False Information in HIV/AIDS Prevention Study Discovered Two Years Ago, Not Included in Final Study, HHS Says
Despite recent reports that federally funded research on an HIV/AIDS prevention model may have included falsified information, HHS on Friday said that the data collectors involved were discovered two years ago and that the falsified information was excluded from the final study, United Press International reports (Mitchell, United Press International, 12/8). The Washington Times on Friday reported that three University of Maryland-Baltimore researchers admitted that they fabricated interviews with teenagers for a study on HIV/AIDS prevention, which received more than $1 million in NIH funding in 1999. Lajuane Woodard, Sheila Blackwell and Khalilah Creek, who were employed by the university's department of pediatrics, said that they made up some of the interviews for a study to evaluate an existing AIDS prevention model, called "Focus on Kids." The study, titled "Effectiveness of Standard Versus Embellished HIV Prevention," involved 817 African-American youths ages 12 to 16 and was originally published in the January issue of the journal Pediatrics by a group of nine researchers led by Ying Wu of West Virginia University (Kaiser Daily HIV/AIDS Report, 12/8). Alan Price, associate director of the HHS Office of Research Integrity, said that the fabricated interviews were discovered in August 2001 and reported to ORI by principal investigator Dr. Bonita Stanton, who is now at Children's Hospital of Michigan. In addition, Stanton removed all data gathered from the interviews conducted by Woodard, Blackwell and Creek.
When information regarding the falsified interviews was discovered in 2001, UMB temporarily halted the study and had a panel of professors from several different institutions review the data to ensure that the falsified information had not tainted study conclusions (United Press International, 12/8). The panel found no problems, and the study was resumed, Dr. Donald Wilson, dean of the UMB School of Medicine, said. All three data collectors -- who were part-time, temporary employees and were not listed as authors in the final study -- then entered into a voluntary exclusion agreement, which banned them from participating in federally funded research for three years. Reports of the disciplinary action were included in the Dec. 2 Federal Register, the Washington Times reports (Stacy McCain, Washington Times, 12/9).
"Absolutely no fabricated data were used in any of these analyses and we went out of our way to make sure any of the (information collected by) these data collectors ... was eliminated ... even if it looked good," Stanton said, adding that data collection continued for an additional 12 months after the three employees were removed from the study. HHS considers the investigation into the matter closed, Price said. However, Rep. Mark Souder (R-Ind.), chair of the House subcommittee on criminal justice, drug policy and human resources, who has requested additional information about the research from HHS, said that his committee may still consider launching an investigation into the study (United Press International, 12/8). Souder also said that he was considering introducing measures requiring any future misconduct in federally funded studies to be reported directly to the congressional oversight committee "and not just buried in the Federal Register" (Washington Times, 12/9).