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Abstract #155636

Reena V. Gadhia, BA, Anne Lucy Lifflander, MD, MPH, and Timothy Ross, PhD. Child Welfare, Health and Justice Program/ Clinical Trials Project, Vera Institute of Justice, 233 Broadway, 12th Floor, New York, NY 10279, 2123763058, reenagadhia@yahoo.com

In the 1980's and early 1990s the New York City child welfare system faced a crisis precipitated by a tripling in the foster care census and the realization that a growing number of these children were HIV infected. In the absence of an approved treatment for pediatric HIV, child welfare authorities faced strong pressure from community advocates and medical professionals to enroll HIV positive foster children in clinical trials. This required the agency to address a host of legal, ethical and medical issues. The agency's policy for foster child enrollment, formally issued in 1991, resulted in the enrollment of over 500 children in approximately 35 clinical trials.

Recently some community advocates have alleged that the enrollment of foster children violated research ethics and caused harm and even death to the children involved. These allegations led to several investigations by the federal Office for Human Research Protections and generated a media firestorm. In response, New York City officials granted researchers access to all documents related to the development of the clinical trials policy for foster children, including memos, directives, bulletins, meeting notes, external correspondence, and draft versions of clinical trials policy. We will present the results of our review of these documents, which show an agency grappling with several complex issues related to the ethics of enrolling children under their care and custody and assessing experimental treatment options when no alternative treatment options were available. The presentation provides recommendations for the development of guidelines for enrollment under normal and emergency conditions.

Learning Objectives:

• Participants will develop an understanding of the complex issues involved in developing a clinical trials policy for foster children.
• Participants will be able to identify key stakeholders in developing a clinical trials policy for foster children.
• Participants will be able to assess the strengths and weaknesses of existing policies for enrolling foster children in clinical trials in the jurisdictions where participants reside.

Keywords: HIV/AIDS, Research Ethics

Related Web page: www.vera.org/project/project1_1.asp?section_id=5&project_id=79

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.