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###### Department of Health and Human Services

###### Office of the Secretary

# AGENCY:

Office of the Secretary, HHS.

# ACTION:

Notice.

# 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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