The Johns Hopkins press release states:
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.
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.
Update: The Baltimore Sun has a response from Burnham:
Burnham can appeal the decision to the university provost, but he said he does not expect to do that. In an interview today, he said he was gratified that the Hopkins investigation, as well as independent reviews, have verified his results. “I think that strengthens our conviction on the quality of the data and its relevance,” he said. “The importance of measuring the impact of war on populations, I think, is critical.”
Because of the difficulty of carrying out research in Iraq during the war, Burnham and his team partnered with Iraqi doctors at a university in Iraq. Burnham, working out of Jordan, said he made it clear to the doctors that they could collect the first names of children and adults, to help keep the information straight, but that last names could not be collected.
When the surveys came back to him in Jordan, it appeared that some had last names. Many were in Arabic. Burnham said he asked his Iraqi partners and was told that the names were not complete, which he accepted. But Hopkins, in its investigation, found that the data form used in the surveys was different from what was originally proposed, and included space for names of respondents. Hopkins found that full names were collected.