FINDINGS OF SCIENTIFIC MISCONDUCT

Release Date:  April 6, 1999

P.T.

Department of Health and Human Services

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, 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.

INQUIRIES

For further information contact:

Acting Director
Division of Research Investigations
Office of Research Integrity
5515 Security Lane, Suite 700
Rockville, MD  20852
Telephone:  (301) 443-5330

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