This policy and the associated procedures apply to all individuals at St. Olaf College who are engaged in research that is supported by or for which support is requested from the Public Health Service (PHS). The PHS regulations at 42 C.F.R. Part 93 apply to any research, research-training or research-related grant or cooperative agreement with PHS. This policy applies to any person paid by, under the control of, or affiliated with St. Olaf College, such as scientists, trainees, technicians and other staff members, students, fellows, guest researchers, or collaborators.
The policy and associated procedures will be followed when an allegation of possible research misconduct is received by an Institutional Officer.
A. Allegation means a disclosure of possible research misconduct through any written, oral, or other communication to an institutional U.S. Department of Health and Human Services (HHS) official.
B. Conflict of interest means the real or apparent influence of one person’s personal, professional or financial interests with the interests of another person, where potential bias may occur due to the prior or existing personal, professional, or financial interests.
C. Good faith allegation means an allegation made with a belief in the truth of the allegation which is reasonable in light of the information known to the complainant at the time the allegation is made. An allegation is not in good faith if it is made with knowing falsity, or reckless disregard for or willful ignorance of facts that would disprove the allegation.
D. Inquiry means preliminary information gathering and initial fact-finding to determine whether an allegation or apparent instance of research misconduct warrants an investigation.
E. Investigation means the formal development of a factual record and examination and evaluation of that record leading to a decision as to whether research misconduct has occurred, and, if so, to determine the responsible persons recommendations for appropriate actions.
F. ORI means the Office of Research Integrity, the office within the HHS that is responsible for the addressing research integrity and misconduct issues related to PHS supported activities.
G. PHS means the U.S. Public Health Service, an operating component of the DHHS.
H. PHS regulation means the Public Health Service regulation establishing standards for institutional inquiries and investigations into allegations of research misconduct, which is set forth at 42 C.F.R. Part 93, entitled “Public Health Service Policies on Research Misconduct.”
I. PHS support means PHS funding, including grants, contracts, or cooperative agreements or applications therefor.
J. Research misconduct means fabrication, falsification, or plagiarism, in proposing, performing or reviewing research, or in reporting research results. Research misconduct also includes other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another person’s ideas, processes, results or words without giving appropriate credit.
K. Research record means the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided by respondent to HHS or an Institutional Officer in the course of a research misconduct proceeding. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.
L. Respondent means the person against whom an allegation of research misconduct is directed or the person whose actions are the subject of a research misconduct proceeding.
M. Responsible Institutional Officer means St. Olaf’s designated official who is responsible for ensuring that allegations of research misconduct are responded to in compliance with those procedures. In most instances, the Responsible Institutional Officer will be the Assistant Provost or her/his designee.
N. Research misconduct means fabrication, falsification, or plagiarism, in proposing, performing or reviewing research, or in reporting research results. Research misconduct also includes other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism is the appropriation of another person’s ideas, processes, results or words without giving appropriate credit.
O. Complainant means a person who in good faith makes an allegation of research misconduct.
III. Purpose of Policy on Research Misconduct
These policies and procedures are intended to:
1. Comply with the PHS regulations promulgated at 42 C.F.R. § 93;
2. Foster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training;
3. Discourage research misconduct and respond promptly and appropriately to allegations and evidence of research misconduct;
4. Take reasonable steps to protect positions and reputations of good faith complainants, witnesses and committee members and protect them from retaliation by respondents or others;
5. Take all reasonable and practical steps to ensure the cooperation of respondents and other institutional members with research misconduct proceedings; and
6. Ensure that allegations of research misconduct are addressed in a thorough, competent, objective, and fair manner.
IV. Rights and Responsibilities
A. Responsible Institutional Officer
The Assistant Provost will serve as the Responsible Institutional Officer who will have primary responsibility for implementation of the procedures set forth in this document to ensure that allegations of research misconduct are addressed in a thorough, competent, objective and fair manner.
The Responsible Institutional Officer will appoint the inquiry and investigation committees and ensure that necessary and appropriate expertise is secured to carry out a thorough and authoritative evaluation of the relevant evidence in an inquiry or investigation. In selecting inquiry and investigation committee members, the Responsible Institutional Officer will take precautions to ensure that committee members do not have conflicts of interest relating to the complainant, respondent, or witnesses.
The Responsible Institutional Officer will assist inquiry and investigation committees and all institutional personnel in complying with these procedures and with applicable standards imposed by government or external funding sources. The Responsible Institutional Officer is also responsible for sequestering and maintaining files of all documents, equipment, and other evidence and for the confidentiality and the security of these materials.
The Responsible Institutional Officer will report to ORI as required by regulation and keep ORI apprised of the status of research misconduct allegations, inquiries, and investigations as required by regulation to ensure appropriate use of Federal funds and otherwise protect the public interest.
The Complainant will have an opportunity to testify before the inquiry and investigation committees, to review portions of the inquiry and investigation reports pertinent to his/her allegations or testimony, to be informed of the results of the inquiry and investigation, and to be protected from retaliation. Also, if the Responsible Institutional Officer has determined that the complainant may be able to provide pertinent information on any portions of the draft report, these portions will be given to the complainant for comment.
The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation.
The respondent will be informed of the allegations when an inquiry is opened. The respondent will also have the opportunity to be interviewed by and present evidence to the inquiry and/or investigation committees, to review and provide written comment on the draft inquiry and investigation reports and to have these comments reviewed and considered prior to the committee making any final determinations. The respondent will also be notified in writing of the final determination and resulting actions.
The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation. The respondent is also responsible for avoiding any type of retaliation toward the complainant, any witnesses or the committee members. If the respondent is not found to have engaged in research misconduct, the respondent shall have the right to make reasonable and practical requests to the College to assist in protecting his/her reputation.
V. General Policies and Principles
A. Responsibility to Report Misconduct
All employees or individuals associated with St. Olaf College should report observed, suspected, or apparent misconduct in science to the Responsible Institutional Officer. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may call the Responsible Institutional Officer at 507-646-3004 to discuss the suspected misconduct informally. If the circumstances described by the individual do not meet the definition of research misconduct, the Responsible Institutional Officer will refer the individual or allegation to other offices or officials with responsibility for resolving the problem.
At any time, an employee may have confidential discussions and consultations about concerns of possible misconduct with the Responsible Institutional Officer and will be counseled about appropriate procedures for reporting allegations.
B. Protection from Retaliation
Complainant’s witnesses and/or committee members should report any concerns of retaliation to the Responsible Institutional Officer. The College will take prompt and appropriate action in response to any complaints of retaliation in violation this policy. If applicable, upon request, the College will take reasonable and practical efforts aimed at protecting or restoring the position and reputation of any complainant, witness or committee member, and counter potential or actual retaliation against them.
Any employees aware of retaliation against a complainant, witness or hearing committee member should immediately report such concerns to the Responsible Institutional Officer.
C. Due Process
Inquiries and investigations will be conducted in a manner aimed at ensuring due process to the respondent(s) in the inquiry or investigation to the extent possible without compromising public health and safety, the promotion of integrity of research, and the conservation of public funds.
Institutional employees accused of research misconduct 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 to serve in an advisory capacity to the respondent. The College reserves the right to exclude any counsel or adviser who is engaging in conduct the College deems as interfering with the inquiry or investigation.
St. Olaf will strive, to the extent possible, to protect the confidentiality of respondents, complainants, and any research subjects who are identifiable in any records or evidence. Disclosure of the identity of any such individual will be limited, to the extent possible on a need-to-know basis.
E. Evidentiary Standard/Burdens of Proof
Allegations of research misconduct must be proved by a preponderance of evidence. The College has the burden of proof in making a determination of research misconduct. The destruction, absence of, or respondent’s failure to provide records adequately documenting the questioned research is evidence of research misconduct where the preponderance of evidence shows that the respondent’s conduct significantly departed from accepted practices of the relevant research community, and the respondent intentionally, knowingly, or recklessly:
- Destroyed research records;
- Failed to maintain records that could have been maintained; or
- Failed to timely produce records that were available to respondent.
F. Cooperation with Inquiries and Investigations
Institutional employees will cooperate with the Responsible Institutional Officer and other Institutional Officers in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide complete, accurate, and relevant evidence to the Responsible Institutional Officer or other Institutional Officers on misconduct allegations.
G. Preliminary Assessment of Allegations
Upon receiving an allegation of research misconduct, the Responsible Institutional Officer will immediately assess the allegation to determine whether there is sufficient evidence to warrant an inquiry, whether PHS support or PHS applications for funding are involved, and whether the allegation falls under the PHS definition of research misconduct.
The Responsible Institutional Officer will also assess whether there are any appropriate interim measures that the College should take to protect public health, Federal or College funds and equipment, or the integrity of the PHS support research process.
H. Maintenance and Custody of Research Records and Evidence
The College will strive to maintain adequate records of all proceedings relating to allegations of research misconduct and take steps to collect and preserve evidence utilized for such proceedings.
Either prior to or at the time the College notifies the respondent of the allegation, inquiry or investigation, the College will promptly take steps to obtain custody of all the research records and evidence needed to conduct the proceeding and any additional research records or evidence that is discovered during the course of the proceeding. The College will also inventory the evidence and records and sequester them in a secure manner. Alternative storage methods may be utilized where records or evidence is shared by other users, where deemed appropriate, the respondent will be given copies of or supervised access to the research records.
Unless later deemed irrelevant, the records that the College secures for proceedings under these policies and procedures will be retained in a secure manner for at least 7 years (unless instructed by HHS to transfer the documents to HHS or HHS has advised the College in writing that it no longer needs to retain the records).
If documents or records are deemed irrelevant, the College will retain documentation of this determination for the same 7-year period. Any final reports and all records in support of the report will also be retained for the 7-year period.
VI. Conducting the Inquiry
A. Initiation and Purpose of the Inquiry
Following the preliminary assessment, if the Responsible Institutional Officer determines that the allegation provides sufficient information to allow specific follow-up, involves PHS support, and falls under the definition of research misconduct, he or she will initiate the inquiry process. At the time of or before initiating the inquiry, the College will make a good faith effort to notify the respondent in writing. If the respondent is unknown at the time of the inquiry or if additional respondents are identified the College will provide written notice.
The purpose of the inquiry is to conduct an initial review of the evidence to determine whether to conduct an investigation. It is not a full evidentiary review. An investigation will be deemed warranted if there are reasonable grounds to believe that the allegations fall with the definition of research misconduct; involves PHS supported activities; and the preliminary evidence suggests that the allegations may have substance.
In initiating the inquiry, the Responsible Institutional Officer should identify clearly the original allegation and any related issues that should be evaluated.
The College will strive to complete the inquiry within 60 calendar days of its initiation. If the College determines that a longer period of time is necessary, the inquiry record will include documentation of the reasons for exceeding the 60-day period.
B. Sequestration of the Research Records
After determining that an allegation falls within the definition of misconduct in science and involves PHS programs, the Responsible Institutional Officer must ensure that all original research records and materials relevant to the allegation are immediately secured. Alternative storage methods may be utilized where records or evidence are shared by other users.
C. Appointment of the Inquiry Committee
The Responsible Institutional Officer, in consultation with other Institutional Officers as appropriate, will appoint an inquiry committee and committee chair within 10 calendar days of the initiation of the inquiry. The inquiry committee should consist of individuals who do not have real or apparent conflicts of interest, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. These individuals may be scientists, subject matter experts, administrators, lawyers, or other qualified persons, and they may be from inside or outside the College.
The Responsible Institutional Officer will notify the respondent of the proposed committee membership in 10 calendar days. If the respondent submits a written objection to any appointed member of the inquiry committee or expert based on bias or conflict of interest within 7 calendar days, the Responsible Institutional Officer will determine whether to replace the challenged member or expert with a qualified substitute.
D. Charge to the Committee and the First Meeting
The Responsible Institutional Officer will prepare a charge for the inquiry committee that describes the allegations and any related issues identified during the allegation assessment and states that the purpose of the inquiry is to make a preliminary evaluation of the evidence and testimony of the respondent, complainant, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation. The purpose is not to determine whether research misconduct definitely occurred or who was responsible.
At the committee’s first meeting, the Responsible Institutional Officer 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 Responsible Institutional Officer and institutional counsel will be present or available throughout the inquiry to advise the committee as needed.
E. Inquiry Process
The inquiry committee will normally perform a preliminary interview the complainant, the respondent, and key witnesses as well as perform a preliminary examination of relevant research records and materials. Then the inquiry committee will evaluate the evidence and testimony obtained during the inquiry. After consultation with the Responsible Institutional Officer and/or institutional counsel, the committee members will decide whether there is sufficient evidence of possible research misconduct to recommend further investigation.
VII. The Inquiry Report
A. Elements of the Inquiry Report
A written inquiry report will be prepared that states the name and title of the committee members and experts, if any; the allegations; the PHS support; a summary of the inquiry process used; a list of the research records reviewed; summaries of any interviews; a description of the evidence in sufficient detail to demonstrate whether and investigation is warranted or not; and the committee’s determination as to whether an investigation is recommended and whether any other actions should be taken if an investigation is not recommended.
If the College determines that an investigation is warranted, the findings of the inquiry will provide ORI with the written findings of the committee … and a copy of the inquiry report which includes the following information: 1) Name and position of respondent; 2) a description of the research misconducted obligations; 3) the PHS support involved (e.g., grant numbers, grant applications, contracts and publications listing PHS support); 4) the basis for recommending an investigation; and 5) any comments on the report provided by the complainant or respondent. If the College determines that an investigation is not warranted, detailed documentation of this decision will be kept for at least 7 years along with the related documents.
B. Comments on the Draft Report by the Respondent and the Complainant
The Responsible Institutional Officer will provide the respondent with a copy of the draft inquiry report for comment and rebuttal and will provide the complainant, if he or she is identifiable, with an opportunity to comment on those portions of the draft inquiry report that address the complainant’s role and opinions in the investigation.
The Responsible Institutional Officer may establish reasonable conditions for review to protect the confidentiality of the draft report.
2. Receipt of Comments
Within 7 calendar days of their receipt of the draft report, the complainant and respondent will provide comments, if any, to the inquiry committee. Any comments that the complainant or respondent submits on the draft report will become part of the final inquiry report and record. Based on the comments, the inquiry committee may revise the report as appropriate.
C. Inquiry Decision by Responsible Institutional Officer
The Responsible Institutional Officer will review the final inquiry report and will make the determination of whether findings from the inquiry provide sufficient evidence of possible research misconduct to justify conducting an investigation. The inquiry is completed when this determination is made.
The College will notify the respondent whether the inquiry found that an investigation is warranted. The notice will include a copy of the inquiry report and provide the respondent with information about the PHS regulations promulgated at 42 C.F.R. § 93 and these policies and procedures.
VIII. Conducting the Investigation
The College will commence the investigation within 30 days after determining that an investigation is warranted. The College will strive to complete all aspects of the investigation within 120 days after its commencement, including conducting the investigation, preparing the report of findings, providing a draft report for comment and sending the final report to ORI. In the event the Collage deems it necessary to extend the investigation beyond 120 days, the College will seek an extension from ORI in writing.
B. Purpose of the Investigation
The purpose of the investigation is to explore the allegations in a thorough, competent, objective and fair manner, to examine the evidence in depth, and determine whether research misconduct has been committed and by whom. The investigation will also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations. The findings of the investigation will be set forth in an investigation report.
The Responsible Institutional Officer will notify the ORI on or before the date the investigation begins and provide the inquiry report described above in Section VI.A.
C. Notification of Respondent and Sequestration of the Research Records
Within a reasonable time after determining that an investigation is warranted, but before the investigation begins, the College will provide written notice to the respondent of the allegations to be investigated. If new allegations arise during the investigation, the College will provide written notice of these allegations within a reasonable amount of time of deciding to pursue an investigation into them.
To the extent this has not already been done, the Responsible Institutional Officer will immediately sequester any additional pertinent research records that were not previously sequestered during the inquiry. This sequestration should occur before or at the time the respondent is notified that an investigation has begun or whenever additional items become known or relevant to the investigation. The need for additional sequestration of records may occur for any number of reasons, including the institution’s decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. The procedures to be followed for sequestration during the investigation are the same procedures that apply during the inquiry.
D. Appointment of the Investigation Committee
The Responsible Institutional Officer, in consultation with other Institutional Officers as appropriate, will appoint an investigation committee and the committee chair within 10 calendar days of the notification to the respondent that an investigation is planned or as soon thereafter as practicable. The investigation committee should consist of at least three individuals who do not have real or apparent conflicts of interest, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside the institution. Individuals appointed to the investigation committee may also have served on the inquiry committee.
The Responsible Institutional Officer will notify the respondent of the proposed committee membership within 7 calendar days. If the respondent submits a written objection to any appointed member of the investigation committee or expert, the Responsible Institutional Officer will determine whether to replace the challenged member or expert with a qualified substitute.
E. Charge to the Committee and the First Meeting
1. Charge to the Committee
The Responsible Institutional Officer will define the subject matter of the investigation in a written charge to the committee that describes the allegations and related issues identified during the inquiry, defines research misconduct, and identifies the name of the respondent. The charge will state that the committee is to use diligent efforts to ensure that the investigation is thorough and sufficiently documented, and will evaluate all of the research records and evidence relevant to reaching a decision on the merits of the allegations. The committee will also be charged to pursue diligently all significant issues and leads relevant to the investigation and continue the investigation to completion. In conducting its review of the evidence, the investigation committee will interview each respondent, complainant, and any other available person who has been identified as having information related to the investigation, including witnesses identified by the respondent(s). All witness interviews will be recorded or transcribed and the recording or transcription will be given to the witness for review and correction.
During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents, the committee will notify the Responsible Institutional Officer, who will determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents.
2. The First Meeting
The Responsible Institutional Officer will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of these instructions.
F. Investigation Process
The investigation will normally involve examination of all documentation including, but not necessarily limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls. Whenever possible, the committee should interview the complainant(s), the respondents(s), and other individuals who might have information regarding aspects of the allegations.
IX. The Investigation Report
A. Elements of the Investigation Report
The final report submitted to ORI must describe the policies and procedures under which the investigation was conducted, describe how and from whom information relevant to the investigation was obtained, state the findings, and explain the basis for the findings. The report will include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct as well as a description of any sanctions imposed and administrative actions taken by the institution.
B. Comments on the Draft Report
The Responsible Institutional Officer will provide the respondent with a copy of the draft investigation and, concurrently, a copy of, or supervised access to, the evidence on which the report is based and provide the respondent an opportunity for comment and rebuttal. The respondent will be allowed 30 calendar days to review and comment on the draft report. The respondent’s comments will be attached to the final report. The findings of the final report will take into account the respondent’s comments in addition to all the other evidence.
The Responsible Institutional Officer will provide the complainant, if he or she is identifiable, with those portions of the draft investigation report that address the complainant’s role and opinions in the investigation. Comments by the Complainant, if any, must be submitted within 30 days of the date on which the complainant was given the draft investigation report. The report should be modified, as appropriate, based on the complainant’s comments.
In distributing the draft report, or portions thereof, to the respondent and complainant, the Responsible Institutional Officer will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the Responsible Institutional Officer may request the recipient to sign a confidentiality statement or to come to his or her office to review the report.
C. Institutional Review and Decision
Based on a preponderance of the evidence, the Responsible Institutional Officer will make the final determination whether to accept the investigation report, its findings, and the recommended institutional actions. If this determination varies from that of the investigation committee, the Responsible Institutional Officer will explain in detail the basis for rendering a decision different from that of the investigation committee in the institution’s letter transmitting the report to ORI. The Responsible Institutional Officer’s explanation should be consistent with the PHS definition of research misconduct, the institution’s policies and procedures, and the evidence reviewed and analyzed by the investigation committee. The Responsible Institutional Officer may also return the report to the investigation committee with a request for further fact-finding or analysis. The Responsible Institutional Officer’s determination, together with the investigation committee’s report, constitutes the final investigation report for purposes of ORI review.
When a final decision on the case has been reached, the Responsible Institutional Officer will notify both the respondent and the complainant in writing. In addition, the Responsible Institutional Officer 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 internal or non-St. Olaf parties should be notified of the outcome of the case. The Responsible Institutional Officer is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.
D. Transmittal of the Final Investigation Report to ORI
After comments have been received and the necessary changes have been made to the draft report, the investigation committee will issue a final institutional investigative report with attachments, including the respondent’s and complainant’s comments. The final institutional investigation report will be in writing and include:
- A description of the nature of the allegations of research misconduct and the specific allegations reviewed and considered in the investigation;
- A description and documentation of PHS support, including, for example, any grant numbers, grant applications, contracts and publications listing PHS support;
- A copy of those policies and procedures under which the investigation took place;
- The identity and a summary of the research records and evidence reviewed and the identity of any evidence taken into custody but not reviewed;
- A statement of the College’s findings as to whether research misconduct occurred for each separate allegations and if so,
- Whether the research misconduct was falsification, fabrication, or plagiarism, and whether it was intentional, knowing or in reckless disregard;
- A summary of the facts and analysis which supports the conclusion and a discussion of the merits of any explanation by the respondent;
- The PHS support involved;
- An identification of any publications needing correction or retraction;
- The identity of nay persons(s) responsible for the misconduct; and
- Any current or applications or proposals for support that the respondent has pending with any non-PHS Federal agencies.
- An identification and discussion of any comments made by the respondent and complainant to the draft investigation report; and
- A discussion of the relevant research records and records of the College’s research misconduct investigation, including the transcripts/recordings of all interviews, that will be maintained by the College and made available to ORI upon request.
The final institutional investigative report will and the Responsible Institutional Officer’s conclusions based upon the report will be provide to ORI along with a discussion of any pending or completed administrative actions against the respondent.
X. Requirements for Reporting to ORI
A. An institution’s decision to initiate an investigation must be reported in writing to ORI, on or before the date the investigation begins. At a minimum, the notification should include the name of the person(s) against whom the allegations have been made, the general nature of the allegation as it relates to the PHS definition of research misconduct, and the PHS applications or grant number(s) involved. ORI must also be notified of the final outcome of the investigation and must be provided with a copy of the investigation report.
B. If an institution plans to terminate an inquiry or investigation for any reason without completing all relevant processes of these policies and procedures on the basis that the respondent has admitted the allegations of research misconduct, a settlement with respondent has been reached, or for any other reason other than the closing of the matter at the inquiry stage on the basis that an investigation is not warranted, the Responsible Institutional Officer will notify ORI in advance of the planned termination. After consulting with the College about the basis for closing the matter, ORI may conduct an oversight review and take appropriate action which could include directing the College to complete its process; approving or conditionally approving closure of the matter; referring the matter for further investigation by HHS; or taking a compliance action.
C. The Responsible Institutional Officer will immediately notify ORI at any stage of the inquiry or investigation if:
1. health or safety of the public is at risk; including an immediate need to protect human or animal subjects;
2. HHS resources or interests are threatened;
3. research activities should be suspended;
4. there is a reasonable indication of possible violations of civil or criminal law;
5. there is an immediate need to protect the interests of the person(s) involved in the research misconduct proceeding;
6. the College believes the research misconduct proceeding may be made public prematurely so that HHS may take measures to safeguard evidence and protect the rights of those involved; and
7. the research community or public should be informed.
XI. Institutional Administrative Actions
St. Olaf College will take appropriate administrative actions against individuals when an allegation of research misconduct has been substantiated.
If the Responsible Institutional Officer determines that the alleged misconduct is substantiated by the findings, he or she will decide on the appropriate actions to be taken. The actions may include but are not limited to:
- withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found.
- removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, or initiation of steps leading to possible rank reduction or termination of employment;
- restitution of funds as appropriate.
XII. Other Considerations
A. Termination of Institutional Employment 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 misconduct procedures.
If the respondent, without admitting to the misconduct, elects to resign his or her position prior to the initiation of an inquiry, but after an allegation has been reported, or during an inquiry or investigation, the inquiry or investigation will proceed. If the respondent refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the respondent’s failure to cooperate and its effect on the committee’s review of all the evidence.
B. Restoration of the Respondent’s Reputation
If the institution finds no misconduct and ORI concurs, after consulting with the respondent, the Responsible Institutional Officer will, upon request, undertake reasonable efforts to restore the respondent’s reputation. Depending on the particular circumstances, the Responsible Institutional Officer should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of research misconduct was previously publicized, or segregating and placing under seal any reference to the research misconduct allegation in the respondent’s personnel file. Any institutional actions to restore the respondent’s reputation must first be approved by the Responsible Institutional Officer.
C. Protection of the Complainant and Others
Regardless of whether the institution or ORI determines that research misconduct occurred, upon request the Responsible Institutional Officer will undertake reasonable efforts to protect complainants who made allegations of research misconduct in good faith committee members involved in reviewing allegations of research misconduct, and others who cooperate in good faith with inquiries and investigations of such allegations. Upon completion of an investigation, the Responsible Institutional Officer will determine, what steps, if any, are needed to restore the position or reputation of any of these individuals. The Responsible Institutional Officer will also take appropriate steps during the inquiry and investigation to prevent any retaliation against the complainant or others involved with inquiries or investigations of research misconduct.
D. Allegations Not Made in Good Faith
If relevant, the Responsible Institutional Officer will determine whether the complainant’s allegations of research misconduct were made in good faith. If an allegation was not made in good faith, the Responsible Institutional Officer will determine whether any administrative action should be taken against the complainant.
E. Interim Administrative Actions
Institutional Officers will take interim administrative actions, as appropriate, to protect Federal funds and ensure that the purposes of the Federal financial assistance are carried out.
XIII. Record Retention
After completion of a case and all ensuing related actions, the Responsible Institutional Officer will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to the Responsible Institutional Officer or committees. The Responsible Institutional Officer will keep the file for seven years after completion of the matter. ORI or other authorized HHS personnel will be given access to the records upon request.