Research Misconduct
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SUBJECT:
Research Misconduct |
Effective Date:
11/20/2013 |
Policy Number:
10.1.1 |
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Supersedes:
05/02/2012 12/22/2010 06/23/2010 03/27/2009 |
Page 1 of 24 | |
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Responsible Authorities:
Vice President for Research |
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DATE OF INITIAL ADOPTION AND EFFECTIVE DATE:
Initial adoption 12/10/2008; revised 03/27/2009; reviewed (no policy changes) 06/23/2010, reviewed (no policy changes) 12/22/10; reviewed (no policy changes) 05/2/12, reviewed (included reference to students conducting research) for 11/20/13.
APPLICABILITY/ACCOUNTABILITY:
This policy applies to allegations of research misconduct (fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results) involving:
- A person who, at the time of the alleged research misconduct, was employed by, was an agent of, or was affiliated by contract or agreement with Florida Atlantic University, including any courtesy (unpaid) appointments, also known as Affiliate or Voluntary appointments and graduate or undergraduate students conducting research at FAU; and
- Any of (1) research, research training or activities related to that research or research training, such as the operation of tissue and data banks and the dissemination of research information, (2) applications or proposals for behavioral research, research training or activities related to that research or research training, or (3) plagiarism of research records produced in the course of research, research training or activities related to that research or research training. This includes any research proposed, performed, reviewed, or reported, or any research record generated from that research, regardless of whether an application or proposal resulted in a grant, contract, cooperative agreement, or other form of support.
This policy and the associated procedures do not apply to authorship or collaboration disputes and apply only to allegations of research misconduct that occurred within 6 years of the date the FAU received the allegation. Authorship or collaboration disputes involving students should be directed to the dean of undergraduate or graduate studies, as applicable.
While this policy is based upon the model policy of the US Public Health Service (PHS) and has been crafted in close accordance with PHS Regulations (specifically Code of Federal Regulations Title 42, Part 93), it is intended to be FAU's institutional policy applicable to all research conducted by any FAU institutional member, paid or unpaid, regardless of the location of the research or the source of the funding. This policy is intended both to carry FAU's responsibilities under the various agency policies on Research Misconduct and to set out a process for the resolution of any and all instances of research misconduct.
POLICY STATEMENT:
Florida Atlantic University ("University" or "FAU") requires ethical conduct in all teaching and research. Collegiality, respect, and trust among faculty members, students, and staff are essential to FAU's success. All allegations of research misconduct must be resolved promptly and equitably using procedures that safeguard the rights of all faculty, staff and students concerned. This policy is adopted by FAU in compliance and consistent with laws, rules and regulations of the United States, the State of Florida, the Florida Board of Governors, the Florida Atlantic University Board of Trustees, and, for those employees included in the bargaining unit, the FAU Board of Trustees/United Faculty of Florida Collective Bargaining Agreement. It will be updated administratively in accordance with changes in those laws, rules, and regulations.
OVERVIEW
As noted, this FAU Research Misconduct policy is motivated by and flows from the model policy of the US Public Health Service (Department of Health and Human Services), which was developed as a link among misconduct policies of several federal agencies. Given the serious nature of the subject of this policy and its quasi-legal implications, this document involves a high level of detail and specificity. In addition, various terms have specific definitions; see Appendix B (p. 22).
Notwithstanding its basis in the PHS model and the definitions in Appendix B (which follow federal language), this policy is a Florida Atlantic University document, and it applies to all research at FAU regardless of funding source. Because the procedures discussed below are complicated, the following table provides a step-by-step overview of the time line with references to the sections of this document. For completeness here, the four major steps in the process are subdivided into their several components. The table, however, is not meant to be comprehensive concerning the details of the procedure or its rationale.
In brief, (i) allegations of misconduct are (ii) assessed by the Research Integrity Officer; if warranted, an (iii) inquiry committee is formed to gather background and provide the Deciding Officer with sufficient information to pursue an (iv) investigation. At each stage of the process, comments from the Respondent (those against whom the allegations have been made) are included in the process. It is possible to extend some of the steps in the process (notably (5) and (11) in the table below) if warranted and documented appropriately.
| Step | Procedures Section | Event | Deadline (in calendar days) |
|---|---|---|---|
| (1) | A.2 | Report of misconduct allegation | Beginning of process |
| (2) | B.1 | Assessment by Research Integrity Officer | Within 5 days of (1) |
| (3) | B.2/4 | Formation of Inquiry Committee (if warranted) | Within 10 days of (1) |
| (4) | B.4 | Respondent objections to committee make-up | Within 5 days of (3) |
| (5) | B.7 / C | Inquiry Report | Within 20 days of (1) |
| (6) | C.2 | Respondent comments | Within 10 days of (5) |
| (7) | C.3 | Deciding Officer's decision to investigate (or not) | Within 5 days of (6) |
| (8) | D.1 | Investigation begins (if appropriate) | Within 30 days of (7) |
| (9) | D.3 | Formation of Investigation Committee | Within 10 days of (8) |
| (10) | D.3 | Respondent objections to committee make-up | Within 5 days of (9) |
| (11) | D.6 | Investigation Report | Within 80 days of (8) |
| (12) | E.2 | Respondent comments | Within 15 days of (11) |
| (13) | E.3 | Deciding Official decision | Within 5 days of (12) |
Appendix A (p. 16) of this document outlines in detail the responsibilities of the Research Integrity Officer and, in the process, provides a useful perspective on the process itself, an intermediate-level view that lies between this very brief overview and the exposition to follow.
POLICY:
General Policies and Principles
Responsibility to Report Misconduct
All institutional members will report observed, suspected, or apparent research misconduct to the Research Integrity Officer (RIO), who is the Vice President for Research or his/her designee. Any official who receives an allegation of research misconduct must report it immediately to the RIO. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may meet with or contact the RIO at the Division of Research to discuss the suspected research misconduct informally; this may include discussing it anonymously and/or hypothetically. If the circumstances described by the individual do not meet the definition of research misconduct, the RIO will refer the individual or allegation to other offices or officials with responsibility for resolving the problem. Faculty members have the responsibility to oversee all students, graduate and undergraduate, conducting research under their supervision. This includes, to the extent possible, ensuring that the tenets for the responsible conduct of research are known and followed by these students.
At any time, an institutional member may have confidential discussions and consultations about concerns of possible misconduct with the RIO and will be counseled about appropriate procedures for reporting allegations.
Cooperation with Research Misconduct Proceedings
Institutional members will cooperate with the RIO and other institutional officials in the review of allegations and the conduct of inquiries and investigations. Institutional members, including Respondents, have an obligation to provide evidence relevant to research misconduct allegations to the RIO or other institutional officials.
Confidentiality
The RIO shall: (1) limit disclosure of the identity of Respondents and Complainants to those who need to know in order to carry out a thorough, competent, objective, and fair research misconduct proceeding; and (2) except as otherwise prescribed by law, limit the disclosure of any records or evidence from which research subjects might be identified to those who need to know in order to carry out a research misconduct proceeding. The RIO may use written confidentiality agreements or other mechanisms to ensure that the recipient does not make any further disclosure of identifying information.
Protecting Complainants, witnesses, and committee members
Institutional members may not retaliate in any way against Complainants, witnesses, or committee members, including students who may be involved in the process. Institutional members should immediately report any alleged or apparent retaliation against Complainants, witnesses or committee members to the RIO, who shall review the matter and, as necessary, make all reasonable and practical efforts to counter any potential or actual retaliation and protect and restore the position and reputation of the person against whom the retaliation is directed.
Protecting the Respondent
As requested and as appropriate, the RIO and other institutional officials shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made.
During the research misconduct proceeding, the RIO is responsible for ensuring that Respondents receive all the appropriate notices and opportunities related to the policies and procedures of FAU. Respondents may consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the counsel or personal adviser to interviews or meetings on the case. The adviser may advise the Respondent at any stage but will not speak for Respondent or address institutional officials at any meeting, interview or hearing.
Interim Administrative Actions and Notifying the Cognizant Agency of Special Circumstances
Throughout the research misconduct proceeding, the RIO will review the situation to determine if there is any threat of harm to public health, federal funds and equipment, or the integrity of the research process. In the event of such a threat, the RIO will, in consultation with other institutional officials and Cognizant Agency, where applicable, take appropriate interim action to protect against any such threat. Interim action might include additional monitoring of the research process and the handling of federal funds and equipment, reassignment of personnel or of the responsibility for the handling of federal funds and equipment, additional review of research data and results or delaying publication. The RIO shall, at any time during a research misconduct proceeding, notify the Cognizant Agency immediately if he/she has reason to believe that any of the following conditions exist:
- Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
- HHS resources or interests are threatened;
- Research activities should be suspended;
- There is a reasonable indication of possible violations of civil or criminal law;
- Federal action is required to protect the interests of those involved in the research misconduct proceeding;
- The research misconduct proceeding may be made public prematurely and HHS action may be necessary to safeguard evidence and protect the rights of those involved; or
- The research community or public should be informed.
PROCEDURES:
A Rights and Responsibilities
A.1 Research Integrity Officer
The RIO will have primary responsibility for implementation of this policy and its procedures. It is intended that the RIO be an institutional official who is well qualified to administer the procedures and is sensitive to the varied demands made on those who conduct research, those who are accused of research misconduct, those who make good faith allegations of research misconduct, and those who may serve on inquiry and investigation committees.
A detailed listing of the responsibilities of the RIO is set forth in Appendix A. These responsibilities include the following duties related to research misconduct proceedings:
- Consult confidentially with persons who are uncertain about whether to submit an allegation of research misconduct;
- Receive allegations of research misconduct;
- Assess each allegation of research misconduct in accordance with Section B.1 below to determine whether it falls within the definition of research misconduct and warrants an inquiry;
- As necessary, take interim action and notify the Cognizant Agency of special circumstances;
- Sequester research data and evidence pertinent to the allegation of research misconduct in accordance with Section B.3 below and maintain it securely in accordance with this policy and applicable law and regulation;
- Provide confidentiality to the extent permitted or required by law to those involved in the research misconduct proceeding;
- Notify the Respondent and provide opportunities for him/her to review/comment/respond to allegations, evidence, and committee reports in accordance with Section C.2 below;
- Inform Respondents, Complainants, and witnesses of the procedural steps in the research misconduct proceeding;
- Appoint the chair and members of the inquiry and investigation committees, ensure that those committees are properly staffed and that there is expertise appropriate to carry out a thorough and authoritative evaluation of the evidence;
- Determine whether each person involved in handling an allegation of research misconduct has an unresolved personal, professional, or financial conflict of interest and take appropriate action, including recusal, to ensure that no person with such conflict is involved in the research misconduct proceeding;
- In cooperation with other institutional officials, take all reasonable and practical steps to protect or restore the positions and reputations of good faith Complainants, witnesses, and committee members and counter potential or actual retaliation against them by Respondents or other institutional members;
- Keep the Deciding Official and others who need to know apprised of the progress of the review of the allegation of research misconduct;
- Notify and make reports to the Cognizant Agency as required;
- Ensure that administrative actions taken by the institution and the Cognizant Agency are enforced and take appropriate action to notify other involved parties, such as sponsors, law enforcement agencies, professional societies, and licensing boards of those actions; and
- Maintain records of the research misconduct proceeding and make them available in accordance with Section E.5 below.
A.2 Complainant
The Complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with the inquiry and investigation. As a matter of good practice, the Complainant should be interviewed at the inquiry stage and given the transcript or recording of the interview for correction. The Complainant must be interviewed during an investigation, and be given the transcript or recording of the interview for correction.
A.3 Respondent
The Respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry and investigation. The Respondent is entitled to:
- A good faith effort from the RIO to notify the Respondent in writing at the time of or before beginning an inquiry;
- An opportunity to comment on the inquiry report and have his/her comments attached to the report;
- Be notified of the outcome of the inquiry, and receive a copy of the inquiry report that includes a copy of the Cognizant Agency's regulations and the institution's policies and procedures on research misconduct;
- Be notified in writing of the allegations to be investigated within a reasonable time after the determination that an investigation is warranted, but before the investigation begins; and be notified in writing of any new allegations, not addressed in the inquiry or in the initial notice of investigation, within a reasonable time after the determination to pursue those allegations;
- Be interviewed during the investigation, have the opportunity to correct the recording or transcript, and have the corrected recording or transcript included in the record of the investigation;
- Have interviewed during the investigation any witness who has been reasonably identified by the Respondent as having information on relevant aspects of the investigation, have the recording or transcript provided to the witness for correction, and have the corrected recording or transcript included in the record of investigation; and
- Receive a copy of the draft investigation report and, concurrently, a copy of, or supervised access to the evidence on which the report is based, and be notified that any comments must be submitted within 15 days of the date on which the copy was received and that the comments will be considered by the institution and addressed in the final report.
The Respondent should be given the opportunity to admit that research misconduct occurred and that he/she committed the research misconduct. With the advice of the RIO and institutional legal counsel, the Deciding Official may terminate review of an allegation that has been admitted if the institution's acceptance of the admission and any proposed settlement is approved by the Cognizant Agency.
A.4 Deciding Official
The Deciding Official (DO), who is the University Provost or designee, will receive the inquiry report and, after consulting with the RIO, decide whether an investigation is warranted. Any finding that an investigation is warranted must be made in writing by the DO and will be provided to the Cognizant Agency as appropriate, together with a copy of the inquiry report, within 30 days of the finding. If it is found that an investigation is not warranted, the DO and the RIO will ensure that detailed documentation of the inquiry is retained for at least 7 years after termination of the inquiry, so that the Cognizant Agency may assess the reasons why the FAU decided not to conduct an investigation.
The DO will receive the investigation report and, after consulting with the RIO and other appropriate officials, decide the extent to which the institution accepts the findings of the investigation and, if research misconduct is found, decide what, if any, institutional administrative actions are appropriate. This includes administrative actions by the DO acting as the University Provost or the DO referring the matter to another university committee for further review and potential administrative action against faculty or students. The DO shall ensure that the final investigation report, the findings of the DO and a description of the pending or completed administrative action are provided to the Cognizant Agency as required.
B. Conducting the Assessment and Inquiry
B.1 Assessment of Allegations
Upon receiving an allegation of research misconduct, the RIO will immediately assess the allegation to determine whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified, whether it is within the jurisdictional criteria of this policy, and whether the allegation falls within the definition of research misconduct in this policy. An inquiry must be conducted if these criteria are met.
The assessment period should be brief, preferably concluded within 5 days. In conducting the assessment, the RIO need not interview the Complainant, Respondent, or other witnesses, or gather data beyond any that may have been submitted with the allegation, except as necessary to determine whether the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The RIO shall, on or before the date on which the Respondent is notified of the allegation, obtain custody of, inventory, and sequester all research records and evidence needed to conduct the research misconduct proceeding, as provided in paragraph B.3 below.
B.2 Initiation and Purpose of the Inquiry
If the RIO determines that the criteria for an inquiry are met, he or she will immediately initiate the inquiry process. The purpose of the inquiry is to conduct an initial review of the available evidence to determine whether to conduct an investigation. An inquiry does not require a full review of all the evidence related to the allegation.
B.3 Notice to Respondent; Sequestration of Research Records
At the time of or before beginning an inquiry, the RIO must make a good faith effort to notify the Respondent in writing, if the Respondent is known. If the inquiry subsequently identifies additional Respondents, they must be notified in writing. On or before the date on which the Respondent is notified, or the inquiry begins, whichever is earlier, the RIO must take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence and sequester them in a secure manner, except that where the research records or evidence encompass 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. The RIO may consult with the Cognizant Agency for advice and assistance in this regard.
B.4 Appointment of the Inquiry Committee
The RIO, in consultation with other institutional officials as appropriate, will appoint an inquiry committee and committee chair within 10 days of receipt of the allegation, if the allegation is one of research misconduct, or as soon thereafter as practical. The inquiry committee must consist of faculty who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry and should include individuals with the appropriate scientific expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. The RIO may use additional experts when necessary to evaluate specific allegations. The RIO will notify the Respondent of the proposed committee membership to give the Respondent an opportunity to object to a proposed member based upon a personal, professional, or financial conflict of interest. The Respondent has 5 calendar days to submit objections. The DO will make the final determination of whether a conflict exists.
B.5 Charge to the Committee and First Meeting
The RIO will prepare a charge for the inquiry committee that:
- Sets forth the time for completion of the inquiry;
- Describes the allegations and any related issues identified during the allegation assessment;
- States that the purpose of the inquiry is to conduct an initial review of the evidence, including the testimony of the Respondent, Complainant and key witnesses, to determine whether an investigation is warranted, not to determine whether research misconduct definitely occurred or who was responsible;
- States that 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 is within the jurisdictional criteria of this policy; and, (2) the allegation may have substance, based on the committee's review during the inquiry.
- Informs the inquiry committee that they are responsible for preparing or directing the preparation of a written report of the inquiry that meets the requirements of this policy.
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 will be present or available throughout the inquiry to advise the committee as needed.
B.6 Inquiry Process
The inquiry committee will normally interview the Complainant, the Respondent, and key witnesses, as well as examine relevant research records and materials. Then the inquiry committee will evaluate the evidence, including the testimony obtained during the inquiry. After consultation with the RIO, the committee members will decide whether an investigation is warranted based on the criteria in this policy. The scope of the 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 legally 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 that case, the institution shall promptly consult with the Cognizant Agency to determine the next steps that should be taken. See Section C.3 below.
B.7 Time for Completion
The inquiry, including preparation of the draft inquiry report and the recommendation of the RIO on whether an investigation is warranted, must be completed within 20 calendar days of receipt of allegation, unless the RIO determines that circumstances clearly warrant a longer period. If the RIO approves an extension, the inquiry record must include documentation of the reasons for exceeding the 20-day period. The Respondent should be notified of the extension.
C The Inquiry Report
C.1 Elements of the final Inquiry Report
A written inquiry report must be prepared that includes the following information: (1) the name and position of the Respondent; (2) a description of the allegations of research misconduct; (3) the funding source, including, for example, grant numbers, grant applications, contracts and publications listing the support; (4) the basis for recommending or not recommending that the allegations warrant an investigation; (5) any comments on the draft report by the Respondent or Complainant. The inquiry report should also include: the names and titles of the committee members and experts who conducted the inquiry; a summary of the inquiry process used; a list of the research records reviewed; summaries of any interviews; and whether any other actions should be taken if an investigation is not recommended.
Institutional counsel should review the report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the inquiry committee.
C.2 Notification to the Respondent and Opportunity to Comment
The RIO shall notify the Respondent whether the inquiry found an investigation to be warranted, include a copy of the draft inquiry report for comment within 10 days, and include a copy of or reference to the Cognizant Agency's regulations and the FAU policies and procedures on research misconduct.
Any comments that are submitted will be attached to the final inquiry report. Based on the comments, the inquiry committee may revise the draft report as appropriate and prepare it in final form. The committee will deliver the final report to the RIO.
C.3 Institutional Decision and Notification
C.3.1 Decision by Deciding Official
The RIO will transmit the final inquiry report and any comments to the DO, who will determine within 5 days in writing whether an investigation is warranted or further inquiry is required. The inquiry is completed when the DO makes this determination.
C.3.2 Notification to the Cognizant Agency, as applicable.
Within 30 calendar days of the DO's decision that an investigation is warranted, the RIO will provide the Cognizant Agency with the DO's written decision and a copy of the inquiry report. The RIO will also notify those institutional officials who need to know of the DO's decision, including the relevant Chair and Dean. The RIO must provide the following information to the Cognizant Agency 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.
C.3.3 Documentation of Decision Not to Investigate
If the DO decides that an investigation is not warranted, the RIO shall secure and maintain for 7 years after the termination of the inquiry sufficiently detailed documentation of the inquiry to permit a later assessment by the Cognizant Agency of the reasons why an investigation was not conducted. These documents must be provided to the Cognizant Agency or other authorized federal personnel upon request.
D Conducting the Investigation
D.1 Initiation and Purpose
The investigation must begin within 30 calendar days after the determination by the DO that an investigation is warranted. The purpose of the investigation is to develop a factual record by exploring the allegations in detail and examining the evidence in depth, leading to recommended findings on whether research 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 involves clinical trials or potential harm to human subjects or the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation will be set forth in an investigation report.
D.2 Notifying the Cognizant Agency and Respondent; Sequestration of Research Records
On or before the date on which the investigation begins, the RIO must: (1) notify the Cognizant Agency Director of the decision to begin the investigation and provide the Cognizant Agency a copy of the inquiry report; and (2) notify the Respondent in writing of the allegations to be investigated. The RIO must also give the Respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of the investigation.
The RIO will, prior to notifying Respondent of the allegations, take all reasonable and practical steps to obtain custody of and sequester in a secure manner all research records and evidence needed to conduct the research misconduct investigation that were not previously sequestered during the inquiry. Where the research records or evidence encompass 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. The need for additional sequestration of records for the investigation 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 for sequestration during the investigation are the same procedures that apply during the inquiry.
D.3 Appointment of the Investigation Committee
The RIO, in consultation with other institutional officials as appropriate, will appoint an investigation committee and the committee chair within 10 days of the beginning of the investigation or as soon thereafter as practical. The investigation committee must consist of faculty who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation and should include individuals with the appropriate scientific expertise to evaluate the evidence and issues related to the allegation, interview the Respondent and Complainant and conduct the investigation. Individuals appointed to the investigation committee may also have served on the inquiry committee. When necessary to secure the necessary expertise or to avoid conflicts of interest, the RIO may select committee members from outside the institution. The RIO will notify the Respondent of the proposed committee membership to give the Respondent an opportunity to object to a proposed member based upon a personal, professional, or financial conflict of interest. The Respondent has 5 calendar days to file an objection. The DO will make the final determination of whether a conflict exists.
D.4 Charge to the Committee and the First Meeting
D.4.1 Charge to the Committee
The RIO 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 paragraph D.5 below;
- 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.
D.4.2 First Meeting
The RIO 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 policy and the Cognizant Agency's regulations. The RIO will be present or available throughout the investigation to advise the committee as needed.
D.5 Investigation Process
The investigation committee and the RIO must:
- Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and evidence relevant to reaching a decision on the merits of each allegation;
- Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practical;
- Interview each Respondent, Complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the Respondent, and record or transcribe each interview, provide the recording or transcript to the interviewee for correction, and include the recording or transcript in the record of the investigation; and
- Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of any additional instances of possible research misconduct, and continue the investigation to completion.
D.6 Time for Completion
The investigation is to be completed within 80 days of beginning it, including conducting the investigation, preparing the report of findings, providing the draft report for comment and sending the final report to the Cognizant Agency. However, if the RIO determines that the investigation will not be completed within this 80-day period, he/she will submit to the Cognizant Agency a written request for an extension, setting forth the reasons for the delay. The RIO will ensure that periodic progress reports are filed with the Cognizant Agency, if the Cognizant Agency grants the request for an extension and directs the filing of such reports.
E The Investigation Report
E.1 Elements of the Investigation Report
The investigation committee and the RIO are responsible for preparing a written draft report of the investigation that:
- Describes the nature of the allegation of research misconduct, including identification of the Respondent;
- Describes and documents the PHS support, if any, including, for example, the numbers of any grants that are involved, grant applications, contracts, and publications listing PHS support;
- Describes the specific allegations of research misconduct considered in the investigation;
- Includes the institutional policies and procedures under which the investigation was conducted, unless those policies and procedures were provided to the Cognizant Agency previously;
- Identifies and summarizes the research records and evidence reviewed and identifies any evidence taken into custody but not reviewed; and
- Includes a statement of findings for each allegation of research misconduct identified during the investigation. Each statement of findings must: (1) identify whether the research misconduct was falsification, fabrication, or plagiarism, and whether it was committed intentionally, knowingly, or recklessly; (2) summarize the facts and the analysis that support the conclusion and consider the merits of any reasonable explanation by the Respondent, including any effort by Respondent to establish by a preponderance of the evidence that he or she did not engage in research misconduct because of honest error or a difference of opinion; (3) identify the specific source of support; (4) identify whether any publications need correction or retraction; (5) identify the person(s) responsible for the misconduct; and (6) list any current support or known applications or proposals for support that the Respondent has pending with federal agencies.
E.2 Comments on the Draft Report and Access to Evidence
E.2.1 Respondent
The RIO must give the Respondent a copy of the draft investigation report for comment and, concurrently, a copy of, or supervised access to the evidence on which the report is based. The Respondent will be allowed 15 days from the date he/she received the draft report to submit comments to the RIO. The Respondent's comments must be included and considered in the final report.
E.2.2 Confidentiality
In distributing the draft report, or portions thereof, to the Respondent, the RIO 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 require that the recipient sign a confidentiality agreement.
E.3 Decision by Deciding Official
The RIO will assist the investigation committee in finalizing the draft investigation report, including ensuring that the Respondent's comments are included and considered, and transmit the final investigation report to the DO, who will determine within 5 days in writing: (1) whether the institution accepts the investigation report, its findings, and the recommended institutional actions; and (2) the appropriate institutional actions in response to the accepted findings of research misconduct. If this determination varies from the findings of the investigation committee, the DO will, as part of his/her written determination, explain in detail the basis for rendering a decision different from the findings of the investigation committee. Alternatively, the DO may return the report to the investigation committee with a request for further fact-finding or analysis.
When a final decision on the case has been reached, the RIO will normally notify both the Respondent and the Complainant in writing. After informing the Cognizant Agency, the DO 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 Respondent in the work, or other relevant parties should be notified of the outcome of the case. The RIO is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.
E.4 Notice to the Cognizant Agency of Institutional Findings and Actions
Unless an extension has been granted, the RIO must, within the 100-day period for completing the investigation, submit the following to the Cognizant Agency: (1) a copy of the final investigation report with all attachments; (2) a statement of whether the institution accepts the findings of the investigation report; (3) a statement of whether the institution found misconduct and, if so, who committed the misconduct; and (4) a description of any pending or completed administrative actions against the Respondent.
E.5 Maintaining Records for Review by the Cognizant Agency
The RIO must maintain and provide to the Cognizant Agency upon request records of research misconduct proceedings. Unless custody has been transferred to the Cognizant Agency or the Cognizant Agency has advised in writing that the records no longer need to be retained, records of research misconduct proceedings must be maintained in a secure manner for 7 years after completion of the proceeding or the completion of any other proceeding involving the research misconduct allegation. The RIO is also responsible for providing any information, documentation, research records, evidence or clarification requested by the Cognizant Agency to carry out its review of an allegation of research misconduct or of the institution's handling of such an allegation.
F Completion of Cases; Reporting Premature Closures to the Cognizant Agency
Generally, all inquiries and investigations will be carried through to completion and all significant issues will be pursued diligently. The RIO must notify the Cognizant Agency in advance if there are plans to close a case at the inquiry or investigation stage on the basis that Respondent has admitted guilt, a settlement with the Respondent has been reached, or for any other reason, except: (1) closing of a case at the inquiry stage on the basis that an investigation is not warranted; or (2) a finding of no misconduct at the investigation stage, which must be reported to the Cognizant Agency.
G Institutional Administrative Actions
If the DO determines that research misconduct is substantiated by the findings, he or she will decide on the appropriate actions to be taken, after consultation with the RIO. The administrative actions may include, but are not limited to:
- Withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found;
- Removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, or initiation of steps leading to possible rank reduction or termination of employment;
- Restitution of funds to the grantor agency as appropriate;
- Dismissal of a student from a program, College or the University;
- Revocation of a degree from a former student who has received a degree from FAU, ;
- Other action consistent with University policy appropriate to the misconduct. This includes action by the DO acting as University Provost or referral of the matter for further administrative action by the University and if a student has been involved, application of the Student Code of Conduct.
H Other Considerations
H.1 Termination or Resignation Prior to Completing Inquiry or Investigation
The termination of the Respondent's FAU affiliation, by resignation, withdrawal or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the research misconduct proceeding or otherwise limit any of the FAU's responsibilities.
If the Respondent, without admitting to the misconduct, elects to resign his or her position after the institution receives an allegation of research misconduct, the assessment of the allegation will proceed, as well as the inquiry and investigation, as appropriate based on the outcome of the preceding steps. If the Respondent refuses to participate in the process after resignation, the RIO and any inquiry or investigation committee will use their best efforts to reach a conclusion concerning the allegations, noting in the report the Respondent's failure to cooperate and its effect on the evidence.
H.2 Restoration of the Respondent's Reputation
Following a final finding of no research misconduct, including the Cognizant Agency concurrence, the RIO will, at the request of the Respondent, undertake all reasonable and practical efforts to restore the Respondent's reputation. Depending on the particular circumstances and the views of the Respondent, the RIO should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in any forum in which the allegation of research misconduct was previously publicized, and expunging all reference to the research misconduct allegation from the Respondent's personnel file. Any institutional actions to restore the Respondent's reputation should first be approved by the DO.
H.3 Protection of the Complainant, Witnesses, and Committee Members
During the research misconduct proceeding and upon its completion, regardless of whether the institution or the Cognizant Agency determines that research misconduct occurred, the RIO will 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, including students involved in the process. The DO 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 DO approves.
H.4 Allegations Not Made in Good Faith
If relevant, the DO will determine whether the Complainant's allegations of research misconduct were made in good faith, or whether a witness or committee member acted in good faith. If the DO determines that there was an absence of good faith he/she will determine whether any administrative action should be taken against the person who failed to act in good faith.
APPENDIX A
Research Integrity Officer Responsibilities
1.0 General
The Research Integrity Officer (RIO) has lead responsibility for ensuring that the institution:
- Takes all reasonable and practical steps to foster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct;
- Has written policies and procedures for responding to allegations of research misconduct and reporting information about that response to the Cognizant Agency (this document);
- Complies with these written policies and procedures;
- Informs its institutional members about its research misconduct policies and procedures and its commitment to compliance with those policies and procedures;
- Takes appropriate interim action during a research misconduct proceeding to protect public health, federal funds and equipment, and the integrity of the research process.
2.0 Notice and Reporting to, and Cooperation with, the Cognizant Agency
The RIO has lead responsibility for ensuring that the institution:
- Files an annual report with the Cognizant Agency containing the information it requires;
- Sends to the Cognizant Agency with the annual report such other aggregated information as it may prescribe on the institution's research misconduct proceedings and the institution's compliance;
- Notifies the Cognizant Agency immediately if, at any time during the research misconduct proceeding, it has reason to believe that health or safety of the public is at risk, federal resources or interests are threatened, research activities should be suspended, there is reasonable indication of possible violations of civil or criminal law, federal action is required to protect the interests of those involved in the research misconduct proceeding, the institution believes that the research misconduct proceeding may be made public prematurely, or the research community or the public should be informed;
- Provides the Cognizant Agency with the written finding by the responsible institutional official that an investigation is warranted and a copy of the inquiry report, within 30 days of the date on which the finding is made;
- Notifies the Cognizant Agency of the decision to begin an investigation on or before the date the investigation begins;
- Within 120 days of beginning an investigation, or such additional days as may be granted by the Cognizant Agency, provides the Cognizant Agency with the investigation report, a statement of whether the institution accepts the investigation's findings, a statement of whether the institution found research misconduct and, if so, who committed it, and a description of any pending or completed administrative actions against the Respondent;
- Seeks in advance the Cognizant Agency's approval if the institution plans to close a case at the inquiry or investigation on the basis that the Respondent has admitted guilt, a settlement with the Respondent has been reached, or for any other reason, except the closing of a case at the inquiry stage on the basis that an investigation is not warranted or a finding of no misconduct at the investigation stage;
- Cooperates fully with the Cognizant Agency during its oversight review and any subsequent administrative hearings or appeals, including providing all research records and evidence under the institution's control, custody, or possession and access to all persons within its authority necessary to develop a complete record of relevant evidence.
3.0 Research Misconduct Proceeding
3.1 General
The RIO is responsible for:
- Promptly taking all reasonable and practical steps to obtain custody of all research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner;
- Taking all reasonable and practical steps to ensure the cooperation of Respondents and other institutional members with research misconduct proceedings, including, but not limited to their providing information, research records and evidence;
- Providing confidentiality to those involved in the research misconduct proceeding;
- Determining whether each person involved in handling an allegation of research misconduct has an unresolved personal, professional or financial conflict of interest and taking appropriate action, including recusal, to ensure that no person with such a conflict is involved in the research misconduct proceeding;
- Keeping the Deciding Official and others who need to know apprised of the progress of the review of the allegation of research misconduct;
- In cooperation with other institutional officials, taking all reasonable and practical steps to protect or restore the positions and reputations of good faith Complainants, witnesses, and committee members and to counter potential or actual retaliation against them by Respondents or other institutional members;
- Making all reasonable and practical efforts, if requested and as appropriate, to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made;
- Assisting the DO in implementing his/her decision to take administrative action against any Complainant, witness, or committee member determined by the DO not to have acted in good faith;
- Maintaining records of the research misconduct proceeding in a secure manner for 7 years after completion of the proceeding, or the completion of any the Cognizant Agency proceeding involving the allegation of research misconduct, whichever is later, unless custody of the records has been transferred to the Cognizant Agency or it has advised that the records no longer need to be retained;
- Ensuring that administrative actions taken by the institution and the Cognizant Agency are enforced and taking appropriate action to notify other involved parties, such as sponsors, law enforcement agencies, professional societies, and licensing boards, of those actions;
3.2 Allegation Receipt and Assessment
The RIO is responsible for:
- Consulting confidentially with persons uncertain about whether to submit an allegation of research misconduct;
- Receiving allegations of research misconduct;
- Assessing each allegation of research misconduct to determine if an inquiry is warranted because the allegation falls within the definition of research misconduct, is within the jurisdictional criteria of this policy, and is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
3.3 Inquiry
The RIO is responsible for:
- Initiating the inquiry process if it is determined that an inquiry is warranted;
- At the time of, or before beginning the inquiry, making a good faith effort to notify the Respondent in writing, if the Respondent is known;
- On or before the date on which the Respondent is notified, or the inquiry begins, whichever is earlier, taking all reasonable and practical steps to obtain custody of all research records and evidence needed to conduct the research misconduct proceeding, inventorying the records and evidence and sequestering them in a secure manner, except that where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on the instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments;
- Appointing an inquiry committee and committee chair as soon after the initiation of the inquiry as is practical;
- Preparing a charge for the inquiry committee in accordance with the institution's policies and procedures;
- Convening the first meeting of the inquiry committee and at that meeting briefing the committee on the allegations, the charge to the committee, and the appropriate procedures for conducting the inquiry, including the need for confidentiality and for developing a plan for the inquiry, and assisting the committee with organizational and other issues that may arise;
- Providing the inquiry committee with needed logistical support, e.g., expert advice, including forensic analysis of evidence, and clerical support, including arranging witness interviews and recording or transcribing those interviews;
- Being available or present throughout the inquiry to advise the committee as needed and consulting with the committee prior to its decision on whether to recommend that an investigation is warranted on the basis of the criteria in this policy;
- Determining whether circumstances clearly warrant a period longer than that specified in paragraph B.7 of this policy to complete the inquiry (including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted), approving an extension if warranted, and documenting the reasons for exceeding the period specified in the policy on the record of the research misconduct proceeding;
- Assisting the inquiry committee in preparing a draft inquiry report, sending the Respondent a copy of the draft report for comment within a time period that permits the inquiry to be completed within the allotted time, taking appropriate action to protect the confidentiality of the draft report, receiving any comments from the Respondent, and ensuring that the comments are attached to the final inquiry report;
- Receiving the final inquiry report from the inquiry committee and forwarding it, together with any comments the RIO may wish to make, to the DO who will determine in writing whether an investigation is warranted;
- Within 30 days of a DO decision that an investigation is warranted, providing the Cognizant Agency with the written finding and a copy of the inquiry report and notifying those institutional officials who need to know of the decision;
- Notifying the Respondent whether the inquiry found an investigation to be warranted and including in the notice copies of or a reference to Cognizant Agency regulations and the institution's research misconduct policies and procedures;
- Providing to the Cognizant Agency, upon request, the institutional policies and procedures under which the inquiry was conducted, the research records and evidence reviewed, transcripts or recordings of any interviews, copies of all relevant documents , and the charges to be considered in the investigation;
- If the DO decides that an investigation is not warranted, securing and maintaining for 7 years after the termination of the inquiry sufficiently detailed documentation of the inquiry to permit a later assessment by the Cognizant Agency of the reasons why an investigation was not conducted.
3.4 Investigation
The RIO is responsible for:
- Initiating the investigation within 30 calendar days after the determination by the DO that an investigation is warranted;
- On or before the date on which the investigation begins: (1) notifying the Cognizant Agency of the decision to begin the investigation and providing the Cognizant Agency a copy of the inquiry report; and (2) notifying the Respondent in writing of the allegations to be investigated;
- Prior to notifying Respondent of the allegations, taking all reasonable and practical steps to obtain custody of and sequester in a secure manner all research records and evidence needed to conduct the research misconduct proceeding that were not previously sequestered during the inquiry;
- In consultation with other institutional officials as appropriate, appointing an investigation committee and committee chair as soon after the initiation of the investigation as is practical;
- Preparing a charge for the investigation committee in accordance with the institution's policies and procedures;
- Convening the first meeting of the investigation committee and at that meeting: (1) briefing the committee on the charge, the inquiry report and the procedures and standards for the conduct of the investigation, including the need for confidentiality and developing a specific plan for the investigation; and (2) providing committee members a copy of the institution's policies and procedures and the Cognizant Agency's regulations;
- Providing the investigation committee with needed logistical support, e.g., expert advice, including forensic analysis of evidence, and clerical support, including arranging interviews with witnesses and recording or transcribing those interviews;
- Being available or present throughout the investigation to advise the committee as needed;
- Acting, on behalf of the institution, as the responsible party for each of the following steps and for ensuring that the investigation committee: (1) uses diligent efforts to conduct an investigation that includes an examination of all research records and evidence relevant to reaching a decision on the merits of the allegations and that is otherwise thorough and sufficiently documented; (2) takes reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practical; (3) interviews each Respondent, Complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the Respondent, and records or transcribes each interview, provides the recording or transcript to the interviewee for correction, and includes the recording or transcript in the record of the research misconduct proceeding; and (4) pursues diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of any additional instances of possible research misconduct, and continues the investigation to completion;
- Upon determining that the investigation cannot be completed within 120 days of its initiation (including providing the draft report for comment and sending the final report with any comments to the Cognizant Agency), submitting a request to the Cognizant Agency for an extension of the 120-day period that includes a statement of the reasons for the extension. If the extension is granted, the RIO will file periodic progress reports with the Cognizant Agency;
- Assisting the investigation committee in preparing a draft investigation report that meets the requirements of the Cognizant Agency's regulations and the institution's policies and procedures, sending the Respondent a copy of the draft report for his/her comment within 15 days of receipt, taking appropriate action to protect the confidentiality of the draft report, receiving any comments from the Respondent, and ensuring that the comments are included and considered in the final investigation report;
- Transmitting the draft investigation report to institutional counsel for a review of its legal sufficiency;
- Assisting the investigation committee in finalizing the draft investigation report and receiving the final report from the committee;
- Transmitting the final investigation report to the DO and: (1) if the DO determines that further fact-finding or analysis is needed, receiving the report back from the DO for that purpose; (2) if the DO determines whether or not to accept the report, its findings and the recommended institutional actions, transmitting to the Cognizant Agency within the time period for completing the investigation, a copy of the final investigation report with all attachments, a statement of whether the institution accepts the findings of the report, a statement of whether the institution found research misconduct, and if so, who committed it, and a description of any pending or completed administrative actions against the Respondent;
- Notifying, when a final decision on the case is reached, both the Respondent and the Complainant in writing and determining whether law enforcement agencies, professional societies, professional licensing boards, editors of involved journals, collaborators of the Respondent, or other relevant parties should be notified of the outcome of the case.
- Maintaining and providing to the Cognizant Agency upon request all relevant research records and records of the institution's research misconduct proceeding, including the results of all interviews and the transcripts or recordings of those interviews.
APPENDIX B
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 or Cognizant Agency official. The written allegation(s) will be date stamped. In the event that, the allegation is made verbally, the RIO or designee shall promptly reduce it to writing and date stamp the allegation as received on that date. In the event the allegation is received electronically, the RIO, or designee, will date stamp the document immediately upon receipt.
Cognizant agency is the organization associated with the funding source for the research activity in question that is responsible for matters involving research misconduct. For example, the Cognizant Agency for research funded by the National Institutes of Health is the HHS Office of Research Integrity.
Complainant means a person who in good faith makes an allegation of research misconduct.
Days are calendar days, not business days.
Deciding Official (DO) is the University Provost, or designee. The DO is the institutional official who makes final determinations on allegations of research misconduct and any institutional administrative actions. The Deciding Official will not be the same individual as the Research Integrity Officer and should have no direct prior involvement in the institution's inquiry, investigation, or allegation assessment. A Deciding Official's appointment of an individual to assess allegations of research misconduct, or to serve on an inquiry or investigation committee, is not considered to be direct prior involvement.
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.
Good faith as applied to a Complainant or witness, means having a belief in the truth of one's allegation or testimony that a reasonable person in the Complainant's or witness's 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 it is made with knowing or reckless disregard for information that would negate the allegation or testimony. Good faith as applied to a committee member, faculty, or student means cooperating with the purpose of helping an institution meet its responsibilities. A committee member does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
HHS means the United States Department of Health and Human Services.
Inquiry means preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures herein.
Institutional member means a person who is employed by, is an agent of, or is affiliated by contract or agreement with an institution. Institutional members may include, but are not limited to, officials, tenured and untenured faculty, teaching and support staff, researchers, research coordinators, clinical technicians, postdoctoral and other fellows, students, volunteers, agents, and contractors, subcontractors, and sub-awardees, and their employees.
Investigation means the formal development of a factual record and the examination of that record leading to a decision not to make a finding of research misconduct or to a recommendation for a finding of research misconduct that may include a recommendation for other appropriate actions, including administrative actions.
Office of Research Integrity (the Cognizant Agency for HHS) means the office to which the HHS Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS supported activities.
Preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.
Public Health Service (PHS) means the unit within HHS that includes the Office of Public Health and Science and the following Operating Divisions: Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and the Substance Abuse and Mental Health Services Administration, and the offices of the Regional Health Administrators.
Records of research misconduct proceedings means: (1) the research records and evidence secured for the research misconduct proceeding pursuant to this policy and Cognizant Agency regulations, except to the extent the Research Integrity Officer determines and documents that those records are not relevant to the proceeding or that the records duplicate other records that have been retained; (2) the documentation of the determination of irrelevant or duplicate records; (3) the inquiry report and final documents (not drafts) produced in the course of preparing that report, including the documentation of any decision not to investigate; (4) the investigation report and all records (other than drafts of the report) in support of the report, including the recordings or transcripts of each interview conducted; and (5) the complete record of any appeal within the institution from the finding of research misconduct.
Research Integrity Officer (RIO) means the institutional official responsible for: (1) assessing allegations of research misconduct to determine whether they fall within the definition of research misconduct, are covered by Cognizant Agency regulations, or the allegation is sufficiently specific so that potential evidence of research misconduct may be identified; and (2) overseeing inquiries and investigations; and (3) the other responsibilities described in this policy. In the event the RIO has a conflict of interest, then the RIO will refer the matter to the Inquiry Committee and all other duties of RIO will be referred to the chair of the Inquiry Committee.
Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is 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. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion.
Research misconduct proceeding means any actions related to alleged research misconduct, and also including but not limited to, allegation assessments, inquiries, investigations, the Cognizant Agency oversight reviews, and hearings.
Research record means the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to HHS or an institutional official by a Respondent in the course of the research misconduct proceeding.
Respondent means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.
Retaliation means an adverse action taken against a Complainant, witness, or committee member by this institution or one of its institutional members in response to (1) a good faith allegation of research misconduct; or (2) good faith cooperation with a research misconduct proceeding.
POLICY APPROVAL
Executed signature pages are available in the Initiating Authority Office