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November 16, 2024

Prof. suspended for protocol violation

By CINDY CHEN | February 26, 2009

Researcher Gilbert Burnham has been suspended from the role of principle investigator in human subjects research studies for the next five years by the Bloomberg School of Public Health after a year-long internal review of his controversial 2006 Iraqi Mortality Study.

Bloomberg's Institutional Review Board has determined that the full names of the participants were included in the process of data collection.

This lapse deviates from the original protocol and also violates the school's policies on human subjects research. This complaint is unrelated to questions of the credibility of his findings.

Burnham's 2006 study "Mortality after the 2003 Invasion of Iraq: a Cross-Sectional Cluster Sample Survey" is the second take on the initial surveying attempt in 2004. The first study got some attention, but Burnham has been surprised by the amount of scrutiny that has been surrounding this 2006 study. Part of the research contends that the actual number of Iraqi casualties exceeds the official body count that has been released.

In a public release earlier this month, the American Association for Public Opinion Research (AAPOR) says that Burnham violated the code of ethical research. Their code requires that investigators "disclose, or make available for public disclosure, the wording of questions and other basic methodological details when survey findings are made public." Burnham, according to AAPOR, has continually refused to provide even just the facts of his research. This accusation is not the first, however.

Tim Parsons, director of Public Affairs at Bloomberg, confirms that a number of medical journal articles from early last year raised questions about the process of this research. All the speculations about Burnham's study were part of what motivated Bloomberg to conduct the extensive internal review.

"The study has been controversial for some time," Parsons said.

"I've gotten so many hits - this is just another," Burnham said of the recent AAPOR release. After a complaint had been filed to the association, AAPOR had contacted Burnham asking for a disclosure of his research protocol in a way that adheres to the specifications of the organization's own codes. Bloomberg advised Burnham to say no more than the basics in order to avoid further complications.

For the past year, however, Bloomberg's Institutional Review Board had been investigating Burnham's study, specifically its adherence to what was originally approved by the board to be "safe" human subjects research.

Burnham's study was actually able to avoid the standard, full-fledged federal review that had been coming its way because the Bloomberg review board assured the federal reviewers that the lapses in the study only caused minimal increased risk.

The panel of faculty that conducted the review did not embark on examining the statistical credibility of the methodology applied in the 2006 research, though this topic will surely continue to be a topic of discussion within the research community.

Burnham explained that error of including subjects' last names is a result of his disjointed research team. Burnham and his team worked from Jordan, while they collaborated with a group of doctors and surveyors based in a university in Baghdad. Burnham's team provided technical assistance, while the Baghdad team did the actual field work. In the review, Bloomberg found that the form that was actually used in the data collection had been different from the one that the board had approved. The form they used had asked for the full names of its participants.

Burnham had been suspicious about the received names and he questioned his Iraqi colleagues about them. They all assured him that those names were not identifiable because they are not complete names in Arabic. The professional translators at Bloomberg disagreed.

"These are the kinds of things that happen when you have to work across three to four languages. And [my team] couldn't personally go into 99 percent of those surveyed places," Burnham said.

He emphasized that he does believe in the importance of confidentiality in research. The forms did not ask for addresses, not even cities. Burnham said they made a point to keep the surveys as confidential as possible. The risks, he said, of disclosing identities and complete names in Iraq are very serious.

Burnham is relieved that no one has suffered the consequences of this breech. He also emphasized that he trusts the members of his team would never have used information on his subjects that could put them in danger.


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