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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 .

September 29th, 2011 by admin

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