TITLE

VIRTUAL CLINICAL TRIALS: ONE STEP FORWARD, TWO STEPS BACK

AUTHOR(S)
ANDREWS, LORI; KOSTELECKY, KAYLA; SPRITZ, STEPHANIE; FRANCO, ALEXANDRA
PUB. DATE
July 2017
SOURCE
Journal of Health Care Law & Policy;2017, Vol. 19 Issue 2, p189
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Virtual clinical trials have entered the medical research landscape. Today's clinical trials recruit subjects online, obtain informed consent online, send treatments such as medications or devices to the subjects' homes, and require subjects to record their responses online. Virtual clinical trials could be a way to democratize clinical research and circumvent geographical limitations by allowing access to clinical research for people who live far from traditional medical research centers. But virtual clinical trials also depart dramatically from traditional medical research studies in ways that can harm individuals and the public at large. This article addresses the issues presented by virtual clinical trials with regard to: (1) recruitment methods; (2) informed consent; (3) confidentiality; (4) potential risks to the subjects; and (5) the safety and efficacy of treatments that are approved.
ACCESSION #
126275157

 

Related Articles

  • PROTECTION OF HUMAN SUBJECTS: IS EXPANSIVE REGULATION COUNTER-PRODUCTIVE? Charrow, Robert // Northwestern University Law Review;2007 Special Issue, Vol. 101 Issue 2, p707 

    The article highlights regulatory issues related to the implementation of a federal law that requires proposed research of virtually any type that involves human subjects and is either federally funded or within the jurisdiction of the U.S. Food and Drug Administration must be reviewed....

  • Privacy, Pediatrics, and Proprietary Disclosure. Wechsler, Jill // Applied Clinical Trials;Mar2001, Vol. 10 Issue 3, p26 

    Reports on developments related to clinical research trials in the United States as of March 2001. Proposed rules for public disclosure of protocol and safety by the U.S. Food and Drug Administration (FDA); Issuance of final medical privacy rules; Suggestions of the FDA to improve pediatric...

  • Controversy: Informed consent and cluster-randomized trials.  // IRB Advisor;Mar2010, Vol. 10 Issue 3, p31 

    An interview with Children's Hospital of Philadelphia Committees for the Protection of Human Subjects Chairperson Mark Schreiner is presented. When asked about the regulations of the U.S. Food and Drug Administration (FDA) concerning an informed consent in cluster randomized clinical trials,...

  • FDA details compliance for informed consent.  // Medical Ethics Advisor;Apr2012, Vol. 28 Issue 4, p42 

    The article presents information on a guidance issued by the U.S. Food and Drug Administration for complying with regulations regarding a consent document related to clinical trial information.

  • New consent requirement proposed.  // Medical Device Daily;12/31/2009, Vol. 13 Issue 251, p6 

    The article reports on the proposal of the U.S. Food and Drug Administration (FDA) to require that informed consent forms make note of the fact that clinical trials will be listed at the clinicaltrials.gov web site. The announcement was made in the December 29, 2009 issue of the "Federal...

  • FDA Amends Consent for Trials. Goedert, Joseph // Health Data Management;Mar2010, Vol. 18 Issue 3, p34 

    The article reports that a proposed rule to amend informed consent regulations related to clinical trials was issued by the U.S. Food and Drug Administration (FDA).

  • NEW FDA INFORMED CONSENT REGULATIONS EFFECTIVE MARCH 2011.  // Pharma Magazine;Jul/Aug2011, Vol. 7 Issue 4, p28 

    The article focuses on the amended regulations by the U.S. Food and Drug Administration (FDA) which requires the inclusion of statement in informed consent form, that data of the trial will be posted on www.clinicaltrials.gov. It says that clinical trials that meet the applicable clinical trial...

  • A New Look at Informed Consent for Cancer Clinical Trials. Baer, Allison R.; Good, Marge; Schapira, Lidia // Journal of Oncology Practice;Jul2011, Vol. 7 Issue 4, p267 

    The article explores the elements of an informed consent for cancer clinical trials in the U.S. It highlights the recommendations developed by the National Cancer Institute to enhance the readability of informed consent document including the use of words familiar to the reader, definition of...

  • "My Right to Try": The Dangers of Unregulated Stem Cell Clinics. Harris, David T. // Cell & Tissue Transplantation & Therapy;2016, Vol. 8, p1 

    The article discusses claims made by group of patients for expensive stem cell clinical trials of the U.S. Food & Drug Administration in the U.S. It informs about the rise in stem cell clinics with physicians claiming they have a right to treat patients under the practice of medicine. It also...

  • FDA inks draft guidance for risk-based trial monitoring.  // Medical Device Daily;8/30/2011, Vol. 15 Issue 165, p1 

    The article focuses on a draft guidance for clinical trial monitoring that has been issued by the U.S. Food and Drug Administration (FDA). Noted is the aim of the agency to promote the increased use of centralized monitoring methods. The FDA comments on a guidance from the International...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

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

Try another library?
Sign out of this library

Other Topics