Foster Children as Human Subjects in Drug Trials
Posted: Sat Sep 02, 2006 4:51 pm
http://www.acf.hhs.gov/programs/cb/laws ... im0508.pdf
2. Issuance Date: September 21, 2005
3. Originating Office: Children’s Bureau
Information Memorandum
TO: State Child Welfare Agencies
SUBJECT: Foster Children as Human Subjects in Drug Trials
LEGAL AND 45 CFR 46.101; 45 CFR 46.409; 21 CFR 50.56
RELATED
REFERENCE:
PURPOSE: This Information Memorandum provides guidance to State
agencies regarding the use of children in foster care as subjects in
clinical trials of new drugs.
Information:
During the 1980’s and 1990’s, researchers conducted clinical trials of AIDS drugs on
hundreds of HIV – infected children in foster care in at least seven States (Illinois,
Louisiana, Maryland, New York, North Carolina, Colorado and Texas.) Through these
trials, infected children had access to treatment that would not have been available
otherwise and much useful scientific data were gained as well. However, it is not clear
whether all of these children had independent advocates assigned to them by the health
institut ion conducting the research, as required by law. It is also appears that some
States may have failed to obtain proper consent from parents or guardians in a number
of cases.
The purpose of this Information Memorandum is to remind State agencies that any time
children in foster care are used as subjects of clinical research, it is imperative that the
rights of these children be protect through the appointment of an independent advocate
and by gaining consent from a guardian. As always, the health and well-being of
children who cannot speak for themselves must be the State’s highest concern. Further,
the requirements for independent advocates and proper consent apply not only to
clinical trials involving new drugs, but also to any research setting in which children in
foster care are the subjects.
Allowing children in the foster care system to take part in clinical trials or other
research is not prohibited, and States may continue to do so if they believe that children
will ultimately benefit. However, it is important that States that currently allow
children in foster care to participate in clinical trials exercise extreme diligence, in view
of the fact that these children, having been removed from their families, are by
definition more vulnerable and in need of even more protection than children in the
general population.
2. Issuance Date: September 21, 2005
3. Originating Office: Children’s Bureau
Information Memorandum
TO: State Child Welfare Agencies
SUBJECT: Foster Children as Human Subjects in Drug Trials
LEGAL AND 45 CFR 46.101; 45 CFR 46.409; 21 CFR 50.56
RELATED
REFERENCE:
PURPOSE: This Information Memorandum provides guidance to State
agencies regarding the use of children in foster care as subjects in
clinical trials of new drugs.
Information:
During the 1980’s and 1990’s, researchers conducted clinical trials of AIDS drugs on
hundreds of HIV – infected children in foster care in at least seven States (Illinois,
Louisiana, Maryland, New York, North Carolina, Colorado and Texas.) Through these
trials, infected children had access to treatment that would not have been available
otherwise and much useful scientific data were gained as well. However, it is not clear
whether all of these children had independent advocates assigned to them by the health
institut ion conducting the research, as required by law. It is also appears that some
States may have failed to obtain proper consent from parents or guardians in a number
of cases.
The purpose of this Information Memorandum is to remind State agencies that any time
children in foster care are used as subjects of clinical research, it is imperative that the
rights of these children be protect through the appointment of an independent advocate
and by gaining consent from a guardian. As always, the health and well-being of
children who cannot speak for themselves must be the State’s highest concern. Further,
the requirements for independent advocates and proper consent apply not only to
clinical trials involving new drugs, but also to any research setting in which children in
foster care are the subjects.
Allowing children in the foster care system to take part in clinical trials or other
research is not prohibited, and States may continue to do so if they believe that children
will ultimately benefit. However, it is important that States that currently allow
children in foster care to participate in clinical trials exercise extreme diligence, in view
of the fact that these children, having been removed from their families, are by
definition more vulnerable and in need of even more protection than children in the
general population.