Policies & Procedures

Research Integrity Policy

Effective Date:	10/18/2000 (replaced earlier policy 1989-1990)
Amendments:	03/18/2002 08/10/2007
Last Reviewed:	10/17/2008 (current version)

Introduction
Organizational Structure
Inquiry and Investigation Procedure
Imposition of Sanctions
Confidentiality
Responsibilities of the Office of Executive Vice Chancellor and General Counsel
Definitions

Introduction
Federal regulations require that institutions applying for or receiving federal research funding have an established administrative process for reviewing, investigating, and reporting allegations of research misconduct. The following policy outlines Washington University's process for responding to allegations of research misconduct in all areas of research, regardless of the funding source.

The goals of this policy are to resolve allegations of research misconduct as rapidly and fairly as possible and to protect the rights and integrity of both the respondent and the complainant. Research sponsors are to be informed promptly regarding the status of allegations of misconduct in research, in accordance with applicable laws and regulations.

Washington University defines research misconduct as:
1. Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results; or
2. Knowing violations of federal and institutional rules and regulations governing the conduct of research involving human research participants that are serious and continuing; or
3. Violations of the University's Policy for Authorship on Scientific and Scholarly Publications
Research misconduct does not include honest error or differences of opinion or differences in interpretations of data.

A finding of research misconduct requires that:
1. There be a significant departure from the accepted practices of the relevant research community; and
2. The research misconduct be committed intentionally, or knowingly, or recklessly; and
3. The allegation be proven by a preponderance of evidence.
Organizational Structure
1. The Vice Chancellor for Research is the institutional official charged to:
  1. Establish and maintain a culture of compliance and cooperation with all applicable standards imposed by research sponsors and federal regulations.
  2. Inform individuals, including but not limited to, collaborating scientists, sponsors, institutions, and journal editors of research misconduct proceedings on a need-to-know basis.
  3. Establish and maintain records for all research misconduct proceedings.
2. At the School of Medicine, the Vice Chancellor for Research, with approval from the Dean of the School of Medicine, shall appoint a standing committee of five (5) tenured faculty members, known as the Committee on Research Integrity (CRI). The CRI works in conjunction with Washington University’s Research Integrity Officer (RIO) to administer cases of alleged research misconduct by staff, students, and/or faculty members with primary appointments at the School of Medicine. Appointments of the five CRI members shall be for staggered three-year terms, which are renewable. One member shall be a basic research department head; one, a clinical department head; and the other three members will be senior School of Medicine faculty members who are not department heads. The Vice Chancellor for Research shall be responsible for providing appropriate expertise and administrative support to the RIO and the CRI.
3. At the Danforth Campus, the Vice Chancellor for Research, with approval from the Deans of the Schools of Arts and Sciences, Engineering, and Social Work, shall appoint a standing committee of five (5) tenured faculty members, known as the Committee on Research Integrity (CRI). The CRI works in conjunction with Washington University’s Research Integrity Officer (RIO) to administer cases of alleged research misconduct against staff, students, and/or faculty members with primary appointments in the schools other than the School of Medicine. Appointments of the five CRI members shall be for staggered three-year terms, which are renewable. Two CRI members shall be appointed from each of the School of Arts and Sciences and the School of Engineering. The final CRI member will be appointed from the School of Social Work. The Vice Chancellor for Research shall be responsible for providing appropriate expertise and administrative support to the RIO and the CRI.
4. The Vice Chancellor for Research shall appoint a Research Integrity Officer (RIO), who holds the primary responsibility for implementing Washington University’s policies and procedures on research misconduct as outlined herein. The RIO shall:
  1. Assess an allegation to determine whether it falls within the definition of research misconduct and is sufficiently credible to warrant an inquiry.
  2. Serve as the non-voting ex officio chair of all research misconduct proceedings.
  3. Appoint faculty members to serve on the Research Integrity Inquiry Panel (RIIP).
  4. Assist all Washington University personnel to comply with applicable policies, laws, and regulations related to research misconduct proceedings.
  5. Notify individuals and entities within the University of research misconduct proceedings on a need-to-know basis.
5. The Research Ethics and Compliance Office (RECO) has been delegated the responsibility to provide administrative support for all research misconduct proceedings at Washington University and to assist the Vice Chancellor for Research and the RIO to respond to allegations of research misconduct. A member of the RECO shall be present at all meetings, interviews, and other proceedings regarding allegations of research misconduct.
6. In a case involving alleged misconduct by (1) a faculty member who holds a joint appointment in the School of Medicine and in another school of the University, (2) a member of the School of Medicine faculty in collaboration with a faculty member from another school of the University, or (3) a student enrolled in a program that crosses school lines, the RIO shall determine which CRI will take jurisdiction over the case.
7. For each allegation of research misconduct found to be credible and specific, the RIO shall appoint an ad hoc Research Integrity Inquiry Panel (RIIP). The RIIP shall consist of at least two (2) members: the RIO and an ad hoc member who is a standing member of the CRI. The RIO may also solicit help from senior faculty members with expertise in the relevant field from within the University or outside the University. RIIP members shall be carefully selected in order to minimize either the substance or the appearance of personal or professional conflicts of interest. No member of the RIIP will be assigned to a complaint involving his or her own department (small departments) or division (large departments). All RIIP members will continue to serve as members of the CRI for the duration of the case in question.
Inquiry and Investigation Procedure
1. Complaints
  1. All members of the University community are expected to report observed, suspected, or apparent research misconduct. All complaints of research misconduct from sources inside or outside the University will be considered.
  2. An individual should direct a complaint of research misconduct to the RIO, the RECO, or the Vice Chancellor for Research. Alternatively, an individual can direct a complaint to deans, department heads, division chiefs, or as directed by the Washington University Code of Conduct. Any member of the Washington University community who receives an allegation of research misconduct shall promptly forward it to the RIO.
  3. If an individual is concerned about possible research misconduct or is unsure whether an incident qualifies as research misconduct, he or she may contact the RIO or the RECO to discuss the suspected misconduct informally and confidentially.
2. Initial Responsibilities of the RIO
  1. Upon receiving an allegation of research misconduct, the RIO will immediately assess the allegation to determine whether it:
    1. Falls within the definition of research misconduct and
    2. Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
  2. Absent a finding by the RIO that the complaint is frivolous or insubstantial on its face or does not allege an instance of research misconduct, the RIO will promptly initiate the inquiry process.
  3. To initiate the inquiry process, the RIO will:
    1. Appoint the RIIP as described in Section II.G.
    2. Provide notice to the respondent. The RIO shall provide a written notice to the respondent at the initiation of the inquiry. The notification will include a description of all allegations of research misconduct made against the respondent along with an explanation and documentation of the University's policies in regard to allegations of misconduct.
    3. Sequester all original research records relevant to the allegation. At the time or before the respondent is notified of an allegation, the RIO will take all reasonable and practical steps necessary to obtain custody, inventory, and secure all original research records and evidence relevant to the allegation. University students, faculty and staff including but not limited to the complainant and respondent, shall promptly provide all available records and data, including primary research material identified as relevant to the allegation. Copies of such records and data will be returned to individuals who supply the same to the RIO except for materials not amenable to copying. All reasonable steps, consistent with time constraints and other obligations imposed by federal regulations, shall be taken to eliminate or minimize any disruption that might be created for ongoing research efforts by such requirements to produce documentation. Failure to provide relevant records and data will subject an individual to sanctions pursuant to Section IV. below.
    4. Provide notice to institutional officials. At the time or before the RIO notifies the respondent, the RIO shall notify the Vice Chancellor for Research, the respondent’s department head, and the dean of the respondent’s school of all allegations of research misconduct and the initiation of the inquiry process.
3. Inquiry Responsibilities of the RIIP
  1. The responsibility of the RIIP is to conduct a rapid, thorough, and unprejudiced preliminary evaluation of the available facts and circumstances underlying the allegations. The RIIP will determine by a preponderance of the evidence (a) whether or not the conduct, if it did occur, would constitute research misconduct, and (b) whether there is sufficient evidence of the alleged misconduct to warrant a full investigation.
  2. The RIIP will review the evidence and conduct interviews of the complainant, the respondent, and any other key witnesses the RIIP may consider necessary to its inquiry. At this stage the complainant's name may be kept confidential, but he/she must be made aware that as the process moves forward, the complainant's identity may have to be revealed in order to afford the respondent a full and fair opportunity to respond to the charges.
  3. The respondent may have an attorney present at all meetings, interviews, and other proceedings with the RIIP to act as an advisor. Attorneys will not be permitted to actively participate in the proceedings and will be required to channel all communications with the RIO, CRI, RIIP, and/or any members thereof through the Office of the Executive Vice Chancellor and General Counsel.
  4. The RIIP will evaluate the relevant documentation and testimony of all individuals interviewed and shall determine by a preponderance of the evidence (a) whether the allegations, if true, would constitute research misconduct and (b) whether there is sufficient evidence to warrant a full investigation. The RIO shall promptly submit to the respondent a written draft report of its findings and its recommendations for further action. The respondent shall be allowed five (5) working days from receipt of the draft report to comment on the report. Based on the comments received, the RIIP will revise the report as appropriate and will then generate the Final RIIP Report. Any and all comments submitted by the respondent shall be made a part of the final report. The Final RIIP Report will then be submitted to the CRI for review and determination.
  5. Absent extraordinary circumstances, the inquiry shall be completed within sixty (60) calendar days of the initiation of the inquiry. The inquiry may extend beyond sixty (60) calendar days only with the written approval of the Vice Chancellor for Research.
4. Post-RIIP Responsibilities of the CRI
  1. After review of the Final RIIP Report, the CRI shall convene and, by majority vote, decide whether to accept or reject the recommendations of the RIIP and thus whether to initiate an investigation or dismiss the complaint. The RIO shall then notify the respondent, the Vice Chancellor for Research, and the dean of the respondent's school of the determination of the CRI and provide each with a copy of the Final RIIP Report. The respondent’s department head will be notified of the determination of the CRI.
  2. If the CRI and the RIIP agree that an investigation is not warranted, the complaint is dismissed. If the CRI dismisses the complaint for any reason, it shall, in conjunction with the RIO, the Vice Chancellor for Research, and the respondent's dean make diligent efforts to restore the respondent's reputation. Diligent efforts will also be made to protect the complainant from retaliation for his/her activities in cooperation with, or initiation of, the inquiry provided, however, such activities were not undertaken in bad faith. Allegations of research misconduct made in bad faith will subject an individual to sanctions pursuant to Section IV. below.
  3. If the CRI (a) rejects the RIIP's conclusion that an investigation is not warranted or (b) accepts the RIIP’s conclusion that there is sufficient basis to warrant an investigation, a prompt and thorough investigation into the allegation shall be initiated by the CRI within thirty (30) calendar days of the completion of the inquiry.
  4. To initiate an investigation, the RIO will:
    1. Provide notice to the respondent. The notice will include a description of all allegations of research misconduct that will be investigated.
    2. Sequester any additional research records relevant to the allegation. Throughout the investigation, the RIO will exercise all rights and responsibilities related to the gathering of relevant records and data available under Section III.B.3.c.above. Failure of any University student, faculty member, or staff member to provide all relevant records and data will subject the individual to sanctions pursuant to Section IV. below.
5. Investigational Responsibilities of the CRI
  1. The responsibility of the CRI is to determine whether, based on a preponderance of the evidence, research misconduct has occured and to recommend what, if any, corrective actions and sanctions are warranted.
  2. The investigation shall include an examination of all relevant materials and documentation including, but not limited to research data, notebooks, primary research materials and proposals, publications, correspondence, memoranda, and interviews with all individuals involved. The RIO may designate an expert in the respondent's field to assist the CRI in its investigation.
  3. The respondent shall be permitted to have an attorney present to the same extent specified under Section III.C.3 with respect to the RIIP.
  4. Upon completion of its investigation, the CRI shall, by majority vote, decide whether to dismiss the complaint or make a determination that research misconduct occurred.
  5. The CRI will then generate a draft report of its investigation and recommendations for further action, if any. The report may also set forth recommendations as to the appropriate sanctions, if any. The RIO shall promptly submit the draft report to the respondent, who shall be allowed five (5) working days from receipt of the draft report to provide comments on the report. Based on the comments received, the CRI will revise the report as appropriate and generate the Final CRI Report. Any and all comments submitted by the respondent shall be attached to the final report. The RIO will provide a copy of the report to the respondent, the Vice Chancellor for Research, and to the dean of the respondent's school.
  6. The investigation shall be carried through to completion within one hundred twenty (120) calendar days unless circumstances clearly warrant a longer period. The investigation may extend beyond one hundred twenty calendar days only with the written approval of the Vice Chancellor for Research.
6. Additional Responsibilities of the RIO, Vice Chancellor for Research, and the Dean of the Respondent’s School
  1. The RIO, the Vice Chancellor for Research, and the respondent’s dean shall take all appropriate steps to (a) ensure the confidentiality of allegations and the proceedings and deliberations conducted thereto; (b) protect the complainant from retaliation for his/her activities in cooperation with, or initiation of, the inquiry and/or investigation, provided, however, such activities were not undertaken in bad faith; and (c) protect the members of the committees created by this document from retaliation for their activities in conducting the inquiry and/or investigation.
  2. From the time the CRI decides to initiate an investigation or at any other time as required by federal regulations, the Vice Chancellor for Research shall keep external agencies informed regarding the status of research misconduct proceedings in accordance with applicable laws, regulations, and rules. In addition, the Vice Chancellor for Research shall be responsible for complying with notification and record keeping requirements of applicable federal regulations.
Imposition of Sanctions
1. If the CRI determines that research misconduct has occurred, the dean of the respondent's school shall review the Final CRI Report and, subject to the following exceptions, impose such sanctions as the dean considers appropriate under the circumstances. The dean shall impose sanctions no later than thirty (30) calendar days and no earlier than five (5) calendar days after the CRI forwards its report to the dean. Within five (5) calendar days after the CRI forwards its report to the dean, the respondent shall be given an opportunity to present to the dean, in person or in writing (as the respondent may elect), any facts or considerations the respondent believes should be taken into account in the determination of appropriate sanctions.
  1. Should the dean recommend termination of appointment of a faculty member with tenure, or of a non-tenured faculty member prior to the end of a current term of appointment, a proceeding shall be instituted by the University before the Hearing Committee, in accordance with Section IX. of the Washington University Policy on Academic Freedom, Responsibility, and Tenure. The Hearing Committee shall review the reports of the RIIP and CRI and related documentation and may hear such additional relevant, non-cumulative testimony as it deems necessary.
  2. The dean shall impose sanctions against a student in accordance with the University Student Judicial Code or other relevant policies of the student's school.
2. All University students, faculty, and staff are expected to make allegations of research misconduct and cooperate with research misconduct proceedings in good faith. In the event that allegations of research misconduct are made in bad faith or research misconduct proceedings are materially impeded by any University student, faculty member, or staff member, including but not limited to the respondent or complainant, the dean of the appropriate school shall impose sanctions subject to the limitations set forth within paragraph A. of this section.
Confidentiality
All those participating or involved in research misconduct proceedings shall not disclose any information regarding the allegations, the proceedings, or the identity of individuals involved in the proceedings except as necessary to the proper discharge of their responsibilities hereunder and as required by law.
Responsibilities of the Office of Executive Vice Chancellor and General Counsel
Responsibilities of the Office of Executive Vice Chancellor and General Counsel The Office of the Executive Vice Chancellor and General Counsel shall serve as legal advisor to the RIO, the RIIP, and the CRI. Upon request by the RIO, a member of the Office of the Executive Vice Chancellor and General Counsel shall be present at meetings, interviews, and other proceedings during the inquiry and/or investigation. The General Counsel will not be permitted to actively participate in the meetings and interviews.
Definitions
All definitions herein are applicable to Washington University’s Research Integrity Policy and Research Integrity Procedures documents only.
1. Allegation: a disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication to an institutional official.
2. Conflict of interest: the real or apparent interference of one person’s interest with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.
3. Fabrication: making up data or results and recording or reporting them.
4. Falsification: 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.
5. Good faith: having a belief in the truth of one’s statements such that a reasonable person in the same position could have based on the information known to one at the time. An action is not in good faith if made with knowing or reckless disregard or willful ignorance of certain facts that would disprove said action.
6. Plagiarism: the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
7. Preponderance of the evidence: proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.
8. Research: a systematic experiment, study, evaluation, demonstration, or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research).
9. Research record: the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to primary research material, research proposals, laboratory records (physical and electronic), research animals, images, machines and equipment, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, correspondence, and any documents and materials provided by the respondent in the course of a research misconduct proceeding.
10. Respondent: the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.