Ethical Considerations in Clinical Trials

Ethical Considerations in Clinical Trials

Accessible online at: www.karger.com/journals/hed Ethical aspects of biomedical research in humans have been unmasked at a late stage in the history of science. They have been apparent for not more than approximately 60 years, and did not gain attention as a result of ongoing refinements of fundamental human rights. On the contrary, their recognition followed a traditional pattern in the histor...

Ethical considerations for clinical trials in inflammatory bowel disease.

Although advancements in the field of inflammatory bowel disease (IBD) include effective therapies for many patients with Crohn's disease and ulcerative colitis, there remains a large unmet need, and there is a large number of investigational agents in the pipeline. Drug development through clinical trials is critical to understanding the safety and efficacy of new therapies in the affected hum...

Ethical considerations in placebo-controlled randomised clinical trials

SUMMARY Ethical considerations in standard medical care and clinical research are underpinnings to quality medicine. Similarly, the placebo-controlled double-blind randomised clinical trial is the gold standard for medical research and fundamental to the development of evidence-based medicine. Researchers and clinicians are challenged by ethical concerns in the informed consent with a need to m...

e-Informed Consent in Clinical Trials – ethical considerations

This article is dedicated to analyze the possible impact of e-informed consent on clinical trials. The development of e-communication, telemedicine and e-Health, as well as the increasing number of clinical trials has required a new modality to inform and educate patients. Considering the importance of the informed consent from the patients’ point of view, we analyse the developing standards in...

Ethical considerations in AIDS vaccine trials.