Tuesday, December 9, 2003

The dean of the University of Maryland School of Medicine says that fake interviews taken for an AIDS-prevention study were discovered and discounted before the study was published.

“All of the falsified data collected by these employees was removed from the study,” Dr. Donald E. Wilson, whose school conducted the study, said in a statement. “The misconduct was discovered by a University of Maryland research coordinator and reported immediately.”

But the chairman of the House panel that oversees such grants said yesterday that despite Dr. Wilson’s statement, there are still major flaws in reporting of problems with research.

“Public disclosure [of the fabrications] did not occur for nearly 2 years,” said Rep. Mark Souder, Indiana Republican and chairman of the House Government Reform criminal justice, drug policy and human resources subcommittee.

Mr. Souder said he was considering measures to require that any future misconduct in federal research is “reported directly to the [congressional] oversight committees.”

The Washington Times reported Friday on the faked interviews in the study, which received more than $1 million in grants from the National Institutes of Health (NIH).

In his statement, Dr. Wilson said officials at the University of Maryland at Baltimore detected in August 2001 the fabrications by “three part-time, temporary employees” who are no longer with the university.

Dr. Wilson said that after the fabrications were found, “the study was temporarily halted, and all data was systematically scrutinized by a panel of experts. No other problems were found, and the study resumed.”

The fabrications were first reported by the journal Research USA.

When contacted last week by The Times, officials at the National Institute for Mental Health — the NIH division that funded the study — had no comment, referring inquiries to the federal Office of Research Integrity. That office did not respond to requests for comment.

The study’s objective was to evaluate the effect of adding a “parental monitoring” element to an existing AIDS risk-reduction program for youths ages 12 to 16, called Focus on Kids.

The study involving more than 800 black youths in Baltimore housing developments was published in the January issue of the journal Pediatrics. It found that youths whose families participated in the enhanced Focus on Kids program showed “significantly lower rates” for a variety of risk behaviors, including sex without condoms and use of cigarettes and alcohol.

The principal researcher on the study was Dr. Bonita Stanton, now with Children’s Hospital of Michigan in Detroit. She did not return calls last week from The Times seeking comment on the study, but Friday told United Press International that “absolutely no fabricated data were used in any of these analyses.”

Information collected by Lajuane Woodard, Sheila Blackwell and Khalilah Creek, the three employees accused of misconduct, was “eliminated … even if it looked good,” Dr. Stanton said.

Reports of disciplinary action against the three former employees at the University of Maryland at Baltimore were included in the Dec. 2 Federal Register. All three entered into a “voluntary exclusion agreement” effectively prohibiting them from participating in federally funded research for a three-year period beginning Oct. 30.

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