Guidelines for NHANES Research Proposal Submission

by

Natalie Dupree

Margaret McDowell

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

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

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

NCHS NHANES Program Staff

• Planning Branch

• Operations Branch

• Information Management Branch

• Analysis Branch

Planning Branch Activities

• Review current survey content

• Coordinate NHANES Research Consortium activities

• Prepare proposal guidelines

• Solicit proposals

• Coordinate review and evaluation of proposals

• Decisions

Considerations for topic selection and inclusion• Safe, non-invasive procedures

• Proven methodology

• Prevalence of 5% or more

• Feasible in NHANES environment

• Funding available

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

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

Examples of Proposal Topics

• New questionnaire content

• Modify existing questionnaire content

• New examination component (e.g., nasal swab, dermatology exam)

• Lab analyte

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

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

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

Research Proposal Guidelines for NHANES 2005-2006• Letter of Intent

• Initial NHANES Program response

• Full proposal submission

• Evaluation panel review

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

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

NHANES Resources and points of contact

• NHANES website

• NHANES proposal guidelines and planning documents

• Evaluation criteria

• NHANES Listserv

• NHANES Consortium

NHANES Website

• Overview of NHANES

• Questionnaires and survey components

• Data products and reports

• MEC virtual tour

• NHANES 2005-2006 guidelines (future posting)

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