E9-28814. 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:

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;
• 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, [phone].

John Dahlberg,

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