Ethics case study for clinical trials Flashcards
Ethical Concerns in Clinical Trials, Guiding Ethical Codes, Institutional Review Board, Informed Consent, Randomized Controlled Trials, Blinding and Double-Blind Studies, Ethical Principles in Research, COVID-19 Clinical Trials, Social Responsibility and Responsible Publication, International Ethical Standards
Name some ethical codes guiding clinical trials.
Nuremberg Code, Declaration of Helsinki, and country-specific regulations.
Who must approve clinical trials to ensure ethical standards?
Institutional Review Board (IRB).
What is the main goal of a randomized controlled trial (RCT)?
To demonstrate the safety and efficacy of new interventions.
When is an RCT ethically justified to begin?
Lack of convincing evidence that one intervention is superior.
What does randomization ensure in an RCT?
Similarity between control and experimental groups in otherwise uncontrollable aspects.
Why is blinding used in RCTs?
To reduce bias.
What does a “single-blind” study mean?
The participant does not know which intervention is received be the participant, although this is known to the research team.
What does a “double-blind” study mean?
Neither the participant nor the research team knows which intervention is received by the participant.
List five ethical principles in research.
Any five from: Honesty, objectivity, integrity, carefulness, openness, respect for IP, confidentiality, responsible publication, respect for colleagues, social responsibility, non-discrimination, competence, legality, animal care, human subjects protection.
What was a significant ethical challenge in COVID-19 drug trials?
Many were non-randomized and non-blinded.
What limitations did the 2020 Remdesivir trial for COVID-19 treatment face?
Open-label design, insufficient subgroup analyses, lack of recording/disclosure of key information (e.g., time between onset and randomisation, any deviance from protocol as decided by care providers, etc.)
When should clinical trials be stopped?
Either the time point specified in the registered protocol or when it becomes dangerous or no longer beneficial.
Why is social responsibility important in research?
Ensures research benefits society and minimizes harm.
What ethical issues are raised by non-randomized, non-blinded trials in the case study on COVID-19 drugs and vaccines?
Risk of bias and unreliable results.
What were the limitations of the chloroquine and hydroxychloroquine trials?
Lack of randomization, blinding, and small sample size.
