PAc-32 Misconduct in Research

APPLICABILITY:

This policy applies to research, research-training, or research-related activities conducted at Morehead State University or sponsored by the institution.

This policy does not supersede and is not intended to set an alternative to established University and/or Federal procedures for resolving fiscal improprieties, issues concerning the ethical treatment of human or animal subjects, or criminal matters.

INSTITUTIONAL PRINCIPLES:

In accordance with the fundamental ideals of integrity and credibility which are inherent in the conduct of research, this institution holds in high esteem the proper conduct of all research. Any compromise by faculty, staff, or students of the ethical standards required for conducting research must be reported and promptly addressed in order that these ideals be maintained.

Due to the serious effects that allegations of research misconduct may have upon the reputations and careers of those accused, this institution shall hold any proceedings which follow in the strictest confidence allowable by law. Breaches of confidentiality by those appointed to conduct the proceedings shall be treated as serious offenses. Furthermore, allegations are expected to be made in good faith and not for harassment.

In the event that allegations of research misconduct are subsequently found to be groundless, this institution shall undertake diligent efforts, as appropriate, to restore the reputations of those alleged to have engaged in misconduct.

In the event that allegations of research misconduct are substantiated by a preponderance of the evidence, this institution shall pursue the imposition of appropriate sanctions as authorized by statute or University personnel regulations upon those persons found to be responsible for the misconduct.

Additionally, this institution shall undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.

INSTITUTIONAL ASSURANCES:

Morehead State University hereby gives assurance that it shall:

1. Establish, keep current, and upon request provide this policy and any regulations designed to implement this policy to the appropriate agencies authorized by the regulations.
2. Inform its research and administrative staff of this policy, any regulations designed to implement this policy and the importance of compliance with them.
3. Take appropriate action as soon as research misconduct on the part of employees or persons within the organizations' control is suspected or alleged.
4. Inform, in accordance with any regulations, and cooperate with the authorized agencies regarding each investigation of alleged misconduct.
5. Foster a research environment that discourages misconduct in all research and that deals forthrightly with possible misconduct.

DEFINITIONS:

• "University" or "institution" means Morehead State University.
• "President" means the President of Morehead State University.
• "Vice President" means the Vice President for Academic Affairs of Morehead State University.
• "Allegation" means charges of fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the research community for proposing, conducting, or reporting research.
• "Misconduct", "misconduct in research", or "research misconduct" means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the research community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.
• "Complainant(s)" means those person(s) who make formal allegations of misconduct in research.
• "Respondent(s)" means those person(s) who are alleged to have engaged in research misconduct.
• "Inquiry" means information gathering and initial fact finding to determine whether an allegation or apparent instance of misconduct warrant an investigation.
• "Investigation" means the formal examination and evaluation of all relevant facts to determine if misconduct has occurred.
• "Research Review Committee" is the committee appointed by the Vice President to conduct an inquiry and, if warranted, an investigation into allegations of misconduct. The Research Review Committee shall consist of three (3) tenured faculty members chosen with due consideration of the need for appropriate expertise and avoiding conflicts of interest on the part of the committee members. The Research Review Committee shall elect a chair from the membership.
• "Inquiry report" means the report submitted to the Vice President by the Research Review Committee following completion of an inquiry.
• "Investigation report" means the report submitted to the Vice President by the Research Review Committee following completion of an investigation.
• "Appeal" means the official re-examination of the findings of an investigation at the request of the respondent(s).
• "Research Appeal Committee" is the committee appointed by the Vice President at the request of the respondent(s) to re-examine the findings of an investigation. The Research Appeal Committee shall consist of three (3) tenured faculty members chosen with due consideration of the need for appropriate expertise and avoiding conflicts of interest on the part of the committee members. No member of the Research Review Committee for a given case may serve on the Research Appeal Committee for that same case. The Research Appeal Committee shall elect a chair from the membership.
• "Appeal report" means the report submitted by the Research Appeal Committee to the Vice President following an appellate review of an investigation.
• "Final Report" means the report submitted to the OSI after the completion of a formal investigation. It must describe the policies and procedures under which the investigation was conducted, how and from whom information was obtained relevant to the investigation, the findings, and the basis for the findings, and 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 sanctions taken by the institution.
• "OSI" means the Office of Scientific Integrity, a component of the Office of the Director of National Institutes for Health (NIH), which oversees the implementation of all PHS policies and procedures related to research misconduct; monitors the individual investigations into alleged or suspected research misconduct conducted by institutions that receive PHS funds for biomedical or behavioral research projects or programs; and conducts investigations as necessary.
• "OSIR" means the Office of Scientific Integrity Review, a component of the Office of the Assistant Secretary for Health, which is responsible for establishing overall PHS policies and procedures for dealing with misconduct in research, overseeing the activities of PHS research agencies to ensure that these policies and procedures are implemented, and reviewing all final reports of investigations to assure that any findings and recommendations are sufficiently documented. The OSIR also makes final recommendations to the Assistant Secretary for Health on whether any sanctions should be imposed and, if so, what they should be in any case where research misconduct has been established.
• "PHS" means the Public Health Service, an operating division of the Department of Health and Human Services (HHS). References to PHS include organizational units within the PHS that have delegated authority to award financial assistance to support research activities, e.g., Bureaus, Institutes, Divisions, Centers or Offices.
• "Secretary" means the Secretary of HHS and any other officer or employee of the DHHS to whom the authority involved may be delegated.
• "Department" or "Departmental" means the U.S. Department of Health and Human Services (HHS).

PROCEDURAL SUMMARY: 

The following summary is intended to provide an overview of the  procedures to be followed under this policy. Detailed information regarding these procedures is found in subsequent sections.

1. Allegations of research misconduct shall be directed to the Vice President in writing.
2. If the alleged incident falls under the definition of research misconduct in this policy, the Vice President shall immediately (within one week) appoint and convene a Research Review Committee and notify the respondent(s) in writing of the allegations and the initiation of an inquiry.
3. The Research Review Committee conducts an inquiry which must be completed within 60 days of its initiation.
4. At the completion of the inquiry, the Research Review Committee files a written inquiry report with the Vice President including notification of whether a formal investigation is warranted. This report shall not identify the complainant(s).
5. If the Research Review Committee does not find grounds for an investigation, the Vice President notifies the respondent(s) and the complainant(s) and the case is closed.
6. If the Research Review Committee determines that an investigation is warranted, the Vice President notifies the respondent(s) and complainant(s) that an investigation is being initiated. The Vice President shall also inform the President of the need to notify the OSI of the impending investigation.
7. The Research Review Committee shall begin the investigation within 30 days of completing the inquiry. The entire investigatory process (including the investigation, appeal, administrative actions and reporting to the OSI) must be completed within 120 days of initiating an investigation.
8. Upon completion of the investigation, the Research Review Committee shall submit to the Vice President an investigation report with its determination regarding the allegations. This report shall not identify the complainant(s).
9. The Vice President shall notify the respondent(s) in writing of the Research Review Committees' decision and provide them with a copy of the investigation report.
10. The respondent(s) may respond to the investigation report and/or appeal the decision within two weeks of receiving this notification by writing to the Vice President.
11. Should the respondent(s) request an appeal, the Vice President shall appoint a Research Appeal Committee to re-examine the allegations, and the information contained in the inquiry and investigation reports. An appeal report of the findings is submitted to the Vice President.
12. Upon completion of the investigation and appeal process the Vice President reports the outcome to the President.
13. The President may take whatever action is deemed appropriate to the situation within the bounds of Federal, State, and University personnel regulations.
14. The President submits the Final Report to the OSI within the 120 day investigative time limit or as negotiated with the OSI.
15. The OSI may respond, reinvestigate, or impose sanctions of its own.

INQUIRIES:

An inquiry consists of information gathering and initial fact finding to determine whether an allegation or apparent instance of misconduct warrant an investigation.

1. The University shall inquire immediately (within one week) into any allegation or other evidence of possible research misconduct which falls under the definition of misconduct in this policy. An inquiry must be completed within 60 calendar days of its initiation unless circumstances clearly warrant a longer period.
2. A written inquiry report shall be prepared that states what evidence was reviewed, summarizes relevant interviews, and includes the conclusions of the inquiry. If the inquiry takes longer than 60 days to complete, the inquiry report shall include documentation of the reasons for exceeding the 60-day period.
3. The inquiry shall be conducted by a Research Review Committee appointed by the Vice President. The Research Review Committee shall consist of three (3) tenured faculty members chosen with due consideration of the need for appropriate expertise and avoiding conflicts of interest on the part of the committee members. The Research Review Committee shall elect a chair from the membership.
4. The Research Review Committee may consult with the University Attorney and/or research experts within or outside the University in the course of the inquiry.
5. The Research Review Committee shall take diligent efforts to maintain confidentiality and to protect the privacy of the complainant(s) and the respondent(s).
6. If at any time during the inquiry the Research Review Committee becomes aware of any conditions denoted in the "Notification Requirements" section, the Vice President must be notified immediately. The Vice President shall notify the President of any need to make official notification to the OSI.
7. The Research Review Committee shall maintain sufficiently detailed documentation of the inquiry to permit a later assessment, if necessary, of the reasons for determining that an investigation was not warranted. Such records shall be maintained in a secure manner by the Vice President for a period of at least three years after completion of the inquiry, and shall, upon request, be provided to authorized HHS personnel, or the appropriate Federal granting agency.
8. Complete summaries of any interviews shall be prepared, provided to the interviewed party for comment or revision, and included as part of the inquiry report by the Research Review Committee.
9. The Vice President shall give a copy of the inquiry report to the respondent(s) for response. If a written response is returned, it shall become part of the inquiry report.

INVESTIGATIONS:

An investigation consists of the formal examination and evaluation of all relevant facts to determine if misconduct has occurred.

1. An investigation shall be initiated within thirty (30) days of the completion of an inquiry if the Research Review Committee determines that a full investigation is warranted.
2. The Vice President shall notify the President that an investigation is being initiated and of the need to notify the OSI prior to the date the investigation will begin.
3. The Vice President shall notify the complainant(s), and the respondent(s) in writing that an investigation is being initiated.
4. The investigation shall be conducted by the Research Review Committee previously appointed by the Vice President for conducting the inquiry.
5. The investigation shall include examination of all documentation, including but not necessarily limited to relevant research data and proposals, publications, correspondence, and memoranda of telephone calls. Whenever possible, interviews shall be conducted of all individuals involved either in making the allegation or against whom the allegations are made, as well as other individuals who might have information regarding key aspects of the allegations. Complete summaries of the interviews shall be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file by the Research Review Committee.
6. The Research Review Committee may consult with the University Attorney and/or research experts within or outside the University in the course of the investigation.
7. If at any time during the investigation the Research Review Committee becomes aware of any conditions denoted in the "Notification Requirements" section, the Vice President must be notified immediately. The Vice President shall notify the President of any need to make official notification to the OSI.
8. The Research Review Committee shall prepare documentation to substantiate its findings. This documentation becomes part of the investigation report which shall be submitted to the Vice President upon completion of the investigation.
9. It is expected that the entire investigative process shall be completed within 120 days of its initiation. This includes the investigation, preparing the investigation report, making the report available for comment by the respondent(s), completion of the appeal process (if requested), taking administrative actions, and submitting the Final Report to the OSI.
10. If the University cannot complete the entire investigative process (including appeal, sanctions, and reporting) within 120 days of its initiation, the President shall submit to the OSI a written request with an explanation for the delay that includes an interim report on the progress to date and an estimate for the date of completion of the Final Report and other necessary steps. Any consideration for an extension must balance the need for a thorough and rigorous examination of the facts versus the interests of the subject(s) of the investigation and the PHS in a timely resolution of the matter. If the extension is granted, the President shall file periodic progress reports as requested by the OSI. If satisfactory progress is not made by the University, the OSI may undertake its own investigation.
11. At the conclusion of the investigation, the Research Review Committee shall submit its investigation report to the Vice President with the determination of whether the allegations have or have not been substantiated by a preponderance of the evidence.
12. The Vice President shall give a copy of the investigation report to the respondent(s) for response. If a written response is returned, it shall be made part of the investigation report.
13. The respondent(s) may request an appeal of the Research Review Committees' decision by making a written request to the Vice President within two weeks of receiving notification of the investigations' outcome.
14. Should an appeal be requested, the Vice President shall appoint a Research Appeal Committee composed of three (3) tenured faculty members chosen with due consideration of the need for appropriate expertise and avoiding conflicts of interest on the part of the committee members. No member of the Research Review Committee for a given case may serve on the Research Appeal Committee for that same case. The Research Appeal Committee shall elect a chair from the membership.
15. The Research Appeal Committee shall examine the allegations, evidence, and testimony which is contained within the inquiry and investigation reports to determine whether the conclusions drawn by the Research Review Committee are substantiated therein. Additional interviews may be conducted as needed.
16. The Research Appeal Committee is expected to complete its deliberations within the time remaining for the 120 day investigative process, or, failing this to notify the Vice President of the need to request an extension from the OSI.Q. The Research Appeal Committee shall prepare an appeal report and submit it to the Vice President. The appeal report shall indicate whether or not the Research Appeal Committee concurs with the previous findings and on what basis this decision was made.
17. After completion of the investigation/appeal process the Vice President shall report to the President regarding the outcome of the investigation/appeal.
18. The President may take whatever action is deemed appropriate to the situation within the bounds of Federal, State, and University Personnel regulations.
19. Within 120 days of the initiation of the investigation, (or in accordance with any extension negotiated with the OSI), the President shall submit the Final Report to the Director of the OSI.

NOTIFICATION REQUIREMENTS:

Notification to the OSI shall be made as follows with regard to research activities connected with PHS-sponsored biomedical and behavioral research conducted at or sponsored by this institution:

1. The University, through the President, shall submit annually to the OSI, it's assurance that these policies and procedures are being followed and such aggregate information on allegations, inquiries, and investigations/ appeals as the Secretary may prescribe.
2. The decision to initiate an investigation shall be reported in writing to the OSI on or before the date the investigation begins. At a minimum, the notification by the President to the OSI shall include the following in-formation:
   1. name of person(s) against whom the allegations have been made;
   2. general nature of the allegations; and the
   3. PHS applicant or grant number(s) involved.
3. The President shall notify the OSI at any stage of an inquiry or investigation if any of the following conditions exist:
   1. immediate health hazard involved;
   2. immediate need to protect Federal funds or equipment;
   3. immediate need to protect the interest of the complainant(s) or respondent(s);
   4. probability that the alleged incident will be reported publicly;
   5. any reasonable indication of possible criminal violations associated with research activities for which federal funds have been provided or requested is obtained. In this instance notification must occur within 24 hours of obtaining the information.
   6. any developments which disclose facts that may affect current or potential HHS 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.
4. After completion of the investigation/appeal process, the President shall send the Final Report to the Director, OSI, who will decide whether that Office will either proceed with its own investigation or will act on the institution's findings.
5. If the Final Report cannot be completed within 120 days of initiating an investigation, the President shall request an extension from the OSI.
6. If the University plans to terminate an inquiry or investigation for any reason without completing the requirements of the Final Rule, a report of such planned termination including a description of the reasons for such termination, shall be made to the OSI, which will decide whether further investigation should be taken.

ADMINISTRATIVE ACTIONS:

The University may take administrative action as warranted during or following an inquiry or investigation.

1. At any time during the course of an inquiry or investigation, the University, acting through the President may take interim administrative actions, as appropriate, to protect Federal funds and insure that the purposes of the Federal financial assistance are carried out. Notification to the OSI shall be made as appropriate under this policy.
2. In the event an investigation/appeal process finds the allegations groundless, all Federal agencies or other entities initially informed of the investigation shall be notified of the exoneration by the President within one week of completing the Final Report. Additionally, efforts shall be made to restore the reputations of the respondent(s) as appropriate.
3. When an investigation/appeal process finds support for allegations of misconduct, all Federal agencies or other entities initially informed of the investigation shall be notified of the finding of misconduct by the President within one week of completing the Final Report. Consideration shall be given to formal notifications of other involved parties such as, but not all inclusive:
   1. co-authors, co-investigators, and collaborators affiliated with the affected research;
   2. editors of journals in which the affected research was published or submitted for publication;
   3. sponsoring agencies and funding sources affiliated with the affected research.
4. When allegations of misconduct are substantiated, the President may take whatever action is deemed appropriate to the situation within the bounds of Federal, State, and University Personnel regulations. The Final Report to the OSI must indicate what sanctions were imposed, and this report must be filed within 120 days of initiating the investigation unless an extension is granted by the OSI.