Research Ethics Flashcards
What do we have research ethics?
to prevent bad research
what are the 3 significant codes?
Nuremberg code
Declaration of Helsinki
Belmont report
what is the Nuremberg code?
-a set of guidelines formed following WWII to ensure the atrocities committed by the nazi researchers would not be repeated.
-Human beings MUST consent voluntarily to research before they are enrolled to participate
what is the declaration of Helsinki?
-developed by the world medical association in 1964
- outline ethical principles to follow when conducting research with human participants
- the main focus of the document was the ethical complexities of conducting human participant research in foreign countries and ensuring that the protection for human participants not be lessened by things such as national ethical, legal, or regulatory requirements
what is the Belmont report?
- the Tuskegee experiment
-formation of the national research act (US) in 1974
what are the principles of the Belmont report?
-respect for persons: respects the autonomy of people and provides protection for those with diminished autonomy
-benefience: do no harm, maximize benefits and minimize risks
-justice: fair, equal - balance of the burdens and benefits of research
what does respect for persons highlight?
autonomy
voluntariness of participation
informed choice
capacity
what does concern for welfare highlight?
risk must be in proportion to benefits
no unnecessary risks
consideration of the impact of participation on a participant and the community they are part of
what does justice highlight?
fair and equitable treatment
equal distribution of risks and benefits
protection of vulnerable populations
justifiable inclusion
managing power imbalances
what research requires ethical review?
research involving living humans
research involving human biological materials including embryos, fetuses, fetal tissues, reeproductive materials and stem cells
what is research according to ethics review?
an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation
who are human participants according to the ethics review?
those individuals who’s data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question
what are the expcetions when the review this board does not have to be involved?
publicly available information, documents
observation of people in public places
secondary use of de-identified information
what does the REB consider when it reviews research?
protection of human subjects
assess risks and benefits
assess research design to ensure minimal risk and meet objectives
review subject recruitment to ensure informed consent
protect vulnerable groups
what does informed consent entail?
participants must be told exactly what is going to happen to them
participants ar always free to choose to participant, end, or withdraw consent to use data collected from them
consent should be voluntary
there should be no undue influence, coercion, incentives
participants should be confident that their anonymity and confidentiality it respected and protected
what is considered coercion?
overwhelmed by institutional approval
fear of loss of health benefits, employment, or educational status
obligation to participate
financial gain
what are ethical issues if you are a clinician researcher?
role as a clinician/researcher gives you an “insider status”
participants are likely to have knowledge of your position
you need to separate your role as a clinician and researcher
identify your role in the context of the research
make your involvement in the research obvious
what are some suggestions for acting as a clinician researcher?
do not wear professional attire
do not answer questions as an OT
reflect on feelings, biases, and power issues
make these explicit and express them
how might there be power issues in research with your clients?
you have access to client files and data
in research you need to protect their confidentiality so you cannot access this information without permission
need to navigate dual relationship
what is coercion?
threat of harm
what is undue influence?
promise of unfair benefit
what are power issues in multi-disciplinary teams?
hierarchical relationships among health professionals
