[Federal Register Volume 66, Number 247 (Wednesday, December 26, 2001)]
[Notices]
[Page 66417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31579]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) and the Assistant Secretary for Health have taken final action in 
the following case:
    Ms. Vilma Valentin, Boston University School of Medicine: Based on 
the report of an investigation conducted by the Boston University (BU) 
School of Medicine (BU Report) as well as additional analysis conducted 
by ORI in its oversight review, the U.S. Public Health Service (PHS) 
found that Ms. Vilma Valentin, a former counselor and interventionist 
on the BU Inner City Asthma Study at the BU School of Medicine, engaged 
in scientific misconduct by fabricating records in research funded by 
two National Institute of Allergy and Infectious Diseases (NIAID), 
National Institutes of Health (NIH), cooperative agreements: U01 
AI39776, ``Data Coordinating Center for NCICAS II,'' and U01 AI39769, 
``Trial of Interventions to Reduce Asthma Morbidity.''
    Specifically, PHS found that Ms. Valentin fabricated: (1) The data 
on three environmental intervention forms for visits that she allegedly 
made to two patients' homes in early and late August 1999; these visits 
did not take place; and (2) the reports of two telephone calls that she 
allegedly made to the two patients' families during the same period; 
these calls were not made. The study intervention included home visits, 
telephone calls, and advocacy letters, all of which were central to the 
research, which sought to evaluate the effectiveness of two 
interventions to reduce asthma severity. Thus, the data and reports 
could have had a substantive effect on the outcome of the research had 
the institution not corrected the research record.
    While acknowledging the findings of scientific misconduct as set 
forth above and in the BU Report but without admitting liability or 
wrongdoing, Ms. Valentin has entered into a Voluntary Exclusion 
Agreement in which she has voluntarily agreed for a period of three (3) 
years, beginning on December 5, 2001:
    (1) To exclude herself from serving in any advisory capacity to 
PHS, including but not limited to service on any PHS advisory 
committee, board, and/or peer review committee, or as a consultant; and
    (2) That any institution that submits an application for PHS 
support for a research project on which Ms. Valentin's participation is 
proposed, that uses her in any capacity on PHS-supported research, or 
that submits a report of PHS-funded research in which she is involved, 
must concurrently submit a plan for supervision of her duties to the 
funding agency for approval. The supervisory plan must be designed to 
ensure the scientific integrity of Ms. Valentin's research 
contribution.

FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative 
Oversight, Office of Research Integrity 5515 Security Lane, Suite 700, 
Rockville, MD 20852, (301) 443-5330.

Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 01-31579 Filed 12-21-01; 8:45 am]
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