Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Use of Vital Records for Research: What’s Happening in Missouri? Craig Ward, MSW Missouri Department of Health & Senior Services Bureau of Health Informatics

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 What you can expect... A description of how requests for vital records for research are processed in Missouri This presentation will be somewhat subjective.

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Missouri has a good track record in utilizing VR data… in developing vital statistics data resources for public health research and practice. Successive Pregnancy data sets (AKA Maternally-Linked datasets) , , the MICA web-based data query system.

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Steadying influences: Stable leadership (vital statistics managers with 30+ years experience) State statutes and regulations Federal law and national guidelines

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Factors for change: HIPAA - effective 2004 Political change - Missouri elected a new governor in 2004 Organizational change - Consolidation of IT services statewide, reorganization of DHSS and changes in leadership

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Factors for change (cont’d): More requests from researchers Development of complex data systems (ie, data cubes, electronic health records, longitudinal linkages) Need for internal oversight and controls

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Details of Change: Implementation of a Research Project Database Year YTD Total Requests VR VR/PAS Linked2210 PAS1010 Initial Reviews VR = Vital Records System PAS = Patient Abstract System

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Details of change: research protocol management Original requests assigned a tracking number Each step in review process tracked, including IRB review if needed Annual review/extension process implemented

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Protocol for Study/Project Using MO Vital Records A fillable form available on-line at: /ProtocolForm.dot. Current version was revised on 2/25/2008 further revisions in the making Required from researchers in MO DHSS and external researchers.

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Protocol for Study/Project Using MO Vital Records (cont’d) requires start and end dates of the study requires assurances regarding data confidentiality, use of data for specified project only and no contact of individuals without state registrar and state IRB approval

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Initial review process State registrar + 2 VS Research Mgrs + 1 HPR = VR review MO DHSS IRB review is a separate process with different reviewers MO DHSS IRB review not necessary if requested data has no identifiers or is mortality data with no follow-back to family members

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Tracking the Status of VR Research Projects: 2010 Annual Reviews Annual Reviews by Month MonthJanuaryFebruar y MarchAprilMayJune Total Requir es DHSS IRB MonthJulyAugustSeptemb er OctoberNovemb er Decembe r Total Requir es DHSS IRB

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Disclosure of VR information for legitimate research purposes is allowed in MO statute. The registrar of VR may authorize the disclosure of information contained in vital records for legitimate research purposes. The terms ‘legitimate’ and ‘research’ are defined by rule.

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 No data shall be furnished from records for research purposes until… The state registrar has received and approved a formal request The request shall be approved only if adequate assurances are provided that the research is legitimate and that the confidentiality of the records will be protected

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 No data shall be furnished from records for research purposes until…(cont’d) Security measures shall limit access to the records to members of the research staff Any release of records to other agencies shall only be with prior approval from the state registrar Individuals shall not be identified in published data Upon completion of the study, the records shall be destroyed or adequate security provided to prevent access or disclosure

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Vital Record Data Sets Available for Research Use Birth-Death Match File Birth Defects Registry/Surveillance (includes PAS data) Deaths Divorces (Dissolutions of Marriage) Fetal Deaths Live Births (Birth Certificate Data) Marriages Successive Pregnancy (Maternally-Linked Births)

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Approval of a research protocol is for one year at a time. Regardless of how long the study or project is expected to last Annual reviews will continue as long as Department data, even if data collection or data analysis phase is completed.

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Missouri Data Fees In an effort to recover the service cost incurred for staff time and other expenses involved in data delivery, the Bureau of Health Informatics charges fees based on a published fee schedule Fees are assessed for preparation of data based on programming time and materials. Payment is required before data files can be released.

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Fee Schedule (Continued) Beginning in 2010: Requests for record-level data, including de-identified data, will be assessed a fee of $300, due at the time the application is submitted, to cover the costs associated with the initial application review as well as the continual annual review of the study through completion by the Bureau of Health Informatics research staff. The review process will not begin until the application/review fee has been received in full.

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Fee Schedule (Continued) File Access:(Per Data Year) Birth Defect Registry Birth/Death Matched File (1) Births Deaths Divorces Induced Termination of Pregnancies25.00 Marriages Successive Pregnancy (3)

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Further changes being planned: REPORTING REQUIREMENTS Amendments Completed Projects A cover letter that describes the outcome of the study and the status of all data and information. n Copies of reports, citations or publications developed from the research. n Affidavit of Data Disposal

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Satisfied customers are what we strive for “ When I have the opportunity I like to let people who work in departments such as yours [know] that when I started requesting copies of death certificates from all the state[s], I was not looking forward to working with so many bureaucracies. My expectations were of red tape and working through wasted time. I have to let you know, that I couldn't have been more wrong. I have had wonderful responses from all states, and it has been delightful how cooperative and gracious folks have been.” Pat, April 28, 2010

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Disclaimers: The Missouri Department of Health and Senior Services, Section of Epidemiology for Public Health Practice is the original source of all data supporting this presentation. Any analysis, interpretations and conclusions reached are the result of the author, and not the Missouri Department of Health and Senior Services, Section of Epidemiology for Public Health Practice.

Gateway to the Future: Improving the National Vital Statistics System St. Louis, MO June 6 th – June 10 th, 2010 Contact Information Missouri Department of Health and Senior Services Bureau of Health Informatics 920 Wildwood Drive PO Box 570 Jefferson City, MO (573)