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:

Emergent

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      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.  

Non-Emergent

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      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.