Medical News & Exposé
epi
| Exclusive Report |
May 16, 2009 — The Pentagon has stored blood serum specimens from millions of
civilians without their knowledge or permission, for use by health researchers and law
enforcement, according to U.S. Army documents and a leaked RAND study.
The Department of Defense Serum Repository (DoDSR) includes serum specimens
from up to 2.3 million civilians who applied for military service but did not join,
according to the study.
The RAND study, leaked May 1 to the WikiLeaks website, reveals that by 2007, the
U.S. Army had also stored 898,358 blood specimens from the spouses, and possibly
the children and dependent parents, of military personnel.
The $500,000 study identified significant gaps in the Pentagon’s disease surveillance
system. It was commissioned by the U.S. Army Center for Health Promotion and
Preventative Medicine (USACHPPM). Although the study was completed in May 2008
and contains no classified information, it has not been cleared for release.
DNA can be readily obtained from serum samples, rendering the repository a de facto
DNA database of military personnel, former military personnel, their spouses and
applicants who did not ultimately join the military.
It was leaked to WikiLeaks May 1, in the midst of the Mexican swine flu outbreak.
The blood samples have been collected since 1985 to screen military applicants,
personnel and family members for HIV-1, according to Army documents. But without
their knowledge, millions of individuals’ leftover blood serum has been permanently
stored for research and law enforcement investigations by the Armed Forces Health
Surveillance Center in Silver Spring, Maryland.
The resulting serum repository is “by far the largest” such collection in the world,
according to the RAND study.
“(I)t’s total size and annual rate of specimen acquisition are at least ten times those for
the civilian repositories,” the study states.
Nearly 44 million serum samples were stored at the facility as of December 2007, the
study states, representing approximately 10.4 million individuals. The samples are
maintained for research, public health surveillance and criminal investigations and
prosecutions, according to U.S. Army guidelines. (See box at right.)
Postings on the Pentagon’s “Military Health System blog” from July 2008 put the
number at “nearly 45 million” serum specimens.
The RAND study states that
898,358 of those samples are
identified as belonging to
“dependent beneficiaries,”
meaning the children and
spouses of active duty military personnel. Because multiple samples may have been
collected for the same individuals, it is unclear exactly how many civilians are
represented in the repository.
It appears that the inclusion of civilian samples in the repository may be a bureaucratic
SNAFU. The RAND study states:
While military officials reportedly informed RAND researchers that servicemen know
their blood samples will be kept in perpetuity, the researchers “could find no evidence
of explicit communication to that effect,” according to the study.
Pentagon officials told RAND researchers there is no need for consent forms because
blood collection for HIV screening is a condition of employment for military personnel,
the study states.
The study does not directly address the legality of keeping civilians’ samples without
their knowledge or permission.
But the failure to inform individuals that their blood samples will be retained in a
repository may limit the specimens’ usefulness to researchers, the study concluded.
”(S)ince the specimens are drawn without consent, there seems to be no way to use
the sera for any (research) purposes other than de-linked or certain public
health/force health protection uses,” the study states.
De-linking is the process of isolating the serum samples (and any evidence of infection
or toxic exposures in the samples) from personal identifying information. That would
preclude studies that draw on individuals' information in other databases to determine
whether civilians’ health conditions are associated with residential histories, spouses'
military deployments or other health conditions noted in hospital billing records, for
example.
The RAND study states that Army guidelines are largely “silent” on the exact rules of
releasing serum samples for patient care, criminal investigations and prosecutions,
and public health research.
“There appear to be several opportunities for improvement in the treatment of
informed consent,” the study concludes.
EpiNewswire has requested an interview with the lead author of the RAND study and
has filed Freedom of Information Act requests for related U.S. Army documents.
civilians without their knowledge or permission, for use by health researchers and law
enforcement, according to U.S. Army documents and a leaked RAND study.
The Department of Defense Serum Repository (DoDSR) includes serum specimens
from up to 2.3 million civilians who applied for military service but did not join,
according to the study.
The RAND study, leaked May 1 to the WikiLeaks website, reveals that by 2007, the
U.S. Army had also stored 898,358 blood specimens from the spouses, and possibly
the children and dependent parents, of military personnel.
The $500,000 study identified significant gaps in the Pentagon’s disease surveillance
system. It was commissioned by the U.S. Army Center for Health Promotion and
Preventative Medicine (USACHPPM). Although the study was completed in May 2008
and contains no classified information, it has not been cleared for release.
DNA can be readily obtained from serum samples, rendering the repository a de facto
DNA database of military personnel, former military personnel, their spouses and
applicants who did not ultimately join the military.
It was leaked to WikiLeaks May 1, in the midst of the Mexican swine flu outbreak.
The blood samples have been collected since 1985 to screen military applicants,
personnel and family members for HIV-1, according to Army documents. But without
their knowledge, millions of individuals’ leftover blood serum has been permanently
stored for research and law enforcement investigations by the Armed Forces Health
Surveillance Center in Silver Spring, Maryland.
The resulting serum repository is “by far the largest” such collection in the world,
according to the RAND study.
“(I)t’s total size and annual rate of specimen acquisition are at least ten times those for
the civilian repositories,” the study states.
Nearly 44 million serum samples were stored at the facility as of December 2007, the
study states, representing approximately 10.4 million individuals. The samples are
maintained for research, public health surveillance and criminal investigations and
prosecutions, according to U.S. Army guidelines. (See box at right.)
Postings on the Pentagon’s “Military Health System blog” from July 2008 put the
number at “nearly 45 million” serum specimens.
The RAND study states that
898,358 of those samples are
identified as belonging to
“dependent beneficiaries,”
meaning the children and
spouses of active duty military personnel. Because multiple samples may have been
collected for the same individuals, it is unclear exactly how many civilians are
represented in the repository.
It appears that the inclusion of civilian samples in the repository may be a bureaucratic
SNAFU. The RAND study states:
While military officials reportedly informed RAND researchers that servicemen know
their blood samples will be kept in perpetuity, the researchers “could find no evidence
of explicit communication to that effect,” according to the study.
Pentagon officials told RAND researchers there is no need for consent forms because
blood collection for HIV screening is a condition of employment for military personnel,
the study states.
The study does not directly address the legality of keeping civilians’ samples without
their knowledge or permission.
But the failure to inform individuals that their blood samples will be retained in a
repository may limit the specimens’ usefulness to researchers, the study concluded.
”(S)ince the specimens are drawn without consent, there seems to be no way to use
the sera for any (research) purposes other than de-linked or certain public
health/force health protection uses,” the study states.
De-linking is the process of isolating the serum samples (and any evidence of infection
or toxic exposures in the samples) from personal identifying information. That would
preclude studies that draw on individuals' information in other databases to determine
whether civilians’ health conditions are associated with residential histories, spouses'
military deployments or other health conditions noted in hospital billing records, for
example.
The RAND study states that Army guidelines are largely “silent” on the exact rules of
releasing serum samples for patient care, criminal investigations and prosecutions,
and public health research.
“There appear to be several opportunities for improvement in the treatment of
informed consent,” the study concludes.
EpiNewswire has requested an interview with the lead author of the RAND study and
has filed Freedom of Information Act requests for related U.S. Army documents.
Pentagon Stores Civilians' Blood without Knowledge
or Consent for Research, Criminal Prosecutions
or Consent for Research, Criminal Prosecutions
Interior of one of the 15 walk-in freezers in the DoDSR,
showing one of five aisles in each freezer housing
cardboard boxes containing serum specimens. Source:
DoD Serum Repository presentation (WikiCommons).
showing one of five aisles in each freezer housing
cardboard boxes containing serum specimens. Source:
DoD Serum Repository presentation (WikiCommons).
In addition to military service members, beneficiaries and civilian military
applicants also contribute serum specimens to the DoDSR. Civilians applying
for military service are required to be tested for serologic evidence of HIV-1
infection as a criterion for eligibility for service. These specimens are stored in
the DoDSR because testing contracts include packaging and shipment of all
specimens tested for HIV-1 irrespective of military duty status.
applicants also contribute serum specimens to the DoDSR. Civilians applying
for military service are required to be tested for serologic evidence of HIV-1
infection as a criterion for eligibility for service. These specimens are stored in
the DoDSR because testing contracts include packaging and shipment of all
specimens tested for HIV-1 irrespective of military duty status.
Inclusion of civilian serum specimens in the
Pentagon repository may have resulted from
a bureaucratic snafu.
Pentagon repository may have resulted from
a bureaucratic snafu.
"Serum specimens linked to the identities of
their donors shall be provided for use as
evidence in criminal investigations and
prosecutions when compelled by applicable
law in cases in which all of the following
conditions are present:
i. The responsible DoD official has received
a proper judge issued court order;
ii. The serum sample is needed for the
investigation or prosecution of a crime
punishable by one year or more of
confinement;
iii. No reasonable alternative means for
obtaining a serum sample is available;
iv. The use is approved by the Assistant
Secretary of Defense (Health Affairs)
after consultation with the General Counsel
of the Department of Defense."
Source: DoDSR Guidelines
their donors shall be provided for use as
evidence in criminal investigations and
prosecutions when compelled by applicable
law in cases in which all of the following
conditions are present:
i. The responsible DoD official has received
a proper judge issued court order;
ii. The serum sample is needed for the
investigation or prosecution of a crime
punishable by one year or more of
confinement;
iii. No reasonable alternative means for
obtaining a serum sample is available;
iv. The use is approved by the Assistant
Secretary of Defense (Health Affairs)
after consultation with the General Counsel
of the Department of Defense."
Source: DoDSR Guidelines