April 2016

The Social Services Administration (“SSA”) of the State of Maryland Department of Human Resources (“DHR”) has issued a mandatory policy concerning the participation of children and families served by the SSA in human subjects research projects.  All of the following for the enrollment of this population:

• Review of the protocol by the SSA’s Research Review Board (RRB);
• Approval by the Director of the SSA;
• Execution of the consent document by the duly authorized local department of social services agent;
• A signed Memorandum of Understanding; and
• Oversight of the individual children enrolled.

The SSA made a determination that its clients (foster children) may participate only in the following types of human subjects research:

• Research that the JHM IRBs determine meets the definition of minimal risk (DHHS category 45 CFR 46.404); or
• Research that the JHM IRBs determine the research presents a prospect of direct benefit to the potential pediatric participants (DHHS category 45 CFR 46.405).

Note:  The SSA will not approve enrollment of its clients in any research for which the JHM IRBs determine the category to be DHHS 45 CFR 46.406 or DHHS 45 CFR 46.407).  Therefore, the IRBs may not approve requests to enroll foster children into such research projects.  Additionally, research submissions involving this population will not qualify for exempt review and must receive either expedited or convened IRB review as appropriate.

IRB review and approval is required to initiate the SSA review process.  Investigators who wish to enroll foster children must explain in the eIRB application why they believe foster children should be allowed to enroll.  The eIRB application question on foster children or wards of the state must be marked “yes” to start the process.  A copy of the DSS Review Form should be uploaded into the supplemental document section of eIRB.  The JHM IRBs may take action to approve such applications in order to initiate the required SSA review process and the approval notice will state that foster children may not be enrolled until the SSA process is complete.  At the time action is taken, the OHSR will notify the Director of the SSA that RRB review is requested.  A copy of the DSS Review Form and IRB approved consent document will be provided to the Director of the SSA.

The SSA Review Process:

• The RRB review process for a project classified as 45 CFR 46.405 will take approximately 3 weeks to complete.  The RRB review process for projects classified as 45 CFR 46.404 may take 3 – 6 weeks to complete.  The RRB will notify the Director of the SSA of the review outcome.  The Director makes the final decision on whether projects for which RRB approval is granted may include DSS clients. 
• The Director will send written notification of the RRB outcome and SSA decision to the OHSR.
• In cases where the Director of the SSA agrees that DSS clients may be enrolled:

a. A signed MOU executed by the Vice Dean for Clinical Investigation and SSA must be on file with the OHSR.

b. The OHSR will notify the PI when the signed MOU is on file.

c. The Director will notify the duly authorized local department of social services agent who may sign the consent form for an individual client.   When the duly authorized local department of social services agent signs a consent document to allow a DSS client to enroll in a human subjects research project, he/she will monitor the progress of the child during study participation. 

In cases involving Oncology Therapeutic Research, there is an approved alternative process.  The RRB has agreed to conduct an expedited review process in cases where a specific child’s health would be impacted if not enrolled in an IRB-approved Oncology study as soon as possible.  The PI must notify OHSR when such a case is identified to initiate the Oncology review process.

Please Note:  The process described in the guidance applies to all foster children who are clients of a State of Maryland local department of social services.  If an investigator wishes to enroll foster children from a jurisdiction other than Baltimore City, please contact the appropriate local department of social services to assist in identifying who is the duly authorized agent to consent to the participation of the foster child in the research project.