The Johns Hopkins
Bloomberg School of Public Health has completed an
internal review of the
study "Mortality After the 2003 Invasion of Iraq: A
Cross-Sectional Cluster Sample Survey." The
study, led by Bloomberg School Professor Gilbert Burnham,
estimated the number of excess deaths in
Iraq from March 2003 to July 2006; it was published in the
Oct. 14, 2006, edition of The Lancet
The school's review focused on various claims about
the study in academic forums and news
reports regarding data collected for the study, as well as
ethical concerns related to both the study's
implementation and the institutional review board process
in approving the research.
Key review points include the following:
♦ IRB review. The Bloomberg School of Public
Health's IRB acted properly in determining
that the original study protocol was exempt from review by
the full IRB under federal regulations.
The original protocol explicitly stated that no names of
study participants or living household members
would be collected. The protocol also included an
appropriate script to secure verbal consent from
study participants rather than a written consent process
that would have included participants'
♦ Data collection. An examination was
conducted of all the original data-collection forms,
numbering more than 1,800 forms, which included review by a
translator. The original forms have the
appearance of authenticity in variation of handwriting,
language and manner of completion. The
information contained on the forms was validated against
the two numerical databases used in the
study analyses. These numerical databases have been
available to outside researchers and provided to
them upon request since April 2007.
Some minor, ordinary errors in transcription were
detected, but they were not of variables that
affected the study's primary mortality analysis or causes
of death. The review concluded that the
data files used in the study accurately reflect the
information collected on the original field surveys.
♦ Study methodology and statistical approach.
The review did not evaluate aspects of the
sampling methodology or statistical approach of the study.
It is expected that the scientific
community will continue to debate the best methods for
estimating excess mortality in conflict
situations in appropriate academic forums.
Questions have been raised about other features of
study implementation, such as the use of
medical garb worn by interviewers. These practices were
found to be consistent with common,
acceptable field practices and were implemented to reduce
risk to the survey team.
♦ Conduct of study protocol. A review of the
original data-collection forms revealed that
researchers in the field used forms that were different
from the form included in the original
protocol. The forms included space for the names of
respondents or householders, which were
recorded on many of the records. Use of the form and
collection of names violated the study protocol
submitted to the IRB and on which the IRB determined the
study was exempt from full human
The paper in The Lancet incorrectly stated that
identifying data were not collected. An
erratum will be submitted to The Lancet to correct
the text of the 2006 paper on this point.
The review found no evidence that the violations
caused harm to any individuals involved in the
study and that the identifiable information was never out
of the possession of the research team.
Inclusion of identifiers did not affect the results of the
♦ Action taken. Because of violations of the
Bloomberg School's policies regarding human
subjects research, the school has suspended Burnham's
privileges to serve as a principal investigator
on projects involving human subjects research.