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