Human use of humans: Ethics in Research Flashcards
What are ethics and morality?
Ethics: Moral principles that govern a person’s behaviour or the conducting of an activity.
Morality: Concerned with or derived from the code of behaviour that is considered right or acceptable in a particular society.
What are the basic concepts in medical ethics?
Respect for autonomy (autonomy refers to capacity to think, decide, and act on one’s own free initiative.
Beneficience: Promoting what is best for the patient
Non-maleficience: do no harm
Justice
What does the nuremburg code?
Set of research ethics principles for human experimentation. Set after WW2 to ensure consent and absence of coercion in human trials.
What are the important points of the nuremberg code?
- Voluntary, well-informed consent of subject/guardian
- Experiment should aim at positive results that cannot be procured in some other way
- Based on previous knowledge
- Be set up in a way that avoids unnecessary physical and mental suffering and injuries
- Should not be conducted when there is reason to believe it could cause harm
- Risks should be in proportion to the expected benefits
- Preparations and facilities must be provided that adequately protect subject against risks
- Those conducting experiment must be adequately qualified
- Human subjects must be free to withdraw from study at any time
- Staff must stop experiment at any point when it is apparent that contribution would be dangerous
What is the declaration of Helsinki?
World Medical Association broadened Nuremberg code to include the entire world.
Additional laws include:
Right to privacy
Confidentiality of personal information of research subjects
Privacy regarding use of identifiable human information
What are HeLa cells?
Cells that were taken from an African American girl, Henrietta Lacks, that was diagnosed with carcinoma of the cervix and was treated with radium.
These cells were grown and used for medical research following her death.
What does the belmont report do?
Identifies basic ethical principles that should underlie the conduct of biomedical and behavioural research involving human subjects
What is a code?
It is only a code and carries no legal imperative. If a person acts unethically their instituation can take actions. If crime is comitted only then can a person be punished in court.
An act is supported by law
How is informed consent achieved?
Researchers should provide clear and comprehensive information about:
How the data will be used
The form in which the data will be stored.
The purposes and whether they seek:
Specific, extended or unspecified consent for future research or permission from a review body to waive the need for consent.
What does HREC in Australia do?
Provides ethical oversight of research involving humans.
> 200 HRECs in institutions across Australia
What is health informatics ethics?
Sub-set of medical ethics that entails all issues relating to what can be done with data:
Sharing data
Wider responsibility
Implicit in these principles is beneficience and non-maleficence and non-transferability of the responsibility and accountability
What 3 forms can data be collected, stored or disclosed in?
Individually identifiable data (names, images, DOB, address, etc)
Re-identifiable data (identifiers have been removed and replaced by code. This process can be reversed to know identity.
Non-identifiable data (never been labelled with identifiers
What must be included in guidelines for databanks?
Clearly describe how research data will be collected, stored, used, and disclosed, and outline how that process conforms to this national statement.
What is the national statement on Ethical conduct in Human Research used for?
Guidelines made in accordance with the national health and medical research council act of 1992.
Compliance is a requirement for NHMRC funding.
What is AI used for in medicine?
Algorithms to improve diagnostics and help doctors make better decision.
Evaluate insurance/medical benefit claims
Assess medications and usage
Interpret MRIs and CT scans
Machine-learning based clinical guidance challenges the dynamics of responsibility in the doctor-patient relationship and the expectation of confidentiality.
