Section 8, Chapter 3 (Research Protections and Data Requests), Subsection 1 – Research Protections and Request for Release of Data

(Effective:  05/01/19)

3.1 Research Protections and Request for Release of Data

The Department of Social Services’ (DSS) Children’s Division (CD) permits research and release of data involving persons served in accordance with RSMo. Section 210.150.2 and 3. In doing so, however, the Division exhibits due regard for the study subjects’ participation rights with emphasis in areas of privacy and confidentiality.  All research and release of data involving persons served is conducted in accordance with applicable legal requirements.

3.1.1    Request to Conduct Research Procedures:

    1. The entity requesting to do research must complete an Application to Conduct Research/Study form (Form MO 886-4454). Related information must accompany the application including:
      1. Written positions of any Institutional Review Boards (IRBs) that may have reviewed the study proposal.
      2. Copies of any proposed informed consent forms which are subject to approval of the CD. Each research project is unique in at least some aspect and the form should be customized to each project. Consent forms must address the following: Youth in CD custody must, if capable, sign an informed consent participation agreement regardless of the level of their participation if they are at all involved with the research project. Among the study participation parameters, CD youth must understand their ability to opt out after they have begun participation if they initially consent to participating. They must understand that participation is not compulsory and that making a decision not to participate will not be held against them. Guardians (i.e. foster parent, prospective adoptive parent, Children’s Service Worker, etc.) must also sign an informed consent form.
    2. If the request to conduct research is received in the circuit, the Regional Director must forward the completed application, related documents, and recommendation, if desired, to the CD Research Committee at the address set forth below for approval consideration.
    3. The committee (appointed by the Division Director) from Central Office will review the proposal and consider:
      1. Whether the entity completed the application and submitted relevant materials according to guidelines established by DSS and CD.
      2. The Regional Director’s recommendation, when required.
      3. Whether the research proposal is a bona fide request. Defined in RSMo. Section 210.150.2 (13), a bona fide request is from any person who is a tenure-track or full-time research faculty member at an accredited institution of higher education engaged in scholarly research, with the permission of the director.
      4. Whether the research is being conducted for bona fide purposes and has the potential to advance child welfare practice including childcare, in Missouri.
      5. Whether the research involves the use of Protected Health Information (PHI), i.e. Social Security Number (SSN), Departmental Client Number (DCN), Date of Birth (DOB), or client name.   When PHI is Involved the Research Proposal Must:

      1. Outline a viable plan to secure signed authorizations* from the study participants (inclusive of family members) and/or guardians or legal custodians as applicable; or
      2. Outline a viable plan to ensure de-identification (anything, including DOBs, SSNs and case DCNs, that can be tied back to an individual to identify that individual with personal health information) of PHI associated to study participants.
      3. Data received for a specified research study must be used only for the purpose outlined in the application and not for any other or future studies
      4. *It is preferable that the Department’s “Authorization for Disclosure of Health Information” form http://dssweb/dpl/adman/POLICIES/5-103ex2.pdf (Employee Access Only) be used where authorizations are required. Otherwise, it must be ascertained that forms supplied by a researcher are “Privacy Rule”-compliant.  It is permissible under the Privacy Rule that valid authorizations be combined with informed consents (if the authorization is valid and the consent adequately informs what a participant can expect from being involved).

3.1.2 Application Approval/Denial

    1. The Division Director (or designee) will approve (or reject) the research proposal based on the recommendations of the committee members and will forward any approved proposal involving the use of PHI to the Divisional Privacy Officer for further review.
    2. The Division Privacy Officer will review the request to determine whether the matter of client PHI disclosure is adequately addressed in the proposal.
    3. The Divisional Privacy Officer will relate a position to the Division Director (or designee) whether the matter of PHI release is satisfactorily addressed and may submit the proposal to the Department Privacy Review Board if the proposal requires consideration of an ‘authorization to disclose’ waiver. The DSS Privacy Review Board is comprised of the DSS Privacy Officer, divisional privacy officers under the covered entity (DSS), and one qualified individual appointed by the DSS Director. The DSS Privacy Officer is the chairman of the DSS Privacy Review Board.
    4. The Department Privacy Review Board will review the request and determine whether a waiver of the required authorization will be granted. The Divisional Privacy Officer will, in turn, notify the Division Director (or designee) as to whether the Division may proceed (and under what considerations if applicable) where PHI release is an issue. Waiver by the Board of the individual authorization required by Health Insurance Portability and Accountability Act (HIPAA) will be done in compliance with the provisions in 45 CFR 164.512(i).
    5. The committee will inform the requestor, in writing, of the decision. This may include contingencies (such as Regional Director approval if needed, reasons for rejection, and/or request for additional information).
    6. The requestor is required to allow the Children’s Division Director (or designee) to review the research findings before publication. Failure to share findings in past research projects will be a consideration in the approval of future studies.
    7. The requestor is required to send the Children’s Division a copy of final product.
    8. The Division Director shall designate a person in Central Office to monitor research activities for adherence to the agreed upon implementation terms in accordance with standards set forth by the Division Director (or designee). The person/s chosen to monitor such approved research requests shall keep a record of all research activities. At least annually, the person/s chosen to monitor approved requests will conduct a review of research involving program participants to assess areas of overall risk to the Children’s Division (in accordance with COA standard RPM 2.01).

3.1.3   When the Proposed Study Involves Human Subjects

All of the above procedures apply to studies involving human subjects. Allowing children in the foster care system to take part in clinical trials or other research is not prohibited, and may occur in accordance with 45 CFR Part 46 if the Division deems that the child(ren) will ultimately benefit. Research involving human subjects includes data collection through intervention or interaction with the individual or identifiable private information. In addition, an independent advocate is required to be appointed for the child and proper consent from a guardian applies to clinical trials involving new drugs and for any research setting in which children in foster care are subjects. Protocol for Children’s Division Staff

 Children’s Division staff may be contacted by a research hospital when a child in the state’s custody presents and is indentified as a potential study subject. The hospital staff may request the approval of a case manager for the child’s participation in the study. A request could involve emergent/life-threatening or non-emergent situations. Procedures for staff are as follows:


      1.  Make an immediate referral of this matter to your supervisor, who should then take it up the chain of command to the level of field support manager or regional director or FCCM program manager.
      2. Share with your supervisors any pertinent information you might have regarding the child’s medical history or treatment history that might help them make an informed decision regarding the use of the investigational treatment.
      3. The field support manager or regional director or FCCM Program manager will then evaluate the situation and make a determination, based on policy and existing protocols regarding medical treatment of children in the custody of the state. (Note that you may be asked to convene emergency family support team meetings or work with your local court to expedite decisions that might impact the child’s safety and well-being. Please follow the directives of your supervisors in regard to this matter.)
      4. FCCM Directors should notify Regional Directors of decision made and reasons why.  


      1. Obtain clear information about the study from research applicant so you have facts to present to others regarding the study and this child’s participation.
      2. Evaluate any possible harm that could come to this child from participation in the study.
      3. Evaluate the benefits of the child’s participation in the study – focusing primarily on the benefits to the child or his/her family and secondarily on benefits to the division.
      4. Consult with your supervisor regarding his/her feelings on the harm or benefits of the child’s participation.
      5. If time allows, present the request for the child’s participation to the Family Support Team at the earliest possible date. The FST’s decision regarding the child’s participation should be the final decision.
      6. If time does not permit the presentation to the FST, consult with the juvenile office, the guardian ad litem and, if TPR has not occurred, the child’s parent(s) regarding the child’s participation. The decision of the professionals and the parents should be the final decision.

3.1.4    Request for Data Procedures Related to Research

CD staff members are to follow procedures when the request for data involves disclosure of client PHI, i.e. social security number (SSN), Departmental Client Number (DCN), Date of Birth (DOB), or client name. There is no need to obtain authorization to release data when no PHI is being requested.  The Health Insurance Portability and Accountability Act (HIPAA) must be considered before data requests are approved.  All data transfers will be done in compliance with the Information Security Management policy, 6-100http://dssweb/dpl/adman/POLICIES/6-100.pdf (Employee Access Only):

    1. All requests for data must be sent to Central Office. The person designated by the Division Director to review all requests for data will complete a Data Transfer Request if applicable http://dsswebapp/grd/DataTransfer/index.asp (Employee Access Only). The designee will consider:
      1. Whether request for data is a bona fide request (from any person who is a tenure-track or full-time research faculty member at an accredited institution of higher education engaged in scholarly research, with the permission of the director).
      2. Whether request for data was made for bona fide, ethical purposes and its intended use is likely to advance child welfare practice in Missouri.
    2. If data to be transferred includes disclosure of client PHI, the designee will forward the Data Transfer Request electronically to the Divisional Privacy Officer. Under comments section of the Data Transfer Request Form, the designee shall describe what data is needed so that the Divisional Privacy Officer has a good understanding of the request
    3. Divisional Privacy Officer will receive the request electronically at which time he/she makes the decision whether to approve the request.
    4. Divisional Privacy Officer signs off on the request which automatically generates an alert to the CD Security Officer.
    5. The CD Security Officer signs off on the request and it automatically goes to Information Technology Services Division (ITSD).
    6. Staff from ITSD sends a notification to everyone involved including the individual who initiated the request.
    7. The Research and Evaluation Unit of DSS will maintain a file for tracking purposes as required when PHI is involved.

3.1.5   Children’s Division Central Office Contact

Requests to conduct research and requests for agency data should be sent to: Research Committee, Children’s Division, PO Box 88, Jefferson City, MO 65103, or by email to: .