[Federal Register Volume 74, Number 230 (Wednesday, December 2, 2009)]
[Notices]
[Pages 63153-63154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research 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) and the Assistant Secretary for Health have taken final action in 
the following case:
    Rashanda Robertson, Emory University: Based on an assessment 
conducted by Emory University (EU), the Respondent's own admission, and 
additional oversight of that admission conducted by ORI, ORI and EU 
found that Ms. Rashanda Robertson, former Research Coordinator, 
Department of General Medicine, EU, engaged in research misconduct in 
research supported by National Heart, Lung, and Blood Institute 
(NHLBI), National Institutes of Health (NIH), grant K23 HL077597. The 
randomized study for which she coordinated was designed to assess 
whether patient medication compliance was improved by a meeting with a 
clinical pharmacist to discuss the patient's current and newly 
prescribed medications prior to the patient's discharge from the 
hospital. The enrolled subjects randomized to the intervention group 
received a card listing all of their medications and a ``pill box'' to 
help them with medication compliance. The subjects also were called 
three days after discharge to check on their medication compliance.
    Specifically, the U.S. Public Health Service (PHS), EU, and Ms. 
Robertson, in a three-way Voluntary Settlement Agreement, agree that 
the Respondent committed the following acts of research misconduct, 
which she fully acknowledged. In an affidavit obtained by EU, the 
Respondent admitted that during the last two weeks of her employment at 
EU, she fabricated enrollment forms to create enrollees who did not 
exist and falsified the data of some enrollees who did not exist to 
cover up the data fabrication. To create the fabricated enrollment 
forms, the Respondent:
     Identified patients who were eligible for the study based 
on their charge screens but who were considered ineligible after a 
face-to-face screen;
     Obtained patients' names from the screening records and 
used the names to obtain the personal information (address and 
telephone numbers) on these patients from the site hospital's pharmacy 
online system;
     Created a fabricated enrollment form for each of the non-
existent enrollees; specifically, Respondent fabricated a participant's 
name by using the name of a patient who had failed screening and then 
fabricated the date of enrollment by using the date of the patient's 
screening failure; using this method, Respondent fabricated the 
participant names, personal information, and enrollment dates on 
twenty-eight (28) enrollment forms;
     Dispersed the fabricated enrollment forms among those 
enrollment forms, beginning around participant number 136 through 212;
     Falsified the numbering of the enrollment forms for some 
individuals who had actually been enrolled to disperse the fabricated 
enrollment forms among the authentic enrollment forms; Respondent 
falsified the status of some actual participants to include them in the 
intervention group, even though they had not actually received the 
intervention; Respondent falsified the data on both the enrollment form 
and the follow-up form for 16 participants between numbers 137 and 198;

[[Page 63154]]

     Respondent falsified data on the enrollment forms and 
follow-up forms for participant numbers 153 and 154 by changing their 
enrollment numbers.
    ORI acknowledges that the Respondent was remorseful.
    Ms. Robertson has entered into a Voluntary Settlement Agreement in 
which she has voluntarily agreed, for a period of three (3) years, 
beginning on October 14, 2009:
    (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;
    (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 the funding agency for approval; the supervisory plan must be 
designed to ensure the scientific integrity of her research 
contribution; respondent agreed that she will not participate in any 
PHS-supported research until such a supervisory plan is submitted to 
ORI; and
    (3) That any institution employing her submits, in conjunction with 
each application for PHS funds or report, manuscript, or abstract of 
PHS-funded research in which the Respondent is involved, a 
certification that the data provided by the Respondent are based on 
actual experiments or are otherwise legitimately derived and that the 
data, procedures, analyses, and methodology are accurately reported in 
the application, report, manuscript, or abstract. The Respondent must 
ensure that the institution sends a copy of the certification to ORI.

FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative 
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 
750, Rockville, MD 20852, (240) 453-8800.

John Dahlberg,
Director, Division of Investigative Oversight, Office of Research 
Integrity.
[FR Doc. E9-28814 Filed 12-1-09; 8:45 am]
BILLING CODE 4150-31-P