Flashcards in Ethical issues in health research in children Deck (17):
What are the ethical principles impacting research in children?
3. Distributive justice
4. Respect for informed consent
5. Respect for privacy and confidentiality
How does beneficence impact research in children?
Applying evidence-based care generated from research specific to children
How does non-maleficence impact research in children?
Avoiding harmful therapies extrapolated from adult patient data or experience
How does distributive justice impact research in children?
Allowing research benefits to be available to all populations
How does respect for informed consent impact research in children?
Supporting developing autonomy in children considering research participation
How does respect for privacy and confidentiality impact research in children?
Providing confidentiality within the limits of legal requirements
What must all human research in Canada go through?
How does the TCPS restrict risk?
1. Therapeutic risk are allowable if the benefits are greater than risks
2. Non-therapeutic (research only) risks are restricted to no greater than those encountered by persons in everyday life that relate to research
What is the role of REB?
1. Uphold the principle of respect and human dignity
2. Ensure the tenets are upheld in research: free and informed consent, respect for privacy and confidentiality, respect for justice and inclusiveness, and respect for vulnerable persons
3. Provide balanced review of the scholarly nature of the research
4. Ensure potential risks are proportionate to potential benefits
5. Ensure clinical equipose
What are the elements of informed consent?
1. Adequate information
3. Capacity to understand the information
What are examples of potential financial conflicts of interest?
Employment or leadership position in commercial firm, employment as consultant for commercial firm, stock ownership, honoraria, research funding or grant support, expert testimony, patents, or other remuneration, family member investments
What are examples of potential academic conflicts of interest?
Promotion or tenure based on productivity, stature based on publication impact scores, agenda of academic in conflict with research agenda of potential donors/sponsors
What are examples of personal conflicts of interest?
Research results supporting an ideology or preconceived conclusions, recruitment of own patients to research (duty of care)
What populations are at special risk with respect to adequately informed consent?
1. Those needing emergency care
2. Incarcerated or institutionalized
3. Participants in genetic or early phase drug research studies
4. Socially disadvantaged children
5. Children in international health research settings
6. Aboriginal children
7. Those with life-threatening disease
What is a Phase I drug study?
translate experimental models tested in tissue culture or animals to humans, and are primarily focused on establishing safety profiles and toxicity information of new drugs in patients with advanced disease for which there is no effective treatment
What is a Phase II drug study?
Apply drugs in doses that are found to be reasonably safe to determine a preliminary assessment of potential efficacy and develop expanded toxicity profiles, again in patients with advanced disease