Ohio Admin. Code 3344-28-06

Current through all regulations passed and filed through November 4, 2024
Section 3344-28-06 - Conducting the investigation
(A) 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 academic research misconduct has been committed, and if so, the responsible person and the seriousness of the misconduct. The investigation also will determine whether there are additional instances of possible academic research 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 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.

(B) Sequestration of the research records

The research integrity officer shall immediately sequester any additional pertinent research records not previously sequestered during the inquiry process. 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; for example, the university's decision to investigate additional allegations not considered during the inquiry stage may require additional documentation contained within the research records, or the inquiry process may identify additional research records that will be needed during the investigation.

(C) Any such administrative actions taken prior to a final determination should be devised and taken to create minimal interference with the regular research activities of the respondent and other involved parties.
(D) Appointment of the investigation committee

Within ten days of the notification to the respondent that an investigation will be conducted, or as soon thereafter as practicable, the research integrity officer, in consultation with other university officials as appropriate, will appoint an investigation committee.

(E) Appointees may not have served on the inquiry committee. The investigation committee should consist of at least three individuals who do not have any real or apparent conflicts of interest with the respondent or the case in question. The members of the investigation committee shall have the necessary expertise to examine the evidence, interview the principals and key witnesses, and conduct the investigation. The investigation committee members may be scientists, subject matter experts, or other qualified persons, and they may be from inside or outside the university. The investigation committee selects its own chair.
(F) The research integrity officer shall notify the respondent of the proposed investigation committee membership within ten days of the time of the notification to the respondent that an investigation will be conducted. If within five working days of receiving the names of the investigation committee members, the respondent submits a written objection to any appointed :member of the investigation committee based on bias or conflict of interest, the research integrity officer shall determine within five working days whether to replace the challenged :member with a qualified substitute. Substitute members may also be challenged by the respondent within two working days.
(G) Charge to investigation committee and the first meeting
(1) Charge to the committee

The research integrity officer shall define the subject matter of the investigation in a written charge to the committee that describes the allegation(s) and related issues identified during the inquiry, define academic research misconduct, and identify the complainant and the respondent. The charge shall state that the committee is to evaluate the evidence and testimony of the respondent, the complainant, and key witnesses to determine whether there is clear and convincing evidence that academic research misconduct occurred and, if so, to what extent, who was responsible, and its seriousness.

(2) During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents or a modification of the original charge, the committee shall notify the research integrity officer, who shall determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents, to modify the original charge, and to initiate a new inquiry or continue the investigation underway. The respondent must be notified immediately of any significant change.
(3) A copy of the charge shall be sent to the respondent
(4) First meeting

The research integrity officer, with the assistance of university legal counsel, shall convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for conducting the investigation. It is the responsibility of the research integrity officer to assist the investigation committee with plans for organizing the investigation and to answer any questions raised by the investigation committee members. The research integrity officer and university legal counsel shall be present or available throughout the investigation process to advise the investigation committee as needed.

(H) Investigation process

The investigation normally shall include examination of all documentation including, but not necessarily limited to, relevant research data materials, proposals, publications, correspondence, memoranda, and notes of telephone calls. Whenever possible, interviews should be conducted of all individuals involved either in making the allegation or against whom the allegation is made, as well as other individuals who might have information regarding key aspects of the allegations. All interviews should be tape-recorded. Copies of these interview tapes should be prepared, provided to the respondent, and included as part of the investigatory file. A copy of the tape of respondent's interview may be provided to the interviewed party upon request.

(I) Time limit for completing the investigation report

An investigation should ordinarily be completed within one hundred and twenty days of its initiation, with the initiation being defined as the date upon which the committee first meets. This includes time for conducting the investigation- including providing the respondent with the opportunity to confront and question all witnesses, preparing the report of findings, making the report available for comment by the subjects of the investigation, as well as submitting the report to the research integrity officer and the "ORI."

(J) The investigation report

The final report, if submitted to "ORI," shall state the policies and procedures under which the investigation was conducted, describe how and from whom information relevant to the investigation was obtained, state the findings, and explain the basis for the findings. Any final report shall include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct, as well as a description of any intermediate administrative actions taken by the university.

(K) Comments on the draft investigation report
(1) Respondent

The research integrity officer shall provide the respondent with a copy of the draft investigation report for comment and rebuttal. The respondent shall be allowed fourteen days to review and to comment on the draft report. The respondent's comments shall be attached to the final report. In addition to all the other evidence, this report should take into account the respondent's comments.

(2) Complainant

The research integrity officer shall provide the complainant, if they are identifiable, with those portions of the draft investigation report that address the complainant's role and opinions in the investigation. The report should be modified in its final version, as appropriate, based on the complainant's comments.

(3) Confidentiality

In distributing the draft report, or portions, thereof, to the respondent and to the complainant, the research integrity officer shall inform the recipient of the confidentiality under which the draft report is made available. The research integrity officer may establish reasonable conditions to ensure such confidentiality insofar as permitted by the law of the state of Ohio. For example, the research integrity officer may request that the recipient sign a confidentiality statement or to come to his or her office to review the report.

(4) Transmittal of the final investigation report

After comments have been received and the necessary changes, if any, have been made in the draft report, the investigation committee should transmit the final report with attachments, including the respondent's and the complainant's comments, to the deciding official, through the research integrity officer.

(5) Decision by institutional official

Based on the findings presented in the final investigation report, the deciding official shall determine whether misconduct has occurred, and what sanctions or administrative actions are to be undertaken.

Ohio Admin. Code 3344-28-06

Effective: 9/13/1997
Promulgated Under: 111.15
Authorized By: 3344
Amplifies: 111.15