National Health and Nutrition Exam Survey

为国家卫生统计中心（NCHS）提供支持，收集和处理国家健康和营养检查调查（NHANES）的DNA标本和数据。这笔资金将包括支持数据收集合同以外的合同（即实验室或阅读合同），据了解，下一年的费用将每年增加约3%，以支付合同因通货膨胀而自动增加的费用。a) NCHS， CDC将执行以下活动：i)收集，处理和储存DNA标本以供将来分析。国家卫生服务中心将指导数据收集承包商制定和修订食品频率筛选器试点测试方案，并编写培训和实地手册。ii)应NCI的要求，NCHS将在整个数据收集期间为质量控制目的提供协作审查汇总数据的机会。㈢在极少数情况下，国家卫生保健中心将逐案协助分析未公开发布的数据，以解决紧迫的公共卫生问题，这些问题不能等到下列活动（10.a.4）中所述的预定数据发布时才公布。此分析将在安全数据中心等受控条件下进行，或者通过生成不会出现公开问题的表或其他输出来完成。iv) NCHS将在每两年的数据收集后发布数据。（见附件C）如果在2年数据收集期后的第二年第二季度之前没有从数据收集承包商或实验室/阅读组织（合同或联邦）收到相应的数据，数据发布将落后于附件C中概述的时间表。此外，如果方法学或数据质量问题没有得到解决，受影响的数据将不会按照时间表发布。此后，将按照优化国家卫生信息中心资源的时间表，公开发布每2年周期的NHANES数据。v)一些NHANES数据是在研究人群的子样本上收集的。虽然这些数据将以与完整样本数据相同的周期发布，但有时可能需要两年以上的数据才能满足所有分析目标。对于一些完整的样本来说，这可能也是正确的。所有NHANES数据都被认为是敏感数据。因此，NCHS有必要将对某些数据项的访问限制在一个安全的数据中心内vi) NCHS将在一般数据发布前大约3个月向合作者提供一份数据文件进行质量审查。b) NCI应执行以下活动：i)指定一名项目官员作为文件的保管人，负责遵守所有使用条件，并建立和维护安全安排，以防止未经主任、DHANES和NCHS保密官授权的情况发生。ii)在规划数据收集方面提供所需的科学和技术投入。这包括提供制定DNA采集方案所需的输入。iii)为数据分析提供科学和技术投入。iv)就数据集的方法、分析或数据质量问题提供反馈。(1)在收到用于审查的数据之前，应按照附件B中的模型向NCI内部或内部协议中指定的NCI项目官员提供一份表格。在此表格签署后，将有一张CD-ROM发送给NCI。如果国家信息中心的其他工作人员、国家信息中心的顾问或合作者有权审查数据的质量，项目官员必须请求DHANES主任批准。一旦获得批准，他们就应该遵守本协议的要求。(2)在此期间，合作者应审查数据，以评估数据及其文件的质量和有用性。合作者将在两个月内报告数据中的任何不一致或使用数据的困难。国家人口统计中心将是公布或不公布哪些数据的最终仲裁者。(3) NCI同意，在全面发布之前，不会提交任何摘要或手稿，也不会使用这些数据进行公开演讲。c) NCHS、CDC和NCI将共同开展以下活动：i)对数据收集和处理的各个方面建立持续的质量控制程序。这包括必要时进行实地观察，编写和审查收集数据的例行描述性和统计报告。质量保证访问可能每半年对现场数据收集点进行一次。只有在与NCHS项目官员协商后才能安排实地考察，并将与NHANES实地办事处协调。ii)建立一套报告系统，将第1项中所述成分的资金情况在测试时适当地传达给取样人员。3)关于为质量审查提供的NHANES数据的一般要求：由于收集NHANES数据的条件，包括向NHANES受访者提供的保密保证，NCI工作人员应该意识到，他们必须遵守《公共卫生服务法》第308(d)条的所有要求。因此，NCI同意：a)提供给NCI的数据不会泄露给任何其他方。数据将仅由美国国家卫生统计中心发布，而不是由数据收集承包商或任何其他方发布。对这些数据的所有请求都将提交给国家人口统计中心。具体而言，在NCHS有机会讨论308 (d)等要求和分析使用数据的限制之前，NCI不会根据任何州或联邦官员的任何命令提供数据。b)根据《公共卫生服务法》第308(d)条，唯一有权访问数据文件的人是国家卫生保健中心和国家卫生保健中心承包商的工作人员，他们已获得国家卫生保健中心的授权处理该文件，并签署了国家卫生保健中心的保密声明。c)资料将只作研究及统计分析之用。所有基于未公开发布的NHANES数据的报告，均应符合为避免NCHS保密手册第10节中规定的无意披露而制定的程序。报告将在提交演示或出版之前提交评论。NCHS同意在收到意见后10个工作日内向NCI提交意见（如有）。4)关于NHANES中期数据发布的要求：a)中期数据的定义是NHANES数据公开发布的正常两年周期以内的数据。b)可能需要在预定的两年发布之前发布NHANES合作者支持的某些数据项目，例如，但不限于与健康人2010目标或进展审查相关的数据。国家卫生信息中心将与请求者和合作者在个案基础上合作，以各方都能接受的方式发布这些数据项目。c)在使用临时数据或特殊用途数据文件的分析项目完成后，或在提供数据后不迟于三年内，NCI将销毁或向NCHS归还包含NHANES数据的所有原始、备份和衍生文件，并由第10.b.i项所述人员提供其销毁的正式确认。如果NCI需要额外的时间，在征得NCHS保密官的同意后，可协商新协议。5)关于NHANES数据额外使用的要求由于NCHS是所有NHANES数据的保管人，NCI必须请求NHANES主任批准对多余的生物标本进行方法学评估或分析。NCHS将与NCI密切合作，确保以双方都能接受的方式发布/发布数据。使用多余的生物标本将需要提交正式的提案，并进行技术和伦理审查和批准。

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.