ࡱ> _ ?bjbjzyzy l6b6b%ĝĝ@@ҬҬҬ$PFdT.&۸B7%9%9%9%9%9%9%$(+f]%Ҭ8۸۸88]%@.r%h8XҬҬ7%87%J\+"R4#B#%%T.&e,,+",Ҭ+"X ]%]% .&8888,ĝB :  SEQ CHAPTER \h \r 191ܽ Policy and Procedures for Responding to Allegations of Research Misconduct Table of Contents  TOC \f \h \z  HYPERLINK \l "_Toc163630539" I. Introduction  PAGEREF _Toc163630539 \h 1  HYPERLINK \l "_Toc163630540" A. General Policy  PAGEREF _Toc163630540 \h 1  HYPERLINK \l "_Toc163630541" B. Scope  PAGEREF _Toc163630541 \h 1  HYPERLINK \l "_Toc163630542" II. Definitions  PAGEREF _Toc163630542 \h 2  HYPERLINK \l "_Toc163630543" III. Rights and Responsibilities  PAGEREF _Toc163630543 \h 3  HYPERLINK \l "_Toc163630544" A. Research Integrity Officer  PAGEREF _Toc163630544 \h 3  HYPERLINK \l "_Toc163630545" B. Complainant  PAGEREF _Toc163630545 \h 4  HYPERLINK \l "_Toc163630546" C. Respondent  PAGEREF _Toc163630546 \h 5  HYPERLINK \l "_Toc163630547" D. Deciding Official  PAGEREF _Toc163630547 \h 6  HYPERLINK \l "_Toc163630548" IV. General Policies and Principles  PAGEREF _Toc163630548 \h 6  HYPERLINK \l "_Toc163630549" A. Responsibility to Report Misconduct  PAGEREF _Toc163630549 \h 6  HYPERLINK \l "_Toc163630550" B. Cooperation with Research Misconduct Proceedings  PAGEREF _Toc163630550 \h 7  HYPERLINK \l "_Toc163630551" C. Confidentiality  PAGEREF _Toc163630551 \h 7  HYPERLINK \l "_Toc163630552" D. Protecting complainants, witnesses, and committee members  PAGEREF _Toc163630552 \h 7  HYPERLINK \l "_Toc163630553" E. Protecting the Respondent  PAGEREF _Toc163630553 \h 7  HYPERLINK \l "_Toc163630554" F. Interim Administrative Actions and Notifying ORI of Special Circumstances  PAGEREF _Toc163630554 \h 8  HYPERLINK \l "_Toc163630555" V. Conducting the Assessment and Inquiry  PAGEREF _Toc163630555 \h 9  HYPERLINK \l "_Toc163630556" A. Assessment of Allegations  PAGEREF _Toc163630556 \h 9  HYPERLINK \l "_Toc163630557" B. Initiation and Purpose of the Inquiry  PAGEREF _Toc163630557 \h 9  HYPERLINK \l "_Toc163630558" C. Notice to Respondent; Sequestration of Research Records  PAGEREF _Toc163630558 \h 9  HYPERLINK \l "_Toc163630559" D. Appointment of the Inquiry Committee  PAGEREF _Toc163630559 \h 10  HYPERLINK \l "_Toc163630560" E. Charge to the Committee and First Meeting  PAGEREF _Toc163630560 \h 10  HYPERLINK \l "_Toc163630561" F. Inquiry Process  PAGEREF _Toc163630561 \h 11  HYPERLINK \l "_Toc163630562" G. Time for Completion  PAGEREF _Toc163630562 \h 11  HYPERLINK \l "_Toc163630563" VI. The Inquiry Report  PAGEREF _Toc163630563 \h 11  HYPERLINK \l "_Toc163630564" A. Elements of the Inquiry Report  PAGEREF _Toc163630564 \h 11  HYPERLINK \l "_Toc163630565" B. Notification to the Respondent and Opportunity to Comment  PAGEREF _Toc163630565 \h 12  HYPERLINK \l "_Toc163630566" C. Institutional Decision and Notification  PAGEREF _Toc163630566 \h 12  HYPERLINK \l "_Toc163630567" 1. Decision by Deciding Official  PAGEREF _Toc163630567 \h 12  HYPERLINK \l "_Toc163630568" 2. Notification to ORI  PAGEREF _Toc163630568 \h 12  HYPERLINK \l "_Toc163630569" 3. Documentation of Decision Not to Investigate  PAGEREF _Toc163630569 \h 13  HYPERLINK \l "_Toc163630570" VII. Conducting the Investigation  PAGEREF _Toc163630570 \h 13  HYPERLINK \l "_Toc163630571" A. Initiation and Purpose  PAGEREF _Toc163630571 \h 13  HYPERLINK \l "_Toc163630572" B. Notifying ORI and Respondent; Sequestration of Research Records  PAGEREF _Toc163630572 \h 13  HYPERLINK \l "_Toc163630573" C. Appointment of the Investigation Committee  PAGEREF _Toc163630573 \h 14  HYPERLINK \l "_Toc163630574" D. Charge to the Committee and the First Meeting  PAGEREF _Toc163630574 \h 14  HYPERLINK \l "_Toc163630575" 1. Charge to the Committee  PAGEREF _Toc163630575 \h 14  HYPERLINK \l "_Toc163630576" 2. First Meeting  PAGEREF _Toc163630576 \h 15  HYPERLINK \l "_Toc163630577" E. Investigation Process  PAGEREF _Toc163630577 \h 15  HYPERLINK \l "_Toc163630578" F. Time for Completion  PAGEREF _Toc163630578 \h 16  HYPERLINK \l "_Toc163630579" VIII. The Investigation Report  PAGEREF _Toc163630579 \h 16  HYPERLINK \l "_Toc163630580" A. Elements of the Investigation Report  PAGEREF _Toc163630580 \h 16  HYPERLINK \l "_Toc163630581" B. Comments on the Draft Report and Access to Evidence  PAGEREF _Toc163630581 \h 17  HYPERLINK \l "_Toc163630582" 1. Respondent  PAGEREF _Toc163630582 \h 17  HYPERLINK \l "_Toc163630583" 2. Complainant  PAGEREF _Toc163630583 \h 17  HYPERLINK \l "_Toc163630584" 3. Confidentiality  PAGEREF _Toc163630584 \h 17  HYPERLINK \l "_Toc163630585" C. Decision by Deciding Official  PAGEREF _Toc163630585 \h 18  HYPERLINK \l "_Toc163630586" D. Appeals  PAGEREF _Toc163630586 \h 18  HYPERLINK \l "_Toc163630587" E. Notice to ORI of Institutional Findings and Actions  PAGEREF _Toc163630587 \h 18  HYPERLINK \l "_Toc163630588" IX. Completion of Cases; Reporting Premature Closures to ORI  PAGEREF _Toc163630588 \h 19  HYPERLINK \l "_Toc163630589" X. Institutional Administrative Actions [Optional]  PAGEREF _Toc163630589 \h 19  HYPERLINK \l "_Toc163630590" XI. Other Considerations  PAGEREF _Toc163630590 \h 20  HYPERLINK \l "_Toc163630591" A. Termination or Resignation Prior to Completing Inquiry or Investigation  PAGEREF _Toc163630591 \h 20  HYPERLINK \l "_Toc163630592" B. Restoration of the Respondent's Reputation  PAGEREF _Toc163630592 \h 20  HYPERLINK \l "_Toc163630593" C. Protection of the Complainant, Witnesses and Committee Members  PAGEREF _Toc163630593 \h 20  HYPERLINK \l "_Toc163630594" D. Allegations Not Made in Good Faith  PAGEREF _Toc163630594 \h 21  LONG ISLAND UNIVERSITY POLICY AND PROCEDURES FOR RESPONDING TO ALLEGATIONS OF RESEARCH MISCONDUCT I. Introduction TC "I. Introduction" \f C \l "1"  A. General Policy TC "A. General Policy" \f C \l "2"  It is the policy of 91ܽ (LIU) that the research and scholarly activities of its community be carried out with the highest standards of integrity and ethical behavior. While the primary responsibility for maintaining integrity in research rests with those who conduct it, LIU has established standards to ensure a supportive environment for research and compliance with the law. Each member of the LIU community has a personal responsibility for implementing this policy in relation to any scholarly work with which he or she is associated and for helping his or her associates in continuing efforts to avoid any activity that might be considered in violation of this policy. B. Scope TC "B. Scope" \f C \l "2"  This statement of policy and procedures is intended to carry out this institutions responsibilities under various grantor agencies. Because legal requirements of grantor agencies are varied and subject to change, it is the intent of this policy to establish basic principles that will apply to all research misconduct, while using Public Health Service regulations as a guide. The procedures shall be consistent with this policy and shall allow flexibility in complying with reporting, time and other specific requirements imposed by differing laws or regulations. This document 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 this institution; and (1) Grantor agency support of biomedical or behavioral 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 grantor agency support for biomedical or behavioral research, research training or activities related to that research or research training, or (3) plagiarism of research records produced in the course of grantor agency supported 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 for grantor agency funds resulted in a grant, contract, cooperative agreement, or other form of grantor agency support. This statement of policy and procedures does not apply to authorship or collaboration disputes and applies only to allegations of research misconduct that occurred within six years of the date the institution or grantor agency received the allegation, subject to the subsequent use, health or safety of the public, and grandfather exceptions in grantor agencys policies. II. Definitions TC "II. Definitions" \f C \l "1"  Deciding Official (DO) means 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 institutions inquiry, investigation, or allegation assessment. A DOs 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. The Deciding Official for 91ܽ is Dr. Randy Burd, Senior Vice-President for Academic Affairs. Research Integrity Officer (RIO) means the institutional official responsible for: (1) assessing allegations of research misconduct to determine if they fall within the definition of research misconduct specified by grantor agency regulations, and warrant an inquiry on the basis that the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified; (2) overseeing inquiries and investigations; and (3) the other responsibilities described in this policy. The Research Integrity Officer for 91ܽ is Dr. Richard Nader, Chief Research and International Officer. III. Rights and Responsibilities TC "III. Rights and Responsibilities" \f C \l "1"  A. Research Integrity Officer TC "A. Research Integrity Officer" \f C \l "2"  The designated institutional official, Dr. Randy Burd, will appoint the RIO who will have primary responsibility for implementation of the institutions policies and procedures on research misconduct. These responsibilities include the following duties related to research misconduct proceedings: Consult confidentially with persons 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 V.A. of this policy to determine whether it falls within the definition of research misconduct and warrants an inquiry; As necessary, take interim action and notify grantor agency of special circumstances, in accordance with Section IV.F. of this policy; Sequester research data and evidence pertinent to the allegation of research misconduct in accordance with Section V.C. of this policy and maintain it securely in accordance with this policy and applicable laws and regulations; Provide confidentiality to those involved in the research misconduct proceeding as required by applicable laws, and institutional policy; Notify the respondent and provide opportunities for him/her to review/ comment/respond to allegations, evidence, and committee reports in accordance with Section III.C. of this policy; 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 grantor agencies; Ensure that administrative actions taken by the institution and grantor agencies 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 to grantor agencies in accordance with Section VIII.F of this policy. B. Complainant TC "B. Complainant" \f C \l "2"  The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with the inquiry and investigation committees. As a matter of policy or on the basis of case-by-case determinations, the institution may provide to the complainant for comment: (1) relevant portions of the inquiry report (within a timeframe that permits the inquiry to be completed within 60 days of its initiation); and (2) the draft investigation report or relevant portions of it. The institution must require that comments on the draft investigation report be submitted within 30 days of the date on which the complainant received the draft report. The institution must consider any comments made by the complainant on the draft investigation report and include those comments in the final investigation report. C. Respondent TC "C. Respondent" \f C \l "2"  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 grantor agency 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, or refers to grantor agency regulations and the institutions 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 (within 30 days after the institution decides to begin an investigation), 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 30 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/or other institutional officials, the Deciding Official may terminate the institutions review of an allegation that has been admitted, if the institutions acceptance of the admission and any proposed settlement is approved by the grantor agency. As provided in most grantor agency regulations, the respondent will have the opportunity to request an institutional appeal if the institutions procedures provide for an appeal. The arbiter of such an appeal will be the President of 91ܽ. D. Deciding Official TC "D. Deciding Official" \f C \l "2"  The DO will receive the inquiry report and after consulting with the RIO and/or other institutional officials, decide whether an investigation is warranted under the criteria specified in grantor agency regulations. Any finding that an investigation is warranted must be made in writing by the DO and must be provided to grantor agency, together with a copy of the inquiry report meeting the requirements of grantor agency regulations, 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 grantor agency may assess the reasons why the institution decided not to conduct an investigation. The DO will receive the investigation report and, after consulting with the RIO and/or other institutional officials, decide the extent to which this institution accepts the findings of the investigation and, if research misconduct is found, decide what, if any, institutional administrative actions are appropriate. The DO shall ensure that the final investigation report, the findings of the DO and a description of any pending or completed administrative actions are provided to the grantor agency, as required by grantor agency regulations. IV. General Policies and Principles TC "IV. General Policies and Principles" \f C \l "1"  A. Responsibility to Report Misconduct TC "A. Responsibility to Report Misconduct" \f C \l "2"  All institutional members will report observed, suspected, or apparent research misconduct 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 rick.nader@liu.edu to discuss the suspected research misconduct informally, which 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. 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. B. Cooperation with Research Misconduct Proceedings TC "B. Cooperation with Research Misconduct Proceedings" \f C \l "2"  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. C. Confidentiality TC "C. Confidentiality" \f C \l "2"  The RIO shall, as required by grantor agency regulations: (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 should use written confidentiality agreements or other mechanisms to ensure that the recipient does not make any further disclosure of identifying information. The institution will provide confidentiality for witnesses when the circumstances indicate that the witnesses may be harassed or otherwise need protection. D. Protecting complainants, witnesses, and committee members TC "D. Protecting complainants, witnesses, and committee members" \f C \l "2"  Institutional members may not retaliate in any way against complainants, witnesses, or committee members. Institutional members should immediately report any alleged or apparent retaliation against complainants, witnesses or committee members to the RIO, who, in collaboration with LIU Legal Counsel, 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. E. Protecting the Respondent TC "E. Protecting the Respondent" \f C \l "2"  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 notices and opportunities provided for in grantor agency regulations and the policies and procedures of the institution. 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. Lawyers and personal advisors who are present at interviews and meetings are restricted to the role of advising (as opposed to representing) the respondent. F. Interim Administrative Actions and Notifying Grantor Agency of Special Circumstances TC "F. Interim Administrative Actions and Notifying ORI of Special Circumstances" \f C \l "2"  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 grantor agency supported research process. In the event of such a threat, the RIO will, in consultation with other institutional officials and grantor agency, 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 grantor 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; Grantor agency 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 grantor agency action may be necessary to safeguard evidence and protect the rights of those involved; or The research community or public should be informed. V. Conducting the Assessment and Inquiry TC "V. Conducting the Assessment and Inquiry" \f C \l "1"  A. Assessment of Allegations TC "A. Assessment of Allegations" \f C \l "1"  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 grantor agency regulations, and whether the allegation falls within the definition of research misconduct in grantor agency regulations. An inquiry must be conducted if these criteria are met. The assessment period should be brief, preferably concluded within a week. 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 C. of this section. B. Initiation and Purpose of the Inquiry TC "B. Initiation and Purpose of the Inquiry" \f C \l "2"  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. C. Notice to Respondent; Sequestration of Research Records TC "C. Notice to Respondent; Sequestration of Research Records" \f C \l "2"  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 grantor agency for advice and assistance in this regard. D. Appointment of the Inquiry Committee  TC "D. Appointment of the Inquiry Committee" \f C \l "2"  The RIO, in consultation with other institutional officials as appropriate, will appoint an inquiry committee and committee chair as soon after the initiation of the inquiry as is practical. The inquiry committee must consist of individuals 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. E. Charge to the Committee and First Meeting TC "E. Charge to the Committee and First Meeting" \f C \l "2"  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 grantor agency regulations(b); and, (2) the allegation may have substance, based on the committees 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 and grantor agency regulations. 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. F. Inquiry Process TC "F. Inquiry Process" \f C \l "2"  The inquiry committee will normally interview the complainant, the respondent, and key witnesses as well as examining 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 and grantor agency regulations. 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 grantor agency to determine the next steps that should be taken. See Section IX. G. Time for Completion TC "G. Time for Completion" \f C \l "2"  The inquiry, including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted, must be completed within 60 calendar days of initiation of the inquiry, 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 60-day period. The respondent will be notified of the extension. VI. The Inquiry Report TC "VI. The Inquiry Report" \f C \l "1"  A. Elements of the Inquiry Report TC "A. Elements of the Inquiry Report" \f C \l "2"  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 grantor agency support, including, for example, grant numbers, grant applications, contracts and publications listing grantor agency 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. Institutional counsel should review the report for legal sufficiency. Modifications should be made as appropriate in consultation with the RIO and the inquiry committee. The inquiry report should 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. B. Notification to the Respondent and Opportunity to Comment TC "B. Notification to the Respondent and Opportunity to Comment" \f C \l "2"  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 refer to grantor agency regulations and the institutions policies and procedures on research misconduct. The institution will notify the complainant whether the inquiry found an investigation to be warranted and provide relevant portions of the inquiry report to the complainant for comment within 10 days. A confidentiality agreement should be a condition for access to the report. Any comments that are submitted by the respondent or complainant 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. Institutional Decision and Notification TC "C. Institutional Decision and Notification" \f C \l "2"  1. Decision by Deciding Official TC "1. Decision by Deciding Official" \f C \l "3"  The RIO will transmit the final inquiry report and any comments to the DO, who will determine in writing whether an investigation is warranted. The inquiry is completed when the DO makes this determination. 2. Notification to Grantor Agency TC "2. Notification to ORI" \f C \l "3"  Within 30 calendar days of the DOs decision that an investigation is warranted, the RIO will provide the grantor agency with the DOs 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. The RIO must provide the following information to the grantor 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. 3. Documentation of Decision Not to Investigate TC "3. Documentation of Decision Not to Investigate" \f C \l "3"  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 grantor agency of the reasons why an investigation was not conducted. These documents must be provided to the grantor agency or other authorized personnel upon request. VII. Conducting the Investigation TC "VII. Conducting the Investigation" \f C \l "1"  A. Initiation and Purpose TC "A. Initiation and Purpose" \f C \l "2"  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. Under most grantor agency regulations the findings of the investigation must be set forth in an investigation report. B. Notifying the Grantor Agency and Respondent; Sequestration of Research Records TC "B. Notifying ORI and Respondent; Sequestration of Research Records" \f C \l "2"  On or before the date on which the investigation begins, the RIO must: (1) notify the grantor agency of the decision to begin the investigation and provide the grantor 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 the 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 proceeding that were not previously sequestered during the inquiry. 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. C. Appointment of the Investigation Committee TC "C. Appointment of the Investigation Committee" \f C \l "2"  The RIO, in consultation with other institutional officials as appropriate, will appoint an investigation committee and the committee chair as soon after the beginning of the investigation as is practical. The investigation committee must consist of individuals 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. D. Charge to the Committee and the First Meeting TC "D. Charge to the Committee and the First Meeting" \f C \l "2"  1. Charge to the Committee TC "1. Charge to the Committee" \f C \l "3"  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 E. of this section; Defines research misconduct; Informs the committee that it must evaluate the evidence and testimony to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, the type and extent of it and who was responsible; Informs the committee that in order to determine that the respondent committed research misconduct it must find that a preponderance of the evidence establishes that: (1) research misconduct, as defined in this policy, occurred (respondent has the burden of proving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion); (2) the research misconduct is a significant departure from accepted practices of the relevant research community; and (3) the respondent committed the research misconduct intentionally, knowingly, or recklessly; and Informs the committee that it must prepare or direct the preparation of a written investigation report that meets the requirements of this policy and grantor agency regulations. 2. First Meeting TC "2. First Meeting" \f C \l "3"  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 statement of policy and procedures and grantor agency regulations. The RIO will be present or available throughout the investigation to advise the committee as needed. E. Investigation Process TC "E. Investigation Process" \f C \l "2"  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. F. Time for Completion TC "F. Time for Completion" \f C \l "2"  The investigation is to be completed within 120 days of its initiation, including conducting the investigation, preparing the report of findings, providing the draft report for comment and sending the final report to the grantor agency. However, if the RIO determines that the investigation will not be completed within this 120-day period, he/she will submit to the grantor 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 grantor agency if the grantor agency grants the request for an extension and directs the filing of such reports. VIII. The Investigation Report TC "VIII. The Investigation Report" \f C \l "1"  A. Elements of the Investigation Report TC "A. Elements of the Investigation Report" \f C \l "2"  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; The respondents c.v. or resume may be included as part of the identification. Describes and documents the grantor agency support, including, for example, the numbers of any grants that are involved, grant applications, contracts, and publications listing 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 grantor 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, and/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 the 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 funding 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 any federal agencies. B. Comments on the Draft Report and Access to Evidence TC "B. Comments on the Draft Report and Access to Evidence" \f C \l "2"  1. Respondent TC "1. Respondent" \f C \l "3"  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 30 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. 2. Complainant TC "2. Complainant" \f C \l "3"  As a policy, the institution will provide the complainant a copy of the draft investigation report, or relevant portions of it, for comment. The complainants comments must be submitted within 30 days of the date on which he/she received the draft report and the comments must be included and considered in the final report. 3. Confidentiality TC "4. Confidentiality" \f C \l "3"  In distributing the draft report, or portions thereof, to the respondent and complainant, 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. C. Decision by Deciding Official TC "C. Decision by Deciding Official" \f C \l "2"  The RIO will assist the investigation committee in finalizing the draft investigation report, including ensuring that the respondents and complainants comments are included and considered, and transmit the final investigation report to the DO, who will determine 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 notify both the respondent and the complainant in writing. After informing the grantor 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. D. Appeals TC "D. Appeals" \f C \l "2"  Institutions procedures do provide for an appeal by the respondent that could result in a reversal or modification of the institutions findings of research misconduct. Such appeal must be completed within 120 days of its filing, unless the grantor agency finds good cause for an extension, based upon the institutions written request for an extension that explains the need for the extension. If the grantor agency grants an extension, it may direct the filing of periodic progress reports. E. Notice to the Grantor Agency of Institutional Findings and Actions TC "E. Notice to ORI of Institutional Findings and Actions" \f C \l "2"  Unless an extension has been granted, the RIO must, within the 120-day period for completing the investigation or the 120-day period for completion of any appeal, submit the following to the grantor agency: (1) a copy of the final investigation report with all attachments and any appeal; (2) a statement of whether the institution accepts the findings of the investigation report or the outcome of the appeal; (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. F. Maintaining Records for Review by the Grantor Agency TC "Maintaining Records for Review by ORI" \f F \l "2"  The RIO must maintain and provide to the grantor agency upon request records of research misconduct proceedings as that term is defined by grantor agency regulations. Unless custody has been transferred to the grantor agency or the grantor 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 grantor agency proceeding involving the research misconduct allegation. The RIO is also responsible for providing any information, documentation, research records, evidence or clarification requested by the grantor agency to carry out its review of an allegation of research misconduct or of the institutions handling of such an allegation. IX. Completion of Cases; Reporting Premature Closures to the Grantor Agency TC "IX. Completion of Cases; Reporting Premature Closures to ORI" \f C \l "1"  Generally, all inquiries and investigations will be carried through to completion and all significant issues will be pursued diligently. The RIO must notify the grantor agency in advance if there are plans to close a case at the inquiry, investigation, or appeal stage on the basis that the 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 most grantor agencies. X. Institutional Administrative Actions  TC \l1 "X. Institutional Administrative Actions [Optional] 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: 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; and Other action appropriate to the research misconduct. XI. Other Considerations TC \l1 "XI. Other Considerations A. Termination or Resignation Prior to Completing Inquiry or Investigation TC "A. Termination or Resignation Prior to Completing Inquiry or Investigation" \f C \l "2"  The termination of the respondent's institutional employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the research misconduct proceeding or otherwise limit any of the institutions 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. B. Restoration of the Respondent's Reputation TC "B. Restoration of the Respondent's Reputation" \f C \l "2"  Following a final finding of no research misconduct, including grantor agency concurrence where required by the grantor agency regulations, the RIO must, 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. C. Protection of the Complainant, Witnesses and Committee Members TC "C. Protection of the Complainant, Witnesses and Committee Members" \f C \l "2"  During the research misconduct proceeding and upon its completion, regardless of whether the institution or grantor agency determines that research misconduct occurred, the RIO must undertake all reasonable and practical efforts to protect the position and reputation of, or to counter potential or actual retaliation against, any complainant who made allegations of research misconduct in good faith and of any witnesses and committee members who cooperate in good faith with the research misconduct proceeding. The 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. D. Allegations Not Made in Good Faith TC "D. Allegations Not Made in Good Faith" \f C \l "2"  If relevant, the DO will determine whether the complainants 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. NOTES:      42 CFR 93.214  42 CFR 93.102  42 CFR 93.304(c), 93.307(b)  42 CFR 93.304(e), 93.307(f)  42 CFR 308(a)  42 CFR 310(c)  42 CFR 310(g)  42 CFR 310(g)  42 CFR 93.304(f), 93.312(a)  42 CFR 93.316  42 CFR 93.309(c)  42 CFR 93.304(k)  42 CFR 93.304(h)  42 CFR 93.318  42 CFR 93.307(a)  42 CFR 93.307(c)  42 CFR 93.305, 93.307(b)  42 CFR 93.304(b)  42 CFR 93.307(g)  42 CFR 93.309(a)  42 CFR 93.308(a)  42 CFR 93.309(a) and (b)  42 CFR 93.310(a)  42 CFR 93.310(b) and (c)  42 CFR 93.310(d)  42 CFR 93.310(e)  42 CFR 93.310(f)  42 CFR 93.310(g)  42 CFR 93.310(h)  42 CFR 93.311  42 CFR 93.313  42 CFR 93.313(f)  42 CFR 93.312(a), 93.313(g)  42 CFR 93.315  42 CFR 93.317(b)  42 CFR 93.300(g), 93.403(b) and (d)  42 CFR 93.316(a)  42 CFR 93.304(k)  42 CFR 93.304(l) -     Ǽlah -aJmHnHu,jh ->*B*UmHnHphuh -mHnHuh -0JdmHnHujh -0JdUmHnHuj}h -Ujh -U h - h -aJ h -0Jd5!jh ->*B*Uph h -0Jdjh -0JdUh}Jh -jh -U#CaxyB B C l : y\ $ \ $ [ \ $ [1$$a$$1$a$ ! 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