Procedures for Enrollment of Children in Baltimore City DSS Custody as Research Subjects
January 2006

Investigators should follow the procedures described below for providing notice to Baltimore City DSS of research involving foster children and, where necessary, seeking consent from the Baltimore City DSS: [1]

1. Determine Guardianship Status.

a. If possible, the PI should determine whether the child (or children) is in shelter care, or has been placed under the legal guardianship of the DSS or of a foster parent or kinship caregiver. For children in DSS custody, the PI should determine whether the guardianship order for each child is a “limited guardianship” for the purpose of consenting to ordinary medical care, or is a “full guardianship” of the child. 

b. Mr. Jim Becker of Baltimore DSS Legal Services can assist in determining guardianship status. Mr. Becker's email address is jbecker@dhr.state.md.us

2. 404 (or FDA analogue) Studies Enrolling Children in DSS Custody

a. If a study meets waiver criteria, the IRB may grant a waiver of consent for all children in DSS custody, regardless of guardianship category.  If such a waiver is granted, the PI should provide DSS notice of the study by forwarding to Mr. Becker a brief (1-2 paragraphs) email summary of the protocol. 

b. Alternatively, the IRB may determine that it is appropriate to grant a waiver of consent for those subjects under a DSS limited guardianship and/or shelter care, and not grant a waiver of consent for those subjects under a full DSS guardianship.  In such a case, the PI should provide a copy of the protocol and consent form to Jim Becker.  Mr. Becker will forward these materials to the official within DSS who is authorized to consent for subjects under full DSS guardianship.

c. The IRB may determine that for a particular study, waiver of consent is not appropriate for any child in DSS custody.  In this case the PI will determine whether any of the children who will be research subjects are among those for whom DSS holds full legal guardianship.  If the answer is yes, the PI should provide a copy of the protocol and consent form to Jim Becker.  Mr. Becker will forward these materials to the official within DSS who is authorized to consent for those subjects. 

i. Note, however, that if consent has not been waived, those foster children under the limited guardianship of DSS or in “shelter care” may not be enrolled without the consent of a parent or a court order (i.e., DSS will not consent for these subjects) unless the PI can demonstrate to DSS that participation confers a direct health benefit to the individual child subjects. 

3. 405 (or FDA analogue) “Direct Benefit” Studies Enrolling Children in DSS Custody

a. If the IRB has approved a 405 “direct benefit” study that may enroll foster children under either full or limited DSS guardianship, the PI should forward the protocol and consent form to Mr. Becker.  Mr. Becker will forward these materials to the official within DSS who is authorized to consent for these subjects.

b. If the IRB has approved a 405 “direct benefit” study that may enroll children under “shelter care,” a court order or parental permission would be required for participation, even when the research offers the prospect of “direct benefit.”  In the event that a child in shelter care will be enrolled pursuant to a court order or parental permission, the PI should provide notice to DSS by forwarding to Mr. Becker a brief summary of the protocol.