Continuation, Amendment, and Completion of Project Requirements for Administrative/Non-Research Projects
Applicants whose projects have been approved by the Department must maintain their approval in good standing. Annual review is required for each project for as long as DHSS-provided data are held.
Reporting Requirements
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 project. A completed Request for Review[NEEDS LINK] and an Agreement for Oversight[NEEDS LINK] must be submitted to the Project Coordinator at least 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). The Department will attempt to email a reminder notice to the Project Manager on file prior to the current approval expiration date; however, it is the responsibility of the project manager to ensure that annual review materials are submitted whether or not a reminder is received.
A project must be reviewed annually as long as the project is ongoing and DHSS-provided data are retained. Projects in the data analysis phase are considered ongoing. A Request for Review includes the following:
- Project Summary: Provide a summary of all project activities 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addressing how you will overcome the barriers hindering progress, or continuation may be denied and Department support withdrawn.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): Copies of any presentations, reports, and/or articles not previously submitted for DHSS review.
- Project Modification (when applicable): An explanation of any proposed changes to the protocol or changes to the projected end date.
- Project Personnel (when applicable): Report any new staff assigned to the project since the last approval was granted, who have access to the DHSS-provided data. All new staff members must sign a Confidentiality Pledge[NEEDS LINK] prior to being granted access to DHSS data. It is the responsibility of the project manager to ensure that all staff are aware of and adhere to the confidentiality and security procedures.
Amendments
Any changes to a project or personnel require the submission of an amendment request to the Project Coordinator. Proposed project changes must be reviewed and approved by the Department before being implemented. In the rare event that change 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[NEEDS LINK] form to submit amendments.
Completed Projects/Disposition of Data
When projects are completed, project managers must submit the following documents:
- A completed/signed Request for Review[NEEDS LINK] closing out the project.
- Copies of reports, citations and/or articles developed from the project not previously submitted.
- An original signed/notarized Affidavit of Data Disposal.
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. Project Managers are responsible for notifying any consumer whose confidential information the project staff breaches. However, the project manager MUST also notify the DHSS if the project staff has a breach of confidentiality involving data that was provided to the Project Manager by DHSS.
The Department will require that all data and information provided by the DHSS to the Project Manager 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 project staff on the approved project application;
- 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 project. In the event of DHSS withdraws approval, the Department will require that all data provided by the DHSS to the project manager be destroyed.
The Department reserves the right to deny the release of future DHSS data files to the Project Manager for other projects for any breach of the terms of the project application, confidentiality requirements, and/or the failure to comply with the annual review or close out process.