ethics Flashcards
ethical guidelines
- guidelines a study must meet in order to go ahead
(DJCRIB: Doing jumping cartwheels really increases balance)
Diversity
Justice
Conflict of interest
Respect for persons (autonomy and vulnerable people )
Integrity
Beneficence and non-maleficence
diversity
- requires that researchers/ investigators understand, respect, acknowledge and recognise the diversity of the population they are researching
- must consider the needs, cultural values and beliefs of various individuals
justice
- any study within a population fair distributes the benefits & burdens of participation in the study/ various studies
- vulnerable individuals should not bare the unfair burdens of participating constantly in these studies, nor should they be excluded from beneficial studies
addressing conflict of interest
- when the results of the study can be swayed by researchers whom may have a vested interest in the outcome of the study
- it can be professional, political, financial, or academic related
respect
- respect for persons, to have self governance & autonomy
- study participants have a right to informed consent and with drawl from the study without consequences
- protection of the vulnerable members of society
integrity
as an ethical concept, integrity means it is essential that researchers strive to produce viable untampered results in studies
beneficence & non maleficence
- beneficence refers to the fact that the study must be of some benefit either to individuals or whole populations
- non maleficence refers to doing no harm (or at least the harm is clearly outweighed by the potential benefits)
clinical equipoise
- a concept related to beneficence and non maleficence = clinical equipoise
- this is the requirement that researchers must be genuinely uncertain what the outcome of the trial will be and whether the intervention will be worse or better than the current treatment
- the participants should not be subject to any substantial disadvantage from being in the study
- studies can be stopped prematurely if the study is showing benefit or risks to being in the intervention group
informed consent
- important part of the ethics process in a study
- 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 risks, purpose and processes of the study
- that there is reasonable efforts from the research to explain this information
- that the person is competent to give consent
- no coercive factors involved (eg: money bribes)
what needs to be considered for research to be acceptable:
- assess the benefits and harms and ensure the ratio is acceptable (links to beneficence and non-maleficence)
- be aware of potential vulnerabilities of participants (links to all the principles)
- avoid or manage conflicts of interest (links to respect for persons and justice)
- obtain informed consent from participants (links to respect for persons)
- consider how the benefits and burdens of the research should be shared across society (links to justice)
what does beneficence refer to in research
in research it is the obligation to ensure that the research is generating something of value that justifies the costs
what does non-maleficence mean in research
in research this means being aware of the various potential harms to participants and others and either taking steps to avoid these or ensuring that the benefits are sufficient to justify the harms
what do research ethics committees require applicants to show
- an awareness of the various costs or harms to participants, including time, 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
How can conflict of interests be managed
- peer review
- blinding
- open access to data
- auditing
- using independent people to recruit participants
