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E. Investigations of Allegations of Research Misconduct

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Appendices

E. Investigations of Allegations of Research Misconduct

Approved by the Executive Committee, April 2015

Institutions of higher education with one or more faculty members who receive research support from the National Institutes of Health (NIH) or any other agency under the Public Health Service (PHS) are required to develop policies and procedures for handling allegations of research misconduct in projects supported by the PHS. This statement of policy and procedures is intended to carry out Knox College's responsibilities under the Public Health Service (PHS) Policies on Research Misconduct, 42 CFR Part 93. However, this policy applies to Knox College research and related activities, regardless of funding source. The aim of this policy is to promote a culture of honesty in all research, reflecting the closely held values of academic integrity throughout the institution, as represented but not limited to the Knox College Honor Code. Any successful policy must distinguish between deliberate fraud and instances of honest error or debatable interpretation. This policy expresses the College's core commitments to Veritas, a spirit of scientific inquiry, and open and equitable processes to promote learning.

A. General Procedures

  1. The Dean of the College (the "Dean") shall be responsible for the receipt of allegations regarding research misconduct and is responsible for their proper handling, ensuring the competence and fairness in the application of the procedures presented in this document and communicating all findings to the Office of Research Integrity (ORI).
  2. The College shall take all reasonable steps to ensure impartial and unbiased research misconduct proceedings to the maximum extent practicable. Prior to selection, the College will screen those conducting the inquiry or investigation for any unresolved personal, professional, or financial conflicts of interest with the respondent, complainant, potential witnesses, or others involved in the matter. Any such conflict, which a reasonable person would consider to demonstrate potential bias, shall disqualify the individual from selection. If the Dean is determined to have a conflict of interest in any particular case, the Associate Dean of the College shall carry out the responsibilities of the Dean in that case.
  3. The Dean shall inform the College's faculty and staff of these policies and procedures and the importance of compliance with them.
  4. Reports of suspected research misconduct must be presented to the Dean of the College. The report should include a description of the alleged misconduct and provide available evidence. Allegations can be submitted by any means of communication.
  5. The Faculty Affairs Subcommittee of the Executive Committee and a representative designated by the Dean will carry out an "Inquiry" into the allegations. An inquiry is an initial review of the evidence to determine if the criteria for conducting an investigation have been met. This committee will report its findings to the Dean.
  6. If inquiry committee deems the allegations to meet the definition of research misconduct as defined in this policy and to warrant further action, the Dean will launch an "Investigation" of the allegations.  The Investigation shall be conducted by a committee appointed by the Dean in consultation with the Faculty Affairs Subcommittee.
  7. After a thorough investigation of the allegations, the appointed committee will submit a written report to the Faculty Affairs Subcommittee.
  8. In the case of a report of substantiated allegation of misconduct, the Faculty Affairs Subcommittee, in consultation with the Dean of the College, will make recommendations to the President of the College on appropriate sanctions and institutional action.

B. Definitions

"Research misconduct" means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

  1. Fabrication is inventing data or results and recording or reporting them.
  2. Falsification is altering or manipulating equipment, materials, or procedures or changing or selectively reporting data or results in a way that constitutes an inaccurate record of the research undertaken.
  3. Plagiarism means to present someone else's work as one's own without proper attribution and accurate citation.
  4. Serious deviation from commonly accepted practices would include violations of confidentiality agreements in peer review settings; stealing, damaging, or otherwise disrupting the research activities of others; directing, encouraging, or permitting others to engage in the forms of conduct outlined above.

Complainant: Any individual presenting an allegation of scientific misconduct is a complainant.

Respondent: An individual facing an allegation of research misconduct is a respondent.

C. Rights and Responsibilities of the Complainant and Respondent

1. Complainant

Any individual presenting an allegation of scientific misconduct ("complainant") is responsible for making such allegations in good faith, maintaining confidentiality (as described in this policy) throughout the procedure, and cooperating with any inquiry or investigation that occurs. Members of the institution may not retaliate against a complainant or anyone participating in the inquiry/investigation in any way. Instances of alleged or apparent retaliation should be reported immediately to the Dean of the College. The complainant is entitled to be notified of whether the inquiry found that an investigation is warranted.

2. Respondent

An individual facing an allegation of research misconduct ("respondent") must be notified in writing of an inquiry or investigation before the inquiry or investigation begins.  The respondent is responsible for maintaining confidentiality (as described in this policy) throughout the procedures and cooperating with any inquiry or investigation that occurs.  The respondent is entitled to:

  • be notified of whether the inquiry found that an investigation is warranted and provided with the inquiry report and a copy of this policy, and will be given the opportunity to respond in writing, which must be included in the inquiry report.
  • If the inquiry subsequently identifies additional respondents, they also shall be promptly notified in writing.
  • be interviewed during an investigation. The College will notify the respondent sufficiently in advance of the scheduling of his/her interview in the investigation so that the respondent may prepare for the interview.
  • have the College interview witnesses that might have information relevant to allegations addressed in the investigation.
  • read the draft of the investigation report and be given the opportunity to respond in writing, which must be considered and included in the investigation report. Concurrently, the respondent will be given a copy of, or supervised access to, the evidence on which the report is based. The respondent must submit any comments regarding the draft report within 30 days of the date on which the respondent receives the draft report. The Committee will consider and address the respondent's comments before issuing the final report.
  • be notified in writing of the findings of an investigation and the resulting consequences, if relevant.
  • present an admission of guilt and, after consultation with the ORI, have procedures of inquiry and investigation into research misconduct terminated.

D. Confidentiality, Interim Protective Actions, and Protection of Records

Confidentiality

The College shall, as required by 42 CFR § 93.108, limit disclosure of the identity of respondents and complainants, to the extent possible, to: (1) those who need to know in order to carry out a thorough, competent, objective and fair research misconduct proceeding; and (2) ORI as it conducts its review of the research misconduct proceeding and any subsequent proceedings. Except as otherwise prescribed by law, any information obtained during the research misconduct proceeding that might identify research subjects shall be maintained securely and confidentially and shall not be disclosed, except to those who need to know in order to carry out a research misconduct  proceeding.

Interim Protective Actions

At any time during a research misconduct proceeding, the Dean shall take appropriate interim administrative actions to protect public health, Federal funds and equipment, and the integrity of  the PHS supported research process. At any time during a research misconduct proceeding, the College shall notify ORI immediately if it has reason to believe that any of the following conditions exist:  (1) health or safety of the public is at risk, including an immediate need to protect human or animal subjects; (2) HHS resources or interests are threatened; (3) research activities should be suspended; (4) there is a reasonable indication of violations of civil or criminal law; (5) federal action is required to protect the interests of those involved in the research misconduct proceeding; (6) the College believes the research misconduct proceeding may be made public prematurely, so that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved; or (7) the College believes that the research community or the public should be informed.

Maintenance and Custody of Research Records and Evidence

Either before or concurrent with notice to the respondent the allegation, the College shall promptly take all reasonable and practical steps to obtain custody of all research records and other evidence needed to conduct the research misconduct proceeding, inventory those materials, and sequester them in a secure manner. Where appropriate, the College will give the respondent copies of, or reasonable, supervised access to, the research records. In cases where the research records or evidence encompasses scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.

Unless custody has been transferred to HHS, or ORI has advised the College in writing that it no longer needs to retain the records, all records of research misconduct allegations and proceedings – including documentation of a decision not to investigate – will be maintained by the College in a secure manner for 7 years after the completion of the proceeding or the completion of any PHS proceeding involving the research misconduct allegation, whichever is later. Irrelevant or duplicate records (as determined by the Dean) need not be retained; however, the Dean must document the determination of irrelevant or duplicate records.

E. Inquiry

Upon receipt of allegations of research misconduct, the Dean shall promptly assess whether the allegation to determine if: (1) it meets the definition of research misconduct in this policy; and (2) in the allegations is sufficiently credible and specific so that potential evidence of research misconduct may be identified.  If the allegation is found to meet these three criteria, the Dean shall order an immediate inquiry into the matter to be conducted by a designated representative of the Dean and the Faculty Affairs Subcommittee of the Executive Committee (collectively, the "inquiry committee").

  • Such inquiry will be completed within 60 calendar days including the submission of a written report to the Dean, unless the inquiry committee determines that more time is required. If the inquiry takes longer than 60 days to complete, the inquiry committee shall include documentation of the reasons for the delay in the inquiry record.
  • Due precautions against real or apparent personal, professional, or financial conflicts of interest in an inquiry shall be taken.

Inquiry Process

The inquiry committee will normally interview the complainant, the respondent, and key witnesses, as well as examining relevant research records and materials.  

The inquiry committee will then evaluate the evidence, including the testimony obtained during the inquiry. An investigation is warranted if the committee determines: (1) there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct; and, (2) the allegation may have substance. After consultation with the Dean, the committee members will make a written determination of whether an investigation is warranted based on the criteria in this policy.  

The inquiry committee shall prepare an inquiry report and give the respondent a reasonable opportunity to comment on it. The inquiry report shall contain the following information: (1) the name and position of the respondent(s); (2) a description of the allegations of research misconduct; (3) relevant funding sources including PHS support involved (e.g., grant numbers, grant applications, contracts, and publications), if any; (4) the basis for recommending that the alleged actions warrant an investigation, if such a recommendation is made; and (5) any comments on the report by the respondent or the complainant.

An inquiry is not required to and does not normally include deciding whether misconduct definitely occurred, determining definitely who committed the research misconduct, or conducting exhaustive interviews and analyses. However, if a sufficient admission of research misconduct is made by the respondent, misconduct may be determined at the inquiry stage if all relevant issues are resolved. In such cases, the institution shall promptly consult with ORI to determine the next steps to be taken.

F. Notifications to and Cooperation with ORI

If the inquiry committee determines that an investigation is warranted, the Dean will provide ORI with the inquiry committee's written decision and a copy of the inquiry report within 30 calendars days of the determination and on or before the date on which the investigation begins. The Dean will also notify those institutional officials who need to know of the committee's decision. The Dean must provide the following information to ORI upon request: (1) the institutional policies and procedures under which the inquiry was conducted; (2) the research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents; and (3) the charges to be considered in the investigation.

The Dean shall promptly advise ORI of any developments during the course of the investigation which disclose facts that may affect current or potential Department of Health and Human Services funding for the individual(s) under investigation or that the PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest.

The Dean shall notify the ORI of the final outcome of the investigation with a written report that thoroughly documents the investigative process and findings.

The College shall, upon request, provide records relevant to a research misconduct allegation, including the research records and evidence, to authorized Department of Health and Human Services (HHS) personnel.

The College shall cooperate fully and on a continuing basis with ORI during its oversight reviews of this institution and its research misconduct proceedings during the process under which the respondent may contest ORI findings of research misconduct and proposed HHS administrative actions. This includes providing, as necessary to develop a complete record of relevant evidence, all witnesses, research records, and other evidence under the College's control or custody, or in the possession of, or accessible to, all persons that are subject to the College's authority.  

G. Investigation

If findings from an inquiry provide sufficient basis, a formal investigation shall be initiated within 30 calendar days of the completion of an inquiry.  Such an investigation shall be conducted by a committee of impartial experts appointed by the Dean upon the recommendation of the Faculty Affairs Subcommittee. The investigation shall be completed within 120 calendar days, including conducting the investigation, preparing the report of findings, providing the draft report for comment, and sending the final report to ORI. If unable to complete the investigation within 120 days, the College must ask ORI for an extension in writing.

  1. The investigation committee will have five (5) members.
  2. Due precautions against real or apparent conflicts of interest in an investigation shall be taken.
  3. The affected individual(s) shall be accorded confidential treatment to the maximum extent possible, a prompt and thorough investigation, and an opportunity to comment on allegations and findings of the investigation.
  4. The Public Health Service's (PHS) Office of Research Integrity (ORI), at the National Institutes of Health (NIH), shall be informed at the outset of the determination to have a formal  investigation.
  5. Should a reasonable indication of possible criminal violations be discovered, ORI shall be informed within 24 hours.

Investigation Process

The Dean 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;
  • Identifies the respondent;
  • Informs the committee that it must conduct the investigation as prescribed in section E;
  • Defines research misconduct;
  • Informs the committee that it must evaluate the evidence and testimony to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, the type and extent of it and who was responsible;
  • Informs the committee that in order to determine that the respondent committed research misconduct it must find that a preponderance of the evidence establishes that: (1) research misconduct, as defined in this policy, occurred (respondent has the burden of proving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion); (2) the research misconduct is a significant departure from accepted practices of the relevant research community; and (3) the respondent committed the research misconduct intentionally, knowingly, or recklessly; and
  • Informs the committee that it must prepare or direct the preparation of a written investigation report that meets the requirements of this policy and 42 CFR § 93.313.

Initial Meeting: The Dean 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 this statement of policy and procedures and 42 CFR Part 93.  The Dean will be present or available throughout the investigation to advise the committee as needed.

Committee activities: The investigation committee will interview the complainant, the  respondent, and key witnesses, as well as examining all relevant research records and materials. The committee shall be diligent in ensuring that the investigation is thorough, maintaining a spirit of impartiality to the maximum extent possible, and pursue all significant issues and leads, including any evidence of additional instances of misconduct.  The committee must determine, for each allegation, whether the preponderance of evidence substantiates the claim of research misconduct or the evidence indicates a case of honest error or difference of opinion.

Maintenance of records: The committee will maintain complete and thorough records of all material examined and all interviews conducted.  Transcripts or recordings of all interviews must be produced and maintained.

Investigation report: The committee must submit a written draft report on its investigation and deliberations to the Dean of the College.  The Dean must provide the respondent with an opportunity to respond to the draft report; any response must be included in the final report. The Dean will return the final report to the committee. This report must include:

  • Description of the specific allegations investigated.
  • Detailed description of PHS support.
  • A copy of institutional policies and procedures used.
  • The charge to the investigation committee.
  • A summary of the records and evidence reviewed, identifying any evidence taken into custody but not reviewed. The report should also describe any relevant records and evidence not taken into custody, and explain why.
  • Analysis of each specific allegation of misconduct, including evidence used in evaluating the allegation and any reasonable explanations provided by the respondent.
  • Identify any specific PHS support related to each allegation.
  • Identify whether the misconduct was fabrication, falsification, plagiarism, or other serious deviation from accepted practices.
  • Identify the person(s) responsible for the misconduct.
  • The criteria used for determining a finding of misconduct.
  • Identify any publications needing correction or retraction.
  • list any current support or known applications or proposals for support that the respondent has pending with non-­PHS federal agencies.
  • An opportunity for the respondent to comment and inclusion and consideration of the comments.

H. Determination of Findings and Institutional Action

The Final Investigation Report will be forwarded to the Faculty Affairs Subcommittee of the Executive Committee.  In the event that an allegation of research misconduct has been substantiated, the Faculty Affairs Subcommittee, in consultation with the Dean, will determine appropriate sanctions and make recommendations to the President of the College for institutional action.  The respondent will be notified in writing of any institutional action resulting from the investigation.

Upon completion of an investigation, the Dean shall make all reasonable and practical efforts to protect or restore the reputations of persons alleged to have engaged in misconduct when allegations are not confirmed, and to protect or restore the positions and reputations of any complainant, witness, or committee member and to counter potential or actual retaliation against those complainants, witnesses, and committee members.

The College will also cooperate with and assist ORI as needed to carry out any administrative actions HHS may impose as a result of a final finding of research misconduct by HHS.

Knox College

http://www.knox.edu/offices/academic-affairs/faculty-handbook/appendices/e-investigations-of-allegations-of-research-misconduct

Printed on Friday, July 29, 2016

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