BACKGROUND For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readabili...

This Article reviews the essential findings of studies of variations in quality of care according to three categories of care: effective care, preference-sensitive care, and supply-sensitive care. It argues that malpractice liability and informed consent laws should be based on standards of practice that are appropriate to each category of care. In the case of effective care, the legal standard...

The past 15 years have been marked by an increasingly stringent regulatory atmosphere regarding the administration of ECT, leading to delays in treatment and declines in usage. Regulatory changes requiring judicial intervention in clinical decisions are driven by the notion that only the courts can provide adequate due process protections when legal rights and clinical need conflict. We retrosp...

Respecting the informed consent and its implementation is one of the fundamental components of high-quality health care. This article discusses the informed consent with an overview of Croatian and international legal documents and scientific studies dealing with this issue. Based on the review of the literature it can be concluded that this is an important issue that contains several key compo...

Because the legal and ethical aspects of informed consent are often foremost in clinicians’ minds, it is easy to forget that the purpose of informed consent is to aid in decision making. Informed consent forms, for example, are often written with legal and institutional priorities in mind,1 and patients in turn assume that the primary purpose of such forms is to protect physicians and their ins...

INTRODUCTION Medical student should be trained in medical ethics and one of the most essential issues in this field is taking informed consents. In this research, we compared the effect of effectiveness of teaching methods on students' ability intaking informed consent from patients. METHODS This semi-experimental study was carried out on fifty eight subjects from the 4th-year students  of Sh...

BACKGROUND Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed. METHODS The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionabl...

The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local...

Bronchoscopy is an established research tool in Malawi, enabling collection of pulmonary samples for immunological, pharmacological, and microbiological studies. It is, however, an invasive clinical procedure that offers no direct benefit to volunteering participants when used in a research capacity alone, and thus informed consent is essential. This study aimed to explore TB patients' understa...

Typically, a consent document in the United States is a printed form with blank spaces in which the operative procedure is filled in. The form is signed by the patient, and placed into the medical record. At first glance, it would seem that the patient was told of the operative procedure and gave his or her consent. Yet informed consent, or, more accurately, lack of informed consent, is a frequ...