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February 23, 2009

Review Completed of 2006 Iraq Mortality Study

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, Dr. Gilbert Burnham, estimated the number of excess deaths in Iraq from March 2003 to July 2006 and was published in the October 14, 2006, edition of The Lancet medical journal.

The Bloomberg 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 (IRB) process in approving the research.

Key review points include:

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’ signatures.

Data Collection

An examination was conducted of all the original data collection forms, numbering over 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 data collection 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 subjects review.

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 the identifiable information was never out of the possession of the research team. Inclusion of identifiers did not affect the results of the study.

Action Taken

Because of violations of the Bloomberg School’s policies regarding human subjects research, the School has suspended Dr. Burnham’s privileges to serve as a principal investigator on projects involving human subjects research.

Public Affairs media contact: Tim Parsons at 410-955-7619 or tmparson@jhsph.edu