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Promoting, Facilitating, and Enhancing Research at Northwestern Univerisity

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Polcies and Guidelines for Investigators in Scientific Research

Integrity in Research and Procedures for Reviewing Alleged Misconduct

Introduction

The University endorses the following introductory statement in the Framework for Institutional Policies and Procedures to Deal with Fraud in Research, issued November 4, 1988, by the Association of American Universities, National Association of State Universities and Land-Grant Colleges, and Council of Graduate Schools.

Fraud in research undermines the scientific enterprise in ways that go far beyond the waste of public funds. Although an uncommon event relative to the large scientific literature, violations of accepted standards inevitably appear in this as in all human pursuits. Institutions engaged in research have a major responsibility, not only to provide an environment that promotes integrity, but also to establish and enforce policies that deal effectively and expeditiously with allegations or evidence of fraud.

In dealing with this problem it is important not to create an atmosphere that might discourage openness and creativity. Good and innovative science cannot flourish in an atmosphere of oppressive regulation. Moreover, it is particularly important to distinguish fraud from the honest error and ambiguities of interpretation that are inherent in the scientific process and are normally corrected by further research.

This policy:

1. provides a statement on integrity in research and definitions of research misconduct;
2. describes the responsibilities of research personnel, administrators, and members of the academic community;
3. sets forth the procedures for dealing with instances of alleged misconduct in research.

This policy applies to all persons affiliated with Northwestern University–faculty, students, other trainees, and all members of the research staff. Cases of research misconduct involving students are subject to the normal disciplinary rules governing students, but may be reviewed, as appropriate, under this policy. The policy applies to the conduct of research and/or related activities, whether the research is funded or not; presentation and/or publication of results; process of applying for funds; expenditure of project funds; and fiscal reporting on the use of project funds.

It is the policy of the University to require high ethical standards in research; to inquire into and, if necessary, investigate and resolve promptly and fairly all instances of alleged misconduct; and to comply in a timely manner with agency requirements for reporting on cases of possible misconduct when sponsored project funds are involved.

Since a charge of misconduct, even if unjustified, may damage an individual's career, any such issue must be handled in a prudent and confidential manner. An inquiry or investigation must be handled promptly and expeditiously with full attention given to the rights of all individuals involved.

Definitions

Research misconduct is defined as fabrication, falsification, plagiarism, or other practices that seriously deviate from those commonly accepted within the academic community for proposing, conducting, and reporting on research. Research misconduct is to be distinguished from honest error and differences of interpretation. It includes, but is not limited to the following.

1. Falsification or misrepresentation of data, including:
1. reporting experiments, measurements, or statistical analyses never performed;
2. manipulating or altering data or other manifestations of the research to achieve a desired result;
3. falsifying or misrepresenting background information, including biographical data, citation of publications, or
   status of manuscripts;
4. selective reporting, including deliberate suppression of conflicting or unwanted data.
2. Plagiarism, being a misrepresentation of another's work as one's own.
3. Abuse of confidentiality, including use of ideas and preliminary data gained from:
   1. access to privileged information through the opportunity for editorial review of manuscripts submitted to journals, and
   2. the opportunity for peer review of proposals being considered for funding by agency panels or by internal committees, such as the Institutional Review Board, University Research Grants Committee, Animal Care and Use Committee.

Responsibilities

1. Research Personnel. Researchers are responsible for maintaining the highestethical standards in their research. Principal investigators are responsible for:
   1. assuring that these standards are communicated to and maintained by all who work under their supervision, directly or indirectly;
   2. assuring the validity of all information communicated by their research groups;
   3. assuring adequate citation of contributions from those within and outside each research group.
   Co-authorship should reflect scientific involvement and responsibility for work reported. Although collaborative relationships between investigators are based on trust, some joint evaluation of data should be an integral part of the review process, even when unique laboratory procedures necessitate long-distance collaboration.
2. Administrators. The provost and the vice president for research are responsible for ensuring the implementation of this policy on integrity in research. They will provide for widespread dissemination of the policy and will assure that appropriate review procedures are promptly implemented when allegations of research misconduct are reported. The vice president for research will maintain accurate records and, where required, will ensure that proper and timely reporting to relevant agencies is made for any investigation of substantial misconduct. The vice president for research also represents the University when it is determined that present or former research personnel are the subject of complaints or investigations that involve outside institutions. In the event of a determination of research misconduct, the provost may invoke sanctions according to established University procedures.
3. Members of the Academic Community. Members of the academic community are responsible for reporting what they believe to be misconduct on the part of research personnel. The identity of confidential sources will be protected to the extent consistent with the needs of an inquiry or investigation. Those individuals who provide information in good faith about questionable conduct are to be protected against reprisals.

Procedures for Reviewing Alleged Misconduct

1. Reports of alleged misconduct are to be made directly to the appropriate dean, who will immediately inform the vice president for research of the substance of the allegations. Complaints that relate to University research centers, involve more than one school, or by their nature require special consideration (as, for example, cases brought by or against a dean) may be addressed directly to the vice president for research, who will notify the provost of the allegation and, thereafter, of its disposition.
2. A preliminary and informal evaluation of the complaint will be made by the dean or the vice president for research, either of whom may consult in confidence with others as appropriate before passing on the matter.
3. If the dean or the vice president for research finds that there are no reasonable grounds for the allegation, and if the vice president for research or the provost concurs, the complaint will be dismissed without giving any notice to the subject of the complaint. A written report stating the reasons for the dismissal shall be maintained, but will not be made a part of the record of the subject of the complaint. The complainant, who shall be notified of the dismissal, may appeal a decision for dismissal directly to the vice president for research or to the provost.

1. The purpose of an inquiry is to determine whether an allegation or apparent instance of misconduct warrants a full investigation or requires that special actions be taken pending resolution of the allegation or apparent misconduct. The inquiry will determine whether the allegation of misconduct appears to be well founded, the seriousness of the alleged misconduct, scope of the alleged incident, and relevance of any other information that is available. An inquiry should be completed within sixty (60) days after an allegation is made.
2. To the extent possible, inquiries and resultant investigations will be conducted in a confidential manner so as to protect the affected parties. Although a person participating directly in the conduct of an inquiry or investigation must be qualified to evaluate the situation, no such person may have a personal interest in the matter or its outcome.
3. If, after evaluation, the dean believes a complaint warrants further review, the dean may initiate an inquiry or refer the case directly to the vice president for research. In either event, the subject of the complaint shall be notified in writing of the complaint and shall be given a copy of the procedures for reviewing alleged misconduct. The departmental chair will also be notified. At the school level, the inquiry will be conducted by an ad hoc committee of at least three (3) tenured or full-time clinical faculty members chosen by the dean in consultation with the vice president for research. If an inquiry is made at the University level, the vicepresident for research will appoint an ad hoc committee of at least three (3) tenured or full-time clinical faculty from the University at large, and the same procedures for inquiry will be followed.
4. The inquiry committee will review the merit of the allegations and recommend a course of action to the dean or the vice president for research, as appropriate, including whether a full investigation should be conducted. The inquiry committee may have access to documents relating to the alleged misconduct and may interview the complainant and the subject of the complaint. It shall not, however, attempt to reach a decision on the merits of the complaint.
5. After receiving the written report of the inquiry committee, the dean will forward the findings of the committee, along with his/her recommendations, to the vice president for research, who will determine whether to dismiss the case or to proceed with an investigation. The subject of the complaint and the departmental chair will be notified in writing of the vice president's decision.
6. If the complaint is made directly to the vice president for research, the vice president may refer the complaint to the dean for handling at the school level or, after informing the dean, form an ad hoc committee of faculty to conduct an inquiry. After receiving the report of the inquiry committee, the vice president for research will determine whether to dismiss the the case or to proceed with an investigation.
7. If the complainant disagrees with a decision of the vice president for research to dismiss the case, the complainant may appeal to the provost. The provost then will review the case and make a final determination as to appropriate action.
8. If a decision not to investigate is rendered, all the information assembled in the course of the inquiry will be maintained in confidence to permit a later assessment of the reasons for determining that an investigation was not warranted.

1. The purpose of an investigation is to examine thoroughly an allegation of research misconduct and to determine whether such misconduct has taken place.
2. If the vice president for research determines to proceed with an investigation, he/she will appoint a committee of tenured or full-time clinical faculty to investigate the complaint. When appropriate, the vice president for research may appoint experts from outside the University to serve on the committee. Granting agencies supporting the research work under investigation will be notified by the vice president for research that an investigation is taking place, as may be required by the agency. Specific agency requirements, such as the time within which certain steps are to be taken, will be observed and communicated by the vice president for research to the investigating committee and to the subject of the complaint. (For example, Public Health Service guidelines require that an investigation be undertaken within 30 days of the completion of an inquiry and that an investigation be completed within 120 days of its initiation, unless a request for an extension is granted by the Office of Scientific Integrity.)
3. The investigation will include, but not be limited to, review of grant or contract files, reports, scholarly publications, manuscripts, and other documents; inspection of laboratory or clinical facilities and/or materials; interviewing of parties with an involvement in, or knowledge about, the case; and submission of a formal report of committee findings, including response of the subject of the complaint.
4. The subject of the complaint will be given a copy of the complaint, the report of the inquiry committee, and the charge to the investigatory committee by the vice president for research. The subject also will be kept informed by the investigatory committee chairperson of the progress of the investigation and will be given the opportunity to respond to the complaint orally and in writing and to provide information for consideration by the committee.
5. The investigatory committee will focus on matters limited to the charge given to it by the vice president for research, but may review previous research efforts of the affected personnel or records of previous complaints of research misconduct, if germane to the investigation.
6. Neither the University nor the subject of the complaint may have legal counsel present at the meetings of the committee, except at the express invitation of the committee. Should legal counsel be invited, the invitation will be extended to both parties. When invited, legal counsel may observe but shall not participate in the proceedings. With the prior approval of the investigatory committee, the subject of the complaint may be accompanied by a non-attorney colleague.
7. The investigatory committee will prepare a draft final report and provide a copy of such report to the subject of the complaint, who may review and comment, offer corrections, acceptits conclusions, or deny the allegations. The final report of the committee will be transmitted to the vice president for research, along with any minority reports and responses by the subject of the complaint. The committeeís report will respond to the charge given by the vice president for research and will assess the validity of the allegations.
8. The report of the committee and its attachments, along with the recommendation of the vice president for research, will be forwarded by the vice president to the provost for review and disposition. If the provost finds that the subject of the complaint has not engaged in research misconduct, the provost will dismiss the complaint. If the provost finds that the subject of the complaint has engaged in research misconduct, the provost may initiate University procedures leading to possible sanctions. The provost will inform the subject of the complaint and the vice president for research, dean, and departmental chair of his/her decision.

1. At the conclusion of the investigation, or at any other time required by an involved granting agency, the vice president for research will notify the granting agency of the facts of the case, the conclusions rendered, and the disposition of the matter by the University. The vice president for research will notify other outside parties as may be appropriate, including publishers or institutions with whom the party found to have committed research misconduct is now or has been professionally affiliated. The provost will consider release of information about the incident to the public.
2. If the alleged misconduct is not substantiated by the investigation, formal efforts will be made to restore fully the reputation of the subject of the complaint. If it is further demonstrated that the charges were brought under malicious or dishonest circumstances, the provost may bring appropriate action against the complainant or others involved.
3. A permanent record of committee reports, exhibits, minutes of meetings, and other materials will be kept by the vice president for research. These records will be protected from release if release would compromise the conduct of an investigation, constitute unwarranted invasion of privacy, or reveal the content of communications or recommendations of action to be taken. In the case of sponsored projects, the vice president for research is responsible for determining and complying with reporting requirements, representing the University in all negotiations with the sponsor, and implementing any administrative actions that may be directed by the sponsor.
4. Consistent with the procedures described above, those responsible for the conduct of inquiries and investigations shall have at any time the authority to supplement and clarify applicable procedures, provided that adequate notice is given to persons affected by such actions.

Guidelines for Investigators in Scientific Research

Introduction

These Guidelines for Investigators in Scientific Research were formulated by the Research Affairs Committee of the General Faculty Committee. They reflect the commitment of the faculty and administration of Northwestern University to maintain the highest level of integrity in University research and scholarly activity.

If adopted by research groups in all schools of the University, the practices described in these guidelines should assure quality and integrity in research and accuracy in the scientific reports produced at Northwestern. These recommendations are not intended as rules, but rather as guidelines from which investigators in various disciplines can formulate specific procedures to ensure the quality and integrity of their research.

Because these guidelines must be an essential part of Northwestern University's research culture, it is essential that faculty disseminate this information to associated students and staff.

Supervision of Research Trainees

Careful supervision of new investigators by their preceptors is in the best interests of the institution, preceptor, trainee, and scientific community. The complexity of scientific methods and advanced statistical analyses, as well as the necessity for caution in interpreting possibly ambiguous data, require that preceptors assume an active role in guiding new investigators, particularly trainees without substantial research experience.

Data Gathering, Storage, and Retention

A common denominator in most cases of alleged scientific misconduct is the absence of a complete set of verifiable data. The retention of accurately recorded and retrievable results is of the utmost importance for the progress of scientific inquiry. A scientist must have access to his/her original results in order to respond to questions, including those that may arise without any implication of impropriety. Moreover, errors may be mistaken for misconduct when the primary experimental results are unavailable.

Authorship

In recent years, a gradual diffusion of responsibility for multiauthored or collaborative studies has led to the publication of papers for which no single author was prepared to take full responsibility. Two critical safeguards in the publication of accurate scientific reports are:

1. active participation of each co-author in verifying that portion of the manuscript which falls within his/her specialty area, and
2. designation of one author who is responsible for the validity of the entire manuscript.

Publication Practices

Certain practices make it difficult for reviewers and readers to follow a complete research sequence:

1. rapid publication of data without adequate tests of reproducibility or assessment of significance;
2. publication of fragments of a study;
3. submission of multiple similar abstracts or manuscripts differing only slightly in content.

In such circumstances, if any of the work is questioned, it is difficult to determine whether the research was done inaccurately, methods were described imperfectly, analyses were flawed, or inappropriate conclusions were drawn. Investigators should review each proposed manuscript with these potential problems in mind.

Guidelines for Scientific Research

Because groups in the various schools address different scientific problems with different methods, each school or department should develop specific variations on, or additions to, these guidelines to identify practices that seem most likely to enhance the quality of research conducted by its members.

These guidelines are closely modeled after Guidelines for Investigtors in Scientific Research adopted by Harvard Medical School Spring 1988.