Policy 7113 – Misconduct in Scientific Research or Research Training
Revision Date: 04/18/2023
Last Review: 04/18/2023
Responsible Office: Office of Research and Partnerships
Reference: Public Health Service Office of Research Integrity
Allegations of scientific misconduct are to be submitted in writing to the Chief Research Officer (CRO). The CRO will form a subcommittee of the Research Council (chair designated by the CRO) to conduct inquiries and investigations into allegations of scientific misconduct in research, funded or non-funded, and retain the required documentation of each inquiry or investigation on file. Notification of inquiries and their outcomes will be given to the University President, the Provost, and the Dean of the College of the respondent(s) [i.e., person(s) against whom allegations are made]. In addition, other administrators may be notified as deemed necessary by the CRO.
If the research in which the alleged misconduct occurred is supported by or involves an application for Public Health Service (PHS) funds, the CRO must notify the Office of Research Integrity (ORI) within the US Department of Health & Human Services on or before the day the investigation begins.
The policies governing the conduct of inquiries and investigations into allegations of research misconduct—regardless of whether ORI notification is required—are based on the Code of Federal Regulations (CFR), specifically, 42 CFR Subpart C Sections § 93.300-93.3191 and the guidance provided by the ORI. Therefore, this particular policy and procedures do not apply to misconduct involving misuse or misappropriation of research funds or equipment.
CRO: Chief Research Officer
Misconduct: Consistent with 42 CFR Subpart C §93.103, research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results, and does not involve honest error or difference of opinion.
PHS: Public Health Service. The following agencies distribute PHS funds:
- National Institutes of Health (NIH)
- Food and Drug Administration (FDA)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Agency for Healthcare Research & Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
ORI: Office of Research Integrity
Respondent(s): Person(s) from whom a response is requested as a result of allegations of misconduct being made against them.
Upon receipt of an allegation of research misconduct, the CRO must notify the respondent(s) in writing when an inquiry is initiated. If deemed necessary, the CRO will “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 securely sequester them, except that where the research records or evidence encompass scientific instruments shared by several 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.” [§ 93.307(b)]
The subcommittee of the Research Council formed by the CRO:
Will meet within the next three days the University is in session to review the allegations and initiate an inquiry. As defined in CFR 93.212, “Inquiry means preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures of §§ 93.307-93.308.” Specifically, “The purpose of an inquiry is to conduct an initial review of the evidence to determine whether to conduct an investigation. Therefore, an inquiry does not require a full review of all the evidence related to the allegation.” [§ 93.307(c)]. An inquiry aims to decide if an allegation warrants an investigation [§ 93.307(d)].
An investigation is warranted if there are:
- A reasonable basis for concluding that the allegation falls within the definition of research misconduct under this part and involves PHS-supported biomedical or behavioral research, research training, or activities related to that research or research training, as provided in § 93.102; and
- Preliminary information-gathering and preliminary fact-finding from the inquiry indicate that the allegation may have substance.
The inquiry must be completed within 60 calendar days of its initiation unless circumstances warrant a more extended period. If the inquiry takes longer than 60 days to complete, the record of the inquiry shall include documentation of the reasons for exceeding the 60 days. At the conclusion of the inquiry, the subcommittee will submit an inquiry report to the CRO following the format outlined in § 93.309.
If the subcommittee decides that an investigation is not warranted, “sufficiently detailed documentation of inquiries” should be provided to the CRO “to permit a later assessment by ORI of the reasons why the institution decided not to investigate. Consistent with § 93.317, institutions must securely keep these records for at least 7 years after the termination of the inquiry and upon request, provide them to ORI or other authorized HHS personnel.”
The respondent(s) shall be allowed to review and comment on the inquiry report. Any comments received must be made part of the record.
If an investigation is deemed warranted [§ 93.310], the CRO must inform the respondent that an investigation is being initiated and provide written notice of any new allegations of research misconduct not addressed during the inquiry or in the initial notice of investigation.
The investigation must be initiated within 30 days of the inquiry’s conclusion. If PHS funds are involved (see Policy section), the ORI must be informed on or before the day the investigation begins.
During the investigation, the subcommittee will:
- Take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable, including the participation of persons with appropriate scientific expertise who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry or investigation.
- Afford the affected individual(s) confidential treatment to the maximum extent possible, a prompt and thorough investigation, and an opportunity to comment on allegations and findings of the inquiry and/or the investigation.
- Interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the respondent.
- Record or transcribe each interview, provide the recording or transcript to the interviewees for correction, and include the recording or transcript in the investigation record.
- Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion.
- The investigation must be completed within 120 days, including preparing the report of the findings as specified in § 93.313.
- If the ORI had been informed of the decision to initiate an investigation, the CRO will submit the following to the ORI at the conclusion of the process.
- Investigation Report, including attachments and any appeals.
- Whether the institution found research misconduct, and if so, who committed the misconduct.
- Whether the institution accepts the investigation’s findings.
- Description of any pending or completed administrative actions against the respondent.
- Supporting information such as figures, photographs, transcripts of interviews, recordings of interviews, etc.
All records pertaining to the investigation will be retained securely for 7 years, as outlined in § 93.317.
III. Special Circumstances
At any time during a research misconduct proceeding (including but not limited to allegation assessments, inquiries, investigations, ORI oversight reviews, hearings, and administrative appeals), an institution must notify ORI immediately if it has reason to believe that any of the following conditions exist [§ 93.318]:
- Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
- HHS resources or interests are threatened.
- Research activities should be suspended.
- There is a reasonable indication of possible civil or criminal law violations.
- Federal action is required to protect the interests of those involved in the research misconduct proceeding.
- The research institution believes the research misconduct proceeding may be made public prematurely so that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved.
- The research community or public should be informed.
IV. Record Retention
The CRO and the subcommittee will maintain sufficiently detailed documentation of inquiries to permit a later assessment of the reasons for determining that an investigation was not warranted, if necessary. Such records shall be securely maintained for at least seven years after the termination of the inquiry.
The investigation typically will include examining all documentation, including but not necessarily limited to relevant research data and proposals, publications, correspondence, and memoranda of telephone calls. In addition, whenever possible, interviews should be conducted with all individuals involved either in making the allegation or against whom the allegation is made, as well as other individuals who might have information regarding key aspects of the allegations; complete summaries of these interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file. These records shall be securely maintained for at least seven years after the termination of the investigation.