28 Flashcards
What is beneficence ?
Beneficence refers to the obligations that we have to ‘benefit’ others
In research it is the obligation to ensure that the research is generating something of value that justifies the cost
What is non-maleficence ?
Non-maleficence refers to the obligation that we have not to harm others without a justifying reason
In reasearch this means being aware of the various potential harms to participants and others, and either taking steps to avoid these or ensure it that the benefits are sufffienct to justify the hardship
General policies for balancing benefits are harms
Typically, research ethics committees require applicants to show:
- an awareness of the various cost or harms to participants, including time, resources, coercive factories, and any opportunity costs (oncluding other treatments)
- strategies to address these harms or cots
- an awareness of potential cultural sensitivies or interests, including the implications for Maori
- evidence of the scientific validity of the research
What is clinical equipoise
The requirement that researches only provide an experiemantal treatment if the existence for the experimental treatment is equal to that available for the standard treatment
The idea is that the participant sould not suffer any substantial disadvantage from being in the study
There can be disagreement about when evidence is ‘equally poised’
Debate about which ‘standard treatment’ the intervention should be compared
What is a vulnerable person
Any person who is more at risk of exploitation, becuase of social or physical disadvantages
Poor
Race
Education
Older people
Prisoner
Cildrn
Ill
What is a conflict of interest
A situation where a person holds two or more potentially incomparable interests
These are of concern in research where the researchers have interests that might comprise the values and standards of ethically appropriate research
4 ways conflicts of interest can arise in research
- professionally
- academically
- financially
- politically
How conflicts of interest may be manages
- peer review
- blinding
- open access data
- auditing
- using independent people to recruit participants
Informed consent
Informed consent is ordinarily required when participants are enrolled in research studies
Adequelty informed consent requires
- disclosure of the purpose, risks and processes of the study
- reasonable efforts form researcher to explain this information
- the person is competent to give consent
- the absence of coercive factors (financial too)
Is verbal concentration valid?
Consent must be in writing - verbal consent is is suffficnt for most treatments
What does justice require:
- transparency
- that all people are considered of equal worth
- that efffots are made to make society equitable
Justice applied to research means
- within a population there should be a fair distribution of the benefits and burdens of participation in a study. Investigates muscat avoid imposing unfair burden of participation on particular groupss
- studies cshould be defined so threat the inclusion and exclusion are fair. People should not be excluded on the basis of sex, sexuality, ethnicity, national origin, religion, education or socioeconomic status, except where such exclusion or inclusion is essential to the purposes of the study
- founders and researchers should support and design research that could help reduce inequity
Ethics comittees in NZ - REVIWE PROCESSES
- the ministry of health administers 4 health and disability ethics committees for oversight of health research
AND ALSO: - advisory committee on assisted reproductive technologies (ACART)
- ethics committee on assisted reproductive technologies (ECART)
Research institutions UoO have their own committees
