TITLE

California's new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity

AUTHOR(S)
Luce, John M.
PUB. DATE
June 2003
SOURCE
Intensive Care Medicine;Jun2003, Vol. 29 Issue 6, p1024
SOURCE TYPE
Academic Journal
DOC. TYPE
journal article
ABSTRACT
The article discusses on California's new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity. In the United States federally funded clinical research is governed by the Code of Federal Regulations for the Protection of Human Subjects, which also is called the Common Rule. Many critically ill patients are incapable of giving informed consent because their decision-making capacity is impaired by their underlying diseases or by the administration of psychoactive drugs. The California Health and Safety Code formerly required that investigators obtain informed consent from the subject him or herself or through a legally authorized representative defined as a court appointed conservator.
ACCESSION #
16629437

 

Related Articles

  • Clinical research in critically ill patients: the situation in Italy. Zamperetti, Nereo; Latronico, Nicola // Intensive Care Medicine;Jul2008, Vol. 34 Issue 7, p1330 

    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....

  • "I don't like that, it's tricking people too much…": acute informed consent to participation in a trial of thrombolysis for stroke. Mangset, M.; Førde, R.; Nessa, J.; Berge, E.; Bruun WyIIer, T. // Journal of Medical Ethics;Oct2008, Vol. 34 Issue 10, p751 

    Background: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding. voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how...

  • DNR policies in North America: A procedural morass -- resuscitation practices revisited. Puri, V. K. // Indian Journal of Critical Care Medicine;Jan-Mar2006, Vol. 10 Issue 1, p35 

    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...

  • Ability of family members to predict patient's consent to critical care research. Ciroldi, Magali; Cariou, Alain; Adrie, Christophe; Annane, Djilali; Castelain, Vincent; Cohen, Yves; Delahaye, Arnaud; Joly, Luc; Galliot, Richard; Garrouste-Orgeas, Maité; Papazian, Laurent; Michel, Fabrice; Barnes, Nancy; Schlemmer, Benoit; Pochard, Frédéric; Azoulay, Elie; Joly, Luc Marie; Garrouste-Orgeas, Maité; Barnes, Nancy Kenstish; Pochard, Frédéric // Intensive Care Medicine;May2007, Vol. 33 Issue 5, p807 

    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...

  • Who should consent for research in adult intensive care? Preferences of patients and their relatives: a pilot study.  // Journal of Medical Ethics;Nov2009, Vol. 35 Issue 11, p14 

    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...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics