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 News

 

  • Cindy Gates, Vice President of Education & Consulting Services at WIRB has been invited to speak

    on “Recent Developments in Human Subjects Protection Regulation” at MAGI’s Clinical Research Conference – 2012 East in Washington, DC, May 20-23, 2012 and at HCCAs Research Compliance Conference on “Risk Based Monitoring” in Austin, Texas June 3-6, 2012.

  • New federal requirement for consent 21 CFR 50.25(c)

    Effective March 7, 2012, a new federal requirement for consent forms takes effect. New federal regulation 21 CFR 50.25(c) states:

    “When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

    Because not all research reviewed by WIRB will need to have the statement referenced above in consent forms, we are in the process of updating our initial review submission forms with the following new question:

    Is this research an “applicable clinical trial” that must be registered on ClinicalTrials.gov? yes no

    If yes, effective March 7, 2012, the consent form must include the following statement (verbatim)

    "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

    For more information see Federal Register: January 4, 2011 (Volume 76, Number 2) Page 256-270

    When the question is answered “yes,” WIRB will include the required statement in the consent form if it is not already there.

    If the question is answered “no”, WIRB will not include the required statement, but will not remove it when it is in the submitted consent forms.

    WIRB encourages submitters to use our online “smart form” to submit new research, but if you prefer to download and complete the Word or PDF forms posted on our web site, please be sure to use the current version (which is labeled “2012” in the footer). WIRB cannot accept the older versions of the form after February 29, 2012.

    Existing approved consent forms will not be modified to include the statement unless WIRB receives a request to add it.
 

 Events

 

  • March 12-17, ASCPT 2012 Annual Meeting

    WIRB will be attending the ASCPT 2012 Annual Meeting in National Harbor, MD. For more information, visit www.ascpt.org.

  • April 14-17, ACRP 2012 Global Conference & Exhibition

    WIRB will be a GOLD Sponsor this year at the ACRP 2012 Global Conference & Exhibition in Houston, TX. Visit WIRB at Booth #700 & 702. For more information, visit www.acrp2012.org.

  • April 18-20, 2012 AAHRPP Conference: Quality Human Research Protection Programs

    WIRB will be attending the AAHRPP Conference in Denver, CO. For more information, visit www.aahrpp.org.

  • June 1-5, ASCO 2012 Annual Meeting

    WIRB will be an Exhibitor at the ASCO 2012 Annual Meeting in Chicago, IL. Visit WIRB at Booth #11147. For more information, visit www.chicago2012.asco.org.

  • June 22, OHRP 2012 Community Forum

    WIRB will be an Exhibitor at the OHRP 2012 Community Forum at UPMC in Pittsburgh, PA.

  • June 24-28 DIA 2012 Annual Meeting

    WIRB will be an Exhibitor at the DIA 2012 Annual Meeting in Philadelphia, PA. Visit WIRB at Booth #2107. For more information, visit www.diahome.org.