Responsible Office: Academic Affairs
Policy Administrator: Chief Academic Officer
Scope: |Faculty |Staff |Student

Approved By: President's Council

Approved Date: 7/17/2017

Effective Date: 7/17/2017

Category: Academics

Description/Purpose:

Saint Francis University is committed to the highest ethical standards of integrity for its administration, faculty and student body. The University expects all research conducted under its auspices to adhere to the strictest levels of intellectual honesty.  This policy has been designed to meet the requirements of the National Science Foundation (NSF), the U.S. Public Health Service (PHS), under which the National Institutes of Health (NIH) operates, and other federal agencies. 

Consequence:

Details:

According to federal policy, research misconduct, also referred to as scientific misconduct, means fabrication, falsification, or plagiarism in proposing or performing research [...], reviewing research [...], or in reporting research results [...].¹ It does not include honest error or honest differences in interpretations or judgments of data.

Saint Francis University will provide an environment that promotes every researchers commitment to personal responsibility for ones behavior and intellectual honesty. The University will support the training of student researchers in the principles of proper research practices.

Scope:

This policy and the associated procedures apply to all individuals at Saint Francis University engaged in research as defined in Part 2 of this document, including any research that is supported by the federal government or for which federal support is requested. This policy applies to any person paid by, under the control of, or affiliated with the institution, such as faculty, students working as laboratory or research assistants, or collaborators at Saint Francis University.

This policy and associated procedures applies to all allegations of research misconduct and will normally be followed when an allegation of possible research misconduct is received by any institutional official or committee. Particular circumstances in an individual case may dictate variation from the normal procedure deemed in the best interests of the institution and funding agency. Any change from normal procedures also must ensure fair treatment to the subject of the inquiry and/or investigation. Any significant variation should be approved in advance by the Chief Academic Officer of Saint Francis University.

 Definitions:

 Allegation means a disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication to an institutional official.²

• 45 C.F.R. § 689.1(a)

• 42 C.F.R. §93.201

Complainant means a person who in good faith makes an allegation of research misconduct.³

Conflict of interest means the real or apparent overlap of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal, financial or professional relationships.

Deciding Official means the Chief Academic Officer of Saint Francis University. The Chief Academic Officer will make determinations on allegations of research misconduct and any responsive institutional actions. The Deciding Official will not be the same individual as the Research Integrity Officer.

Evidence means any document, tangible item, or testimony offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact.⁴

Federal support means federal grants, contracts, or cooperative agreements or applications therefore.

Good faith as applied to a complainant or witness, means having a belief in the truth of ones allegation or testimony that a reasonable person in the complainants or witnesss position could have based on the information known to the complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if made with knowing or reckless disregard for information that would negate the allegation or testimony.⁵

Inquiry means the preliminary information-gathering and preliminary fact-finding to determine whether an allegation or apparent instance of research misconduct has substance and if an investigation is warranted.⁶

Investigation means a formal development, examination and evaluation of a factual record to determine whether research misconduct has taken place, to assess its extent and consequences, and to evaluate appropriate action.⁷

NSF means the National Science Foundation.

OIG means the Office of the Inspector General, the office within the National Science Foundation (NSF) that is responsible for the research misconduct and research integrity activities.

• 42 C.F.R. §93.203

• 42 C.F.R. §93.208

• 42 C.F.R. §93.210

• 45 C.F.R. § 689.2(b); 42 C.F.R. § 93.212

• 45 C.F.R. § 689.2(b); 42 C.F.R. § 93.215

ORI means the Office of Research Integrity, the office within the U.S. Department of Health and Human Services (DHHS) that is responsible for the research misconduct and research integrity activities of the U.S. Public Health Service.

PHS means the U.S. Public Health Service, an operating component of the DHHS.

PHS regulation means the Public Health Service regulation establishing standards for institutional inquiries and investigations into allegations of research misconduct, which is set forth at 42 C.F.R. Part 93.

Preponderance of the evidence means evidentiary proof that, when contrasted with proof supporting the opposing view, leads to the conclusion that the fact in dispute is more probably true than not.

Research, for the purposes of this document, is defined as any systematic investigation, including research development (pilot testing), designed to develop or contribute to generalizable knowledge. Generalizable knowledge includes any systematically generated products of research intended for dissemination beyond the institutional setting (e.g., program evaluation research for internal use would not usually be applicable).

Research Integrity Officer means the institutional official responsible for assessing allegations of research misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations.

Research misconduct, for the purposes of this document and as defined by the federal Office of Science and Technology Policy, is fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results as referenced in Part  1.

1. Fabrication means making up data or results or recording or reporting them.⁸

2. Falsification means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.⁹

3. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.¹⁰

Research misconduct does not include honest error or differences of opinion.¹¹  A finding of research misconduct requires that:

• there be a significant departure from accepted practices of the relevant researchcommunity;

• the misconduct be committed intentionally, knowingly, or recklessly; and

• 45 C.F.R. § 689.1(a)(1)

• 45 C.F.R. § 689.1(a)(2)

• 45 C.F.R. § 689.1(a)(3)

• 45 C.F.R. § 689.1(b)

• the allegation be proven by a preponderance of the evidence.¹²

Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

Retaliation for the purpose of this policy means an adverse action taken against a complainant, witness, or committee member by an institution or one of its members in response to:

• a good faith allegation of research misconduct; or

• good faith cooperation with a research misconduct proceeding.¹³

Subject means the person against whom an allegation of research misconduct is directed or the person whose actions are the matter of the inquiry or investigation. There can be more than one subject in any inquiry or investigation.

1. Policy:

3. Rights and Responsibilities

3.1.  Research Integrity Officer

The Chief Academic Officer will appoint a Research Integrity Officer (RIO) whose primary responsibility will be the implementation of the procedures described in this document. The RIO will be an institutional official who has first-hand experience of the research process, is qualified to handle the necessary procedural requirements, and is sensitive to the demands made on those who are accused of research misconduct and on those who report allegations of research misconduct in good faith. Preferably, the RIO will be a tenured faculty member, in which case, he/she will not be responsible for direct academic supervision of other faculty, i.e. the positions of dean of a school or chair of a department are incompatible with the office of RIO.

The RIO will appoint the inquiry and, if necessary, investigation committees, in consultation with the Chief Academic Officer, and will ensure that necessary and appropriate expertise is secured to carry out a thorough evaluation of the pertinent evidence in an inquiry or investigation. Because the strongest asset that a researcher has is his/her reputation, the RIO is charged with taking all reasonable steps to ensure that confidentiality is maintained throughout the process.

• 45 C.F.R. § 689.1(c)

• 42 C.F.R. § 93.226

The RIO will assist inquiry and investigation committees and all institutional personnel in complying with these procedures in a timely manner and in complying with applicable standards imposed by government or external funding sources. The RIO is also responsible for maintaining files of all documents and evidence and for the confidentiality and the security of the files.

The RIO will report to OIG, ORI, or other federal agencies as required by regulation and will keep them appraised of any developments during the course of the inquiry or investigation that may affect current or pending federal funding for the subject(s) or that the federal agency needs to know to ensure appropriate use of federal funds and otherwise protect the public interest.¹⁴  At the conclusion of the inquiry or investigation procedures, the RIO will forward to the relevant federal agency copies of the findings and, if appropriate, the evidence accumulated in the process.

The RIO will be responsible to develop materials to be used in the training of students in acceptable research practices.

3.2.  Complainant

The complainant will have an opportunity to testify before the inquiry and, if applicable, investigation committees, to review portions of the inquiry and investigation reports pertinent to his/her allegations or testimony, to be informed of the results of the inquiry and investigation, and to be protected from retaliation. Also, if the Research Integrity Officer has determined that the complainant may be able to provide pertinent information on any portions of the draft report, these portions will be given to the complainant for comment.¹⁵

The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry and/or investigation.

3.3.  Subject

The subject will be informed of the allegations when an inquiry is opened and notified in writing of the final determinations and resulting actions. The subject will also have the opportunity to be interviewed by and present evidence to the inquiry and investigation committees, to review the draft inquiry and investigation reports, and to have the advice of personal counsel. Counsel, however, may not participate in the committee (inquiry or investigation) proceedings.

The subject is responsible for maintaining confidentiality and cooperating with the inquiry or investigation. If the subject is not found guilty of research misconduct, he or she has the right to receive reasonable and practical institutional assistance in restoring his or her reputation.¹⁶

• 45 C.F.R. § 689.2(b); 42 C.F.R. § 93.215

• 42 C.F.R. § 93.310(g)

• 42 C.F.R. § 93.304(k)

3.4.  Deciding Official

The Deciding Official will receive the inquiry and/or investigation report and any written comments made by the subject or the complainant on the draft report. The Deciding Official will consult with the Research Integrity Officer or other appropriate officials and will determine whether to conduct an investigation, whether research misconduct occurred, whether to impose sanctions, or whether to take other appropriate administrative actions [see Part 10].

4. General Policies and Principles

4.1.  Responsibility to Report Misconduct

All employees, individuals or committees associated with Saint Francis University have the ethical obligation to report observed, suspected, or apparent research misconduct to the Research Integrity Officer. If an individual or committee is unsure whether a suspected incident falls within the definition of research misconduct, they may call the RIO to discuss the suspected research misconduct informally. If the circumstances described by the individual do not meet the definition of research misconduct, the RIO will refer, if appropriate, the individual or allegation to other offices or officials with responsibility for resolving the problem.

At any time, an employee may have confidential discussions and consultations about concerns of possible research misconduct with the RIO and will be counseled about appropriate procedures for reporting allegations.

Individuals may also report suspected misconduct directly to a funding agency.

4.2.  Protecting the Complainant

The Research Integrity Officer will monitor the treatment of individuals who bring allegations of research misconduct or of inadequate institutional response thereto, and those who cooperate in inquiries or investigations. The RIO will ensure that these persons will not be subject to retaliation in the terms and conditions of their employment or other status at the institution and will review instances of alleged retaliation for appropriate action.

Employees and students should immediately report any alleged or apparent retaliation to the RIO.

Also the institution will protect the privacy of those who report research misconduct in good faith to the maximum extent possible. For example, if the complainant requests anonymity, the institution will make an effort to honor the request during the allegation assessment or inquiry within applicable policies and regulations and state and local laws. The complainant will be advised that if the matter is referred to an investigation committee and the complainant's testimony is required, anonymity may no longer be guaranteed.  Saint Francis University will undertake reasonable and practical efforts to protect the positions and reputations of those persons who, in good faith, make allegations.¹⁷

4.3.  Protecting the Subject

Inquiries and investigations will be conducted in a manner that will ensure fair treatment to the subject(s) in the inquiry or investigation and confidentiality to the extent possible without compromising public health and safety or thoroughly carrying out the inquiry or investigation.¹⁸

Institutional employees accused of research misconduct may consult with legal counsel, faculty or staff supervisor or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice.

4.4.  Confidentiality

The Research Integrity Officer will

• limit disclosure of the identity of the subject(s) and complainant(s), to the extent possible,to those who need to know in order to carry out a thorough, competent, objective and fair research misconduct proceeding; and

• except as otherwise prescribed by law, will limit the disclosure of any records or evidence from which the subject(s) might be identified to those who need to know in order to carry out a research misconduct proceeding.¹⁹

The RIO should use written confidentiality agreements or other mechanisms to ensure that the complainant, witnesses and members of the inquiry or investigation committees do not make any disclosure of identifying information.

4.5.  Cooperation with Inquiries and Investigations

Saint Francis University employees will cooperate with the Research Integrity Officer and other university officials in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence to the RIO or other institutional officials on research misconduct allegations.

4.6.  Preliminary Assessment of Allegations

• 42 C.F.R. § 93.304(l)

• 42 C.F.R. § 93.304(a)

• 45 C.F.R. § 689.5(b); 42 C.F.R. § 93.108. Saint Francis University, however, is obligated to disclose the identity of subjects and complainants (if known) to the overseeing funding office, if any, (see 42 C.F.R. § 93.108(a)(1)).

Upon receiving an allegation of research misconduct,the Research Integrity Officer will immediately assess the allegation to determine whether the allegation falls under the definition of research misconduct, whether there is sufficient evidence to warrant an inquiry, and whether funding agencies must be notified. If the subject is a student, the RIO will consult with the Chief Academic Officer to determine if the procedures outlined in the Academic Honesty policy apply.

Procedures:

5. Conducting the Inquiry

5.1.  Initiation and Purpose of the Inquiry

Following the preliminary assessment, if the Research Integrity Officer has determined that the allegation provides sufficient information to allow specific follow-up, and falls under the definition of research misconduct, he/she will immediately initiate the inquiry process. In initiating the inquiry, the RIO should identify clearly the original allegation and any related issues that should be evaluated. The purpose of the inquiry is to make a preliminary evaluation of the available evidence and testimony of the subject, complainant, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation. The purpose of the inquiry is not to reach a final conclusion about whether research misconduct definitely occurred or who was responsible. The findings of the inquiry must be set forth in an inquiry report.

The subject will be informed of the allegations before an inquiry is initiated.

5.2.  Securing the Research Records

After determining that an allegation falls within the definition of research misconduct, the Research Integrity Officer must ensure that all original research records and materials relevant to the allegation are immediately secured. In other words, the RIO must ensure that all original research records are placed under supervision so that they cannot be manipulated. In order to not disrupt any legitimate research being done, the subject(s) will be allowed to keep copies of the research records.  The RIO may need to consult with university counsel on the proper procedure to secure records that are in the subjects personal possesion.

5.3.  Appointment of the Inquiry Committee

The Research Integrity Officer, in consultation with the Chief Academic Officer, will appoint an inquiry committee and committee chair within 15 calendar days of the initiation of the inquiry. The inquiry committee should consist of 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 allegation, interview the principals and key witnesses, and conduct the inquiry. These individuals may be scientists, subject matter experts, administrators, lawyers, or other qualified persons, and they may be from inside or outside the institution. There must be a minimum of three individuals on the inquiry committee and a majority of the committee members must be tenured faculty.

The RIO will notify the subject of the proposed committee membership within 10 calendar days of the appointment of the inquiry committee.

If the subject submits a written objection to any appointed member of the inquiry committee or expert based on bias or conflict of interest within 5 days of notification of the membership, the RIO will determine whether to replace the challenged member or expert with a qualified substitute.

5.4.  Charge to the Committee and the First Meeting

The Research Integrity Officer will prepare a charge for the inquiry committee that describes the allegations and any related issues identified during the allegation assessment and states that the purpose of the inquiry is to make a preliminary evaluation of the evidence and testimony of the subject, complainant, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation. The purpose is not to determine whether research misconduct definitely occurred or who was responsible.

At the committee's first meeting, the RIO will review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee. The RIO and university counsel will be present or available throughout the inquiry to advise the committee as needed.

5.5.  Inquiry Process

The inquiry committee will normally interview the complainant, the subject, and key witnesses as well as examining relevant research records and materials. Then, the inquiry committee will evaluate the evidence and testimony obtained during the inquiry. After consultation with the Research Integrity Officer and university counsel, the committee members will decide whether there is sufficient evidence of possible research misconduct to recommend further investigation. The scope of the inquiry does not include deciding whether research misconduct occurred or conducting exhaustive interviews and analyses.

6.  The Inquiry Report

6.1.  Elements of the Inquiry Report

A written inquiry report must be prepared that states

• the name and title of the committee members and experts, if any;

• the allegations;

• federal support, if any;

• a summary of the inquiry process used;

• a list of the research records reviewed;

• summaries of any interviews;

• a description of the evidence in sufficient detail to demonstrate whether an investigation iswarranted or not; and

• the committee's recommendation as to whether an investigation should be undertaken and whether any other actions should be taken.

University counsel will review the report for legal sufficiency.

6.2.  Comments on the Draft Report by the Subject and the Complainant

The Research Integrity Officer will provide the subject with a copy of the draft inquiry report for comment and rebuttal and will provide the complainant, if he or she is identifiable, with portions of the draft inquiry report that address the complainant's role and opinions in the investigation.

6.2.1.  Confidentiality

The Research Integrity Officer may establish reasonable conditions for review to protect the confidentiality of the draft report.

6.2.2.  Receipt of Comments

Within 10 calendar days of their receipt of the draft report, the complainant and subject will provide their written comments, if any, to the inquiry committee. Any comments that the complainant or subject submit on the draft report will become part of the final inquiry report and record. Based on the comments, the inquiry committee may revise the report as appropriate.

6.3.  Time Limit for Completing the Inquiry Report

The inquiry committee will normally complete the inquiry and submit its report in writing to the Research Integrity Officer no more than 45 calendar days following its first meeting, unless the RIO approves an extension for good cause. If the RIO approves an extension, the reason for the extension will be entered into the records of the case and the report. The subject also will be notified of the extension.

6.4  Inquiry Decision

The Research Integrity Officer will transmit the final report and any comments to the Deciding Official, who will make the determination of whether findings from the inquiry provide sufficient evidence of possible research misconduct to justify conducting an investigation. The inquiry is completed when the Deciding Official makes this determination, which will be made within 60 calendar days of the first meeting of the inquiry committee.²⁰  Any extension of this period will be

²⁰ 45 C.F.R. § 689.4(b)(1);  42 C.F.R. § 93.307(g). The NSF requires the inquiry to be completed within 90 days of the first meeting of the committee. For the purpose of uniformity in this policy, we will always use the more stringent of the federal policies, in this case that of PHS.

based on good cause and recorded in the inquiry file. If an investigation is warranted, it must begin within 30 calendar days of the Deciding Official's determination.²¹

6.5.  Notification

The Research Integrity Officer will notify both the subject and the complainant in writing of the Deciding Official's decision of whether to proceed to an investigation and will remind them of their obligation to cooperate in the event an investigation is opened.  The subject will receive a copy of the inquiry report.  The RIO will also notify all appropriate institutional officials of the Deciding Official's decision. If a federal agency is involved, it will be notified, in writing, of the outcome of the inquiry within 30 calendar days of the decision.  A copy of the inquiry report must be included in the communication and all additional documentation must be available upon request.

7.  Conducting the Investigation

7.1.  Purpose of the Investigation

The purpose of the investigation is to examine the allegations in detail, to evaluate the evidence in depth, and to determine specifically whetherresearch misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible research misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged research misconduct may have particular relevance to the research record. The findings of the investigation will be set forth in an investigation report.

7.2.  Securing the Research Records

The Research Integrity Officer will immediately secure any additional pertinent research records that were not previously secured during the inquiry. This should occur before or at the time the subject is notified that an investigation has begun. The need for additional securing 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 are the same procedures that apply during the inquiry.

7.3.  Appointment of the Investigation Committee

The Research Integrity Officer, in consultation with the Chief Academic Officer, will appoint an investigation committee and a committee chair within 15 calendar days of the notification to the subject that an investigation is planned or as soon thereafter as practical. The investigation committee should

²¹ 42 C.F.R. § 93.310(a)

consist of 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.²²  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. There must be a minimum of three individuals on the investigation committee and a majority of the committee members must be tenured faculty.

The ROI will notify the subject of the proposed committee membership within 10 days of the appointment of the investigation committee. If the subject submits a written objection to any appointed member of the investigation committee or expert within five days of notification of the membership, the RIO will determine whether to replace the challenged member or expert with a qualified substitute.

7.4.  Charge to the Committee

The Research Integrity Officer 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 subjects;

• Informs the committee that it must conduct the investigation as described in section 7.6;(d) Defines research misconduct;

• Informs the committee that it must evaluate the evidence and testimony to determinewhether, 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 subject committed researchmisconduct it must find that a preponderance of the evidence establishes that:

  • research misconduct, as defined in this policy, occurred (subject has the burden ofproving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion);

  • the research misconduct is a significant departure from accepted practices of therelevant research community; and

  • the subject committed the research misconduct intentionally, knowingly, or recklessly;

• Informs the committee that during the investigation, if additional information becomesavailable that substantially changes the subject matter of the investigation or would suggest additional subjects, the committee will notify the RIO, who will determine whether it is necessary to notify the subject of the new matter or to provide notice to additional subjects; and

• Informs the committee that it must prepare or direct the preparation of a written investigationreport that meets the requirements of this policy and federal regulations.²³

  • 42 C.F.R. § 93.310(f)

  • 45 C.F.R. § 689.4(b)(5); 42 C.F.R. § 93.313.

7.5.  First Meeting

The Research Integrity Officer, with the assistance of university counsel, 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 federal funding is involved, the federal regulation.

7.6.  Investigation Process

The investigation committee will be appointed and the process initiated within 30 calendar days of the completion of the inquiry, if findings from that inquiry provide a sufficient basis for conducting an investigation.²⁴

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.²⁵  Whenever possible, the committee should interview the complainant(s), the subjects(s), and other individuals who might have information regarding aspects of the allegations. Interviews of the subject should be tape recorded or transcribed. All other interviews should be transcribed, tape recorded, or summarized. Summaries or transcripts of the interviews should be prepared, and included as part of the investigatory file.²⁶

7.7.  Evidentiary Standards

An institutional finding of research misconduct must be proved by a preponderance of the evidence. Saint Francis University has the burden of proof for making a finding of research misconduct. The destruction, absence of, or subject's failure to provide research records adequately documenting the questioned research is evidence of research misconduct where the university establishes by a preponderance of the evidence that the subject intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records and failed to produce them in a timely manner and that the subject's conduct constitutes a significant departure from accepted practices of the relevant research community.

The subject has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised. In determining whether the institution has carried the burden of proof imposed by this part, the Deciding Official will give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the subject.

• 42 C.F.R. § 93.310(a)

• 42 C.F.R. § 93.310(e)

• 42 C.F.R. § 93.310(g)

8.The Investigation Report

8.1.  Elements of the Investigation Report

The final submitted report, which will go to the Deciding Official and any other required entities, must describe 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. The report will include the actual text or an accurate summary of the views of any individual(s) found to have engaged in research misconduct as well as a recommendation regarding any sanctions to be imposed and administrative actions to be taken by the institution.²⁷

8.2.  Comments on the Draft Report

8.2.1.  Subject

The Research Integrity Officer will provide the subject with a copy of the draft investigation report for comment and rebuttal. The subject will be allowed 10 calendar days to review and comment on the draft report. The subject's written comments will be attached to the final report. The findings of the final report should take into account the subject's comments in addition to all the other evidence.

8.2.2.  Complainant

The Research Integrity Officer will provide the complainant, if he or she is 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, as appropriate, based on the complainant's comments.

8.2.3.  University Counsel

The draft investigation report will be transmitted to university counsel for a review of its legal sufficiency. Comments should be incorporated into the final report as appropriate.

8.3.  Confidentiality

In distributing the draft report, or portions thereof, to the subject and complainant, the Research Integrity Officer will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the RIO may request the recipient to sign a confidentiality statement or to come to his or her office to review the report.

8.4.  Institutional Review and Decision

²⁷ 42 C.F.R. § 93.313.

After comments have been received and the necessary changes have been made to the draft report, the investigation committee should transmit the final report with attachments, including the subject's comments, to the Deciding Official, through the Research Integrity Officer.

Based on whether the investigation was thorough, fair and complete, the Deciding Official will make the final determination whether to accept the investigation report, its findings, and the recommended institutional actions. If this determination varies from that of the investigation committee, the Deciding Official will explain in detail the basis for rendering a decision different from that of the investigation committee in the institution's letter transmitting the report to the relevant funding agency or agencies. The Deciding Official's explanation should be consistent with the definition of research misconduct in this document, the institution's policies and procedures, and the evidence reviewed and analyzed by the investigation committee. The Deciding Official may also return the report to the investigation committee with a request for further fact-finding or analysis. The Deciding Official's determination, together with the investigation committee's final report, constitutes the final investigation report for purposes of federal review.

When a final decision on the case has been reached, the Research Integrity Officer will notify both the subject and the complainant in writing. In addition, the Deciding Official will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the subject in the work or other relevant parties should be notified of the outcome of the case. The Deciding Official will inform University administrators as necessary to implement appropriate corrective actions and/or sanctions. The RIO is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.

8.5.  Transmittal of the Final Investigation Report to Relevant Entities

The final report from the Deciding Official, with attachments, will be transmitted to OIG, ORI and/or other relevant entities by the Research Integrity Officer.

8.6.  Time Limit for Completing the Investigation Report

An investigation should ordinarily be completed within 120 days of its initiation, with the initiation being defined as the first meeting of the investigation committee. This includes conducting the investigation, preparing the report of findings, making the draft report available to the subject of the investigation for comment, submitting the report to the Deciding Official for approval, and submitting the report to the relevant entities.²⁸

9.  Specific Requirements for Reporting to OIG or ORI When NSF or PHS Funding Is Involved

²⁸ 45 C.F.R. § 689.4(b); 42 C.F.R. § 93.311(a).  See comment on note 20.

9.1.  Initiation of an investigation

A decision to initiate an investigation must be reported in writing by the Research Integrity Officer to the OIG or ORI on or before the date the investigation begins.²⁹  At a minimum, the notification should include the name of the person(s) against whom the allegations have been made, the general nature of the allegation as it relates to the definition of research misconduct, and the NSF or PHS applications or grant number(s) involved. OIG or ORI must also be notified of the final outcome of the investigation and must be provided with a copy of the investigation report.³⁰  Any significant variations from the provisions of the institutional policies and procedures should be explained in any reports submitted to OIG or ORI.

9.2.  Termination of an investigation

If an institution plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the NSF or PHS regulation when NSF or PHS funding is involved, the Research Integrity Officer will submit a report of the planned termination to OIG or ORI, including a statement of the reasons for the proposed termination.³¹

9.3.  Time Extension(s)

If the institution determines that it will not be able to complete the inquiry and/or investigation within the time frames required, the Research Integrity Officer will submit to OIG or ORI a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the request is granted, the RIO will file periodic progress reports as requested by the OIG or ORI.³²

9.4.  Admission of Research Misconduct

When NSF or PHS funding or applications for funding are involved and an admission of research misconduct is made, the Research Integrity Officer will contact ORI or OIG for consultation and advice. Normally, the individual making the admission will be asked to sign a statement attesting to the occurrence and extent of research misconduct. When the case involves PHS funds, the institution is not permitted to accept an admission of research misconduct as a basis for closing a case or not undertaking an investigation without prior approval from ORI.³³

• 45 C.F.R. § 689.4(b)(2); 42 C.F.R. § 93.309

• 45 C.F.R. § 689.4(b)(4); 42 C.F.R. § 93.313

• 42 C.F.R. § 93.309(c)

• 45 C.F.R. § 689.4(b)(4); 42 C.F.R. § 93.311(c)

• 42 C.F.R. § 93.316.

9.5.  Special Circumstances

The Research Integrity Officer will notify ORI or OIG at any stage of the inquiry or investigation if: (a) there is an immediate health or safety hazard involved;³⁴

• there is an immediate need to protect federal resources, reputations or other interests;³⁵

• there is a reasonable indication of possible civil or criminal violation;³⁶

• research activities should be suspended;³⁷

• there is an immediate need to protect the interests of the person(s) making the allegationsor of the individual(s) who is the subject of the allegations as well as his/her co-investigators and associates, if any;³⁸

• the scientific community or the public should be informed;³⁹ or

• it is probable that the alleged incident is going to be reported publicly and the appropriatefederal agency needs to take steps to protect its interests.⁴⁰

10.  Institutional Administrative Actions

Saint Francis University will take appropriate administrative actions against individuals when an allegation of research misconduct has been substantiated.⁴¹

If the Deciding Official determines that the alleged research misconduct is substantiated by the findings, he or she will decide on the appropriate actions to be taken, after consultation with the Research Integrity Officer. The actions may include:

• withdrawal or correction of all pending or published papers and/or abstracts emanating fromthe research where research misconduct was found.

• removal of the responsible person from the particular project, letter of reprimand, specialmonitoring of future work, probation, suspension, salary reduction, or initiation of steps leading to possible rank reduction or termination of employment; (c) restitution of funds as appropriate.

• completion of appropriate training, specified by the Deciding Official.

• disciplinary action against the subject, up to and including termination from employment.

  • 45 C.F.R. § 689.4(c)(1); 42 C.F.R. § 93.318(a)

  • 45 C.F.R. § 689.4(c)(2); 42 C.F.R. § 93.318(b)

  • 45 C.F.R. § 689.4(c)(3); 42 C.F.R. § 93.318(d)

  • 45 C.F.R. § 689.4(c)(4); 42 C.F.R. § 93.318(c)

  • 45 C.F.R. § 689.4(c)(5); 42 C.F.R. § 93.318(e)

  • 45 C.F.R. § 689.4(c)(6); 42 C.F.R. § 93.318(g)

  • 42 C.F.R. § 93.318(f)

  • 45 C.F.R. § 689.4(a)(3); 42 C.F.R. § 93.315(d).

11.  Other Considerations

11.1.  Termination of Institutional Employment or Resignation Prior to Completing Inquiry or Investigation

The termination of the subject's institutional employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the research misconduct procedures.

If the subject, without admitting to the research misconduct, elects to resign his or her position prior to the initiation of an inquiry, but after an allegation has been reported, or during an inquiry or investigation, the inquiry or investigation will proceed.  If the subject refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the subject's failure to cooperate and its effect on the committee's review of all the evidence.

11.2.  Restoration of the Subject's Reputation⁴²

If the institution finds no research misconduct and, where relevant, if OIG or ORI concur, after consulting with the subject, the Research Integrity Officer will undertake reasonable and practical efforts to restore the subject's reputation. Depending on the particular circumstances, the RIO should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of research misconduct was previously publicized, or expunging all reference to the research misconduct allegation from the subject's personnel file. Any institutional actions to restore the subject's reputation must first be approved by the Deciding Official.

11.3.  Protection of the Complainant and Others⁴³

During the research misconduct proceeding and upon its completion, regardless of whether the institution, OIG, or ORI determines that research misconduct occurred, the Research Integrity Officer must undertake all reasonable and practical efforts to protect the position and reputation of, or to counter potential or actual retaliation against, any complainant who made allegations of research misconduct in good faith and of any witnesses and committee members who cooperate in good faith with the research misconduct proceeding. The Deciding Official will determine, after consulting with the RIO, and with the complainant, witnesses, or committee members, respectively, what steps, if any, are needed to restore their respective positions or reputations or to counter potential or actual retaliation against them. The RIO is responsible for implementing any steps the Deciding Official approves.

• 42 C.F.R. § 93.304(k)

• 42 C.F.R. § 93.304(l).

11.4.  Allegations Not Made in Good Faith

If relevant, the Deciding Official will determine whether the complainant's allegations of research misconduct were made in good faith. If an allegation was not made in good faith, the Deciding Official will determine whether any administrative action should be taken against the complainant.

11.5.  Interim Administrative Actions

Institutional officials will take interim administrative actions, as appropriate, to protect federal funds and ensure that the purposes of the federal financial assistance are carried out.

11.6.  Special Circumstances

If an allegation of research misconduct is brought up against the Research Integrity Officer, the Chief Academic Officer will appoint an Acting RIO for the purpose of conducting the inquiry and, if appropriate, the investigation related to this case.  Allegations of research misconduct will not affect the status of the RIO regarding his/her other duties until the time when/if a charge of research misconduct is substantiated.

If an allegation of research misconduct is brought up against the Chief Academic Officer, the President will appoint an Acting Deciding Official for the purpose of conducting the inquiry and, if appropriate, the investigation related to this case.  Allegations of research misconduct will not affect the status of the Deciding Official regarding his/her other duties until the time when/if a charge of research misconduct is substantiated.

12.  Appeals

The subject has the right to appeal a finding of research misconduct or the sanctions leveled against him/her. The following guidelines will be observed.

12.1.  Scope of the Appeal

Appeals will be limited to:

• claims that errors took place in the investigation process in ways that created a significantpossibility that the outcome was incorrect; or

• grievances of sanctions imposed by Saint Francis University as a result of the finding of research misconduct.

If option (a) applies, the appeal must indicate the nature of any alleged procedural error. Under no circumstances the Appeal Board will review the factual finding of misconduct. As such, the record of the investigation will become the record used by the Appeal Board.

12.2.  Submission of the Appeal

Appeals must be submitted in writing to the Office of the President withing 15 calendar days of receipt of notice of the Deciding Officials decision. The subject must also submit a copy of the appeal to the Deciding Official, who will forward it to the Research Integrity Officer to keep as part of the official record (see Part 13). No penalties against the subject will be in effect until a final decision is made on the appeal.

12.3.  Appeal Board

The President will appoint an Appeal Board and an Appeal Board Chair within 15 calendar days of the reception of the subjects appeal. The Appeal Board should consist of individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the procedures followed during the inquiry and investigation phases. These individuals may be faculty, administrators, or students. Individuals appointed to the Appeal Board may not have served on the inquiry or investigation committees. The Appeal Board will consist of three members. At least two of these must be tenured faculty.

12.4.  Disposition

The Appeal Board will issue a recommendation to the President of Saint Francis University regarding the merits of the appeal. The decision of the President will be final.

12.5.  Time Limits

The decision must be completed within 120 calendar days of the submission of the appeal.⁴⁴

12.6.  Time Extension(s)

If a decision cannot be reached within 120 calendar days of the submission of the appeal, a reasonable time extension can take place provided that the subject is notified of this extension prior to the deadline. The time extension must be approved in writing by OIG, ORI or the relevant integrity office if there has been an involvement by NSF, PHS, or other federal agency in the research.⁴⁵  If such an extension is granted, the filing of periodic progress reports may be required by the agency.⁴⁶

• 42 C.F.R. § 93.314(a)

• 42 C.F.R. § 93.314(b)

• 42 C.F.R. § 93.314(c).

13.  Record Retention

After completion of a case and all ensuing related actions, the Research Integrity Officer will prepare a complete file, including the records of any inquiry, investigation and/or appeal, and copies of all documents and other materials furnished to the RIO or committees. The RIO will keep the file for seven years after completion of the case to permit later assessment of the case. Authorized federal personnel will be given access to the records upon request.⁴⁷

⁴⁷ 42 C.F.R. § 93.317(b).