What is the definition of Medical research?
To understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions
What is the duty of the physician?
To promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research
What should take precedence in medical research?
The rights and interests of individual research subjects
What research populations are considered vulnerable and need special protection?
- Pregnant Women
- Human fetuses and neonates
- Prisoners
- Children
- Mentally disabled
- Economically and/or educationally disadvantaged
To whom should the experimental protocol be submitted?
- The concerned research ethics committee
2. The committee must be transparent, independent
Who is responsible for the human subject?
The physician and never the research subject
What is the role of risk and benefits to the subject?
If the importance of the objective outweighs the risks and burdens to the research subjects
When is medical research justified?
xxx
What safeguards must be provided to research subjects?
xxx
What requirements are there for “informed”?
- Informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provision
- Informed of the right to refuse to participate
For persons who are unable to give consent, what 2 requirements must be met?
- The physician must seek informed consent from the legally authorized representative
- If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee
At the conclusion of the study, what must be assured to every patient?
Post-trial access for all participants who still need an intervention identified as beneficial in the trial
