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Duke Taking New Steps to Safeguard Research Integrity

In the aftermath of now discredited genomic research involving a former Duke cancer researcher, Duke University is taking several steps to safeguard data transparency and accountability and the chain of data evidence.

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Durham, NC - In the aftermath of now discredited genomic research involving a former Duke cancer researcher, Duke University is taking several steps to safeguard data transparency and accountability and the chain of data evidence, a top Duke research official told the Academic Council Thursday.

It's impossible to develop a system that will completely eliminate academic fraud if a researcher is intent on misconduct, said Sally Kornbluth, vice dean for the basic sciences in the School of Medicine. "But this case highlighted that we can take a hard look at the infrastructure and the culture around research to reduce it," she said. "And we can provide safeguards for people who are trying to do the right things, but make errors or are guilty of sloppiness. In research, errors are more likely to be made through sloppiness than through fraud."

Among the changes will be a revised information technology system for research data to ensure the data that is originally entered in a study is the same data used in the end analysis and to document whenever data is altered.

Former Duke faculty member Anil Potti is currently being investigated for research misconduct. A key element of the investigation is that the original data developed in several Potti research studies was not the data used in its analysis, Kornbluth said.

Kornbluth said the planned information technology will create a "data lockbox."

"We want to see when changes are made and who makes the changes," she said. "Had that been in place in this case, the discrepancy in data would have been revealed earlier."

But the Potti case also revealed the difficulty of supervising modern medical research where it is unlikely that any one researcher or even a single lab would have a wide set of necessary skills, including running complex biostatistical calculations.

Kornbluth said there was "a dire need" in many research labs for quantitative expertise to review data. As a result, Duke has taken steps to embed biostatisticians in clinical research groups. Already this change has attracted attention from other research institutions looking to reduce errors in data analysis.

"We also want to ensure a culture of loyal dissent," Kornbluth told faculty members. "We want people to feel free to raise concerns when they see research problems. This is through a combination of creating places to raise concerns anonymously and to have leadership throughout the institution where people feel comfortable to raise their hands and speak out."

The university made errors in its follow-up to the concerns expressed by the National Cancer Institute (NCI) in the Potti case, Kornbluth said. The NCI concerns were prompted by earlier investigations made by two MD Anderson Cancer Center researchers in Texas that cast doubt on the Potti data.

After hearing of the NCI concerns, Duke brought in external reviewers to examine Potti's data and determine whether the analysis was correct. The team confirmed the research, but Kornbluth said what was missed at the time was that the original dataset was not used in the analysis.

"You often walk a fine line between trusting your faculty, particularly those with a stellar track record," she said. "We thought this was an arcane statistical review. They were asked to validate the statistical methodology. We gave the investigative team the data and they cranked through it and confirmed the results. What we didn't appreciate was that the raw data was different from the data used in the analysis.

"There was no intent to hide anything. We had a very vigorous response from the [Potti lab] that the data should speak for itself, and we let that happen. But it was a fundamental mistake not to give the investigative team the Texas concerns about the original data. They didn't know about those concerns, and I wish they had."