POPH progress test - Ethics Flashcards
Why ethics?
Ethics is about values and norms - ‘how we should live’
Health is a value driven exercise so health and ethics have long been associated
Research in the life sciences raises particular ethical concerns which scientists need to understand
Healthcare practice raises distinct ethical concerns which healthcare professionals need to understand
What is the value of health research?
We like to learn, an evolving knowledge is important
It enables better healthcare i.e. we do it to help people (beneficence)
What are the dangers of health research?
The research processes can be harmful. The ends may not justify the means
Those studied or observed in research may be vulnerable to particular types of harm
The benefits of research may not be fairly distributed
What can we do to make research ethically ok?
Assess the benefits and risks and ensure the ratio is acceptable (beneficence and non-maleficence)
Be aware of potential vulnerabilities to participants
Avoid or manage conflicts of interest
Obtain informed consent from patients
Consider how the benefits and burdens of the research should be shared across society
Introduce regulations and process to ensure these all happen
Ethical guidelines
Diversity
Justice
Conflict of interest
Respect for persons (respect for autonomy and vulnerable people)
Integrity
Beneficence and non-maleficence
Also introduction of Maāori principles into the guidelines
Beneficence and non-maleficence
Beneficence refers to the obligations that we have to ‘benefit’ others. In research, it refers to the fact that the study must be of some benefit either to individuals or whole populations
Non-maleficence refers to the obligation that we have not to harm others without a justifying reason. Refers to doing no harm (or at least the harm is clearly outweighed by the potential benefits)
There are examples of research regimes during the time of Hitler and these examples highlight that no amount of scientific benefit could justify the cruelty and murder committed by these regimes
Typically research ethics requires applicants to show:
An awareness of the various costs or harms to a patient including timel, resources, coercive factors and any opportunity costs (including other treatments)
Strategies to address these harms or costs
An awareness of potential cultural sensitivities or interests, including in NZ the implications for Māori
Evidence of the scientific validity of the research
Clinical equipoise
Is the requirement that researchers only provide an experimental treatment if the evidence for the experimental treatment is equal to that available for the standard treatment. The idea is that the participant should not suffer any substantial disadvantage from being in the study.
A concept related to Beneficence and Non-maleficence
Researchers must be genuinely uncertain what the outcome of the trial will be, and whether the intervention will be better or worse than the current treatment
Studies can be stopped prematurely if the study is showing benefit or risks to being in the intervention group
Protecting vulnerable people
A vulnerable person is any person who is more at risk of exploitation because of social or physical disadvantages. Examples might be:
Poorer people
Those subject to racial or religious discrimination
People who are less educated
Those suffering from cognitive impairments
Older people
Prisoners
Children
People who are ill (patients)
Research involving vulnerable people needs to include measures to protect those people from exploitation. Ethics committees will normally not permit researchers to do anything that may take advantage of the participants vulnerability
Conflicts of interest
A conflict of interest is a situation where a person holds two or more potentially incompatible interests. These are of concern in research where the researcher (s) have interests that might compromise the values discussed.
The results of the study can be swayed by researchers whom may have a vested interest in the outcome of the study
Conflicts of interest can arise in research in various ways:
Professionally
Academically
Note - For professionally and academically - obviously it is in the interest of the researcher to find a result, could mean a lot to them in terms of prestige
Financially - For example, drug companies exist to produce profits
Politically - Policies politicized so that what you vote for dictates what science you ‘believe’ in
Conflicts of interest can be managed in various ways, such through peer review, blinding, open access to data, auditing, and using independent people to recruit participants
Nevertheless, such conflicts appear to be an increasing threat to the integrity of research
Informed consent
Informed consent is ordinarily required when participants are enrolled in research studies
In every study, participants need to give written informed consent however this is ongoing and they can withdraw from the study if they wish
Informed consent requires…
Disclosure of the purpose, risks and processes of the study
Reasonable efforts from the researcher to explain this information
That the person is competent to give consent
The absence of any coercive factors (including financial inducements)
Justice
Justice requires that any study within a population fairly distributes the benefits and burdens of participation in the study/various studies
Vulnerable individuals should not bear the unfair burdens of participating constantly in these studies, nor should they be excluded from beneficial studies
Justice requires
Transparency
That all people are considered of equal worth
That efforts are made to make society equitable
Studies should be designed so that the inclusion and exclusion conditions for participants are fair. People should not be excluded on the basis of sex, ethnicity, national origin, religon, education or socioeconomic status, except where such exclusion or inclusion is essential to the purposes of the study
Diversity
Diversity is an ethical concept that requires researchers to understand, respect, acknowledge and recognise the diversity of the population they are investigating
Must consider the needs, cultural values and beliefs of various individuals
Integrity
As an ethical concept, integrity means it is essential that researchers strive to produce viable, untampered results in studies
Respect
Respect for persons - to have self-governance and autonomy
Study participants have a right to informed consent and withdrawl from the study without consequence
Protection of the vulnerable members of society
