Vaccine Safety Research, Data Access, and Public Trust (2005) / Chapter Skim
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Appendix G Notice and Request for Comment on Procedures and Costs for Use of the Research Data Center
Appendix G Notice and Request for Comment on Procedures and Costs for Use of the Research Data Center
Pages 132-142
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From page 132... ...
Appendix G Notice and Request for Comment on Procedures and Costs for Use of the Research Data Center 132
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From page 133... ...
has been given HUMAN SERVICES Researcher -- Supplied Data the responsibility and resources for General Requirements for Guest Researchers General Requirements for Remote Access conducting analytic epidemiologic Centers for Disease Control and Use of RDC/NCHS investigations of residents of Prevention Costs for Using the RDC communities in the vicinity of DOE Procedures and Costs for Use of the Disclosure Review Process facilities, workers at DOE facilities, and Appendix I -- Examples of Data Available Research Data Center other persons potentially exposed to through the NCHS RDC radiation or to potential hazards from AGENCY: National Center for Health Appendix II -- Requirements for the Release non-nuclear energy production and use. Statistics, Centers for Disease Control of NCHS Micro Data Appendix III -- Disallowed SAS Functions, HHS has delegated program and Prevention (CDC)
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From page 134... ...
of the confidential data files remain in the consistent with the guidelines Public Health Service Act (42 U.S.C. RDC where access to unit records is published in the NCHS Staff Manual on 242m(d)
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. Proposals requesting remote output from the remote access system as staff to create the analytic files required access should include an appendix well as the security provisions by the project.
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From page 136... ...
For NCHS staff before removal from the include in their proposals a signed RDC files that are owned by NCHS, this RDC. Output is restricted to summary ``Agreement Regarding Conditions of determination is made by the owners of tables of geographic or patient-level data Access to Confidential Data in the the researcher-supplied data that will be (e.g., line listings of diagnoses by study Research Data Center for the National merged with the NCHS owned RDC identifier will be prohibited)
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granted access except those authorized Deliberate violation of any of these Researchers using the NCHS RDC will by NCHS Research Data Center staff. conditions may result in cancellation of be charged for space and equipment 2.
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Disclosure review material derived from the data should disclosure limitation: The Confidentiality consists of looking for tabular cells less acknowledge NCHS as the source and and Data Access Committee's Checklist on than 5, tables with geographic variables Disclosure Potential of Data (http:// should include a disclaimer that credits www.fcsm.gov/committees/cdac/ in any dimension, models with any analyses, interpretations, or checklist_799.doc) and Statistical Policy geographic variables (or variables conclusions reached by the author Working Paper 22, Report on Statistical tantamount to geographic variables)
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From page 139... ...
In addition to the above disallowed data files that reside at CDC to conduct new Documentation for variables and datasets statements and functions, users of the remote vaccine safety studies: used in VSD studies completed after August access system cannot use any statements or The VSD data files are comprised of several 2002 are maintained according to the CDC functions that write permanent data files to separate data sets derived from computerized data sharing policy regarding archival of data the hard disk. data sources from seven participating VSD that are available on the Web at http:// MCOs.
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From page 140... ...
CDC is · Disclaimers must be included in the conditions may result in cancellation of the not involved in the MCO IRB process at any manuscript which state: data access agreement, and the researcher time. General information pertaining to the The research was conducted using data may be escorted from the premises by the rules and regulations of IRB submission can from the Vaccine Safety Datalink Project, duly authorized Federal protection service on be found at http://www.cdc.gov/od/ads/ through the data sharing program at the duty at NCHS.
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From page 141... ...
Those desiring to make I certify that no confidential data or formal oral presentations should notify information viewed or otherwise obtained Food and Drug Administration the contact person before November 23, while I am a researcher in the National 2004, and submit a brief statement of Center for Health Statistics (NCHS) Research Oncologic Drugs Advisory Committee; the general nature of the evidence or Data Center (RDC)
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From page 142... ...
Prevention Research Data Center; Amendment Proposed routine use number 2 will release information to ``agency Disease, Disability, and Injury In the notice document announcing contractors or consultants'' who have Prevention and Control Special the ``Procedures and Costs for Use of the been engaged by the agency to assist in Emphasis Panel (SEP) : Reproductive Research Data Center,'' appearing on accomplishment of a CMS function Health Research, Request for page 67584 in the Federal Register issue related to this system of records (SOR)
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