the standard treatment for curing syphilis, yet the study continued until 1972
- First Critic was Irwin Shatz (1965)
Consequences
28 people died from the disease, 100 died from related diseases, 40 wives infected, 19 children contracted congenital syphilis.
Decleration of Helsinki (1964)
Broadened the concerns of the Nuremburg Code
Significant additions include:
- Right to ‘privacy’
- confidentiality of personal information of research subjects
- Privacy regarding the use of identifiable human information
- Seven revisions, with the last (64th WMA General Assembly ) in 2013
Human use of Human Beings
- Tuskagee study
- HeLa cells)
Tuskegee Syphilis Experiment (1932-1972)
Initially not inherently unethical in 1932 - no cure available
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Henrietta Lacks (HeLa Cells)
- Diagnosed with cervical cancer
- Two tissue samples were taken without her permission (healthy + cancerous)
- Cultured to create the first immortal human cell line
Significance
Key in Research involving
- Polio Vaccine
- Cancer Research
- AIDS
- Gene mapping
- General health/commerical products
- 20 tons of her cell have since been grown
Ethical Issues
- Family Medical Records published without consent
- Genome published without family permission
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Belmont Report
Fundamental principles for using human subjects
- Commissioned as a result of the Tuskagee study
- Issued by the OHRP
- Issued 30th Sept 1978
- Published on 18th April 1979
Considerations
- Boundaries between biomedical research and accepted practice of medicine
- How risk-benefit criteria and the appropriateness of human involvement are assessed
- Guidelines for selecting humans subjects
- Definition of informed consent in research settings
Critique
Ethical analysis should be extended to cultural, gender, ethnic and geographical considerations
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