Lecture 22: Research ethics Flashcards
What does Beneficence mean?
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 costs
What does Non-maleficence mean?
Non-maleficence refers to the obligation that we have not to harm others without a justifying reason. 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 does clinical equipoise mean?
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
What is a vulnerable person in relation to studies?
A vulnerable person is any person who is more at risk of exploitation, because of social or physical disadvantages
What are Conflicts of Interest in studies?
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 and standards of ethically appropriate research
Conflicts of interest can arise in research in various ways:
* Professionally
* Academically
* Financially
* Politically
What is Informed Consent?
disclosure, comprehension, competence, coercion (make descision without influence from others eg. financial)
What does justice in studies require?
- Transparency
- That all people are considered of equal worth
- That efforts are made to make society equitable
What are the Review Processes in NZ?
The Ministry of Health administers 4 Health and Disability Ethics Committees for oversight of health research
Also
- Advisory Committee on Assisted Reproductive Technologies (ACART)
- Ethics Committee on Assisted Reproductive Technologies (ECART)
Also
Research Institutions (such as the University of Otago) have their own Committees
What are the four National Ethics Advisory Committee (NEAC) 2019 Principles? What are the other four Te Ara Tika principles?
Beneficence
Non-Maleficence
Respect for people
Justice
Te Ara Tika principles:
Tika
Manaakitanga
Whakapapa
Mana (chiefs mana)
What does the tika principle refer to?
Tika refers to what is right and what is good for any particular situation. Importantly, in the context of ethics it relates to the design of a study, and whether the research achieves proposed outcomes, benefits participants and communities and brings about positive change.
What does the Manaakitanga principle refer to?
Manaakitanga refers to caring for others, nurturing relationships and being careful in the way we treat others. Aroha (respect, love), generosity, sharing and hosting are essential parts of manaakitanga, as is upholding the mana of all parties
What does the Whakapapa principle refer to?
Whakapapa refers to relationships; the term encompasses the quality of those relationships, the reasons for their formation and the structures or processes that have been established to support them
What does the mana principle refer to?
Mana refers to power, prestige, leadership or authority bestowed, gained or inherited individually or collectively. It infers that each individual has the right to determine their own destiny upon their own authority. Mana is an influencing factor in leadership and interpersonal and inter-group relationships, including those entailed in research. Shared knowledge upholds the mana of research participants
What does the respect principle underline?
Respect for people underlies the general human rights principle of autonomy but is also significant in cases where autonomy – and, in particular, a person’s capacity to exercise informed consent – is reduced.
What does the justice principle entail?
Justice requires that people are treated fairly and equitably. This includes fairly distributing or balancing the benefits and burdens of a study to populations and individual participants.
