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New. SHIRB Continuing Review Policy

The New SHIRB Continuing Review Policy was emailed to the sites in September. All study coordinators should have received a copy. If you need a copy of the new policy, Please contact the Research Compliance office at 784-7840.

Effective 3/7/12, all qualifying new studies must contain the following language in the patient informed consent document. The Sunrise Health IRB will begin requiring this statement with new studies submitted for the January 2012 meeting. Studies approved by the Sunrise Health IRB prior to 12/31/11 do not require this language to be inserted into the consent form. For your convenience, we have had this language translated into Spanish. If you choose to cut and paste this statement into an existing consent form, please ensure that the formatting is consistent with the original document. Modified consent forms must be submitted with an amendment form to the IRB for approval prior to issuing to a patient. This administrative change meets expedited review criteria. Again, note that studies approved by the Sunrise Health IRB prior to 12/31/11 are exempt.

THIS STATEMENT MUST BE INSERTED VERBATIM. UNDER NO CIRCUMSTANCES CAN THE STATEMENT BE REVISED.

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.

About the Sunrise Health Hospitals

Consumer’s Choice 15 Consecutive Years

Nevada’s most comprehensive Children’s Hospital

The Nevada Neurosciences Institute at Sunrise

Las Vegas’ first hospital wired for the digital age (Southern Hills)

Comprehensive Breast Center with film and digital screening mammograms requiring no physician referral

ACoS Comprehensive Cancer Center

Region’s first network of certified Primary Stroke Center

Regional Level II Trauma Center

Las Vegas only network of accredited Chest Pain Centers

Welcome to the Office of Research Compliance

The Office of Research Compliance was created to develop, coordinate, communicate, plan, implement, and monitor compliance in human subjects research at Sunrise Health sites. The responsibilities and functions of this office include the following:

  • Facilitate research compliance initiatives throughout Sunrise Health and Sunrise Health -related entities.
  • Provide training of investigators, clinical coordinators, and other research-related staff concerning research-related statutory and regulatory requirements and Sunrise Health policies.
  • Develop a mechanism to raise questions and to receive appropriate guidance concerning research-related statutory and regulatory requirements.
  • Regularly review research activity through its Institutional Review Board to assess research compliance and to identify potential noncompliance.
  • Develop and maintain a process to report instances of possible noncompliance and for such reports to be fully and independently reviewed.
  • Develop a process for formulating and recommending corrective action plans to address any instances of noncompliance with Sunrise Health research-related policies and with federal and state laws and regulations related to research.
  • Create and incorporate standards and policies to guide research activities.

The Office of Research Compliance has developed this web site to provide all researchers the guidance and information needed to maintain compliance in the area of human subjects research.

The Office of Research Compliance is the administrative unit of the Institutional Review Board.

The Institutional Review Board

All research projects involving human subjects, conducted at Sunrise Health institutions, must be approved by the Sunrise Health Institutional Review Board (SHIRB) .

In accordance with the Department of Health and Human Services (DHHS), 45 CFR 46, and the regulations of the Food and Drug Administration, 21 CFR 50, the IRB has the authority to review, approve, require modifications in, or disapprove all human-subjects research activities that fall within its jurisdiction. The jurisdiction of the Sunrise Health IRB is defined by its Federal-wide Assurance document with the DHHS and by Sunrise Health institutional policies.

The Board of Trustees of Sunrise Health has designated the IRB as the compliance committee responsible for reviewing and approving human subjects research. No human subjects research activity may be conducted at any Sunrise Health institution unless the SHIRB has reviewed and approved the research prior to commencing the research activity.

This site will offer resources such as the IRB’s standard operating procedures manual, Federal-wide assurance information, IRB requirements and procedures, committee information, training requirements, application information, meeting schedules, and useful links for those involved in research. In coordination with the IRB, we hope to provide the best service we can to the research community at Sunrise Health institutions.

If you have any questions regarding the IRB, please contact the IRB Office at (702) 731-8559, or email sunrise.orc@hcahealthcare.com .

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    the man in the rockefeller suit
    the astonishing rise and spectacular fall of a serial impostor

    “Riveting.”
    –O, the Oprah Magazine

    “Fascinating. [The Man in the Rockefeller Suit] is a brisk narrative that has all the pace and drive of a suspense novel.” –The New York Times

    “A tailor-made riveting read… Forget fiction. Pop this jaw-dropper in your beach bag.” –USA Today

    “[An] impeccably reported and fascinating book.” –Los Angeles Times

    “This spectacular story is all in the entertaining details.”
    –Newsweek/ The Daily Beast
    (One of 10 Must Read Summer Books)

    “[A]n intense and compellingly told tale of a self-made man, in every sense of that term.” –The Washington Times

    “Fascinating.”
    –People Magazine (4 stars)

    “Irresistibly lucid and propulsive… Impossible to put down —Patricia Highsmith couldn�’t have written a more compelling thriller.” –Kirkus (starred review)

    “[A] fascinating account [Seal] brilliantly reconstructs and dissects Gerhartsreiter�’s strange life.” –Publishers Weekly (starred review)

    “It is impossible to read the book without getting caught up in his story on an almost hypnotic level.” –Booklist (starred review)

    “Should please anyone who enjoys a good comeuppance The talented Mr. Rockefeller could have come right out of a Hitchcock film.” –Library Journal

    The Author

    A journalist for thirty-five years, Mark Seal is a contributing editor at Vanity Fair and the author of Wildflower: An Extraordinary Life and Mysterious Death in Africa, about the murdered wildlife filmmaker and naturalist Joan Root. Seal was a 2010 National Magazine Award finalist for his Vanity Fair profile of Clark Rockefeller.

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    Paperback title will be released
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    The story of Clark Rockefeller is a stranger-than-fiction twist on the classic American success story of the self-made man- because Clark Rockefeller was totally made up. The career con man who convincingly passed himself off as a Rockefeller was born in a small village in Germany. At seventeen, obsessed with getting to America, he flew into the country on dubious student visa documents and his journey of deception began.

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    The story of The Man in the Rockefeller Suit is a probing and cinematic exploration of an audacious impostor-and a man determined to live the American dream by any means necessary.

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