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...

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,...

Most differences, shortcomings and contradictions regarding voluntary informed consent for participation in clinical research relate to the South African-specific guidance documents, i.e. South African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa (2006) and Ethics in Health Research: Principles, Structures and Processes (2004). These doc...

Nocebo effects, i.e., adverse treatment effects which are induced by patients' expectations, are known to contribute to the experience of physical symptoms such as pain and itch. A better understanding of how to minimize nocebo responses might eventually contribute to enhanced treatment effects. However, little is known about how to reduce nocebo effects. In the current randomized controlled st...

event rates in the studies invalidate the results of our study (1). First, we disagree that a prominent apparent nocebo effect biases toward underdetection of side effects in placebo-controlled trials. The nocebo phenomenon refers to symptoms, physiologic changes, or both that follow administration of a placebo that the patients believe to be an active drug (2). Since patients enrolled in place...

introduction: the purpose of the screening of fetal anomalies in pregnancy is empowering women to make an informed choice and reduce uncertainty in decision making. on the other hand, screening may cause worry and anxiety in pregnant women. this study was conducted with aim to determine the relationship between informed choice in pregnant women about screening of fetal anomalies with worry and ...