Study Designs - Lecture Twenty-Two Flashcards
Research Ethics
Ethics
Values and norms
NEAC Guidelines
Respect for persons Justice Beneficence and non-maleficence Integrity Diversity Addressing conflict of interest
Consideration No.1
Beneficence and Non-Maleficence
Beneficence and Non-Maleficence
Weighing benefits and harms in research
Beneficence
Obligations that we have to ‘benefit’ others
Non-Maleficence
Obligation that we have not to harm others without a justifying reason
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 Maori
Evidence of the scientific validity of the research
Consideration No.2
Protecting potentially vulnerable groups
Vulnerable people examples
Poorer people People subject to racial or religious discrimination People who are less educated Those suffering cognitive impairments Older people Prisoners Children People who are ill (patients)
Consideration No.3
Conflicts of Interest
Conflicts of Interest
Situation where a person holds two or more potentially incompatible interests
How can conflicts of interest be managed?
Peer review, blinding, open access to data, auditing, and using independent people to recruit participants
Consideration No.4
Informed Consent
Adequately informed consent requires
Disclosure of the purpose, risks, and processes of the study
Reasonable efforts from the researcher to explain this information
That the person is competent to give consent
The absence of any coercive factors (including financial inducements)
Consideration No.5
Justice