Below are the guidelines and procedures adopted by The University of Texas Health Science Center at Houston (“university”) for allegations of research misconduct.
The university’s underlying policy regarding research misconduct can be found in HOOP Policy 202 Honesty in Research.
Allegation: Any written or oral statement or other indication of possible research misconduct made to a university official.
Complainant: Person who in good faith makes an allegation of scientific research misconduct.
Conflict of interest: Real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.
DHHS: United States Department of Health and Human Services.
Research Misconduct: Fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.
Good Faith Allegation: Allegation made with the honest belief that research misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation.
Inquiry: Gathering information and initial fact-finding to determine whether an allegation or apparent instance of research misconduct warrants an investigation.
Investigation: Formal examination and evaluation of all relevant facts to determine if research misconduct has occurred, and, if so, to determine the responsible person and the seriousness of the misconduct.
ORI: Office of Research Integrity, the office within the U.S. Department of Health and Human Services (DHHS) that is responsible for the research misconduct and research integrity activities of the U. S. Public Health Service.
PHS: U. S. Public Health Service, an operating component of the DHHS.
PHS Regulation: Public Health Service regulation establishing standards for institutional inquiries and investigations into allegations of research misconduct, which is set forth at 42 C.F.R. Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science."
PHS Support: PHS grants, contracts, or cooperative agreements, or applications therefore.
Research Record: Data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.
Respondent: Person against whom an allegation of research misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There can be more than one respondent in any inquiry or investigation.
Retaliation: Any action that adversely affects the employment or other institutional status of a complainant that is taken by the university or an employee because the complainant has, in good faith, made an allegation of research misconduct or of inadequate institutional response thereto or has cooperated in good faith with an investigation of such allegation.
The university’s Provost and Executive Vice President of Research (“Provost”) will serve as the university’s Research Integrity Officer who will have the primary responsibility for implementation of the procedures set forth in this appendix.
The Provost will appoint the inquiry and investigation committees and ensure that necessary and appropriate expertise is secured to carry out a thorough and authoritative evaluation of the relevant evidence in an inquiry or investigation. The Provost will make every effort to ensure that confidentiality is maintained.
The Provost will assist inquiry and investigation committees and all university personnel in complying with these procedures and with applicable standards imposed by government or external funding sources. The Provost is also responsible for maintaining files of all documents and evidence and for the confidentiality and the security of the files.
For research supported by PHS, the Provost will report to ORI as required by regulation and keep ORI apprised of any developments during the course of the inquiry or investigation that may affect current or potential DHHS funding for the individual(s) under investigation or that PHS needs to know to ensure appropriate use of federal funds and otherwise protect the public interest. The Provost will notify ORI at any stage of the inquiry or investigation if:
The complainant may have an opportunity to testify before the inquiry and investigation committees, to review portions of the inquiry and investigation reports pertinent to his/her allegations or testimony, to be informed of the results of the inquiry and investigation, and to be protected from retaliation in accordance with HOOP Policy 108 Protection from Retaliation. If the Provost determines the complainant may be able to provide pertinent information on any portions of the draft report, the Provost will give the complainant the relevant portions for comment. The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation.
The respondent will be informed of the allegations when an inquiry is opened and may be notified in writing of the final determinations and resulting actions. The respondent will be given an opportunity to be interviewed by and present evidence to the inquiry and investigation committees, to review the draft inquiry and investigation reports, and to receive advice from his/her personal counsel.
The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation. If the respondent is not found guilty of research misconduct, he or she has the right to receive assistance from the university in restoring his or her reputation.
The Provost acting as the Deciding Official will receive the inquiry and/or investigation report and any written comments made by the respondent or the complainant on the draft report. The Provost will consult with other appropriate university officials and will determine whether to conduct an investigation, whether misconduct occurred, whether to impose sanctions, or whether to take other appropriate administrative actions (refer to Section X, Institutional Administrative Actions).
All employees or individuals associated with the university should report observed, suspected, or apparent research misconduct to the Provost. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may call the Provost to discuss the suspected misconduct informally. If the circumstances described by the individual do not meet the definition of research misconduct, the Provost will refer the individual or allegation to other offices or officials with responsibility for resolving the problem.
At any time, an employee may have confidential discussions and consultations about concerns of possible misconduct with the Provost and will be counseled about appropriate procedures for reporting allegations.
The Provost should seek legal advice from the Office of Legal Affairs and/or the University of Texas System Office of General Counsel at all stages.
The Provost will monitor the treatment of individuals who bring allegations of misconduct or of inadequate response by the university (e.g., complainants), and those who cooperate in inquiries or investigations. The Provost will ensure these persons will not be retaliated against in the terms and conditions of their employment or other status at the university and will review instances of alleged retaliation for appropriate action. Employees should immediately report any alleged or apparent retaliation to the Provost or to other university officials in accordance with HOOP Policy 108 Protection from Retaliation.
The university will protect the privacy of those who report misconduct in good faith to the maximum extent possible. For example, if the complainant requests anonymity, the university will make an effort to honor the request during the allegation assessment or inquiry within applicable policies and regulations and state and local laws, if any. The complainant will be advised that if the matter is referred to an investigation committee and the complainant's testimony is required, anonymity may no longer be possible. Diligent efforts will be used to protect the positions and reputations of those persons who, in good faith, make such allegations.
Inquiries and investigations will be conducted in a manner that will ensure fair treatment to the respondent(s) in the inquiry or investigation and confidentiality to the extent possible without compromising public health and safety or thoroughly carrying out the inquiry or investigation.
University employees accused of research misconduct regarding a PHS project may consult with their personal legal counsel or a non-attorney personal adviser (who is not a principal or witness in the case) to seek advice and may, with the specific prior written approval of the Provost, bring the counsel or personal adviser to interviews or meetings on the case.
If the respondent is not charged with research misconduct, then the Provost will use practical efforts to protect and/or restore the respondent’s reputation.
University employees will cooperate with the Provost and other university officials in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence to the Provost or other university officials on misconduct allegations.
Upon receiving an allegation of research misconduct, the Provost will immediately assess the allegation to determine whether there is sufficient evidence to warrant an inquiry and whether the allegation falls under the definition of research misconduct. An inquiry must be conducted if these criteria are met.
Following the preliminary assessment, if the Provost determines the allegation provides sufficient information to allow specific follow-up and falls under the definition of research misconduct, then he or she will immediately initiate the inquiry process. In initiating the inquiry, the Provost should clearly identify the original allegation and any related issues that should be evaluated. The purpose of the inquiry is to make a preliminary evaluation of the available evidence and testimony of the respondent, complainant, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation. The purpose of the inquiry is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible. The findings of the inquiry must be set forth in an inquiry report.
After determining that an allegation falls within the definition of research misconduct, the Provost must ensure that all original research records and materials relevant to the allegation are maintained in a secure manner. For research supported by PHS, on or before the date on which the respondent is notified, or the inquiry begins, whichever is earlier, the Research Integrity Officer must take all reasonable and practical 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, except that where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. The Provost may consult with ORI for advice and assistance in this regard.
The Provost, in consultation with other university officials as appropriate, will appoint an inquiry committee of at least three persons and a committee chair within 10 calendar days of the initiation of the inquiry. The inquiry committee will consist of individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. These individuals may be scientists, subject matter experts, administrators, ethicists, or other qualified persons, and they may be from inside or outside the university. At least one member shall have an active faculty appointment at the university.
The Provost will promptly notify the respondent of the proposed committee membership. If the respondent submits a written objection to any appointed member of the inquiry committee or expert based on bias or conflict of interest within 7 calendar days, the Provost will determine whether to replace the challenged member with a qualified substitute.
The Provost will prepare a charge for the inquiry committee that describes the allegations and any related issues identified during the allegation assessment and states that the purpose of the inquiry is to make a preliminary evaluation based on the evidence and testimonies of the respondent, complainant, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation as required by the PHS regulations. The purpose is not to determine whether research misconduct definitely occurred or who was responsible.
At the committee's first meeting, the Provost or designee 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. The Provost and university counsel will be present or available throughout the inquiry to advise the committee as needed.
The inquiry committee will normally interview the complainant, the respondent, and key witnesses as well as examining relevant research records and materials. The inquiry committee will evaluate the evidence and testimony obtained during the inquiry. After consultation with the Provost and university counsel, the committee members will decide whether there is sufficient evidence of possible research misconduct to recommend an investigation. The scope of the inquiry does not include deciding whether misconduct occurred or conducting exhaustive interviews and analyses.
A written inquiry report must be prepared that states the name and title of the committee members; the allegations; the PHS support, if any; a summary of the inquiry process used; a list of the research records reviewed; summaries of any interviews; a description of the evidence in sufficient detail to demonstrate whether an investigation is warranted or not; and the committee's determination as to whether an investigation is recommended and whether any other actions should be taken if an investigation is not recommended. University counsel will review the report for legal sufficiency.
The Provost will provide the respondent with a copy of the draft inquiry report for comment and rebuttal and will provide the complainant, if he or she is identifiable, with portions of the draft inquiry report that address the complainant's role and opinions in the investigation or a summary of the inquiry findings for comment.
The inquiry committee will normally complete the inquiry and submit its report in writing to the Provost no more than 60 calendar days following its first meeting, unless the Provost approves an extension for good cause. If the Provost approves an extension, the reason for the extension will be entered into the records of the case and the report. The respondent also will be notified of the extension.
The Provost may establish reasonable methods to protect the confidentiality of the draft report in a manner similarly set forth in IV.B above.
Within 14 calendar days of their receipt of the draft report, the complainant and respondent will provide their comments, if any, to the inquiry committee. Any comments that the complainant or respondent submits on the draft report will become part of the final inquiry report and record. Based on the comments, the inquiry committee may revise the report as appropriate.
The Provost will make the determination of whether findings from the inquiry provide sufficient evidence of possible research misconduct to justify conducting an investigation. The inquiry is ended when the Provost makes this determination.
The Provost will notify both the respondent and the complainant in writing of the decision of whether to proceed to an investigation and will remind them of their obligation to cooperate in the event an investigation is warranted. The Provost will also notify all appropriate university officials of the inquiry decision.
For research supported by PHS, if the Provost decides to proceed to an investigation, he or she will notify the ORI of the decision to begin the investigation and provide ORI a copy of the inquiry report. The notification must be made on or before the date the investigation begins.
The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged misconduct involves clinical trials or potential harm to human subjects or the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation will be set forth in an investigation report.
The Provost will immediately secure any additional pertinent research records that were not previously secured during the inquiry. This sequestration should occur before or at the time the respondent is notified that an investigation has begun. The need for additional sequestration of records may occur for any number of reasons, including the university's decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. The procedures to be followed for sequestration during the investigation are the same procedures that apply during the inquiry.
The Provost, in consultation with other university officials as appropriate, will promptly appoint an investigation committee and a committee chair. The investigation committee will consist of at least three individuals and a committee chair who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. These individuals may be scientists, administrators, subject matter experts, ethicists, or other qualified persons, and they may be from inside or outside the university. Individuals appointed to the investigation committee may also have served on the inquiry committee.
The Provost will promptly notify the respondent of the proposed committee membership. If the respondent submits a written objection to any appointed member of the investigation committee, the Provost will determine whether to replace the challenged member with a qualified substitute.
The investigation committee will be appointed and the investigation will begin within 30 days of the completion of the inquiry.
The Provost or designee will define the subject matter of the investigation in a written charge to the committee that (a) describes the allegations and related issues identified during the inquiry, (b) defines research misconduct, and (c) identifies the name of the respondent. The charge will state that the committee is to evaluate the evidence and testimony of the respondent, complainant, and key witnesses to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, to what extent, who was responsible, and its seriousness. To conclude misconduct occurred, the investigation committee must find that a preponderance of the evidence establishes that: (1) misconduct, as defined by the policy, occurred; (2) the misconduct is a significant departure from accepted practices of the relevant research or scholarship community; and (3) the respondent committed the misconduct intentionally, knowingly, or recklessly. The committee is also charged with making recommendations regarding actions to be taken based on its findings.
During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents, the committee will notify the Provost, who will determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents.
The Provost or designee, with the assistance of university counsel, will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of these instructions and the PHS regulation.
The investigation will normally involve examination of all documentation including, but not necessarily limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls. Whenever possible, the committee should interview the complainant(s), the respondent(s), and other individuals who might have information regarding aspects of the allegations. Interviews of the respondent should be tape recorded or transcribed. All other interviews should be transcribed, tape recorded, or summarized. Summaries or transcripts of the interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigation file.
The draft investigation report must be submitted by the investigation committee to the Provost and shall contain the following elements:
The Provost will give the respondent a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the evidence on which the report is based. The respondent must submit his/her comments on the draft investigation report, if any, within 30 days of the date the respondent received the draft investigation report. The respondent's comments will be attached to the final report. The findings of the final report should take into account the respondent's comments in addition to all the other evidence.
The Provost may provide the complainant, if he or she is identifiable, with those portions of the draft investigation report that address the complainant's role and opinions in the investigation. The report may be modified, as appropriate, based on the complainant's comments. The complainant must submit his/her comments on the draft investigation report, if any, within 30 days of the date the respondent received the draft investigation report. The complainant's comments will be attached to the final report. The findings of the final report should take into account the complainant's comments in addition to all the other evidence.
The draft investigation report will be transmitted to the university’s Office of Legal Affairs for a review of its legal sufficiency. Comments may be incorporated into the report as appropriate.
In distributing the draft investigation report, or portions thereof, to the respondent and complainant, the Provost will inform the recipient of the confidentiality under which the draft report is being made available and may establish reasonable conditions to ensure such confidentiality. For example, the Provost may request the recipient sign a confidentiality statement or to come to his or her office to review the report.
Based on a preponderance of the evidence, the Provost will make the final determination whether to accept the investigation report, its findings, and the recommended institutional actions. For research supported by PHS, if this determination varies from that of the investigation committee, the Provost, in the university's letter transmitting the report to ORI, will explain in detail the basis for rendering a decision different from that of the investigation committee. The Provost's explanation should be consistent with the definition of research misconduct, university policies and procedures, and the evidence reviewed and analyzed by the investigation committee. The Provost may also return the report to the investigation committee with a request for further fact-finding or analysis. For research supported by PHS, the Provost's determination, together with the investigation committee's report, constitutes the final investigation report for purposes of ORI review.
When a final decision on the case has been reached, the Provost may notify both the respondent and the complainant in writing. In addition, the Provost will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The Provost is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.
After comments have been received and the necessary changes have been made to the draft investigation report, the investigation committee will transmit the final report with attachments, including the respondent's and complainant's comments, to the Provost. The Provost is responsible for forwarding the following to the ORI within 120 calendar days of the initiation of the investigation: (1) a copy of the final investigation report with all attachments ;(2) a statement of whether the institution accepts the findings of the investigation report ; (3) a statement of whether the institution found misconduct and, if so, who committed the misconduct; and (4) a description of any pending or completed administrative actions against the respondent.
An investigation should ordinarily be completed within 120 calendar days of its initiation, with the initiation being defined as the first meeting of the investigation committee. This includes conducting the investigation, preparing the report of findings, making the draft report available to the subject of the investigation for comment, submitting the report to the Provost for approval, and, for research supported by PHS, submitting the report to the ORI. For research supported by PHS, an extension may be requested from the ORI when it appears that disciplinary or termination procedures will not be completed within the 120-calendar day time frame. 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 the university plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the PHS regulation, the Provost will submit a report of the planned termination to ORI, including a description of the reasons for the proposed termination.
If the institution determines that it will not be able to complete the investigation in 120 calendar days, the Provost will submit to ORI a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the request is granted, the Provost will file periodic progress reports as requested by the ORI.
When PHS funding or applications for funding are involved and an admission of research misconduct is made, the Provost will contact ORI for consultation and advice. Normally, the individual making the admission will be asked to sign a statement attesting to the occurrence and extent of misconduct. When the case involves PHS funds, the university cannot accept an admission of research misconduct as a basis for closing a case or not undertaking an investigation without prior approval from ORI.
The university will take appropriate administrative actions against individuals when an allegation of misconduct has been substantiated.
If the Provost determines that the alleged misconduct is substantiated by the findings, he or she will decide on the appropriate actions to be taken. The actions may include:
The termination of the respondent's employment at the university, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the misconduct procedures.
If the respondent, without admitting to the misconduct, elects to resign his or her position prior to the initiation of an inquiry, but after an allegation has been reported, or during an inquiry or investigation, the inquiry or investigation will proceed. If the respondent refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the respondent's failure to cooperate and its effect on the committee's review of all the evidence.
If the university finds no misconduct and, for research supported by PHS, ORI concurs, after consulting with the respondent, the Provost will undertake reasonable efforts to restore the respondent's reputation. Depending on the particular circumstances, the Provost should consider notifying those individuals aware of or involved in the investigation or the final outcome, publicizing the final outcome in forums in which the allegation of research misconduct was previously publicized, and/or expunging all reference to the research misconduct allegation from the respondent's personnel file.
Regardless of whether the university or, for research supported by PHS, ORI determines that research misconduct occurred, the Provost will undertake reasonable efforts to protect complainants who made allegations of research misconduct in good faith and others who cooperate in good faith with inquiries and investigations of such allegations. Upon completion of an investigation, the Provost will determine and implement, after consulting with the complainant, what steps, if any, are needed to restore the position or reputation of the complainant. The Provost will also take appropriate steps during the inquiry and investigation to prevent any retaliation against the complainant.
If relevant, the Provost will determine whether the complainant's allegations of research misconduct were made in good faith. If an allegation was not made in good faith, the Provost will determine whether any administrative action should be taken against the complainant.
University officials will take interim administrative actions, as appropriate, to protect federal funds and ensure that the purposes of the federal financial assistance are carried out.
After completion of a case and all ensuing related actions, the Provost will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to the Provost or committees. The Provost will keep the file for 7 years after completion of the case to permit later assessment of the case. For research supported by PHS, ORI or other authorized DHHS personnel will be given access to the records upon request.