02-9620. Findings of Scientific Misconduct

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:

Joao Carlos deSales, San Francisco Department of Public Health: Based on the report of an investigation conducted by the San Francisco Department of Public Health (SFDPH) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Joao Carlos deSales, former study counselor at SFDPH, engaged in scientific misconduct by falsifying data supported under National Institutes of Health subcontract SFP-N01-A1-35176-HMEISTERI-94 to SFDPH under National Institute of Allergy and Infectious Diseases (NIAID), NIH, contract 5-N01-AI35176-019, “Domestic Master Contract for HIV Vaccine Efficacy Trials,” awarded to ABT Associates, Inc.

Specifically, from April through September of 1999, Mr. deSales switched randomization assignments on four pairs of subjects and subsequently altered the research records to conceal his conduct. Mr. deSales' switching of the randomization assignments, if undetected, could have biased the study so as to invalidate the conclusions on the effectiveness of intensive counseling sessions on reducing the rate of new HIV infections.

Mr. deSales has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed for a period of three (3) years, beginning on April 4, 2002:

(1) to exclude himself 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 Mr. deSales' participation is proposed or which uses him in any capacity on PHS supported research, or that submits a report of PHS-funded research in which Mr. deSales is involved, must concurrently submit a plan for supervision of his duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of his research contribution. A copy of the supervisory plan must also be submitted to ORI by the institution.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative Oversight, Office of Research Integrity, 5515 Security Lane, Suite 700, Rockville, MD 20852. [phone].

Chris B. Pascal,

Director, Office of Research Integrity.