week 11- ethics and knowledge Flashcards
(32 cards)
ethics and history
- history places ethics into perspective
- those who fail to study history are condemned to repeat it
ethics
disciplined study of morality
morality
what should one’s behaviour and character be?
nuremberg code
- beginning of research ethics, had 10 rules
- research must be voluntary, must have legal capacity to agree/refuse research, must understand what they’re agreeing to, must have informed consent
historical unethical research
a) nazi experiments
b) untreated syphilis in black males
c) nutritional studies on first nations
d) san antonio contraceptive study
e) cameron’s LSD and brainwashing
f) jewish chronic disease study
g) willowbrook hospital- hepatitis study
h) schizophrenia medication study
i) ivory coast AIDS study
national regulations and policy on ethics
a) CNA code of ethics (1983): last revised in 2017
b) health canada: good clinical practice consolidated guidelines (2022)
c) CIHR, NSERC, SSHRC: tri council policy statement, last revised in 2022
protection of human rights
right to self determination, right to privacy and dignity, right to anonymity and confidentiality, right to fair treatment, right to protection from discomfort and harm
CNA code of ethics
- providing safe, compassionate, competent and ethical care
- promoting health and well being
- promoting and respecting informed decision-making
- honouring dignity
- maintaining privacy and confidentiality
- promoting justice
- being accountable
basic ethical principles
respect for persons, beneficence, justice
respect for persons
- treat individuals as autonomous agents
- allow people to choose for themselves
- give extra protection to those with limited autonomy
beneficence
- acts of kindness or charity that go beyond duty
- obligations derived from beneficence include do no harm, prevent harm, promote good
justice
- treat people fairly
- fair sharing of burdens and benefits of research
- free of power imbalances
how ethical principles are applied to research
a) respect: informed consent, respect for privacy
b) beneficence: sound research design, competent investigators, favourable risk-benefit ratio
c) justice: equitable selection of participants
human participant
a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information
informed consent
a) what it is: ongoing process of communications and mutual understanding, shared responsibility for protection
b) what it is not: a piece of paper, a moment in time, a legal contract
elements of informed consent
- study involving research states (purpose, expected duration and description of procedures)
- identification of experimental procedures
- reasonably foreseeable risks or discomforts
- reasonably foreseeable benefits for participants
- confidentiality
- compensation for research-related injury
- who can answer questions
- voluntary participation
- present in consent that generally involves an intervention
- payment
- who has access to records
- probability of random assignment
- special qualifications of investigator
comprehension of consent
- consent is not valid unless the participant understands what they’re agreeing to
- minimum grade 6-8 reading level
- responsibility for ensuring understanding rests with researcher who must consider the nature of the population, type of information, circumstance and timing, and language/culture
research ethics board
- review research projects and assess that ethical standards are met in relation to the protection of the rights of human participants
- is recruitment fair? is there a power imbalance? is there more benefit than risk? is autonomy maximized? is inclusion/exclusion criteria adequate?
components of REB
- at least five members of various backgrounds to promote complete and adequate project review
- members qualified by virtue of expertise, experience and reflect professional, gender, racial and cultural diversity
- membership must include one member whose concerns are primarily nonscientific
- at least one member from outside the institution
- REB members have mandatory training in scientific integrity and prevention of scientific misconduct
REB is responsible for protecting participants from undue risk and loss of personal rights and dignity
REB approval categories
a) exempt: low risk, nonvulnerable, nonsensitive, short duration
b) expedited review: minimal risk, nonvulnerable, nonsensitive topics (w/in 2 months)
c) full board review (6-8 months)
approval criteria of REB
- risks minimized
- risks balanced by benefits
- participant selection equitable
- procedures for obtaining informed consent
- procedures for consent documentation
- data monitoring provisions
- privacy and confidentiality measures
- safeguards for vulnerable participants
vulnerable participants
children, prisoners, mentally disabled, economically disadvantaged, educationally disadvantaged
*subtle vulnerability: language, culture, pregnancy, students, employees. substance misuse, health status
research involving indigenous people
- guidelines set by tri-council as good practices for researchers and REBs to follow
- created as a result of past injustices, including unethical research
- trentu specific policies
scientific fraud and misconduct
- fraudulent studies increase risk to all
- misconduct and unauthroized studies increase risk as ell
- can harm participants
- basing clinical practice on false data
- nurses obligated to report if they witness
