Source: https://www.wssu.edu/about/offices-and-departments/legal-affairs/policies-and-procedures/chapter-400-research-intellectual-property/400.9.html
Timestamp: 2018-01-17 15:21:47
Document Index: 360097904

Matched Legal Cases: ['§ 93', 'art 93', '§ 93', '§ 93', '§ 93', '§ 93', 'art 93', '§ 93', '§ 93', '§ 93', 'art 93']

400.9 - Research Misconduct - Winston-Salem State University
University Group Policy #400.9
Consistent with Federal regulations and the policy of the UNC Board of Governors on research misconduct, Winston-Salem State University has created this policy on how the institution will respond to allegations relative to research misconduct.
As a community of scholars in which truthfulness and integrity are fundamental, the University must establish procedures for the investigation of allegations of misconduct of research with due care to protect the rights of those making the allegations, those accused, and the University. Furthermore, federal regulations require the University to have explicit procedures for addressing incidences in which there are allegations of misconduct in research. Therefore, in congruence with the University of North Carolina, Winston-Salem State University has created its specific policy on how the institution will respond to allegations relative to research misconduct.
In developing a regulation on integrity in scholarship and scientific research, the faculty and administration recognize that researchers and scholars are highly principled. However, since the actions of every individual cannot be accounted for, this regulation represents a mechanism to deal with dishonest behavior. It is not the intention of the regulation to stifle free thinking or limit creativity. It is recognized that research results or findings and theories believed in all honesty to be correct at one time may still be proven wrong in the normal course of scholarly investigation.
In the belief that honesty and integrity are essential to the search for knowledge, it is the policy of Winston-Salem State University that all persons involved in research and scholarship must guard the truth, uphold the highest standards in their research, and protect and ensure the public’s trust in Winston-Salem State University, its research, and its researchers. It is clear that misconduct in scholarly research cannot be prevented by university regulation or federal law but only by each individual’s firm commitment to academic ideals and integrity. Mentors, project directors, and department and unit heads must stress the importance of such commitment upon faculty, students, staff, and research assistants and associates.
Whenever any Winston-Salem State University faculty member, graduate student, undergraduate student, or any other person involved in research is accused of misconduct in research, the university will conduct an inquiry, make a determination concerning the truth or falsity of the allegations, and take appropriate disciplinary action. The process of inquiry will be expeditious and protect the rights of all those concerned, including the complainant, the accused, witnesses, and committee members.
Compliance Officer or CO means the institutional official responsible for overseeing inquiries and investigations.
Conflict of interest means the 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 or future personal or professional relationships.
Criteria warranting an inquiry means that an inquiry is warranted if the allegation (1) falls within the definition of research misconduct in this policy, (2) is within 42 CFR § 93.102, and (3) is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
Deciding Official or DO means the institutional official who makes the final determinations on allegations of research misconduct and any responsive institutional actions. The deciding official will have no direct prior involvement in the institution’s inquiry, investigation, or allegation assessment.
Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record [i.e., the record of data or results that embody the facts emerging from the research, and includes but is not limited to, research proposals, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, books, background information, including biographical data, citation of publications or status of manuscripts].
Good faith, as applied to a complainant or witness, means having a belief in the truth of one’s allegation or testimony that a reasonable person in the complainant’s or witness’s position could have based on the information known to the complainant or witness at the time. An allegation or cooperation with a research misconduct proceeding is not in good faith if it is made with knowing or reckless disregard for information that would negate the allegation or testimony. Good faith as applied to a committee member means cooperating with the purpose of helping an institution meet its responsibilities under 42 CFR Part 93. A committee member does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
Inquiry means preliminary information-gathering and preliminary fact finding that meets the criteria and follows the procedures of 42 CFR §§ 93.307-93.309.
Office of Research Integrity or ORI means the office to which the HHS Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS-supported activities.
Preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not. It means that a review of the evidence leads to a finding that is more likely than not, or more than 50% likely.
PHS support means PHS funding, or applications or proposals therefore, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training, that may be provided through: PHS grants, cooperative agreements, or contracts or subgrants or subcontracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements or contracts.
Records of research misconduct proceedings means: (1) the research records and evidence secured for the research misconduct proceeding pursuant to this policy and 42 CFR §§ 93.305, 93.307(b), and 93.310(d), except to the extent the institution subsequently determines and documents that those records are not relevant to the proceeding or that the records duplicate other records that have been retained; (2) the documentation of the determination of irrelevant or duplicate records; (3) the inquiry report and final documents (not drafts) produced in the course of preparing that report, including the documentation of any decision not to investigate, as required by 42 CFR § 93.309(c); (4) the investigation report and all records (other than drafts of the report) in support of the report, including the recordings or transcripts of each interview conducted; and (5) the complete record of any appeal within the institution from the finding of research misconduct.
Research misconduct means fabrication, falsification, or plagiarism, or other practices that seriously deviate from those that are commonly accepted within the research community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data. Research misconduct may also be termed scientific misconduct, misconduct in research, or misconduct in science.
Research record means the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to HHS or an institutional official by a respondent in the course of the research misconduct proceeding. Other examples of research records include but are 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. “Data or results” shall be interpreted broadly to encompass all forms of scholarly information about the research at issue without regard to the type of recording or storage media, including, but not limited to, raw numbers, field notes, interviews, notebooks and folders, laboratory observations, computers and other research equipment, CD-ROMs, hard drives, floppy disks, Zip disks, back-up tapes, machine counter tapes, research interpretations and analyses, tables, slides, photographs, charts, gels, individual facts, statistics, tissue samples, reagents, and documented oral representations of research results, as well as any documents and material provided to HHS or an institutional official by a respondent in the course of the research misconduct proceeding.
Research sponsor means the agency, institution, or organization, if any, that sponsored the research that is the subject of an inquiry or investigation. The research sponsor can be governmental, private, or non-profit in nature. It also includes the Office of Research Integrity of the U. S. Department of Health and Human Services for research that is sponsored by any part of DHHS.
Retaliation means an adverse action taken against a complainant, witness, or committee member by this institution or one of its institutional members in response to (1) a good faith allegation of research misconduct or (2) good faith cooperation with a research misconduct proceeding.
In any inquiry or investigation that involves research sponsored by a federal agency where that federal agency uses a definition of research misconduct that is different from the one in this regulation, the committee must use that agency’s definition for purposes of the university’s responsibilities to that agency. In carrying out the inquiry or investigation for the university’s own purposes, the committee will use either the agency’s definition or the definition in section U, above.
All employees or individuals associated with Winston-Salem State University will report observed, suspected, or apparent research misconduct to the chair of the unit where the respondent is employed/appointed. Any official who receives an allegation of research misconduct must report it immediately to the chair of the unit where the respondent is employed/appointed. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may meet with or contact the chair of the unit where the respondent is employed/appointed to discuss the suspected research misconduct informally, which may include discussing it anonymously and/or hypothetically. If the circumstances described by the individual do not meet the definition of research misconduct, the chair will refer the individual or allegation to other offices or officials with responsibility for resolving the problem.
At any time, any individual may have confidential discussions and consultations about concerns of possible misconduct with the chair, dean, CRO, Director, and/or CO and will be advised regarding appropriate procedures for reporting allegations. These appropriate procedures begin with consultation with the chair of the appropriate discipline, committee or body, or equivalent unit head. If for any reason the respondent cannot discuss the concerns of possible misconduct with the chair, then the discussions will begin with the dean of the appropriate discipline, committee or body, or equivalent unit head.
Institutional employees will cooperate with institutional officials in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence to institutional officials regarding research misconduct allegations.
The Provost shall, as required by 42 CFR § 93.108: (1) limit disclosure of the identity of respondents and complainants to those who need to know in order to carry out a thorough, competent, objective, and fair research misconduct proceeding; and (2) except as otherwise prescribed by law, limit the disclosure of any records or evidence from which research subjects might be identified to those who need to know in order to carry out a research misconduct proceeding. The Provost will use written confidentiality agreements or other mechanisms to ensure that the recipient does not make any further disclosure of identifying information.
Winston-Salem State University may provide confidentiality for witnesses when circumstances indicate that the witnesses may be harassed or may otherwise need protection.
The CO will monitor the treatment of individuals who bring allegations of misconduct and those who cooperate in inquiries or investigations. Any instances of retaliation will be referred to the Provost for appropriate action. The Provost will ensure that these persons will not be retaliated against in the terms and conditions of their employment or other status at the institution. Employees should immediately report any alleged or apparent retaliation to the CO.
To the maximum extent possible, Winston-Salem State University will also protect the privacy of those who report misconduct in good faith. For example, if the complainant requests anonymity, the institution 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 guaranteed. Institutions are required to undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.
As requested and as appropriate, the Provost and other institutional officials shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made.
Inquiries and investigations will be conducted in a manner to 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 failing to thoroughly carrying out the inquiry or investigation.
During the research misconduct proceeding, the CO is responsible for ensuring that respondents receive all the notices and opportunities provided for in 42 CFR Part 93 and the policies and procedures of the institution. Respondents may consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the counsel or personal adviser to interviews or meetings on the case.
F. Interim Administrative Actions and Notifying ORI and/or the Appropriate Oversight Agency or Sponsor of Special Circumstances
Throughout the research misconduct proceeding, the CO will review the situation to determine if there is any threat of harm to public health, federal funds and equipment, or the integrity of the PHS-supported research process. In the event of such a threat, the Provost will, in consultation with the CO, other institutional officials and ORI, take appropriate interim action to protect against the threat. If other sponsors are involved, the appropriate oversight agency or sponsor will be consulted as well. Interim action might include additional monitoring of the research process and the handling of federal funds and equipment, reassignment of personnel or of the responsibility for the handling of federal funds and equipment, additional review of research data and results, or delaying publication. The Director shall, at any time during a research misconduct proceeding, notify ORI immediately if he/she has reason to believe that any of the following conditions exist:
If other sponsors are involved and if these or similar conditions exist, the appropriate oversight agency or sponsor will be notified.
See Related Resources (below) for full Research Misconduct policy.
A. Chair of the Appropriate Discipline, Committee or Body, or Equivalent
The chair of the appropriate discipline, committee or body, or equivalent (chair) will discuss allegations confidentially with the complainant and prepare a report to the dean of the appropriate discipline, committee or body, or equivalent (dean) if the allegation seems serious enough to warrant reporting. In addition, the chair’s responsibilities will include the following:
Receive allegations of research misconduct and
Assess each allegation of research misconduct in accordance with “Conducting the Assessment and Inquiry - Assessment of Allegations” portion of this policy to determine whether it falls within the definition of research misconduct and warrants an inquiry.
NOTE: If a research misconduct allegation is made involving research within a center or institute, information will be reported to the immediate supervisor of the center or ins
The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation. As a matter of good practice, the complainant should be interviewed at the inquiry stage and given the transcript or recording of the interview for correction. The complainant must be interviewed during an investigation, and be given the transcript or recording of the interview for correction.
On the basis of case-by-case determinations, Winston-Salem State University may provide to the complainant for comment: (1) relevant portions of the inquiry report (within a timeframe that permits the inquiry to be completed within sixty [60] days of its initiation); and (2) relevant portions of the draft investigation report. Comments on the draft investigation report must be submitted within thirty (30) days of the date on which the complainant received the draft report. Any comments made by the complainant on the draft investigation report will be considered during the investigation proceeding and included in the final investigation report.
The complainant will have the opportunity to testify before the inquiry and investigation committees, to review all portions of the inquiry and investigation reports pertinent to his/her allegations or testimony, to be informed of all the results of the inquiry and investigation, and to be protected from retaliation. Also, the complainant must be afforded an opportunity to review draft reports including their comments before those reports are officially acted upon, to ensure accuracy of representation. The complainant will be informed of the allegations when an inquiry is opened and will be notified in writing of the final determinations and the resulting administrative actions.
The Compliance Officer (CO) shall be an institutional official who is qualified to handle the procedural requirements involved and who is sensitive to the varied demands made on those who conduct research, those who are accused of misconduct, and those who report apparent misconduct in good faith.
The CO will have primary responsibility for implementation of the institutional policies and procedures governing research misconduct allegations, including the following specific responsibilities:
Consult confidentially with persons uncertain about whether to submit an allegation of research misconduct, advise such persons of this policy, and advise that they further discuss with the chair;
Sequester research data and evidence pertinent to the allegation of research misconduct in accordance with “Conducting the Assessment and Inquiry -Notice to Respondent; Sequestration of the Research Records” of this policy and maintain it securely in accordance with this policy and applicable law and regulation;
Assist the inquiry and investigation committees and all institutional personnel in complying with these procedures and with applicable standards imposed by government or external funding sources;
Notify the respondent, after approval of the Provost and Vice Chancellor for Academic Affairs (Provost) as well as institutional counsel, and provide opportunities for him/her to review/comment/respond to allegations, evidence, and committee reports in accordance with “Conducting the Assessment and Inquiry -Notice to Respondent; Sequestration of the Research Records”portion of this policy;
Provides the inquiry and investigation committees with needed logistical support, e.g., expert advice, including forensic analysis of evidence, and clerical support, including arranging witness interviews and recording or transcribing those interviews;
Organize and manage the inquiry and investigative committees and ensure that confidentiality is maintained;
Keep the Deciding Official (DO) and others who need to know apprised of the progress of the review of the allegation of research misconduct;
Maintain records of all documents and evidence pertaining to the research misconduct proceeding; and
Maintain the confidentiality and security of all files.
The CO will prepare all documents necessary to be submitted to the research sponsor and/or the federal agency responsible for research compliance oversight. In the case of non-sponsored research that has already been published or which is under external review, where that research is the subject of an inquiry or investigation, the CO will prepare all necessary documents to be submitted to the publisher or potential publisher.
D. Dean of the Appropriate Discipline, Committee or Body, or Equivalent
The dean of the appropriate discipline, committee or body, or equivalent (dean) will review the report presented by the chair and will forward the report to the Provost and the Dean of the School of Graduate Studies and Research and Chief Research Officer (CRO), with a copy to the CO. In addition, the dean’s responsibilities will include the following:
Receive allegations of research misconduct; and
Assess each allegation of research misconduct in accordance with the“Conducting the Assessment and Inquiry - Assessment of Allegations” portion of this policy to determine whether it falls within the definition of research misconduct and warrants an inquiry; and
In consultation with appropriate institutional officials, review reports to determine whether to conduct an investigation, whether misconduct occurred, whether to impose sanctions, and whether to take other appropriate administrative actions.
E. Dean of the School of Graduate Studies and Research and Chief Research Officer
The responsibilities of the Dean of the School of Graduate Studies and Research and Chief Research Officer (CRO) will include the following:
Receive a report of allegation from the dean;
Review the allegation in consultation with the dean of the appropriate discipline, committee or body, or equivalent, the Director of Sponsored Programs (Director), the CO, and any subject matter experts;
Upon approval of the Provost, initiate the inquiry process;
Receive the inquiry and/or investigation report and any written comments made by the respondent and/or the complainant on the draft report(s); and
F. Deciding Official
The Deciding Official (DO) is the Chancellor of Winston-Salem State University. The DO will make the final decision regarding administrative actions in consultation with the Provost, the CRO, institutional counsel, dean, and/or chair. The DO will also ensure that all administrative actions taken by the institution are enforced.
In addition, the DO, in cooperation with other institutional officials, will take all reasonable and practical steps to protect or restore the positions and reputations of good faith complainants, witnesses, and committee members.
The DO will receive the inquiry report and, after consulting with appropriate institutional officials, will decide whether an investigation is warranted under the criteria in 42 CFR § 93.307(d). Any finding that an investigation is warranted must be made in writing by the DO and must be provided to ORI and/or the appropriate oversight agency or sponsor, together with a copy of the inquiry report meeting the requirements of 42 CFR § 93.309, within thirty (30) days of the finding. If it is found that an investigation is not warranted, the DO will ensure that detailed documentation of the inquiry is retained for at least seven (7) years after termination of the inquiry, so that ORI may assess the reasons why the institution decided not to conduct an investigation.
The DO will receive the investigation report and, after consulting with other appropriate officials, decide the extent to which Winston-Salem State University accepts the findings of the investigation and, if research misconduct is found, decide what, if any, institutional administrative actions are appropriate. The DO shall ensure that the final investigation report, the findings of the DO, and a description of any pending or completed administrative action are provided to ORI and/or the appropriate oversight agency or sponsor, as required by 42 CFR § 93.315.
G. Director of Sponsored Programs
The responsibilities of the Director of Sponsored Programs (Director) include the following:
As necessary, take interim action and notify ORI of special circumstances, in accordance with "General Policies and Principles - Interim Administrative Actions and Notifying ORI and/or the Appropriate Oversight Agency or Sponsor of Special Circumstances" of this policy;
Take appropriate action to notify other involved parties, such as sponsors and professional societies, of those actions; and
Make records of the research misconduct proceeding available to ORI and/or the appropriate oversight agency or sponsor in accordance with “Conducting the Investigation - Investigation Process” portion of this policy.
If the research is federally funded, the Director will report to the research sponsor as required by applicable regulations. The Director will also keep the research sponsor apprised of any developments during the course of the inquiry or investigation that may affect current or potential federal funding for the individual(s) under investigation. The research sponsor will be provided with the information to ensure appropriate use of federal funds and otherwise protect the public interest.
In the case of a non-federal sponsor of research where that research is the subject of an inquiry or investigation, the Director will keep the non-federal sponsor informed as to the inquiry and investigation as appropriate under the circumstances.
In the case of non-sponsored research that has already been published or which is under external review, where that research is the subject of an inquiry or investigation, the Director will keep the publisher of that research or potential publisher of that research informed as to the inquiry and investigation as appropriate under the circumstances.
The Director will officially transmit all documents necessary to be submitted to the research sponsor and/or the federal agency responsible for research compliance oversight.
In the case of non-sponsored research that has already been published or which is under external review, where that research is the subject of an inquiry or investigation, the Director will officially transmit all documents necessary to be submitted to the publisher or potential publisher.
H. Institutional Counsel
Institutional counsel will assist the CO with sequestering research data and evidence pertinent to the allegation of research misconduct in accordance with "Conducting the Assessment and Inquiry - Notice to Respondent; Sequestration of the Research Records" section of this policy and maintain it securely in accordance with this policy and applicable law and regulation. Institutional counsel will also ensure that the process and all administrative actions are conducted in accordance with legal requirements.
In addition, institutional counsel, in cooperation with other institutional officials, will take all reasonable and practical steps to protect or restore the positions and reputations of good faith complainants, witnesses, and committee members. In the event of a finding of research misconduct, institutional counsel will notify involved parties such as law enforcement agencies and licensing boards of the resulting administrative actions taken by the institution.
I. The Provost and Vice Chancellor for Academic Affairs
The Provost and Vice Chancellor for Academic Affairs (Provost) 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, along with the CRO, dean, and/or other subject matter experts will review the report to determine whether to conduct an investigation, whether misconduct occurred, whether to impose sanctions, and whether to take other appropriate administrative actions. The recommendation(s) will be prepared and submitted to the DO.
Other responsibilities of the Provost will include the following:
Determine whether each person involved in handling an allegation of research misconduct has an unresolved personal, professional, or financial conflict of interest and take appropriate action, including refusal, to ensure that no person with such conflict is involved in the research misconduct proceeding; and
In cooperation with other institutional officials, take all reasonable and practical steps to protect or restore the positions and reputations of good faith complainants, witnesses, and committee members and counter potential or actual retaliation against them by respondents or other institutional members.
The Department of Public Safety will assist the CO with sequestering research data and evidence pertinent to the allegation of research misconduct in accordance with"Conducting the Assessment and Inquiry - Notice to Respondent; Sequestration of the Research Records" portion this policy and maintain it securely in accordance with this policy and applicable law and regulation.
A good faith effort from the CO to notify the respondent in writing at the time of or before beginning an inquiry;
An opportunity to comment on the inquiry report and have his/her comments attached to the report;27
Be notified of the outcome of the inquiry, and receive a copy of the inquiry report that includes a copy of, or refers to, 42 CFR Part 93 and the institution’s policies and procedures on research misconduct;28
Be notified in writing of the allegations to be investigated, within a reasonable time after the determination that an investigation is warranted, but before the investigation begins (within thirty [30] days after the institution decides to begin an investigation), and be notified in writing of any new allegations, not addressed in the inquiry or in the initial notice of investigation, within a reasonable time after the determination to pursue those allegations;
Be interviewed during the investigation, have the opportunity to correct the recording or transcript, and have the corrected recording or transcript included in the record of the investigation;30
Receive a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the evidence on which the report is based, and be notified that any comments must be submitted within thirty (30) days of the date on which the copy was received and that the comments will be considered by Winston-Salem State University and addressed in the final report.
The respondent will be informed in writing of the allegations when an inquiry is opened and will be notified in writing of the final determinations and the resulting administrative actions. The respondent may be interviewed by the inquiry and investigation committees. The respondent will also have the opportunity to be interviewed by and to present evidence to the inquiry and investigation committees, to review the draft inquiry and investigation reports, and to have the advice of legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) and may bring the counsel or personal adviser to interviews or meetings on the case.
The respondent shall be given the opportunity to admit that research misconduct occurred and that he/she committed the research misconduct. With the advice of the Provost, institutional counsel, and CRO, the DO may terminate Winston-Salem State University’s review of an allegation that has been admitted if the institution’s acceptance of that admission and any proposed settlement is approved by ORI and/or the appropriate oversight agency or sponsor.
If the respondent is not found guilty of research misconduct, he/she has the right to receive institutional assistance in restoring his or her reputation.
This regulation and the associated procedures apply to all individuals at Winston-Salem State University engaged in research, regardless of the sponsor of the research.
Approved by Cabinet May 21, 2007
Adopted June 15, 2007
Misconduct Research (PDF)