Tuttle's Almanac
2005-05-19 00:36:04 UTC
Federal Health Official Says Standards for
Enrolling Foster Kids in Experiments Vary Widely
http://ap.tbo.com/ap/breaking/MGB0KL74W8E.html
WASHINGTON (AP) - Current regulations are adequate to ensure that
foster children enlisted in federal medical experiments are protected,
a Bush administration official said Wednesday.
"I'm not aware of any changes that need to be made," said Health and
Human Services Deputy Assistant Secretary Donald Young.
Rep. Pete Stark, D-Calif., said prisoners are guaranteed more protection
under the guidelines concerning clinical trials than foster children.
The prisoners have an advocate expressly appointed to represent their
interests on local institutional review boards.
The House Ways and Means human resources subcommittee called the hearing
to examine the practice after The Associated Press reported earlier this
month that federally funded researchers had tested AIDS drugs on hundreds
of foster children since the late 1980s, often without providing independent
advocates to safeguard the children's interests.
Young said his agency began surveying states and found a wide variance in
how and when permission is given to enlist foster children in research.
"Information gathered from several state foster care agencies suggests
that authority to provide permission for other than standard medical
treatment typically lies either with the judge supervising the foster
care case, with a senior official within the foster care agency or
with a guardian" appointed by the court, he explained.
"Some states continue to preclude the enrollment of foster children in
experimental trials altogether, or will provide permission on behalf of
the child only if the biological parents also give permission for the
child's participation."
Nonetheless, the administration believes drug testing on children is
essential to ensure the best medicines for children suffering from
ailments like AIDS reach the marketplace and that current federal regulations,
if followed, offer adequate protections, Young said.
"We also recognize, however, the importance of continued vigilance to
ensure the regulations are adhered to by investigators and the IRBs
(institutional review boards) that oversee their activities," he testified.
Dr. Alan R. Fleischman, a top medical ethicist, told the panel he
believed research on foster children can be conducted safely and
ethically and that it would have been wrong to exclude foster kids
outright from AIDS drug testing during the height of the AIDS crisis in the 1990s.
"The only way to provide the best treatment to any child with HIV
at that time was through the clinical trials - the drugs were just
not available any other way," Fleischman told the panel in prepared testimony.
The AP reported that researchers and the review boards that supervised
their work often did not provide independent advocates for the foster
children enlisted in AIDS drug trials, even in cases where they had
signed agreements in New York and Illinois promising to do so in exchange
for gaining access to the child wards.
Federal law also requires the appointment of such advocates in studies
where there is a greater than minimal risk and the benefits to the
patient aren't as certain as current treatments in the marketplace.
Marjorie A. Speers, executive director of the Association for the
Accreditation of Human Research Protections Programs, told the panel
in her prepared testimony that the use of foster wards presents
"special ethical dilemmas" to the review boards that oversee federal studies.
The boards "must make specific determinations regarding the level of risk
involved in a proposed study and whether there is a prospect of direct
benefit to the individual subjects," she said. "These determinations are
not easy to make because IRBs must interpret regulatory terms, such as
'minimal risk' or 'minor increase over minimal risk.'"
Roberta Harris, a top Wisconsin health official, told the panel that her
state has declined to enroll foster children in medical experiments for
several reasons, including a desire to protect the mostly poor,
disadvantaged families in the system from "giving consent under duress."
"The types of research that have unfortunately occurred in our nation
in the past also make it difficult for us to earn the trust and
confidence of the families we are seeking to help," Harris said in
prepared testimony.
_________________________________________________________
Enrolling Foster Kids in Experiments Vary Widely
http://ap.tbo.com/ap/breaking/MGB0KL74W8E.html
WASHINGTON (AP) - Current regulations are adequate to ensure that
foster children enlisted in federal medical experiments are protected,
a Bush administration official said Wednesday.
"I'm not aware of any changes that need to be made," said Health and
Human Services Deputy Assistant Secretary Donald Young.
Rep. Pete Stark, D-Calif., said prisoners are guaranteed more protection
under the guidelines concerning clinical trials than foster children.
The prisoners have an advocate expressly appointed to represent their
interests on local institutional review boards.
The House Ways and Means human resources subcommittee called the hearing
to examine the practice after The Associated Press reported earlier this
month that federally funded researchers had tested AIDS drugs on hundreds
of foster children since the late 1980s, often without providing independent
advocates to safeguard the children's interests.
Young said his agency began surveying states and found a wide variance in
how and when permission is given to enlist foster children in research.
"Information gathered from several state foster care agencies suggests
that authority to provide permission for other than standard medical
treatment typically lies either with the judge supervising the foster
care case, with a senior official within the foster care agency or
with a guardian" appointed by the court, he explained.
"Some states continue to preclude the enrollment of foster children in
experimental trials altogether, or will provide permission on behalf of
the child only if the biological parents also give permission for the
child's participation."
Nonetheless, the administration believes drug testing on children is
essential to ensure the best medicines for children suffering from
ailments like AIDS reach the marketplace and that current federal regulations,
if followed, offer adequate protections, Young said.
"We also recognize, however, the importance of continued vigilance to
ensure the regulations are adhered to by investigators and the IRBs
(institutional review boards) that oversee their activities," he testified.
Dr. Alan R. Fleischman, a top medical ethicist, told the panel he
believed research on foster children can be conducted safely and
ethically and that it would have been wrong to exclude foster kids
outright from AIDS drug testing during the height of the AIDS crisis in the 1990s.
"The only way to provide the best treatment to any child with HIV
at that time was through the clinical trials - the drugs were just
not available any other way," Fleischman told the panel in prepared testimony.
The AP reported that researchers and the review boards that supervised
their work often did not provide independent advocates for the foster
children enlisted in AIDS drug trials, even in cases where they had
signed agreements in New York and Illinois promising to do so in exchange
for gaining access to the child wards.
Federal law also requires the appointment of such advocates in studies
where there is a greater than minimal risk and the benefits to the
patient aren't as certain as current treatments in the marketplace.
Marjorie A. Speers, executive director of the Association for the
Accreditation of Human Research Protections Programs, told the panel
in her prepared testimony that the use of foster wards presents
"special ethical dilemmas" to the review boards that oversee federal studies.
The boards "must make specific determinations regarding the level of risk
involved in a proposed study and whether there is a prospect of direct
benefit to the individual subjects," she said. "These determinations are
not easy to make because IRBs must interpret regulatory terms, such as
'minimal risk' or 'minor increase over minimal risk.'"
Roberta Harris, a top Wisconsin health official, told the panel that her
state has declined to enroll foster children in medical experiments for
several reasons, including a desire to protect the mostly poor,
disadvantaged families in the system from "giving consent under duress."
"The types of research that have unfortunately occurred in our nation
in the past also make it difficult for us to earn the trust and
confidence of the families we are seeking to help," Harris said in
prepared testimony.
_________________________________________________________