CONSORT Guidelines Flashcards
What are the seven requirements to determine whether a research trial is ethical?
- Social or scientific value
- Scientific validity
- Fair subject selection
- Favourable risk-benefit ratio
- Independent review
- Informed consent
- Respect for potential and enrolled subjects
What is the social or scientific value requirement?
Evaluation of an intervention that will improve well-being and increase knowledge; must not exploit and scarce resources.
What is scientific validity requirement?
Use of accepted scientific principles and methods to produce reliable and valid data.
What is fair subject selection requirement?
Selection of subjects so that stigmatized and historically excluded and vulnerable populations are not targeted for risky research and rich and powerful are not favoured for risky research; in line with principle of justice.
What is a favourable risk-benefit ratio?
Minimization of risks and enhance benefits; risk to subject is proportional to benefit to society. Nonmaleficence, beneficence, and nonexploitation.
What is independent review?
Review of design of research trial, proposed subjects population, and risk-benefit ratio by individuals unaffiliated with research. Goes with public accountability and minimizing potential conflicts of interest.
What is informed consent?
Provision of information to subjects about purpose of research, procedures, potential risks, benefits, alternatives. Respect for autonomy.
What is respect for potential and enrolled subjects?
Respects by:
- Permit withdrawal
- Protect privacy through confidentiality
- Informing subjects of newly discovered risks or benefits
- Informed subjects of results of clinical research
- Maintain welfare of subjects
Does with respect for autonomy and welfare.
What is the differences between privacy and confidentiality?
Privacy: applies to the person
Confidentiality: applies to the data
What is clinical equipoise?
Genuine uncertainty in the expert medical community over whether a treatment will be beneficial.
What is the ethical concern with sample size?
Too many: exposed more people to risk
Too little: underpowered and not able to measure benefit
