TITLE

Stick to the statistics on risk in informed consent documents

PUB. DATE
May 2009
SOURCE
Clinical Trials Administrator;May2009, Vol. 7 Issue 5, p58
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
This article explains that Yen-Hong Kuo, a biostatistician at the Jersey Shore University Medical Center in Neptune, New Jersey, is opposing the claim by Indepent Research Board (IRB) members, investigators and others that potential crinical trial participants will find hard data and numbers confusing when reading these descriptions of risk in informed consent documents. Kuo points out that investigators should put in the informed consent document both the statistics related to possible risks and descriptions or characteristics of that risk.
ACCESSION #
37811769

 

Related Articles

  • When is an inducement 'undue'? Is a payment ever coercive?  // Clinical Trials Administrator;Sep2008, Vol. 6 Issue 9, p103 

    The article explains the reasons why payments to research participants are a significant issue to clinical research professionals. According to Neal Dickert, a resident at Johns Hopkins Hospital in Baltimore, Maryland, paying people too much money might invalidate their ability to give informed...

  • Hope goes on trial. Brink, Susan // U.S. News & World Report;1/14/2002, Vol. 132 Issue 1, p51 

    Discusses informed consent among participants of medical clinical trials. Confusion among participants who do not understand that experiments may not be designed to help them but to develop future treatments; How confusion results from a lack of information regarding the trial; Mention of...

  • Assessment tool helps gauge consent abilities of Alzheimer's subjects.  // Clinical Trials Administrator;Sep2008, Vol. 6 Issue 9, p106 

    This article discusses research being done on the use of the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) to gauge consent abilities of people with Alzheimer's disease. It references a study published in the "American Journal of Geriatric Psychiatry" in 2008. The...

  • Calendar of Events.  // Applied Clinical Trials;Aug2004, Vol. 13 Issue 8, p56 

    Presents a calendar of events of interest to clinical trial professionals, compiled as of August 2004. Risk Assessment and Management; 11th Annual Workshop in Japan for Biostatistics; 1st Annual Japan Workshop for Pharmacogenomics.

  • ‘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...

  • Assessing the Ethics of Medical Research in Emergency Settings: How Do International Regulations Work in Practice? Halila, Ritva // Science & Engineering Ethics;Sep2007, Vol. 13 Issue 3, p305 

    Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a...

  • The Ethics of Research in Emergency Medicine. Biros, Michelle H. // Science & Engineering Ethics;Sep2007, Vol. 13 Issue 3, p279 

    The article comments on ethical issues that arise in emergency research. Researchers face difficulties in dealing with human subjects when doing research in emergency settings. Aside from the challenges encountered in designing and implementing studies that include critically ill patients, it is...

  • Start-up consultations improve site compliance.  // Medical Ethics Advisor;Feb2011, Vol. 27 Issue 2, p22 

    The article reports on start-up consultation, a study created to improve clinical trial site compliance in the U.S. It mentions that this type of consultation involves human subject research (HSR) regulatory experts who works with researchers to ensure that their documentation and consent...

  • Aging strategies call for 'reformed consent'  // IRB Advisor;Dec2009, Vol. 9 Issue 12, p142 

    The article calls for the reform of written informed consent (IC) forms used in clinical trial research involving human subjects. It suggests the presentation of IC document in a slide show accompanied by a narrative. Also recommended is the presentation of IC information in a way that would...

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