TITLE

KISS rule: Investigators need to keep it simple

PUB. DATE
October 2009
SOURCE
Clinical Trials Administrator;Oct2009, Vol. 7 Issue 10, p118
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
This article reports on the failure of researchers to develop an optimal way of giving study participants information they want to hear during the informed consent process, according to David H. Strauss of the New York State Psychiatric Institute. A regulatory-driven list of criteria is included in the informed consent document. He says informed consent documents should address important issues such as alternatives and what it means to be in a study that is placebo-controlled and randomized.
ACCESSION #
44312386

 

Related Articles

  • The Therapeutic Orientation to Clinical Trials. Miller, Franklin G.; Rosenstein, Donald L. // New England Journal of Medicine;4/3/2003, Vol. 348 Issue 14, p1383 

    Contends that a therapeutic orientation to clinical trials obscures the ethical differences between clinical research and medical care. View that it interferes with informed consent and with the development of a concept of professional integrity; Discussion of the physician and patient...

  • The Integral Role of Clinical Research in Clinical Care. Grunberg, Steven M.; Cefalu, William T. // New England Journal of Medicine;4/3/2003, Vol. 348 Issue 14, p1386 

    Discusses the ethical issue and distinction of clinical research and clinical care. The conflict between individualization of patient care and the standardization of scientific method; Arguments pro and con regarding clinical trials; Topics of paying patient volunteers and of informed consent.

  • Strategies for accelerated study startup. Searcy, Sam // CenterWatch Monthly;Nov2014, Vol. 21 Issue 11, p6 

    The article discusses the strategies, processes and technology for accelerating the start-up of a clinical research. Topics discussed include the development of customized form templates, the preparation of Site Information Forms ahead of site selection, and the use of Informed Consent Form....

  • Conducting clinical trials comes under greater scrutiny. Hilton, Listte // Dermatology Times;May2005, Vol. 26 Issue 5, p14 

    The article focuses on the rules for conducting clinical trials in the U.S. Form 1572 is one of the basic regulatory documents in clinical trials that lists commitments of the researchers. According to this document, researchers need to obtain informed consent from subjects involved in clinical...

  • 'Mirroring' the Ethics of Biobanking: What Analysis of Consent Documents Can Tell Us? Jurate, Serepkaite; Zivile, Valuckiene; Eugenijus, Gefenas // Science & Engineering Ethics;Dec2014, Vol. 20 Issue 4, p1079 

    Biobanks have been recognized as a key research infrastructure and how to approach ethical questions has been a topic of discussion for at least a decade by now. This article explores the characteristics of donors' participation in European biobanks as reflected in the consent documents of a...

  • Open access as a requirement for research ethics approval. Rogers, Wendy // BMJ: British Medical Journal;10/17/2015, Vol. 351 Issue 8029, ph5299 

    A letter to the editor is presented in response to the article "Restoring Study 329: Efficacy and Harms of Paroxetine and Imipramine in Treatment of Major Depression in Adolescence," by J. Le Noury and colleagues in the September 16, 2015 issue.

  • What's on your mind?  // Applied Clinical Trials;Jul2002, Vol. 11 Issue 7, p18 

    Explores the principle of informed consent to participate in clinical trials. Legal meanings and implications; Administration of study drugs; Evaluation of email as a safe means of information transfer in clinical trials.

  • Pediatric Informed Consent. Simar, M. Renee; Johnson, Virginia A. // Applied Clinical Trials;Jul2002, Vol. 11 Issue 7, p46 

    Compares adult and pediatric informed consent to clinical trials. Principles of pediatric consent; Algorithms for pediatric assent and parental permission; Sample guidance documents that refer to pediatric research.

  • Three Ways to Improve the Consent Process. McDaniel, Darren; Baker, Matt; McDaniel, Todd // Applied Clinical Trials;Oct2002, Vol. 11 Issue 10, p60 

    Offers suggestions to improve consent in clinical trials. Writing of a consent form; Institutional review boards' observation of the consent process; Acknowledgement of subjects' responsibility.

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