Research Use

The department may authorize the disclosure of information contained in vital records and patient abstract files for legitimate research. Legitimate research is a systematic study designed to develop or contribute to generalizable knowledge of a defined population in accordance with generally accepted standards or principles governing research. There are three categories of data sets available depending on study requirements based on the minimum reasonably necessary to accomplish the intended purpose: De-identified, Limited Data Set, and Identifiable.

Research Processes

Investigators whose studies have been approved by the Department must maintain their approval in good standing. Annual review is required for each study for as long as DHSS-provided data are held.

Initial Research Use Information

Statutes, Rules and Regulations Pertaining to Vital Records Data

Missouri state statutes (193.045, 193.245, & 193.255) and the Code of State Regulations (19 CSR 10-10.090 Access to Vital Records) allow for the release of record-level vital records data by the Missouri Department of Health and Senior Services. The statutes listed above only apply to vital events occurring within Missouri’s borders. The records of vital events that occur to Missouri residents in other states are the property of the state where the events take place.

Under section 610.035, RSMo, the department is prohibited from disclosing any Social Security number of a living person unless such disclosure is permitted by federal law, federal regulation or state law. Section 208.120, RSMo prohibits the department from disclosing any information obtained by them in the discharge of their official duties relative to the identity of applicants for or recipients of benefits or the contents of any records (e.g., Medicaid, Food Stamps). Public assistance information can be provided on de-identified records only.

45 C.F.R. Part 160 and Part 164. Vital Records requestors for research purposes will only be provided access to the minimum information necessary to achieve their specific research requests. Requestors are prohibited from disclosing any information that would identify a person and are also prohibited from the re-release of the data provided.

Statutes, Rules and Regulations Pertaining to Patient Abstract System Data

Missouri state statutes (192.067, 192.665, & 192.667) and the Code of State Regulations (19 CSR 10-33.010 Reporting Patient Abstract Data by Hospitals and Ambulatory Surgical Centers) allow for the release of Patient Abstract System (PAS) data by the Missouri Department of Health and Senior Services. The Department and other public health authorities are authorized to utilize PAS information for epidemiologic studies and for surveillance. The statutes listed above apply to Missouri residents only.

Application Procedures

To request record-level data (whether identified or de-identified) for research, a principal investigator must submit a completed Research Protocol Application. The application requires detailed information about the study protocol, justification for all data elements requested (each data element must be related to the hypotheses), and measures to ensure the confidentiality and security of the data. All information must be clear, consistent and specific. General descriptions do not allow accurate assessment of the value of the study or the need for the data items. Release of data from vital records and/or the Patient Abstract System by the Missouri Department of Health and Senior Services is granted to an agency/institution for the sole purpose of the research project described in the protocol application. The applicant will be required to complete and submit an Agreement for Oversight. The Agreement for Oversight requires both the requestor’s signature and the Agency/Institutional Official’s signature with the authority to bind the agency into the agreement (must be two different staff). All persons that will have access to the data must be listed in the application and will be required to sign Confidentiality Pledge prior to being granted access to the study data.

It is the principal investigator's responsibility to design a valid study that would make a contribution to public health, and it is not the department's role to help refine a faulty study or a poorly described study until it meets generally acceptable scientific standards. Protocols of this nature will be rejected and further processing of such applications will be discontinued. An application will be immediately rejected if it is determined that:

it does not clearly describe a well-designed research or epidemiologic study,
the data will be used for commercial or marketing purposes, or private gain,
being a co-investigator would overburden the department, or
there is reason to believe that confidentiality of the data would be jeopardized by its release.

Researchers interested in obtaining DHSS data should first familiarize themselves with the data sets prior to designing their studies (see Data and Surveillance Systems). Only those data elements related to the hypotheses and necessary for the study should be requested. The principal investigator will be notified of any discrepancy between the list of data elements requested in the research protocol and those determined by DHSS staff to be needed. Vital Records and Patient Abstract Data custodian contact information may be found under the Contact Us link.

Please note:

All research proposals involving Patient Abstract System files/data are also reviewed by an independent Data Release Advisory Committee (DRAC). If the study involves identifiable record-level data for living subjects; linkage with another data set; or contact with family, next-of-kin, or acquaintances, proposals will also be submitted to the Department of Health & Senior Services (DHSS), Institutional Review Board (IRB) for review before study approval determination can be made by the appropriate data steward(s).

The following forms must also be completed for DHSS IRB review and approval (when applicable):

Abstract of Protocol

IRB Form 1 ‘Request for Review of Research Protocol’

Protocol Template

Checklist for Submission of Research/Study Protocols

If a study does not involve DRAC and/or DHSS IRB review, we suggest submitting a completed application at least two to three months prior to when data will be needed. Studies involving DRAC and/or DHSS IRB review generally require a longer review period, so we suggest submitting the completed application and IRB packet at least four to five months prior to when data will be needed. Protocol applications are reviewed on an ‘as time permits’ basis between other priority projects. The complexity of the requested data sets and the number of priority projects may impact the response time. Please plan accordingly.

Regardless of the duration of the study, approval is only for one year at a time. Annual review is required for each study for as long as Department data are held.

Review Process

A primary reviewer is assigned to each application to conduct a preliminary review and to correspond with the applicant if the information provided is unclear or incomplete. If insufficient documentation is presented to determine approval, additional information will be requested to clarify the application. The primary reviewer will be reviewing issues such as the purpose of the request, ensuring the research design demonstrates adequate scientific rigor, the appropriateness of requested data to answering proposed research questions, ensuring provisions for maintaining confidentiality and security protections are adequate, and the availability of department resources to fill the request.

Once the primary reviewer completes the review, a recommendation is provided to either the State Registrar and/or PAS Authority or their designee, as needed, to approve or deny the application. Applications requiring DRAC and/or DHSS IRB review will then be distributed to the appropriate members for review/approval. You will be notified in writing of the final decision by the DHSS IRB Chair and the Project Coordinator. If your protocol application is approved, you will receive a Scope of Work (Project Estimate/Quote) outlining the requested files for your review/approval. Once the signed Scope of Work has been received back, the records/files will be prepared on the basis of your research application in accordance with Missouri statutes, rules and regulations. If your request is denied, you will be notified of the reasons within 60 days of the denial.

Approval Criteria

Studies and/or research projects must meet the following specific standards and criteria:

be scientifically valid and statistically sound;
contribute to public health practice;
not use Department resources unreasonably and unnecessarily;
be conducted ethically and with integrity;
be in compliance with state and federal statutes and regulations, including confidentiality provisions;
be reviewed by the Department Institutional Review Board when required; and
be consistent with Department policy.

Fee Schedule

In an effort to recover the service cost incurred for staff time and other expenses involved in data delivery, the Department will access fees for their data and services based on the posted Fee Schedule. Fees are assessed for preparation of data based on programming time and materials. Pre-payment is required before data files will be released.

Application Submissions

All applicants must complete, sign, date, and submit the research protocol application, Agreement for Oversight, Confidentiality Pledge(s), and appropriate DHSS IRB forms when applicable. If data files are requested, a completed Data Element Checklist is also required for each data set being requested. Combined checklist will be rejected.

Completed packets should be mailed to the Project Coordinator at the address listed under "Contact us." Electronic submission of applications with all applicable signatures is acceptable. When scanning, please scan in black and white only. Please do not scan black and white documents in color (default) due to size limitations.

Annual Review

Approved applications/continuations for use of Missouri vital records and/or patient abstract system data are valid for one year at a time, regardless of the duration of the research project or study. For studies not requiring DHSS IRB annual review, a completed Request for Review Form and an Agreement for Oversight must be submitted to the Project Coordinator 20 calendar days prior to the current approval expiration date. The Agreement for Oversight requires both the requestor’s signature and the Agency/Institutional Official’s signature with the authority to bind the agency into the agreement (must be two different staff). For studies requiring DHSS IRB annual review, a completed Request for Review Form, Agreement for Oversight, and an IRB Form 2 must be submitted to the Project Coordinator 45 calendar days prior to the current approval expiration date. The Department will attempt to email a reminder notice to the Principal Investigator on file prior to the current approval expiration date; however, it is the responsibility of the Principal Investigator to ensure that annual review materials are submitted whether or not a reminder is received.

A study must be reviewed annually as long as the study is ongoing and DHSS-provided data are retained. Projects in the data analysis phase are considered ongoing. A Request for Review Form includes the following:

Project Summary: Provide a summary of all research activities that have occurred since the last approval was granted. Continuous progress is essential for continued department support and extension approval. If you have not made any progress, plans should be developed and reported addressing how you will overcome the barriers hindering progress, or continuation may be denied and Department support withdrawn.
Supporting Documents (when applicable): A current signed DHSS IRB Form 2; a current copy of your sponsoring or affiliated institutional review board approval(s); an annual progress report (when applicable); copy of current Consent Form (when applicable); copy of Human Research Protection Training certificates, completed within the last 3 years for the PI and DHSS Co-PI; as well as copies of any presentations, reports, and/or articles not previously submitted for DHSS review.
Project Modification (when applicable): A written description of proposed changes and copies of any proposed revisions to study protocols and forms, or any changes to the projected end date.
Study Personnel (when applicable): Report any new staff assigned to the research project or study since the last approval was granted, who have access to DHSS-provided data. All new staff members must sign a Confidentiality Pledge prior to being granted access to DHSS data. It is the responsibility of the Principal Investigator to ensure that all staff are aware of and adhere to the confidentiality and security procedures.

Amendments

Any changes to a study protocol require the submission of an amendment request to the Project Coordinator. Proposed project changes must be reviewed and approved by the Department’s Data Steward and IRB (when applicable) before being implemented. In the rare event that changes to the project must be made without the prior approval, in order to protect subject safety and welfare, the Project Coordinator must be notified as soon as possible after the changes have been made.

Please use the Request for Review form and IRB Form 2, when applicable, to submit amendments, with all required back-up documentation.

Project completion/disposition of data

When projects are completed, investigators must submit the following documents:

A completed/signed, final Request for Review Form closing out the study.
Copies of reports, citations and/or articles developed from the research not previously submitted.
An original signed/notarized Affidavit of Data Disposal.
A completed/signed, final IRB Form 2 (when applicable).
A copy of the final project report (when applicable).

Termination/failure to comply

If the DHSS receives a credible report or evidence that unauthorized release of data or other breach of confidentiality has occurred, the Department will investigate whether such has occurred and whether the project should be suspended. Researchers are responsible for notifying any consumer whose confidential information the research team breaches. However, the researcher MUST also notify the DHSS if the researcher has a breach of confidentiality involving data that was provided to the researcher by DHSS.

The Department will require that all data and information provided by the DHSS to the principal investigator be destroyed if the DHSS determines one or more of the following have occurred:

data have been released to unauthorized persons;
the identity of a person, patient, physician, or provider has been revealed to a person not listed as research staff on the approved research protocol;
data are being used in an unapproved manner.

Per 192.067(5), RSMo, “any department of health and senior services employee, public health authority or coinvestigator of a study who knowingly releases information which violates the provisions of this section shall be guilty of a class A misdemeanor and, upon conviction, shall be punished as provided by law.”

The attorney general shall have exclusive authority to bring an action to obtain actual damages for a willful and knowing violation of 407.1500(1), RSMo and may seek a civil penalty not to exceed one hundred fifty thousand dollars per breach of the security of the system or series of breaches of a similar nature that are discovered in a single investigation.

Failure to comply with the annual review or close out process could result in the immediate withdrawal of DHSS approval of the research study/project. In the event of DHSS withdraws approval, the Department will require that all data provided by the DHSS to the principal investigator be destroyed.

The Department reserves the right to deny the release of future DHSS data files to the Principal Investigator for other research studies for any breach of the terms of the protocol application, confidentiality requirements, and/or the failure to comply with the annual review or close out process.