1) Project Title:
National Health and Nutrition Examination Survey 2008-2009, DNA component.
2) Purpose:
To provide support to the National Center for Health Statistics (NCHS), for collection and processing of DNA specimens and data in the National Health and Nutrition Examination Survey (NHANES).
This funding will include support for contracts other than the data collection contract (ie; laboratory or reading contracts), it is understood that costs for the following year will increase by approximately three percent per year to cover automatic increases in the contracts for inflation.
a) NCHS, CDC will perform the following activities:
i) Collect, process, and store DNA specimens for future analysis. NCHS will direct the data collection contractor in establishing and revising protocols for the food Frequency Screener pilot testing and in preparing training and field manuals.
ii) NCHS will provide an opportunity to collaboratively review summary data for purposes of quality control at the request of NCI throughout the data collection period.
iii) On rare occurrences, NCHS will, on a case-by-case basis, facilitate analysis of data not publicly released to address compelling public health problems that cannot wait until the scheduled data release as described in the following activity (10.a.4). This analysis will occur under controlled conditions such as a secure Data Center, or be accomplished by producing tables or other output that does not present disclosure problems.
iv) NCHS will release data after each two years of data collection. (See Attachment C) If the respective data is not received from the data collection contractor, or the laboratory/reading organization (contract or Federal), by the 2nd quarter of the year following the 2-year data collection period, data release will lag behind the schedule outlined in Attachment C. Additionally, if methodologic or data quality problems are not resolved, the affected data will not be released according to schedule. Thereafter, data will be released publicly from each 2-year cycle of NHANES on a schedule that optimizes NCHS resources.
v) Some NHANES data is collected on sub-samples of the population studied. Although these data will be released on the same cycle as full sample data, there may be instances when more than two years of data will be needed to meet all analytic objectives. This may be true for some full samples as well. All NHANES data are considered sensitive data. Therefore, it will be necessary for NCHS to limit access to certain data items to a secure Data Cener
vi) NCHS will provide collaborators a data file for quality review approximately 3 months before the general data release.
b) NCI, will perform the following activities:
i) Designate a Project Officer as custodian of the files who will be responsible for observance of all conditions of use and for the establishment of and maintenance of security arrangement to prevent unauthorized by the Director, DHANES and by the NCHS Confidentiality Officer.
ii) Provide scientific and technical input as needed in planning data collection. This includes providing input needed to develop the protocols for the DNA collection.
iii) Provide scientific and technical input on data analyses.
iv) Provide feedback on datasets regarding methodologic, analytic, or data quality issues.
(1) A form following the model in Attachment B will be provided to the NCI project officer designated on the inter-or Intra-NCI agreement prior to receipt of the data for review. After this form is signed a CD-ROM will be forwarded to NCI. If other staff of NCI, consultants to or collaborators with NCI, are to be given access to review the quality of data, the project officer must request approval from the Director, DHANES. Once approval is granted, they are expected to abide by the requirements of this agreement.
(2) During this time period the collaborators should review the data to assess the quality and usefulness of the data and its documentatio |