Research Misconduct Policy & Procedures

Gettysburg College’s Research Misconduct

Policy & Procedures

I. Introduction

The College policies, definitions, and procedures regarding research misconduct are required to conform to federal regulation 42 CFR Part 93 which states that the College must assume primary responsibility for prevention, detection, and investigation of research misconduct and must take action to ensure the integrity of research, the protection of the rights of research subjects and the public, and the observance of legal requirements related to federal research funding.

College policies establish standards of ethical behavior for all members of the College community and prescribe procedures for due process and discipline for deviation from those standards. The policy and procedures on Research Misconduct deal with violations of a subset of these standards and apply to prohibited conduct in proposing, carrying out, and reporting research. Specifically, Research Misconduct procedures are invoked when the following allegations are made:

• Fabrication, falsification, or plagiarism, in proposing, performing, or reviewing research, or in reporting research results;
• Failure to comply with requirements for the protection of human or animal subjects

Policies and procedures for dealing with other violations of ethical standards, such as misappropriation of College or sponsor resources, intentional breach of College rules or sponsor regulations, or failure to follow financial disclosure disqualification regulations can be found in:

Gettysburg College’s Employee Handbook
Gettysburg College’s Faculty Handbook
Gettysburg College’s Student Rights and Responsibilities Handbook

Principal Investigators have primary responsibility for the design, execution, and management of research projects they direct, and must be vigilant in seeing that the standards of professional and ethical conduct are maintained in all phases of their projects. In order to protect both the integrity and the autonomy of the College, it is crucial that researchers assume these high standards, and that in the event of allegations of misconduct, the College administer a fair system of review.

Suspected violations of ethical standards of research should be reported immediately to the Dean of Academic Advising (involving students), the Provost (involving faculty), or the Human Resources Office (involving administrators or staff), as appropriate. If extramural funds are suspected to be involved, the Director of Foundation, Government, and Faculty Grants must be informed immediately to assure timely compliance with sponsor regulations.

In order to comply with Federal sponsor regulations and reassure the public that the College’s traditional standards are being upheld, the College must reaffirm its policies, to specify procedures and appropriate safeguards for handling investigations, and to foster an environment that discourages misconduct in all research. The following procedures conform to the Public Health Service regulations issued by the Office for Research Integrity (ORI) of the United States

Department of Health and Human Services (HHS), 42 Code of Federal Regulations (CFR) Part 93.

N.B. While 42 CFR Part 93 applies to all individuals who may be involved with a project supported by, or who have submitted a grant application to, the Public Health Service (PHS), this College policy applies to all individuals engaged in College research, whatever the funding source.

II. Investigation of Alleged Research Misconduct

1. Definitions

Research misconduct means fabrication, falsification, or plagiarism, in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.

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.

Failure to comply with requirements for the protection of human or animal subjects.

Complainant means a person who, in good faith, makes an allegation of research misconduct.

Respondent means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.

PHS or Public Health Service means the unit within the United States Department of Health and Human Services that includes the Office of Public Health and Science and the following Operating Divisions: Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, the Substance Abuse and Mental Health Services Administration, and the offices of the Regional Health Administrators.

PHS Support means PHS funding, or applications or proposal therefor, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research of training that may be provided funding for PHS intramural research, PHS grants, cooperative agreements, or contract or subgrants or subcontracts under those PHS funding instruments, or salary or other payments under PHS grants, cooperative agreements, or contracts.

Retaliation means any adverse action taken against an individual in response to a good faith allegation of research misconduct, or good faith cooperation or participation in the procedures outlined in this policy.

B. Requirements for Findings of Research Misconduct

A finding of research misconduct requires that:

1. the misconduct is a significant departure from accepted practices of the relevant research community;
2. the misconduct be committed intentionally, knowingly, or recklessly; and
3. the allegation be proven by a preponderance of the

C. Delegation of Authority and Responsibility

The President delegates to the Provost responsibility for:

• Coordination of all procedures related to allegations of research misconduct by anyone performing research under the College’s aegis.

• Fostering a research environment that discourages misconduct in all

• Dissemination of policy and maintenance of records related to misconduct in

• Appointment of an individual Research Integrity Officer (RIO) who, in turn, may appoint individuals to conduct inquiries and investigations into allegations of research

misconduct. If extramural funds are involved, the Provost determines whether the law, regulation, or the terms or conditions of the award: (1) require notification of the sponsor;

(2) specify time limits; or (3) require other actions to assure compliance. The Provost coordinates with the RIO, the President’s Office, the Development Office, and other concerned parties to assure compliance.

• Assurance of appropriate confidentiality or anonymity, fairness, and objectivity of

• Assurance of a full and complete inquiry, investigation, and resolution process. Assurance that no real or apparent conflicts of interest arise in those appointed to pursue this process.
• Assurance that they have the appropriate disciplinary expertise and that due regard is given to the prevailing standards of the field.
• Maintenance of confidentiality of records, in accord with established College policy, relating to the investigation and resolution of incidents of misconduct in research.

• If appropriate or required, notification by Provost to concerned parties such as sponsors, co-authors, collaborators, editors, licensing boards, professional societies, and criminal authorities of the outcome of investigations, taking care to clear the name of anyone falsely charged.

• Protecting, to the maximum extent possible, the positions and reputations of those persons who, in good faith, make allegations of research misconduct, and those against whom allegations of misconduct are not confirmed.
• Efforts to restore the reputation of persons alleged to have engaged in misconduct when allegations are not confirmed.

N.B. In most cases, Research Integrity Officer (RIO) assesses allegations of research

misconduct, determines when such allegations warrant inquiries, and oversees inquiries and investigations. If such personnel are unavailable or have conflicts of interest with regard to the person or persons alleged to have committed the misconduct, the Provost may appoint another appropriate person.

D. Inquiries and Investigations into Allegations of Misconduct in Research

College policy and procedures provide that it is primarily the responsibility of Principal Investigators to maintain ethical standards, and direct reporting of allegations to the Provost. However, all individuals associated with the College should report observed or suspected research misconduct to the Provost.

An allegation should, in addition to stating the nature of the suspected misconduct, present the evidence that leads the reporting individual to believe that an incident of research misconduct has occurred. The RIO, will immediately respond, as outlined below, to each allegation or other evidence of possible misconduct. For projects that received PHS Support, federal regulations apply to allegations of research misconduct that occurred within six years of the date that HHS or the College received the allegations, subject to certain exceptions. The College, in its discretion, may investigate and address allegations of research misconduct occurring at any time and in any project.

If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she should contact the Office of the Provost (717-337-6820) and ask to speak with either the IRB Administrator--in the case of human subjects research, or the IACUC Administrator-- in the case of animal research, so as to discuss the suspected misconduct informally. If the circumstances described do not meet the definition of research misconduct, the IRB or IACUC Administrator, serving as the RIO pro tem, will refer the individual or allegation to other offices or officials with responsibility for resolving the problem. If the circumstances, in the opinion of the RIO pro tem, do meet the definition of research misconduct, the person will be instructed to contact the RIO directly.

The informal discussion of possible research misconduct, as well as all subsequent stages in this procedure will be, to the extent possible, consistent with appropriate, necessary, and thorough assessment, inquiry, and investigation, treated as confidential.

1. Preliminary Assessment: The RIO, in consultation with the Provost, will promptly assess the reported incident to determine if it constitutes a bona fide allegation of research

misconduct— (1) does the alleged incident fit the definition of research misconduct; (2) is the evidence sufficiently credible and specific so that potential evidence of research misconduct may be identified; (3) is the alleged research misconduct within the jurisdictional criteria of 42 CFR § 93.102(b); and (4) does the allegation fall within the definition of research misconduct in 42 CFR § 93.103. If it is concluded that an allegation of research misconduct meets these criteria, the misconduct procedure enters its inquiry phase. Ideally, the preliminary assessment should be concluded within a week after the allegation is lodged with the RIO.

In conducting the assessment, the RIO is not required to 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, however, 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 the paragraph which follows, describing the sequestration of research records during the Inquiry phase.

2. Inquiry: If the result of the Preliminary Assessment is that the allegation of research misconduct may have merit, the Provost appoints an Inquiry Committee of two or more persons, including the RIO, to conduct an inquiry in order to determine whether there is sufficient substance to the allegation to warrant a formal investigation. The Inquiry Committee will not include any person(s) who have conflicts of interest with the Complainant, Respondent, or witnesses involved in the inquiry. The purpose of the inquiry phase is not to reach a final conclusion as to whether misconduct occurred or who was responsible. This phase of information gathering and fact-finding should take no more than sixty calendar days from the receipt of the allegation unless circumstances clearly warrant a longer If the inquiry phase must be extended beyond sixty days, the reasons for doing so will be documented.

The RIO will prepare a charge for the Inquiry Committee that:

1. Sets forth the time for completion of the inquiry;
2. Describes the allegations and any related issues identified during the preliminary assessment;
3. 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;
4. 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; and,
5. 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 any applicable federal regulation or requirements.

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. As a member of the Inquiry Committee, the RIO will be present or available throughout the inquiry to advise the Committee as needed.

At the time of or before the beginning of the inquiry, the RIO must make a good faith effort to notify the Respondent (the individual about whom misconduct allegations have been made) in writing that an inquiry is being undertaken and of the procedure that will be followed; indicates the membership of the Inquiry Committee; and, describes the nature of the misconduct allegation(s).

The Respondent then has five days to challenge, in writing, the Inquiry Committee's membership based on bias or conflict of interest. The RIO will determine whether to replace the challenged member with a qualified substitute.

On or before the date on which the Respondent is notified, and in the course of the inquiry, or of any subsequent investigation, the RIO will take reasonable 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 as is necessary to protect the integrity of the investigation. The exception to such sequestration would be if the research records and/or evidence encompass scientific instruments that are shared by a number of users. In such cases, custody may be limited to copies of the data or evidence on such instruments, so long as these copies are substantially equivalent to the evidentiary value of the instruments. The RIO may consult with OPI for advice and assistance in this regard.

Where appropriate, the Respondent will be provided copies of, or reasonably supervised access to, the research records.

All records of the Gettysburg College research misconduct proceeding will be retained for seven years after the proceeding's conclusion.

If the research at issue receives or has received Federal funding and, at any point during an inquiry or subsequent investigation, it is ascertained that any of following conditions pertain, the College will notify ORI, HHS, or any other required agency.

• Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
• HHS resources or interests are

• Research activities should be

• There is reasonable indication of possible violations of civil or criminal
• Federal action is required to protect the interests of those involved in the research misconduct proceeding.

• The College believes the research misconduct proceeding may be made public prematurely so that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved.

• The research community or public should be informed.

Matters pertaining to the inquiry will be treated confidentially to the maximum extent possible consistent with fact finding and required reporting to funding agencies.

An initial written report of the inquiry shall be prepared that: (a) includes the name and position of the Respondent; (b) describes the evidence that was reviewed: (c)summarizes any interviews that were conducted: (d) identifies any PHS support provided for the research (e.g. grant numbers, applications, contracts, and publications listing PHS support); (e)states the conclusion of the Inquiry Committee; and, (f) if an investigation is recommended, explains the basis for that recommendation.

The Respondent shall be notified of the outcome of the inquiry and given a copy of the initial report of inquiry and shall be invited to comment in writing. The College may share all or portions of the initial report of inquiry with the complainant and invite the complainant to provide comments in writing. If comments are provided, the comments will be included in the final inquiry report.

Upon receipt of the final inquiry report, the RIO will make, in writing, the determination of whether an investigation is warranted to the Provost. If the research misconduct alleged is within the scope of ORI’s regulations and there is a determination that an investigation is warranted, a copy of the final inquiry report shall be provided to ORI within 30 days.

Records of the inquiry, including all documentary evidence, interview notes, the inquiry report, and the RIO’s written determination shall be maintained in a secure manner for at least seven years. If such an inquiry is terminated before its completion, a report of the planned termination, including the reasons for such an action, should be made to those ORI, HHS, or any other required agency. The inquiry report and supporting documentation will be provided to relevant authorized federal agencies upon request.

If it is determined that there is sufficient evidence to warrant a formal investigation, the RIO, with the approval of the Provost, shall (within 30 calendar days) initiate the process.

3. Investigation: An Investigative Committee is appointed to determine whether research misconduct has occurred, and, if so, to make recommendations with respect to the imposition of disciplinary sanctions. The Investigative Committee will not include any person(s) who have conflicts of interest with the Complainant, Respondent, or witnesses involved in the inquiry. The investigation phase should be completed within 120 days from the appointment of the Investigative Committee, unless circumstances warrant a longer period. If the investigation stage is extended beyond 120 days the reasons for doing so will be documented.

In the case of a faculty member, the Investigative Committee is appointed by the Provost. It will be constituted from members of the faculty in consultation with the members of College’s Institutional Review Board or Institutional Animal Care and Use Committee and contain from one to three members. A larger committee may be appointed if, in the opinion of the Provost, it would facilitate the investigation.

In the case of academic researchers (visiting scholars, professional researchers, nonfaculty academics, etc.), the Provost appoints an investigative committee that, typically, will include a member of the researcher's relevant peer group plus one or two members of the faculty.

In the case of a student, the Provost refers the matter to the Head of the Student Honor Commission, under the supervision of one of the Deans of Academic Advising.

The RIO will notify the Respondent(s) in writing that an investigation is being undertaken, will inform him/her of the allegations that will be investigated, as well as of the composition of the Investigative Committee and the procedures that will be followed in the course of the investigation. In the event that new allegations arise in the course of the investigation, the Respondent will be so notified in writing.

The Respondent has five days to challenge, in writing, the Investigative Committee's membership based on bias or conflict of interest. The RIO will determine whether to replace a challenged member with a qualified substitute.

The investigation will normally include examination of pertinent documents, including but not necessarily limited to relevant research data and proposals, publications, correspondence, and memoranda. Typically, the investigative committee will conduct interviews as part of its fact-finding process, including interviews with the Complainant and Respondent. Whenever it is feasible, investigators shall create and maintain recorded records of their interviews.

The RIO shall, as required by 42 CFR § 93.108,: (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.”If an investigation is terminated before its completion, a report of the planned termination, including the reasons for such an action, will be made, when required, to ORI, HHS or any other required agency.

The College will notify relevant Federal funding agencies if, during the course of the investigation, facts are disclosed that may affect current or potential Federal funding for individual(s) under investigation or that the Federal agency needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest.

When required by law, an extension of the investigation beyond 120 days must be requested from ORI, HHS, or another relevant agency. The extension request should include an explanation for the delay, an interim report on the progress to date, an outline of what remains to be done, and an estimated date of completion.

When the investigation is completed, the Chair of the Investigative Committee shall prepare, and submit to the Provost, a written, draft investigation report. The draft investigation report shall include:

1. a description of the nature of the allegations of research misconduct;
2. a description and documentation of the PHS Support (if any) provided (e.g. grant numbers, grant applications, contracts, and publications listing PHS Support;
3. the specific allegations of research misconduct considered in the investigation;
4. the policies and procedures under which the investigation was conducted; and
5. for each separate allegation of research misconduct identified during the investigation, a finding as to whether research misconduct did or did not occur;
6. for each finding of research misconduct:

i. an explanation of whether each instance of research misconduct constitute falsification, fabrication, or plagiarism;

ii. a statement of whether each instance of research misconduct was intentional, knowing, or made with reckless disregard;

iii. a summary of the facts and analysis which support the conclusion and address any reasonable explanation offered by the Respondent;

iv. the specific PHS Support (if any) involved;

v. a determination of whether any publications need correction or retraction;

vi. the person responsible for any research misconduct; and,

vii. any current PHS Support or known applications/proposals for support that the person has pending with any federal agencies.

In a separate communication to the Provost, the investigative committee shall offer its recommendations with respect to disciplinary sanctions, if any.

The Provost shall make the draft investigation report and access to the evidence on which the draft report is based. The Respondent will have the opportunity to submit written comments on the draft investigation report. The Provost may provide the draft investigation report or portions of it to the Complainant. The Respondent and Complainant (if applicable) shall have 30 days to provide comments on the draft investigation report. The draft investigation report, together with any comments submitted, shall constitute the Final Investigation Report.

Based upon a reading of the Final Investigation Report, the Provost will make a determination of whether or not research misconduct has been committed. The Provost will, if appropriate and/or required by law, provide the Final Investigation Report to ORI, HHS, or other relevant agencies along with notice of the Provost’s determination and any disciplinary action that will be taken. Documentation to substantiate an investigation’s findings will also be made available to the Director of ORI.

4. Disciplinary Action: After considering the Final Investigation Report, the Provost will determine what, if any, disciplinary action should be taken; such action may include a reprimand or other alteration of status of the faculty member in In a case where the Provost believes that the appropriate sanction is the termination of a faculty member, the Provost shall make that recommendation to the President and the President shall decide whether termination is appropriate. As to all sanctions other than termination, the Provost determines the sanction. In addition, the Provost has the authority to mitigate the effects of the misconduct by withdrawing Gettysburg College’s name and sponsorship from pending abstracts and papers and by notifying persons known to have relied upon any work affected by the misconduct.

If, in the case of an academic researcher (visiting scholars, professional researchers, non-faculty academics, etc.) , the Provost intends to impose disciplinary sanctions, the researcher is notified in writing of such intention, and is invited to respond to the allegations and proposed discipline in a personal conference with the Provost or RIO. The researcher and the Provost or RIO, shall each be entitled to bring a representative of their choice to such a conference. If the Provost and the researcher arrive at a mutually agreeable settlement, the matter is disposed of in accordance therewith.

If discipline is to be imposed upon the researcher pursuant to the settlement, or if there is no settlement, but the researcher has informed the Provost that he/she does not intend to contest the proposed discipline, the Provost may thereupon impose such discipline.

If, in the case of students, the Honor Commission makes a finding of research misconduct and sanctions are levied, the appeal process described in the Gettysburg College Honor Code book may be invoked.

As required by law, the Provost shall report any disciplinary actions taken by the College to ORI, HHS, or any other external funding agency that requires it.

5. Appeal Process: If discipline other than dismissal is imposed without the agreement of the faculty researcher, an appeal of the sanction (not the Provost’s substantive decision as to whether misconduct has occurred) may be made to the President in writing by Respondent within 15 days of the receipt of the decision from the The President will respond in writing to the faculty researcher within 15 days of receipt of the appeal request. The President’s decision regarding the sanction to be imposed is final. The appeal and other processes set forth above are the only processes available to a Respondent accused of research misconduct. The Faculty Grievance Policy is not applicable to these cases.

E. Restoration of Reputation and Prohibitation Against Retaliation

Restoration of the Respondent’s Reputation: If the College finds no research misconduct, after consulting with the Respondent as needed, the RIO will undertake reasonable efforts to restore the Respondent’s reputation. Depending on the circumstances, the RIO may consider notifying 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 expunging references to the alleged research misconduct from the Respondent’s personnel file(s).

7. Restoration of Reputation of Other Participants: Regardless of whether the College determines that research misconduct occurred, the RIO will make reasonable efforts to protect Complainants who made allegations of research misconduct in good faith and the reputations of any individuals who cooperated or participated in proceedings pursuant to this Upon the completion of the investigation and appeal (if any), the RIO will determine, in consultation with the affected personnel as needed, what steps, if any, are need to restore their positions or reputation and the RIO shall coordinate the implementation of any such steps.
8. Protection Against Retaliation: The College prohibits Retaliation against any Complainant, witness, committee member, or other person who cooperates or participates in any proceedings undertaken pursuant to this policy. The College shall make reasonable and practical efforts to counter potential or actual Retaliation and will review instances of alleged College personnel should immediately report any alleged or apparent Retaliation to the RIO.