The following summarise the ten points of the Nuremberg Code. Which do you think was given primacy given the situation in the WWII concentration camps?
- Research should cease if the participant withdraws consent or there is reason to believe continuation of the research would be harmful
- Voluntary, informed consent is essential for research participation
- Experiments should only be conducted by qualified scientists demonstrating “the highest degree of skill and care”
- Risk benefit analyses should justify any research involving human participants
- Experiments should be beneficial for society and results not obtainable through other means
- Experimenters must avoid all unnecessary risks or harms to participants
- Experiments should be designed in line with current knowledge, including from animal trials
Reason 2: Voluntary consent is essential ofr research participation
What does the Respect for persons principle entail?
- Aims to ensure all participants give voluntary, informed consent for participation and that researchers maintain confidentiality and respect for the human dignity of participance
What does the ehtical principle of non-maleficence entail?
- Ensure that no undue risks or harms befall research participants, including psychological,physical,or social harms
What does the ehtical principle of Beneficence entail?
- To ensure all research is beneficial for society and that any risks to participants are justified in terms of the potential benefits of the results.
What does the ethical principle of justice entail?
- Aims to ensure the risks and benefits of research are fairly distributed across the population and involves transparent recruitment methods with clear inclusion and exclusion criteria
What does the ethical principle of scientific integrity entail?
- This principle aims to ensure results of studies are disseminated for critical review, that methods are replicable so their validity can be confirmed, and that experiments do not hide or later any of their results.
Yuan has been asked to participate in a clinical trial. He has been provided a consent form with a lot of medical jargon that he doesn’t understand. He asks the experimenters to explain the form to him but they refuse, insisting that if he signs it they will make sure nothing bad happens to him. In so doing the experimenters have violated the principle of:
Respect for persons
Experimenters studying the impact of loneliness on health among the elderly decide they cannot do a randomised controlled trial because of the risk of causing psychological distress among participants in the control group. In making this decision the experimenters were particular aware of the requirements for:
Non-maleficence (made sure that there would be no psychological harm)
Experimenters have discovered a drug that effectively reduces the size of malignant tumours. They are preparing a manuscript for publication but are concerned if they lay out their methodology too precisely that other laboratories will copy their research and commercialise the results. As such they decide to leave out a few steps in their method so it can’t be repeated by others. This violates the principle of :
Scientific Integrity (methodology should be published so that it is replicable)
Which types of studies may need HREC approval? questionnaires/surveys psychological testing physiological treatments observational studies accessing existing medical records collecting body tissues/fluids
All of them
What are questions that could be associated with scientific integrity on the ehtics committee?
does the research protocol promote accurate and honest recording of results?
how will the results be disseminated to the public and other researchers?
is the research necessary given existing knowledge?
has a detailed literature review been conducted?
are the researchers suitably qualified to conduct this research?
What are questions that could be associated with justice on an ethics committee?
Are the participant recruitment protocols fair?
do participants directly or indirectly benefit from their participation in the research?
will participants have access to the results of the study?
What are questions that could be associated with respect for persons on an ethics committee? -
how is participant welfare and privacy protected?
is the research sensitive to the cultural needs of participants?
how is informed consent guaranteed?
What are questions that could be associated with Beneficence and non-maleficence on an ethics committee?
does the research contribute something positive to society?
are the risks justified in the light of the potential benefits?
is there any compelling reason the research should not go forward (e.g. could the results be damaging to a particularly subset of the population?)
What is undue inducement?
- A reward for participating in research that is potentially coercive e.g. offering money to an impoverished person such that they feel they cannot afford to refuse.
When are unethical practices more likely to occur?
- When the researchers or institutions have a conflict of interest
What is duality of interests?
- Where two or more interests co-exist in the same situation or relationship
What is a conflict of interest?
- When a duality of interests leads to contradictory goals (e.g. If the goal of protecting participant welfare conflicts with the goal of producing a viable pharmaceutical product for research sponsors)
What is the ethical theory of consequentialism?
- focuses entirely on the consequences of actions to determine whether they were right or wrong
if the ends are good this justifies the means
includes UTALITARIANISM, a theory that focuses on achieving the greatest good for the greatest number e.g. maximising the happiness, health or preference satisfaction of as many people as possible
sometimes criticised for reducing people to numbers in an equation
What is the ethical theory of Egalitarianism?
a political and social theory focused on promoting EQUALITY
concerned with fair distribution of goods, including health
sometimes criticised for ignoring personal responsibilities
What is the ehtical theory of Libertarianism?
focused on individual FREEDOM, RIGHTS and RESPONSIBILITIES
defines fairness as equal ability to enjoy what one has earned
sometimes criticised for failing to acknowledge the impact of social disadvantage on opportunity
What is the ethical theory of Deontological theories?
- focused on RIGHTS DUTIES and other intrinsic moral features of actions, rather than their consequences
- includes Kantianism, the theory that posits one should never treat another human being as a “mere means” to some goal, but always as an end unto themselves
- sometimes criticised for being too strict to be practically useful
What is virtue ethics?
focused on the characteristics of a virtuous person and their actions
sometimes criticised for lacking action guidance if virtues are in conflict in a situation
What is caustistical reasoning?
focused on determining paradigm cases that can serve as precedents for future decisions
aims to treat like cases alike
sometimes criticised for relying on past decisions that might be outdated
