UTMB HANDBOOK OF OPERATING PROCEDURES

Section 5 Faculty Policies Subject 5.7 Educational and Research Support Services Policy 5.7.5 Research Misconduct/Fraud

04/01/98-Originated 04/20/00-Reviewed w/ changes -Reviewed w/out changes Council of Deans -Author

Research Misconduct/Fraud

Audience

This policy is for use by all UTMB faculty and staff.

Definition

Misconduct/fraud in research means fabrication, falsification, plagiarism, or other practices that materially deviate from those that are commonly accepted within the academic community for proposing, conducting, or reporting research. It does not include honest errors or honest differences in interpretations or judgments of data. Misconduct may further be defined as retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad faith (Federal Register, Vol. 56, No. 93, Tuesday, May 14, 1991, Rules and Regulations).

Policy

The University of Texas Medical Branch strives to create a research climate that promotes faithful adherence to high ethical standards in the conduct of research without inhibiting the productivity and creativity of persons involved in research. Misconduct or fraud in research is an offense that damages not only the reputation of those involved but also that of the entire educational community. Misconduct/fraud in research is a major breach of the relationship between a faculty or staff member and the institution. In order to maintain the integrity of research projects, every person engaged in research must keep a permanent auditable record of all experimental protocols, data, and findings. Co-authors on research reports of any type, including publications, must have had a bona fide role in the research and must accept responsibility for the quality of the work reported. Scholarly activities which involve faculty/student collaboration are encouraged and may be positively recognized in faculty personnel processes. Issues related to faculty/student collaboration may include matters such as expected contributions of each party, order of authorship, and/or type of citation to be given, and must be addressed early in any scholarly project. Decisions must be congruent with the ethics and scholarly customs of each discipline involved. Specific recognition of the nature and scope of individual student contributions must be made in all published materials.

Policy (cont’d)

Any inquiry or investigation of allegations of misconduct/fraud in research must proceed promptly and with due regard for the reputation and rights of all individuals involved. The University will take all reasonable steps to assure that: • the persons involved in the evaluation of the allegations and evidence have appropriate expertise; • no person involved in the procedures is either biased against the accused person(s) or has a conflict of interest; and, • affected individuals will receive confidential treatment to the maximum extent possible.

Addressing Misconduct/ Fraud

Allegations of misconduct/fraud in research should be brought to the attention of the University’s Scientific Integrity Officer who is appointed by the President. If the allegations were not brought forward by the department chair or the appropriate school dean, the Scientific Integrity Officer will notify the department chair and appropriate school dean of the allegations. These allegations will be brought to the attention of the principal investigator of the research program and any researchers affected by the allegations. If such allegations involve a department chair or a school dean, the allegations should be brought to the attention of the President. Allegations shall be reviewed by the University’s Scientific Integrity Committee comprised of six faculty members appointed by the President. The Scientific Integrity Officer, with due regard for the reputations of all parties involved, will immediately convene the Committee to begin the inquiry process which consists of two steps: the initial allegation assessment and, if necessary, the more formal full inquiry. The entire inquiry process shall not exceed a total of sixty (60) calendar days unless circumstances clearly warrant a longer period, in which case the inquiry record must include documentation of the reasons for exceeding the sixty (60) day period. At the conclusion of the inquiry, a written report shall be prepared and delivered to the President. The report will consist of the complaint, evidence reviewed, a summary of all relevant interviews, and the conclusion(s) of the inquiry, together with the rationale for such

Addressing Misconduct/ Fraud (cont’d)

conclusion(s). The President shall provide the person(s) against whom the allegation(s) has been made a copy of the report and request that any comment in response be made within ten (10) days. If they comment on that report, their comments will be made part of the record. The President, with such advice or consultation as may be deemed appropriate, shall review the inquiry report, the inquiry record, and the comments, if any, of the person(s) accused of misconduct and determine either: • that the allegations are unfounded and that no further proceedings are warranted; or • that there is substantial evidence to support the truth of the allegations, and that hearing procedures to discipline or terminate the accused person(s) should be commenced pursuant to the established due process procedures of the University and the Board of Regents of the University of Texas System. The investigative hearing procedures must begin within thirty (30) days after the conclusion of the inquiry and shall be conducted in accordance with the Regents’ Rules and Regulations, Part I, Chapter III, Section 6.3. This process will include, but not be limited to, conducting an investigation; preparing the report of findings; making that report available for comment by the subjects of the investigation; and submitting the report to the Office of Research Integrity (ORI) or other appropriate funding agencies. The findings shall be delivered to the Board of Regents who will by majority of the total membership approve, reject, or amend such findings, recommendations, and suggestions, or return the report to the same tribunal for hearing additional evidence. An attorney from the U. T. System Office of General Counsel will be available to represent the University in the hearing. If it is determined during an inquiry or investigation that the alleged misconduct/fraud is not substantiated, diligent efforts will be undertaken by the University to restore the reputation of the accused person(s). Diligent efforts will also be taken during an inquiry or investigation to protect the position and reputation of the person(s) who, in good faith, made the allegations.

Addressing Misconduct/ Fraud (cont’d)

In the event that the allegations are admitted by the accused person(s) or the hearing procedures result in a determination that the allegations of misconduct/fraud are true, the University will notify the sponsoring agency, appropriate oversight office (ORI for Public Health Service funding), and other involved granting agencies of the facts related to the allegations, the conclusions reached, and the penalty imposed by the University. In addition, notice will be given to the editors of all journals to which articles related to the affected research have been submitted. This notice will also be given to co-authors, collaborators, professional societies, new and/or prior institutions and affiliations, and local or federal police authorities, where appropriate.

Appeal Process

After the hearing tribunal has submitted its report and the President has announced sanctions, the respondent may use the appeal process in the Board of Regents’ Rules and Regulations to appeal the sanction(s).

Allegations Related to Public Health Service Projects

In the event that allegations of misconduct in science are made with regard to an application for a grant of funds for research, research-training, a research-related activity, or a cooperative agreement under the Public Health Service (PHS) Act, appropriate interim administrative actions will be taken to protect federal funds and to ensure that the purposes of the federal financial assistance are being carried out. In addition, the following actions must be taken: • Notify the Office of Research Integrity (ORI) of the Office of the Director of the National Institutes for Health when it appears at any time during the inquiry or other procedures that: • an immediate health hazard is involved • there is an immediate need to protect federal funds or property, or to protect the interests of the person(s) making the allegations or of the person(s) against whom allegations have been made and/or their co-investigators • it is probable that the alleged misconduct will be made public information exists reasonably indicating that there has been a criminal violation, in which the ORI must be notified within 24 hours of obtaining such information • Notify ORI of any developments during the course of the investigation which disclose facts that may affect current or potential Department of Health and Human Services (HHS)

Allegations Related to Public Health Service Projects (cont’d)

funding for individual(s) under investigation or that the PHS needs to know to ensure appropriate use of federal funds to otherwise protect the public interest. • Notify the ORI that a decision has been made to initiate disciplinary or termination procedures (the “investigation” under the PHS rules), including the name of the person(s) against whom allegations of misconduct have been made, the general nature of the allegations, and the PHS application or grant number(s) involved. • Notify the ORI of any decision that an inquiry or other procedure based upon the allegations will not be pursued to completion together with the reasons for such decision. • Provide ORI with a final report within 120 calendar days of initiation of the investigation of any disciplinary or termination procedure, including a description of such procedures, the sanction imposed, how and from whom relevant information was obtained, the conclusions reached, the basis for such conclusions, and any statement or views of the person(s) found to have engaged in misconduct. • Request an extension of time from ORI when it appears that disciplinary or termination procedures will not be completed within 120 days. The request must include an interim report on progress to date, an explanation for the delay in completion, and an estimate of the anticipated date of completion. If an investigation is not warranted, detailed documentation of the inquiry will be maintained for at least three years and provided to authorized HHS personnel upon request.

Retention of Records

Retention of records shall be in accordance with the Board of Regents’ Rules and Regulations. In addition, the Public Health Service requires that the findings of any inquiry or hearing be sealed upon completion, and that the documents be held at least three years, longer if possible.