Guidelines for NHANES Research Proposal Submission

1. Guidelines for NHANES Research Proposal Submission by Natalie Dupree Margaret McDowell

2. Objectives • To provide a brief overview of NHANES • To describe the planning process for NHANES 2005-2006 • To provide collaborators with information about the research proposal preparation process

3. Goals of NHANES • Study the relationship of diet, nutrition and health • Explore emerging public health issues • Establish a national probability sample of genetic material for future research

4. NHANES sample design • Continuous data collection beginning in 1999 • Multi-stage probability sample • Annual national sample of 7,000 interviewed and 5,000 examined persons • Estimates of population subgroups require two or more years of data

5. NCHS NHANES Program Staff • Planning Branch • Operations Branch • Information Management Branch • Analysis Branch

6. Planning Branch Activities • Review current survey content • Coordinate NHANES Research Consortium activities • Prepare proposal guidelines • Solicit proposals • Coordinate review and evaluation of proposals • Decisions

7. Considerations for topic selection and inclusion • Safe, non-invasive procedures • Proven methodology • Prevalence of 5% or more • Feasible in NHANES environment • Funding available

8. Proposal evaluation criteria • Methods clearly stated • Public health significance documented • Participant burden • Data uses outlined • Target group(s) identified • Data relevant across other NHANES topics • Confidentiality and disclosure issues addressed

9. Analytic issues related to planning survey content • Cross-sectional design w/capability for longitudinal follow-up • Validated methods and data collection instruments used. • Ideally, a link between interview and examination content • Minimum 2-year data collection cycle

10. Examples of Proposal Topics • New questionnaire content • Modify existing questionnaire content • New examination component (e.g., nasal swab, dermatology exam) • Lab analyte

11. What is the collaborator’s role in the survey planning process? • Subject matter expertise and technical support • QA/QC evaluation of data during collection • Participation in NHANES field staff training • Funding support

12. Confidentiality and subject protection issues • Assurances for privacy, confidentiality,and safety of subjects • Institutional Review Board (IRB) approval of protocol and survey materials • Office of Management and Budget (OMB) approval- especially respondent burden issues

13. NHANES 2005-2006 planning timelines • Pilot testing (if needed): 1+ years prior to data collection • Synchronize w/survey’s 2 year data collection cycles (’05-’06, ’07-’08, etc.) • MEC configuration lead time • Survey information system and database preparation: ~6 months lead time

14. Research Proposal Guidelines for NHANES 2005-2006 • Letter of Intent • Initial NHANES Program response • Full proposal submission • Evaluation panel review

15. Letter of intent • Name of project • Statement of public health significance • Target age/gender group(s) • Research objectives • Summary of methodology • Questionnaire vs. exam • If questions – where to administer

16. Estimating Costs • Questionnaires: Guidelines provided (cost per minute, cost to modify CAPI) • Examination costs: Exam time, staff time, per sample domain • Data processing and preparation costs • CDC costs • NHANES Survey Costs: sampling, instrumentation, training, and reporting

17. NHANES Resources and points of contact • NHANES website • NHANES proposal guidelines and planning documents • Evaluation criteria • NHANES Listserv • NHANES Consortium

18. NHANES Website • Overview of NHANES • Questionnaires and survey components • Data products and reports • MEC virtual tour • NHANES 2005-2006 guidelines (future posting)

19. Summary • Learn about the Survey • Follow guidelines and instructions • Select appropriate topics and target groups • Link interview and exam components • Identify funding • Address human subjects issues