California's new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity
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The article discusses the complexity of clinical research in critically ill patients, due to incompetency and inability to give valid consent. It relates on the legislative decree in Italy, wherein an informed consent may be granted by either the legal representatives or by the patients....
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More than twenty-five years have elapsed since the first Do Not Resuscitate (DNR) policies were proposed. A historical review of the application of DNR policies is provided with its rationale and perceived effects. A viewpoint is presented, that acceptance of implied consent for cardiopulmonary...
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Objective: A European Union Directive provides for the designation of a surrogate who can consent to or refuse inclusion of an incapacitated patient in research studies. The accuracy with which surrogates consent to research on behalf of patients has not been evaluated in the... - ‘No Time to be Lost!’. Kompanje, Erwin J. O. // Science & Engineering Ethics;Sep2007, Vol. 13 Issue 3, p371
Severe Traumatic Brain Injury (TBI) remains a major cause of death and disability afflicting mostly young adult males and elderly people, resulting in high economic costs to society. Therapeutic approaches focus on reducing the risk on secondary brain injury. Specific ethical issues pertaining...
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Introduction: Research in intensive care is necessary for the continuing advancement of patient care. In research, informed consent is considered essential for patient protection. In intensive care, the modalities of informed consent are currently being debated by both lawyers and the medical...
- A change in the Dutch Directive on Medical Research Involving Human Subjects strongly increases the number of eligible intensive care patients: an observational study. Veelo, Denise P.; Spronk, Peter E.; Kuiper, Michael A.; Korevaar, Johanna C.; van der Voort, Peter H. J.; Schultz, Marcus J. // Intensive Care Medicine;Nov2006, Vol. 32 Issue 11, p1845
Objectives: To determine the effect of a change in the "Dutch Directive on Medical Research Involving Human Subjects" (DD) on the number of eligible intensive care unit (ICU) patients for medical research. In addition, we determined how family members experience their role as acting... - The Historical, Ethical, and Legal Background of Human-Subjects Research. Rice, Todd W. // Respiratory Care;Oct2008, Vol. 53 Issue 10, p1325
The current system of human-subject-research oversight and protections has developed over the last 5 decades. The principles of conducting human research were first developed as the Nuremberg code to try Nazi war criminals. The 3 basic elements of the Nuremberg Code (voluntary informed consent,...
- Protection of Human Subjects in Research Trials. York, Donald H. // American Journal of Electroneurodiagnostic Technology;Jun2003, Vol. 43 Issue 2, p54
Discusses the required protection of human subjects in U.S. research trials. Requirements for informed consent in human trials; Concept of informed consent, as stated in the Nuremberg Code; Definition of research under the U.S. Code of Federal Regulations; Difference between research and...
