A. Initiation and Purpose
The investigation must begin within 30 calendar days after the DO has determined that, based on the findings of the inquiry, that the investigation is warranted. The purpose of the investigation is to examine the evidence in depth to determine if misconduct has been committed, by whom, and to what extent. In addition, the investigation will determine if there are additional instances of possible research misconduct that would justify broadening the scope of the investigation beyond that covered in the initial allegation. If clinical trials are involved and there is the potential for harm to human subjects or the general public, or if the research forms the basis for public policy, clinical practice, or public health practice, expansion of the scope is particularly important. The investigation must result in a report of its findings. [42 CFR § 93.310 and § 93.313]
B. Sequestration of Evidence
Prior to notifying the respondent of the allegations, the RIO will take all reasonable and practical steps to obtain custody of, inventory, and sequester in a secure location any research evidence that was not previously sequestered during the inquiry stage becomes known or relevant including that thought to be needed to investigate any additional allegations or instances of possible misconduct that have resulted in broadening of the scope of the investigation. [42 CFR § 93.310(d)]
C. Notifications [42 CFR § 93.310(b) and (c)]
On or before the initiation date of the investigation, the RIO shall make the following notifications:
- The ORI Director shall be notified of the decision to begin the investigation. A copy of the inquiry report should accompany the notification.
- The respondent shall be notified of the decision to begin an investigation and the allegations to be investigated including any new allegations not addressed in the inquiry. This notification must be written.
- In addition, the respondent will be given a list of any additional proposed members of the committee and given no more than 7 calendar days to object to a member because of a conflict of interest. The institution will make the final determination of the existence of a conflict.
D. Configuration of the Committee
The RIO will contact members of the inquiry committee regarding their ability to serve on the investigation committee. Replacement and/or additional members should be appointed as needed to replace those unable to serve e.g. because of conflict of interest concerns and to provide any additional expertise needed to address issues that resulted in a broadened scope for the investigation.
Other members will be appointed by the RIO in consultation with the inquiry committee and other institutional officials as appropriate.
E. Presentation of the Charge to the Committee
At the first meeting of the investigation committee, the RIO will present the charge after review of the inquiry report. The charge will include the initial allegations as well as any additional allegations and issues identified during the course of the inquiry; and the purpose and scope of the investigation. The original and any additional respondents will be identified. The committee also will be informed of its responsibility to conduct the investigation as described in VII.F. and to prepare a written report that meets the requirements of this policy and 42 CFR § 93.309(a). The RIO will discuss the charge with the committee, answer questions, assist with the development of plans to conduct the inquiry within the time limit, and emphasize the need to maintain confidentiality.
F. Conduct of the Investigation
The investigation committee will take the following steps to conduct an investigation that is thorough, impartial, unbiased, confidential, and permits the writing of the final report as described in VIII. Throughout this process the RIO and institutional counsel will be present or available to provide advice. The committee will:
- Interview each respondent, complainant, and other individuals who may be able to give relevant information as determined from the interview and as identified by the respondent. Each individual will be provided with a recording or transcript of his/her interview for review and correction. The corrected testimony will be made part of the record of the investigation.
- Examine research evidence pertinent to each allegation so that the decision made regarding each allegation is supported by a preponderance of the evidence.
- Pursue additional issues/allegations that might arise/be received during the course of the investigations as described in VII F. 1 and 2.
G. Time for Completion
The investigation process including preparation of the final report and sending it to ORI is to be completed within 120 days of the start of the process if research involving PHS support is concerned. Should the RIO determine that additional time is needed, s/he may submit a written request for an extension to ORI. This request must include the reason(s) for the delay. If an extension is granted, the RIO will ensure that periodic progress reports are filed as directed. [42 CFR § 93.311]