99-7234. Findings of Scientific Misconduct

[Federal Register Volume 64, Number 57 (Thursday, March 25, 1999)]
[Notices]
[Pages 14450-14451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7234]


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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) has made a final finding of scientific misconduct in the 
following case:
    Ms. Maria Diaz, Rush-Presbyterian-St. Luke's Medical Center: Based 
on the report of the Rush-Presbyterian-St. Luke's Medical Center (RPMC) 
Research Integrity Investigation Committee dated May 13, 1998, which 
included a report of a special National Cancer Institute (NCI) audit, 
and additional information obtained by ORI during its oversight review, 
ORI finds that Ms. Diaz, former data manager for two multicenter cancer 
prevention clinical trials at RPMC,

[[Page 14451]]

engaged in scientific misconduct in this clinical research supported by 
NCI, National Institutes of Health (NIH), cooperative agreements.
    Specifically, Ms. Diaz intentionally fabricated and/or falsified 
research data and information collected at RPMC for the Breast Cancer 
Prevention Trial (BCPT) under the National Surgical Adjuvant Breast and 
Bowel Project (NSABP) and a secondary prevention trial for lung cancer 
sponsored by the M.D. Anderson Cancer Center and Eastern Cooperative 
Oncology Group (ECOG). Ms. Diaz falsified data related to entry 
criteria and treatment compliance on the secondary lung cancer 
prevention trial. She fabricated reports of follow-up examinations for 
subjects entered on the BCPT, falsified laboratory test results, and 
forged signatures of physicians on informed consent documents.
    ORI has implemented the following administrative actions for the 
three (3) year period beginning March 13, 1999:
    (1) Ms. Diaz is prohibited 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) Any institution that submits an application for PHS support for 
a research project on which Ms. Diaz's participation is proposed or 
which 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. Diaz's research contribution. The 
institution also must submit a copy of the supervisory plan to ORI.

FOR FURTHER INFORMATION CONTACT: Acting Director, Division of Research 
Investigations Office of Research Integrity 5515 Security Lane, Suite 
700 Rockville, MD 20852 [phone].
Chris B. Pascal,
Acting Director, Office of Research Integrity.
[FR Doc. 99-7234 Filed 3-24-99 8:45 am]
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