Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care
Table 2
Ethical bases of scientific research and translational medicine.
Fundamental ethical principles underlying the new recommendations
Integrity of the research enterprise
In order to generate high scientific credibility of evidence, a process of supervision by qualified investigators that ensure the correctness of information is desirable.
Primacy of patient welfare
Stem cell research and stem cell-based interventions must be carried out according to the principles of the evidence-based medicine, with the utmost respect for the welfare of research subjects and/or patients.
Respect for research subjects
Consent procedures should prevent the overestimation of the potential benefits of the proposed treatment. Subjects with inadequate decision-making capacity must be protected from nontherapeutic procedures that implicate greater than minor increase over minimal risk.
The principle of respect for research subjects should be interpreted more broadly to include other subjects such as tissue providers and researchers who harbor conscientious objections regarding certain aspects of the research.
Transparency
Researchers should properly inform the public and the scientific community about the results of trials and preclinical research.
Social justice
The successes achieved in the field of clinical translation must be equally and globally distributed with particular regard for disadvantaged populations.
