5.7.7 Conducting the Investigation

5.7.7 Conducting the Investigation abruneau3 Thu, 06/26/2014 - 18:14

Purpose of the Investigation
The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged misconduct involves clinical trials or potential harm to human subjects or the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation will be set forth in an investigation report.

Sequestration of the Research Records
The Provost will immediately sequester any additional pertinent research or other records that were identified during an inquiry and not previously sequestered. This sequestration should occur before or at the time the respondent is notified that an investigation has begun. The need for additional sequestration of records may occur for any number of reasons, including the institution's decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. The procedures to be followed for sequestration during the investigation are the same procedures that apply during the inquiry.

Appointment of the Investigation Committee
The Provost, in consultation with other institutional officials as appropriate, will appoint an investigation committee and the committee chair within ten (10) business days of notifying the respondent that an investigation will take place. The investigation committee should consist of at least three individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside the institution.  Individuals appointed to the investigation committee may also have served on the inquiry committee.

Upon selection, the Provost will notify the respondent of the proposed committee membership. If the respondent submits a written objection within ten (10) business days to any appointed member of the investigation committee or expert, the Provost will determine whether to replace the challenged member or expert with a qualified substitute.

Charge to the Committee
The Provost will define the subject matter of the investigation in a written charge to the committee that describes the allegations and related issues identified during the inquiry, define scientific and other scholarly misconduct, and identify the name of the respondent. The charge will state that the committee is to evaluate the evidence and testimony of the respondent, complainant, and key witnesses to determine whether, based on a preponderance of the evidence, scientific or other scholarly misconduct occurred and, if so, to what extent, who was responsible, and its seriousness.

During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents, the committee will notify the Provost, who will determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents.

The First Meeting
The Provost, with the assistance of the VP-LA&RM, will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of these instructions and, where sponsor support is involved, the applicable sponsor regulation.

Investigation Process
The investigation committee will be appointed and the process initiated within thirty (30) calendar days of the completion of the inquiry, if findings from that inquiry provide a sufficient basis for conducting an investigation.

The investigation will normally involve examination of all documentation including, but not necessarily limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls.  Whenever possible, the committee should interview the complainant(s), the respondents(s), and other individuals who might have information regarding aspects of the allegations. All other interviews should be transcribed, or tape recorded. Summaries of the tape recordings or transcripts of the interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file.