Research Integrity

1.0 Introduction

Based upon its philosophy of education and ethical standards, St. Mary’s University expects a commitment not only to the pursuit of academic excellence, but honesty, truth, integrity and the highest standards in all endeavors. Achieving such high standards of integrity requires researchers to conduct as well as provide careful supervision of all research activities, including research conducted by students; competent use of methods; adherence to ethical standards of the discipline; and the refusal to engage in or to condone instances of fraud or misconduct.

Proposed common federal regulations governing the conduct of research funded by any federal agency were published in the Federal Register in October, 1999. Working under the umbrella of the Office of Science and Technology Policy, federal agencies began to develop common definitions of misconduct in research and to establish recommendations for managing research misconduct at research institutions receiving agency support for sponsored research. The policy was published in December 2000, and agencies were given one year to implement the policy. This policy indicates that while the federal agencies and the institutions share responsibility for the research process, institutions have the primary responsibility for monitoring the conduct of research on their campuses and ensuring the integrity of the research process. The policy also makes clear that federal agencies supporting research may proceed to investigate allegations of misconduct under specific conditions outlined in the policy statement. Most allegations of misconduct in sponsored research fall under the investigative authority of the agency’s Office of Inspector General (OIG). Reporting requirements for findings of misconduct in sponsored research are specific to each agency.

This policy contains the common definitions relevant to misconduct in research and research-related activities as well as the procedures for filing complaints and the disciplinary actions facing any individual or groups engaged in misconduct in research. For purposes of this policy the term “researcher” is defined as any St. Mary’s University faculty, staff or student conducting research as an affiliate of the university, whether using St. Mary’s University facilities or not, and any other researcher conducting research on St. Mary’s University’s campus. This policy and associated procedures will be followed when an allegation of possible misconduct in scholarly research activities is received by an institutional official.

2.0 Research Practices Covered by this policy

2.1 Definition of Misconduct in Scholarly Research

• 2.1.1 Fabrication, falsification of research data as well as plagiarism, theft of ideas or intellectual property, or appropriation of another’s work.
• 2.1.2 Failure to acknowledge or recognize the contribution of others, including co-researchers, students, and research assistants.
• 2.1.3 Use of the unpublished works of others without permission, and the use of archival material in violation of the Copyright Act.
• 2.1.4 Abuse of supervisory power affecting collaborators, assistants, students and others associated with the research.
• 2.1.5 Failure to account for, misapplication, or misuse of funds acquired for support of research.
• 2.1.6 Failure to comply with relevant federal and local statutes or regulations for the protection of researchers, human participants, the health and safety of the public, or welfare of laboratory animals.
• 2.1.7 Failure to comply with regulations of the relevant agency or agencies concerning the conduct of research.
• 2.1.8 Failure to reveal any material conflict of interest to St. Mary’s University officials, to research sponsors and/or to those who commission work.
• 2.1.9 Failure to reveal any material conflict of interest when asked to undertake reviews of grant applications or manuscripts for publication, or to test products for sale or distribution to the public.

2.2 Protection of Human Subjects and the Welfare of Laboratory Animals

• 2.2.1 Human Subjects
  Humans participating in research as research subjects are protected by Federal regulations and institutional policy if the researcher obtains (1) data through intervention or interaction with the individual or (2) private information about the individual(s). All research conducted at St. Mary’s University that includes human subjects must be reviewed and approved by an independent committee called the Institutional Review Board (IRB). Researchers affiliated with St. Mary’s University but conducting research involving human subjects at other sites or in collaborative research environments elsewhere are subject to IRB-HS policies at the lead institution. No human research may be conducted without an IRB-HS approval. The IRB is responsible for determining if a research proposal takes all the necessary steps to ensure the protection of human subjects involved in a particular research proposal.
• 2.2.2 Laboratory Animals
  The term animal is defined as any live, vertebrate animals used or intended for use in research, research training, biological testing, or for related purposes. The University has its Institutional Animal Care and Use Committee (IACUC), which is charged with overseeing issues related to the use of animals in research. More details on the policy of the University can be found in the Faculty Handbook (Sec. 2.12.18 Policy on Humane Care and Use of Laboratory Animals) or at the Academic Grants website.

2.3 Conflict of Interest

It is essential to recognize situations of existing, potential, or apparent conflict of interest promptly. A conflict of interest is defined as “any situation, whether compensated or uncompensated, in which a university employee’s intellectual independence or the university’s integrity would be compromised as a result of decisions made in the process of conducting research or in those activities associated with the research” (“Conflict of Interest Regarding Sponsored Research Policy,” p. 3). A conflict of interest arises in the following circumstances but is not limited to these circumstances:

• 2.3.1 When the personal or business interests of the researcher, including the interests of his/her relations and associates, conflicts with the researcher’s obligations to the University, including respect for the University’s policies and students, or staff, under his/her supervision;
• 2.3.2 When, without prior written agreement or beyond the institutionally authorized limits of “substantial use” policy (Faculty Handbook p. 85), use is made of University resources, including secretarial, office and administrative services, technical services, laboratories, premises, logo, insignia, for the personal gain or benefit of the researcher or for the gain or benefit of others related to or associated with the researcher.
• 2.3.3 When the work of students is directed or done with a view to benefiting the personal or business purposes of the researcher, his/her associates or relations, to the detriment of the university and/or to students’ academic progress.
• 2.3.4 When the personal or business interests of the researcher, his/her associates or relations compromise the independence and impartiality necessary to perform his/her duties.
• 2.3.5 When a researcher uses confidential information that is gathered in the course of his/her duties for personal or business gain or for the gain of his/her associates or relations.
• 2.3.6 If, in the course of his/her duties, a researcher incurs an obligation to an individual or business that is likely to benefit from special treatment or favors granted by the researcher or the University.
• 2.3.7 When a researcher accepts an executive appointment, employment, or shares in any non-university organization that might reasonably expect them to disclose confidential or proprietary information to which they have access by virtue of their University appointments. Researchers are reminded that under St. Mary’s University Conflict of Interest Policy they are required to report any potential conflict of interest to the University Research Conduct Committee (see Conflict of Interest Regarding Sponsored Research). Examples of potential conflict of interest situations are provided in that policy.

2.4 Data Management Practices

The retention of accurately recorded and retrievable results is of the utmost importance for the progress of scholarly inquiry. Researchers must have access to original results in order to respond to questions regarding their research. Errors may be mistaken for misconduct when the primary experimental results are unavailable.

• 2.4.1 Primary data should normally remain in the school or department at all times and should be preserved as long as there is a reasonable need to refer to them. Results should be recorded accurately and be retrievable for five years, or for the period of time stipulated in the Terms and Conditions of the award in the case of sponsored projects, following publication where the medium permits. Original primary research data should be recorded, when possible, in bound books with numbered pages or on appropriately protected electronic media. An index should be maintained to facilitate access to data. In no instance should primary data be destroyed while investigators, colleagues or readers of published results may raise questions answerable only by reference to the data except in the case where there is a bona fide requirement for confidentiality.
• 2.4.2 Entitlement to ownership, reproduction and publication of primary data, software and other products of research will vary according to the circumstances under which research is conducted. A common understanding of ownership must be reached among collaborators, supervisors, students and the University before the research is undertaken; otherwise, the university retains ownership except where superseded by federal or institutional policies/regulations.
• 2.4.3 Issues of confidentiality will arise in some disciplines and areas of research, and these issues must be appropriately addressed by the department or research unit involved prior to the research being undertaken.
• 2.4.4 Subject to any limitations imposed by the terms of grants, contracts or other arrangements for the conduct of research, the principal investigator and all co-investigators must have free access to all original data and products of the research at all times. With the knowledge and prior written authorization of the principal investigator, a member of the research team may make copies of the primary data for his/her own use.
• 2.4.5 When a principal investigator (either faculty member or student) leaves the University, arrangements for the safekeeping of records, data and products of research must be made. In the case of students, the data ordinarily stays in the University; in the case of faculty members, they would normally take the data with them.

2.5 Mentor and Trainee Responsibilities

• 2.5.1 To ensure that all research is conducted to the highest possible ethical standard and with scholarly and academic integrity.
• 2.5.2 To provide their collaborators, students, staff and assistants with information necessary to prevent misconduct as defined in this policy.
• 2.5.3 To monitor the work of students, research assistants, etc. and oversee the designing of research methodology and the processes of acquiring, recording, examining, interpreting and storing data. Simply editing the results of a research project does not constitute supervision nor does supervision alone constitute a right to authorship.
• 2.5.4 Collegial discussions among all research personnel in a research unit should be held regularly to contribute to the scholarly efforts of group members and to provide informal review.
• 2.5.5 A faculty member listed as the principal investigator or co-investigator should be able to verify the authenticity of all data or other factual information generated in his/her research.

2.6 Collaborative Research

Researchers increasingly collaborate with colleagues who have the expertise and resources needed to carry out a project. Any project that requires more than one person working on it requires some collaboration. There is an added burden in such collaborations due to the complex roles of the relationships, common but not necessarily identical interests, diverse management requirements, and cultural differences. As a result, collaborators should

1. share findings with colleagues in the collaboration and be attentive to what others are doing;
2. report and discuss findings as well as problems;
3. make other collaborators aware of any important changes;
4. share related news and developments so that everyone in the collaboration is equally knowledgeable about important information;
5. have effective management plans that cover financial issues, training and supervision, formal agreements, and compliance.

2.7 Authorship and Publication

• 2.7.1 In order to ensure the publication of accurate scholarly reports, two requirements must be met:
  
  1. the active participation of each author in verifying and taking responsibility for the part of the manuscript to which she/he has contributed;
  2. the designation of one author who is responsible for the validity of the entire manuscript.
• 2.7.2 The principal criterion for authorship should be that the author(s) has/have made a significant intellectual and practical contribution. The concept of “honorary authorship” is unacceptable.
• 2.7.3 Students must be given appropriate recognition for authorship or collection of data in any publication.

3.0 Procedures for Investigation and Resolution of Complaints of Alleged Breach of Research Integrity Policy

This policy is applicable to all allegations of breach of the Research Integrity Policy, which includes the following, but is not intended to override current policies and procedures concerned with specific research issues:

1. Abuse of human subjects and laboratory animals;
2. Conflict of Interest;
3. Data Collection, Gathering and Retention;
4. Responsibilities of Supervisors and Mentors;
5. Collaborative Research;
6. Authorship and Publication;
7. Intellectual Property, Copyright

3.1 Rights and Responsibilities

• 3.1.1 Research Integrity Officer
  The Vice President for Academic Affairs will appoint the Research Integrity Officer (RIO). The term of appointment shall be two years. The RIO has the following responsibilities:
  1. after receiving an allegation of research misconduct, determine if sufficient evidence exists to convene an investigation committee
  2. provide written notification and reports of inquiries and investigations to parties involved
  3. appoint the investigation committee and ensure that the appropriate expertise is secured to carry out a thorough evaluation of the evidence (see pg 8),
  4. assist the committee in complying with applicable standards imposed by the various funding agencies,
  5. report to the sponsoring agency’s Office of Research Integrity (ORI) as required by regulation and keep the ORI apprised of any developments during the course of the investigation,
  6. maintain confidentiality as described below.
  7. prepare inquiry and investigation reports as required.
• 3.1.2 Complainant
  A complainant is a person who makes an allegation of scholarly misconduct. The complainant has the following rights and responsibilities: the complainant
  1. will have an opportunity to testify before the inquiry and investigating committee,
  2. will be allowed to review those portions of the inquiry and investigation from his/her recorded or transcribed testimony and may provide corrections to those recorded statements,
  3. is responsible for making allegations in good faith and for maintaining confidentiality,
  4. will be protected from retaliation.
• 3.1.3 Respondent
  The respondent is a person against whom an allegation of research misconduct is directed or the person who is the subject of inquiry or investigation. There can be more than one respondent in any inquiry or investigation. The respondent
  1. will be informed in writing of the allegations when an inquiry is opened and will be notified in writing of the final determinations and resulting actions.
  2. will have the opportunity to be interviewed by the investigation committee and present evidence to the committee,
  3. will be able to review the draft inquiry and investigation report(s) and to have advice of the respondent’s own advisor or counsel,
  4. is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation,
  5. has the right to receive institutional assistance in restoring the researcher’s reputation if the researcher is not found guilty of research misconduct. However, the University is not required to offer the assistance of an advocate in potentially restoring the researcher’s reputation.

3.2 General Policies and Principles

• 3.2.1 Responsibility to Report Misconduct
  All individuals or employees associated with St. Mary’s University should report observed, suspected, or apparent misconduct in research to the Research Integrity Officer. At any time, an employee may have confidential discussions and consultations about concerns of possible misconduct with the Research Integrity Officer and will be counseled about the appropriate procedures for reporting allegations.
• 3.2.2 Protecting the Complainant
  The Research Integrity Officer will monitor the treatment of individuals who bring allegations of misconduct and those who cooperate in inquiries and investigations. The Research Integrity Officer will also ensure that these persons are not the objects of retaliation. Employees should report any alleged or apparent retaliation to the Research Integrity Officer. The institution is required to protect the privacy, positions, and reputations of persons who, in good faith, make allegations. “Good faith” is defined as an intent that originates from an unbiased, honest purpose in the public interest to bring to light perceived misconduct in research endeavors.
• 3.2.3 Protecting the Respondent
  Inquiries and investigations will be conducted in a manner that will ensure fair treatment to the respondent(s) in the inquiry or investigation. Employees accused of research misconduct may consult with legal counsel to seek advice. The role of advisers or counsel in investigation procedures follows the University’s general grievance procedure found at section 2.16.5 “Due Process in Procedures” of the Faculty Handbook.
• 3.2.4 Preliminary Assessment of Allegations
  Upon receiving an allegation of research misconduct, the Research Integrity Officer will immediately assess the allegation to determine whether there is sufficient evidence to warrant an investigation and will complete the inquiry within 60 days of initial allegation. If that evidence exists, the investigation process is initiated.
• 3.2.5 Confidentiality
  To the extent allowed by law, the university shall maintain the identity of respondents and complainants securely and confidentially and shall not disclose any identifying information except to: (1) those who need to know in order to carry out a thorough, competent, objective and fair research misconduct proceeding; and (2) if relevant, to the sponsoring agency’s ORI as it conducts its review of the research misconduct proceeding and any subsequent proceedings.

3.3 Conducting the Investigation

• 3.3.1 Purpose of the Investigation
  The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine whether misconduct has been committed, by whom, and to what extent. As soon as a determination is made of possible misconduct, the Research Integrity Officer will secure, inventory, and sequester all pertinent research records according to 42 CFR Section 93.305.7 and describe any relevant records and evidence not taken into custody and explain why.
• 3.3.2 Appointment of the Investigation Committee
  The Research Integrity Officer, after satisfying the VPAA that appropriate consultation has occurred, will appoint an investigation committee. The VPAA will name a chairperson. The committee should consist of individuals who do not have real or apparent conflict of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence. The RIO and VPAA shall screen proposed individuals for any unresolved personal, professional, or financial conflict of interest with the respondent, complainant, potential witnesses, or others involved in the matter. Any such conflict that a reasonable person would consider to demonstrate potential bias shall disqualify the individual from selection. Additionally, the committee will not include the Research Integrity Officer as a member.
• 3.3.3 Investigation Process
  The investigation committee will be appointed, and the process initiated within 30 calendar days of the completion of the inquiry. The investigation will normally involve examining all relevant documentation, such as research records, computer files, proposals, manuscripts, correspondence, and memoranda. Whenever possible, the committee will interview the complainant(s), the respondent(s), and other key personnel who might have information regarding the allegations. All interviews will be recorded and transcribed. The university shall use its best efforts to complete the investigation within 120 calendar days of the date on which it began, including all required reports and appeal processes. If it becomes apparent that the investigation cannot be completed within that time, the university shall promptly request an extension in writing from the designated ORI, if applicable to sponsored research.
• 3.3.4 The Investigation Report
  The committee is charged with writing an investigation report containing all pertinent information regarding the investigation of the alleged misconduct. The report shall contain the required elements listed in 42 CFR Section 93.312 The respondent(s) will be allowed to view the draft of the report in order to prepare a rebuttal to the allegations. The draft of this report will be made available to the respondent and the complainant for comment and rebuttal. Comments and rebuttals must be provided to the committee within 10 days of receipt of the draft. Once all comments are received, a final report will be written by the committee.
• 3.3.5 Investigation Decision and Notification
  The final report will be transmitted to the Vice President for Academic Affairs, who will make the determination of misconduct based on the findings from the investigation. The VPAA will notify the respondent and the Research Integrity Officer of his/her findings of misconduct.
• 3.3.6 Misconduct Appeal process
  Before any actions are taken in findings of research misconduct, the respondent shall have the right to appeal the university’s decision. All appeal actions must be completed within 120 calendar days from the beginning of the investigation unless an extension has been granted by the sponsoring ORI. In cases of non-sponsored research, the VPAA may grant a reasonable extension period. The respondent must be given sufficient timely notice of the findings to prepare an appeal statement and must be provided with the process for appeal in writing. The Academic Council sitting as a body shall be the final appeal authority in cases of research misconduct. All reasonable steps must be taken to ensure that no member of the Academic Council has unresolved personal, professional, or financial conflicts of interest with the respondent, complainant, or others involved in the matter. Having made the determination of the charges and actions in the case, the VPAA shall recuse him/herself from these deliberations and the appeal process except as he/she may be called as a witness to the proceedings.
• 3.3.7 Actions Taken as a Result of Misconduct
  Pending final appeal decisions on the charge of misconduct, the Vice President for Academic Affairs will determine what actions shall be taken against the person found to have committed misconduct in research. His/her determination shall be commensurate with University policy found in Sections 2.8.6 (Dismissal for Cause), 2.8.7 (Action Short of Dismissal), or 2.8.8 (Progressive Discipline of Faculty Members) of the Faculty Handbook. The appeal process shall follow that described in these sections. In cases of research misconduct findings against staff or students, the appeal processes shall be the same; however, actions taken against staff or students who have committed research misconduct shall follow applicable policies in the Personnel Manual or the Student Handbook.

3.4 Maintenance and Custody of Research Records and Evidence

The university shall take all reasonable steps to obtain, secure, and maintain the research records and evidence pertinent to the research misconduct proceeding. Specifically, the RIO on behalf of the university shall promptly take custody of all research records and evidence needed to conduct the misconduct proceeding, inventory the materials, and sequester the materials in a secure manner.

Materials sequestered for the course of the proceedings shall be strictly monitored and supervised during access by individuals who have a need to know and are involved in the proceedings.

Additional materials related to the misconduct proceedings that come to light in the course of investigation shall also be secured as above to the extent possible.

All records and reports shall be maintained for 3 years from the closing of the proceedings or in the case of sponsored research for 7 years or according to the specific requirements of the agency sponsoring the research unless these records have been transferred to the sponsoring agency or unless the sponsoring agency has advised the university in writing that we no longer need to retain the records.

3.5 Special Circumstances That May Require Protective Actions

The university shall take appropriate interim actions in all cases that arise during the misconduct proceedings to protect public health, federal funds and equipment, and the integrity of the research process. Actions will vary according to circumstances. At any time during a research misconduct proceeding, the university shall immediately notify the appropriate ORI, if applicable, if any of the following conditions exist:

1. Health or safety of the public is at risk
2. Federal resources or interests are at risk
3. Research activities should be suspended
4. There is a reasonable indication of violations of civil or criminal law
5. Federal action is required to protect the interests of those involved in the misconduct proceedings
6. Indications of premature release of information to the public that would jeopardize the proceedings or put the evidence and/or those involved at risk
7. The university determines that the research community or public should be informed.

3.6 Notifying and Reporting to the ORI

The university shall adhere to the requirements of 42 CFR Sections 93.304 – .310 in notifying, reporting, and cooperating with the ORI in cases of research misconduct investigations.