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 documentation. The collaborator will report any inconsistencies in the data or difficulty using the data within two months. NCHS will be the final arbiter of what data will or will not be released. (3) NCI Agrees that no abstracts or manuscripts will be submitted or public presentations occur using the data prior to the general release. c) NCHS, CDC and NCI, will jointly perform the following activites: i) Establish an ongoing quality control program for all aspects of data collection and processing. This includes field observation, if needed, the development and review of routine descriptive and statistical reports of data collected. Quality assurance visits may occure semi-annually to field data collection sites. Field visits will only be scheduled after consultation with the NCHS Project Officer and will be coordinated with the NHANES Field Office. ii) Establish a reporting system for the funding of the components described in Item 1 to be communicated to the sample person at the time of testing, as appropriate. 3) General requirements regarding NHANES data provided for quality review: Because of the conditions under which the NHANES data are collected, including the confidentiality assurances given NHANES respondents, NCI staff should be aware that they are subject to all of the requirements of section 308(d) of the Public Health Service Act. Accordingly, NCI agrees that: a) Data provided to NCI will not be released to any other party. Data will only be released by NCHS and not by the data collection contractor or any other party. All requests for these data will be referred to NCHS. Specifically, data will not be provided by NCI in response to any order from any State or Federal officials until NCHS has had an opportunity to discuss the requirement such as 308 (d) and limitations of the data for analytic use. b) Under section 308(d) of the Public Health Service Act, the only person to be granted access privileges to the data file are staff members of NCI an dNCI contractors who have been authorized by NCHS to work with the file and have signed the NCHS Non-disclosure Statement. c) The Data will be used only for purposes of research and statistical analysis. All reports based on the NHANES data that have not been publicly released, will conform to procedures established to avoid inadvertent disclosure as set forth in Section 10 of the NCHS Manual on Confidentiality. Reports will be submitted to comment prior to submission for presentation or publication. NCHS agrees to submit comments, if any, to NCI within 10 working days of receipt. 4) Requirements regarding release of NHANES interim data: a) Interim data is defined as data covering less than the normal two-year cycle by which NHANES data are publicly released. b) There may be need to release certain data items that are supported by NHANES collaborators before the scheduled two-year release, for example, but not limited to data related to a Healthy People 2010 objective or progress review. NCHS will work with the requestor and the collaborator on a case-by-case basis to release such data items in a manner acceptable to all parties. c) Upon completion of an analytic project using Interim data or a special use data file, or no later than three years after provision of data, NCI will destroy or return to NCHS all original, backup and derived files containing NHANES data and provided official confirmation of their destruction by the persons named in item 10.b.i. Should NCI require additional time, a new agreement may be negotiated subject to approval of the NCHS Confidentiality Officer. 5) Requirements regarding additional uses of NHANES data As NCHS is the custodian of all NHANES data, NCI must request approval of the NHANES Director to conduct methodological evaluations or analyses of excess biological specimens. NCHS will work closely with NCI to ensure that data are published/released in a manner acceptable to both parties. Use of excess biological specimens will require a formal proposal submission and a technical and ethics review and approval.
