During the last decade, genomic cohort study has been developed in many countries by linking health data and genetic data in stored samples. Genomic cohort study is expected to find key genetic components that contribute to common diseases, thereby promising great advance in genome medicine. While many countries endeavor to build biobank systems, biobank-based genome research has raised importa...

The informed consent of human subjects is a fundamental principle of research ethics. Informed consent is a core principle in international codes of research ethics, as well as in discipline-specific guides to the ethical conduct of research. Scholars developing case reports or case studies need to be aware of the considerations that are involved in assuring that the principle of informed conse...

The different approaches of two nations to the issues surrounding informed consent by persons with no or limited capacity of understanding are compared. It is important that efforts to ensure formal compliance with consent procedures should not be allowed to distract attention from the risks of harm to individuals.

The current doctrine of informed consent falls far short of its potential to serve as a valuable safeguard for human research subjects. Instead of providing a channel of communication between physician and subject, informed consent is a lifeless entity responsible for a large portion of the misunderstanding existing between these parties. Acknowledging risk perception principles may help transf...

INTRODUCTION ............................................................................ 174 I. A PRIVATE RIGHT OF ACTION FOR TREATMENT BUT NOT RESEARCH .......................................................................... 177 A. Informed Consent to Treatment ............................... 177 B. Informed Consent to Research .................................. 183 II. THE EVOLVING RESEARC...

The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, t...

That people should only be enrolled in medical research if they have given free and informed consent is now an unquestioned principle of research ethics. It is however a recent innovation. Prior to the prominence given to consent to participation in research in the condemnation of German doctors arraigned at Nuremberg in 1945, informed consent had appeared in American litigation, but only as an...

The aim of this article was to reflect about the Free and Informed Consent (IC) in qualitative researches in the health field. Coming from the experience of being part of a CER (Committee for Ethic in Research) in the health area the authoresses place in debate some important questions, exploring them and conducting suggestions. One of these questions and topic of analysis is the meaning of IC,...