Volume 9 Research
Chapter 7 Policy for Responding to Allegations of Research Misconduct
Responsible Office: Vice President for Research
Originally issued: 04/19/90
Revised 05/20/04, 8/3/07, 10/2012
The purpose of this policy and procedures is to promote the integrity of research conduct on behalf of the Georgia Health Sciences University (GHSU or Institution) by its faculty, technical staff, residents, fellows, students, trainees, and individuals employed on a contractual basis by providing a process for close scrutiny of alleged research misconduct, for full protection of the rights of any person accused of research misconduct, and for the protection of any person who makes allegations under this policy in good faith. This policy is intended to carry out the Institution’s responsibilities under the Public Health Service (PHS) Policies on Research Misconduct, 42 CFR Part 93.
Who Should Read This Policy
Every individual engaged in research for GHSU, including but not limited to faculty, technical
staff, residents, fellows, students, trainees, and individuals employed on a contractual basis
|Mark Hamrick, Senior Vice President for Researchemail@example.com|
|Carlos Isales, Chair, Faculty Research Ethics Committeefirstname.lastname@example.org|
|Andrew Newton, General Counselemail@example.com|
Website Address For This Policy
Searchable Electronic Code of Federal Regulations
Federal Guidance for Handling Allegations of Research Misconduct
I. Definition of Research Misconduct
Research Misconduct is 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 the Georgia Health Sciences University.
The related research may include, but is not limited to the following: (a) supported 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; (b) applications or proposals for sponsor support for biomedical or behavioral research, research training or activities related to that research or research training; or (c) plagiarism of research records produced in the course of 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 funds resulted in a grant, contract, cooperative agreement, or other form of sponsor support.
Requirements throughout this policy and procedures for interaction with the federal Office of Research Integrity (ORI) apply only to PHS-supported research. In matters involving alleged misconduct related to research funded by sponsors other than PHS, similar interactions with those research sponsors will occur.
Research misconduct does not include honest error or differences of opinion. See 42 CFR § 93.103.
A finding of research misconduct under this policy requires that:
- There be a significant departure from accepted practices of the relevant research community; and
- The misconduct is committed intentionally, knowingly, or recklessly; and
- The allegation be proven by a preponderance of evidence. See 42 CFR § 93.104.
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 that the Institution or HHS received the allegation, and if appropriate, subject to the subsequent use, health or safety of the public, and grandfather exceptions in 42 CFR § 93.105(b). Institution reserves the right to review allegations arising before that time, balancing concerns of scientific integrity, subject safety, availability of witnesses and evidence, etc.
II. Rights and Responsibilities
A. Research Integrity Officer
The Senior Vice President for Research will serve as the Research Integrity Officer (RIO). The RIO will have primary responsibility for implementation of the Institution’s policy and procedures on research misconduct. 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 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 this policy to determine whether it falls within the definition of research misconduct and warrants an inquiry;
- As necessary, take interim action and notify the federal Office of Research Integrity (ORI) or other sponsor of special circumstances, in accordance with this policy;
- Sequester research data and evidence pertinent to the allegation of research misconduct and maintain it securely in accordance with this policy and applicable law and regulation;
- Provide appropriate confidentiality to those involved in the research misconduct proceeding as required by 42 CFR § 93.108, and other applicable law, and Institutional policy;
- Notify the respondent and provide opportunities for him or her to review, comment and respond to allegations, evidence and committee reports in accordance with this policy;
- Inform respondents, complainants and witnesses of the procedural steps in the research misconduct proceeding;
- Appoint the chair and members of the inquiry committees (and as appropriate, appoint members outside the Institution as needed to the investigation committee), 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 ORI as required by 42 CFR Part 93, or to the appropriate research sponsor;
- Ensure that administrative actions taken by the Institution and ORI 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 ORI or other sponsor in accordance with this policy.
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 record of the interview for correction. If appropriate to a particular case, the Institution may provide to the complainant for comment: (1) relevant portions of the inquiry report; and (2) relevant portions of the draft investigation report. Comments on these documents must be submitted no later than 30 days from the date the complainant receives the draft report. Comments by the complainant will be considered in the draft investigation report and included in the final investigation report.
The respondent is responsible for maintaining the appropriate 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 or 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 42 CFR Part 93 (if research is PHS-supported) and the institution’s policy 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;
- Subject to witnesses availability and the reasonable judgment of the investigative body, have interviewed during the investigation witnesses who have 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 shall be given the opportunity to admit that the research misconduct occurred and that he or she committed the research misconduct. With the advice of the RIO and/or other institutional officials, the Deciding Official may terminate the Institution’s review of an allegation that has been admitted. If the research misconduct was related to PHS-supported research, the Institution’s acceptance of the admission and any proposed settlement must be approved by ORI.
D. Deciding Official
The Provost as the Deciding Official (DO) shall receive the inquiry report and after consulting with the RIO and/or other Institutional officials, decide whether an investigation is warranted under the criteria in 42 CFR § 93.307(d). Any finding that an investigation is warranted must be made in writing by the DO and must be provided to ORI, together with a copy of the inquiry report meeting the requirements of 42 CFR § 93.309, 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 ORI 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 finding 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 finding of the DO and a description of any pending or completed administrative actions are provided to ORI, as required by 42 CFR § 93.315, or other sponsor as appropriate.
III. General Principles
A. Responsibility to Report Misconduct
Every member of the GHSU campus must report observed, suspected, or apparent research misconduct to the RIO. If an individual is unsure whether a suspected incident meets the definition of research misconduct, he or she may contact the RIO to discuss the suspected research misconduct informally, which may include discussing it 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 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
Every member of the GHSU campus will cooperate with the RIO and other institutional officials in the review of allegations and the conduct of inquiries and investigation. All members of the GHSU campus, including respondents, have an obligation to provide evidence relevant to research misconduct allegations to the RIO or other institutional officials.
Subject to the requirements of Georgia law regarding open records and 42 CFR§ 93.108, 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, contractual or equitable obligations, 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.
D. Protecting Complainants, Witnesses and Committee Members
Members of the GHSU campus may not retaliate in any way against complainants, witnesses, or committee members. Members of the GHSU campus 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 to protect and restore the position and reputation of the person against whom the retaliation is directed. This may include disclosure of the reports of inquiry and/or investigation. Conduct in violation of this section may result in disciplinary action.
E. Protecting the Respondent
As requested and as appropriate, the RIO and other GHSU 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 42 CFR Part 93 and the policy and procedures of GHSU. 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 (subject to reasonable availability in scheduling which does not unduly delay the inquiry or investigative processes). The role of these individuals will be advisory but not participatory.
F. Interim Administrative Actions and Notifying ORI or Other Sponsor 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 PHS supported research process. In the event of such a threat, the RIO will, in consultation with other institutional officials and ORI, 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 research misconduct proceedings, notify ORI or other sponsor immediately if he or 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.
IV. Conducting the Assessment and Inquiry
A. 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 indentified, whether it is within the jurisdictional criteria of 42 CFR § 93.102(b), and whether the allegation falls within the definition of research misconduct in 42 CFR § 93.103. An inquiry must be conducted if these criteria are met.
The assessment period should be brief, preferably concluded within one 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 this Section.
B. 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.
C. 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 ORI for advice and assistance in this regard.
D. Appointment of the Inquiry Committee
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
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 42 CFR § 93.102(b); 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 and 42 CFR § 93.309(a).
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
The inquiry committee will normally interview the complainant, 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 42 CFR § 93.307(d). 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 ORI or other sponsor to determine the next steps that should be taken.
G. Time for Completion
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 records must include documentation of the reasons for exceeding the 60-day period.
V. The Inquiry Report
A. Elements of the 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 PHS or other sponsor support, including, for example, grant numbers, grant applications, contracts and publications listing sponsor 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 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.
B. Notification to Respondent and Opportunity to Comment
The RIO shall notify 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 42 CFR Part 93, if appropriate, and the Institution’s policy and procedures on research misconduct. GHSU may 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.
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
- Decision by Deciding OfficialThe 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.
- Notification to ORI for PHS-Supported ResearchIf the matter relates to PHS-supported research, within 30 calendar days of the DO’s decision that an investigation is warranted, the RIO will provide ORI 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. The RIO must provide the following information to ORI upon request: (1) the Institutional policy 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.
- Documentation of Decision Not to InvestigateIf 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 ORI of the reasons why an investigation was not conducted. If the matter is related to PHS-supported research, these documents must be provided to ORI or other authorized HHS personnel upon request.
VI. Conducting the Investigation
A. 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. Under 42 CFR § 93.313 the findings of the investigation must be set forth in an investigation report.
B. Notifying ORI and Respondent; Sequestration of Research Records
If the matter relates to PHS-supported research, then on or before the date on which the investigation begins, the RIO must notify the ORI Director of the decision to begin the investigation and provide ORI a copy of the inquiry report. The RIO also must notify the respondent in writing of the allegations to be investigated. The RIO must 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 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. The Investigation Committee: Faculty Research Ethics Committee
- The GHSU Faculty Research Ethics Committee shall serve as the Investigation committee that is responsible for carrying out a full investigation of charges of research misconduct as determined to be warranted by the DO. This committee shall be appointed by the Executive Committee of the GHSU University Faculty Senate, from the corps of instruction of the Institution, excluding department chairs and associate deans.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. When necessary to secure appropriate expertise or to avoid conflicts of interest, the RIO may add committee members from outside the Institution.
- Composition and TermThe Research Ethics Committee shall consist of 10 faculty members, two appointed from each college by the Executive Committee of the University Faculty Senate, subject to the approval of the Faculty Senate. Appointees are selected for their expertise and good character. The Subcommittee chair is appointed with approval of the Executive Committee. Faculty holding administrative appointments at the level of Department Chair or higher are not eligible to serve on this subcommittee. The term of office is three years with unlimited eligibility for reappointment. The Chair is a member of the Standards and Scholarship Committee. The Chair meets with the Senior Vice President for Research, as needed. Members are appointed collaboratively by the Chair of University Faculty Senate and the Chair of Scholarship and Standards Committee, with approval of the Executive Committee.
D. Charge to the Committee and the First Meeting
- Charge to the CommitteeThe 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 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 the respondent(s) may opt for a formal hearing for the presentation of evidence and testimony, and opportunity for respondent(s) to present testimony, evidence and question confront witnesses.
- Informs the committee that in order to determine that the respondent committed research misconduct it must find that a preponderance of the evidence establishes that: (1) research misconduct, as defined in this policy, occurred (respondent has the burden of proving by a preponderance of the evidence any affirmative defenses raised, including honest error or a difference of opinion); (2) the research misconduct is a significant departure from accepted practices of the relevant research community; and (3) the respondent committed the research misconduct intentionally, knowingly, or recklessly; and
- Informs the committee that it must prepare or direct the preparation of a written investigation report that meets the requirements of this policy and 42 CFR § 93.313.
- First MeetingThe 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 42 CFR Part 93, if applicable. The RIO will be present or available throughout the investigation to advise the committee as needed.
E. 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;
- Offer the respondent(s) the option of a formal hearing for the presentation of evidence and testimony, and opportunity for respondent(s) to present testimony, evidence and question confront witnesses.
- 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. Interviews of the respondent should be tape recorded or transcribed. All other interviews should be transcribed, tape recorded, or summarized. Summaries or transcripts of the interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file.
- 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
The investigation is to be completed within 120 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 ORI. However, if the RIO determines that the investigation will not be completed within this 120-day period, he or she will submit to ORI a written request for an extension, setting forth the reasons for the delay. The RIO will ensure that periodic progress reports are filed with ORI, if ORI grants the request for an extension and directs the filing of such reports.
VII. The Investigation Report
A. 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 or other sponsor support, including, for example, the numbers of any grants that are involved, grant applications, contracts, and publication listing sponsor support;
- Describes the specific allegations of research misconduct considered in the investigation;
- Includes the Institutional policy and procedures under which the investigation was conducted, unless the policy and procedures were provided to ORI 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: (a) identify whether the research misconduct was falsification, fabrication, or plagiarism, and whether it was committed intentionally, knowingly, or recklessly; (b) 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; (c) identify the specific sponsor support; (d) identify whether any publications need correction or retraction; (e) identify the person(s) responsible for the misconduct; and (f) list any current support or known applications or proposals for support that the respondent has pending with non-PHS federal agencies.
B. Comments on the Draft Report and Access to Evidence
- RespondentThe 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 her or she received the draft report to submit comments to the RIO. The respondent’s comments must be included and considered in the final report.
- ComplainantIf appropriate to a particular case, the Institution may provide to the complainant for comment a copy of the draft investigation report, or relevant portions of it. Comments on these documents must be submitted no later than 15 days from the date the complainant receives the draft report. Comments by the complainant will be considered in the draft investigation report and included in the final investigation report.
- ConfidentialityIn 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.
VIII. Decision by Deciding Official
- The RIO will assist the investigation committee in finalizing the draft investigation report, including ensuring that the respondent’s and complainant’s 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 or 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 ORI, 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.
- AppealsWhile due consideration of all recommendations made by the Investigation Committee shall be given, the final decision on any allegation of research misconduct is the responsibility of the Deciding Officer. Decisions of the Deciding Officer may be appealed to the President by written notice within ten days of the decision.
- Notice to ORI of Institutional Findings and ActionsUnless an extension has been granted, the RIO must, within the 120-day period for completing the investigation (or appeal) submit the following to ORI: (1) a copy of the final investigation report with all attachments (and any appeal); (2) a statements 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.
- Maintaining Records for Review by ORIThe RIO must maintain and provide to ORI upon request, “records of research misconduct proceedings” as that term is defined by 42 CFR § 93.317. Unless custody has been transferred to HHS or ORI 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 PHS proceeding involving the research misconduct allegation. The RIO is also responsible for providing any information, documentation, research records, evidence or clarification requested by ORI to carry out its review of an allegation of research misconduct or of the Institution’s handling of such an allegation.
IX. Completion of Cases: Reporting Premature Closures to ORI
Generally, all inquiries and investigations will be carried through to completion and all significant issues will be pursued diligently. The RIO must notify ORI in advance if there are plans to close a case at the inquiry, investigation, or appeal 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; (2) a finding of no misconduct at the investigation stage, which must be reported to ORI, as prescribed in this policy and 42 CFR § 93.315.
X. 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:
- 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
A. Termination or Resignation Prior to Completing Inquiry or Investigation
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 Institution’s responsibilities under 42 CFR Part 93.
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
Following a final finding of no research misconduct, including ORI concurrence where required by 42 CFR Part 93, 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. Institutional actions may include providing a copy of the inquiry and/or investigative report to appropriate parties. 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
During the research misconduct proceeding and upon its completion, regardless of whether the Institution or ORI 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 that the DO approves.
D. 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 or she will determine whether any administrative action should be taken against the person who failed to act in good faith.