Definitions

A. “Allegation means a disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication to an institutional or HHS official.” 42 CFR § 93.201

B. Burden of proof refers to the responsibilities of certain parties in a misconduct investigation to prove something by a preponderance of evidence.

• The institution or HHS has the burden of proof for making a finding of misconduct if either establishes “that the respondent intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records and failed to produce them in a timely manner and that the respondent’s conduct constitutes a significant departure from accepted practices of the relevant research community.” [42 CFR § 93.106(b)(1)] The records are those that would adequately document the research in question.
• The respondent has the burden of proof to prove any and all affirmative defenses s/he raises. [42 CFR §93.106(b) (2)]
• The respondent has the burden of proof to prove that any mitigating factors are relevant to a decision to impose administrative actions. [42 CFR §93.106(b)(3)]

C. “Complainant means a person who in good faith makes an allegation of research misconduct.” [42 CFR § 93.203] This individual may commonly
be referred to as a whistle-blower. More than one person may be involved.

D. Confidentiality means that the disclosure of the identity of the respondent, complainants, and the revealing of evidence from which the identity of research subjects may be determined must be limited to those with a need to know including ORI for the conduct of the research misconduct proceedings. [42 CFR § 93.108] The Research Integrity Officer may use confidentiality agreements or other mechanisms to ensure that recipients of identifying information do not disclose it to other individuals.

E. 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 unresolved personal, professional, or financial conflicts of interest. There should be no conflict of interest between any individual responsible for carrying out any part of the research misconduct proceeding and the complainant, respondent, or witnesses. [42 CFR § 93.300(b)]

F. Deciding Official (DO) means the institutional official who makes final determinations on reports of inquiries and investigations into allegations of misconduct and any responsive institutional actions. The Dean of the college in which the allegation is made would normally be the deciding official. In the event the Dean is involved in the allegation, or the allegation involves an individual not associated with the college, or if the allegation involves individuals from more than one college, The Vice President for Academic Affairs and Provost is the Deciding Official.

G. “Evidence means any document, tangible item, or testimony offered or obtained during a misconduct proceeding that tends to prove or disprove the existence of an alleged fact.” [42 CFR § 93.208]

H. Good faith [42 § 93.210)

• A complainant or witness is acting in good faith if s/he believes that what they are saying in their allegation or testimony is true based on the information that they have available to them at the time and that a reasonable person in their position would have this same belief.
• A committee member is acting in good faith if s/he is honest and not influenced by any type of conflict of interest in performing their duties to help the University fulfill its responsibilities as described in 42 CFR Part 93.

I. Health and Human Services (HHS) means United States Department of Health and Human Services.

J. Inquiry means the initial gathering and review of the evidence used to determine if an allegation warrants an investigation. [42 CFR § 93.212 and 93.307 (d)]. The scope of the inquiry is limited with respect to interviews and analyses and does not include a determination of whether or not misconduct has occurred.

K. “Institutional member or members means a person who is employed by, is an agent of, or is affiliated by contract or agreement with an institution. Institutional members may include, but are not limited to, officials, tenured and untenured faculty, teaching, and support staff, researchers, research coordinators, clinical technicians, postdoctoral, and other fellows, students, volunteers, agents, and contractors, subcontractors, and subawardees, and their employees. [42 CFR § 93.214]

L. Investigation means the formal examination and evaluation of all relevant facts to determine if misconduct has occurred and, if so, to determine the person(s) responsible and the seriousness of the misconduct. Recommendations for actions for appropriate action may be included in misconduct findings. A decision may also be made not to make a finding of misconduct. [42 CFR § 93.215] Findings are made based on a preponderance of the evidence. The respondent has the burden of proof for any affirmative defenses (including honest error or difference of opinion) raised.

M. Notice means a written communication served in person, sent by mail or its equivalent to the last known street address, facsimile number, or email address of the addressee.” [42 CFR § 93.216}

N. Office of Research Integrity (ORI) is the HHS office responsible for PHS related research integrity and misconduct issues. [42 CFR § 93.217]

O. “Preponderance of 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.” [42 CFR § 93.219]. This is the standard of proof applied to research misconduct findings.

P. Public Health Service (PHS) a unit of the HHS that includes the Office of Public Health and Science and multiple operating divisions and offices. [42 CFR § 93.220]. Funding components of the PHS are defined in 42 CFR § 93.209.

Q. PHS support means PHS funding, or applications, or proposals for the same for biomedical, or behavioral research, or research training, or activities related to these, that may be provided though various PHS funding instruments e.g. grants, cooperative agreements or contracts. [42 CFR § 93.221]

R. Research means a systematic experiment, study, evaluation, demonstration, or survey designed to develop, or contribute to knowledge. Additional details as it applies to public health are described in 42 CFR § 93.222.

S. Research evidence includes any written or non-written account or object that may provide information regarding the alleged scientific misconduct. Evidence includes, but is not limited to, grant or contract applications (both funded and unfunded), grant or contract progress or other reports, laboratory records (both physical and electronic) such as laboratory notebooks, notes, internal reports, correspondence, videos, photographs, digital images, x-ray film, gels, slides, biologic materials, computer files, and printouts, manuscripts (both final and draft versions), publications (print and online), abstracts, theses, oral, and poster presentations, equipment use logs, laboratory procurement records, animal facility records, human, and animal subject protocols, monitoring (including auditor) reports, consent forms, medical charts, and patient research files.

T. Research Integrity Committee (RIC) means the standing committee at the Medical University of South Carolina charged with conducting inquiries and investigations of research misconduct and maintaining confidentiality concerning the proceedings. Members must be thorough, competent, objective, and fair in their actions. No member serving on an inquiry or investigation committee should have real, or apparent personal, professional, or financial conflict of interest with the complainant, respondent, or witnesses. The RIC submits reports of inquiries and investigations to the RIO who, after review, forwards them to the deciding official for the case. It also serves as a resource to the constituent colleges regarding policies and procedures for handling alleged scientific misconduct.

U. Research Integrity Officer (RIO) means the institutional official appointed by the Associate Provost for Research who initially assesses allegations of misconduct to determine if an inquiry is warranted and oversees any resulting inquiries and investigations. This individual performs various intermediary functions in conjunction with this oversight. As required, the RIO will be in contact with ORI during the course of research misconduct proceedings involving PHS supported research. In addition, the RIO will contact ORI as needed for consultation and advice e.g. technical assistance.

V. “Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. (a) Fabrication is making up data or results and recording, or reporting them. (b) 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. (c) Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. (d) Research misconduct does not include honest error or differences of opinion.” [42 CRF § 93.103] In order for a finding of misconduct to be made by the investigation committee intentional, knowing, or reckless commitment of the misconduct and “significant departure from accepted practices of the relevant research community” must be shown by a preponderance of the evidence.

W. Research misconduct proceeding includes assessment, inquiries, investigations, ORI oversight reviews, and other actions related to the allegation of research misconduct. [42 CFR § 93.223]

X. Research record means the record of the data or results embodying the facts of a scientific inquiry and anything provided by the respondent during a misconduct proceeding. [42 CFR § 93.224] The composition of this record is described in research evidence.

Y. Respondent means the individual against whom an allegation of research misconduct has been made. More than one person may be involved. [42 CFR § 93.225]

Z. Retaliation means an adverse action (e.g. affecting employment or institutional status) taken against a complainant, witness, or committee member (inquiry or investigation) by an institution or an institutional member in response to a good faith allegation of research misconduct or cooperation with a misconduct proceeding. [42 CFR § 93.226]