E9-24392. Findings of Research 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:

Norma Couvertier, APT Foundation: Based on the report of an investigation conducted by the APT Foundation and additional analysis conducted by ORI in its oversight review, ORI found that Norma Couvertier, former Research Assistant II, APT Foundation in New Haven, Connecticut, engaged in research misconduct in research supported by National Institute of Drug Abuse (NIDA), National Institutes of Health (NIH), award R37 DA015969.

Specifically, ORI found that Ms. Couvertier engaged in research misconduct by falsifying and fabricating data that were reported on Participant Urine Monitoring and Breathalyzer Result Forms (CRFs) completed by the Respondent for thirty two (32) of the enrolled study participants in the computer Based Training in Cognitive Behavioral Therapy (CBT4CBT) research study. A total of 253 alcohol breathalyzer (BALS) results were recorded for the 32 participants as being 0.000 indicating no alcohol detected, rather than the code 999 used when no breathalyzer test was done.

ORI also found that Ms. Couvetier, on 253 occasions, with 32 different study participants, falsified alcohol breathalyzer test results and knowingly and consistently entered a false negative test (indicated by 0.000) rather than identifying the result as a missing data collection (indicated by code 999).

ORI acknowledges Ms. Couvetier's verbal admissions and willingness to cooperate and assist during the APT Foundation's investigation.

Ms. Couvertier has entered into a Voluntary Settlement Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on September 18, 2009:

(1) To exclude herself from serving in any advisory capacity to the U.S. Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant;

(2) that any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or 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 ORI. The supervisory plan must be designed to ensure the integrity of her research contribution. Respondent agreed that she will not participate in any PHS-supported research until such a supervisory plan is approved by ORI.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852. [phone].

John Dahlberg,

Director, Division of Investigative Oversight, Office of Research Integrity.