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Federal Policies on Research Misconduct

I. PURPOSE

To protect the health and safety of the public, promote the integrity of federally funded research, and preserve public funds, the United States Department of Health and Human Services (HHS) and the National Science Foundation (NSF) require institutions to develop and implement policies and procedures to identify and prevent research misconduct.

II. HISTORY

A. ORI

As a result of widespread research misconduct occurring in institutions receiving Public Health Service (PHS) funding, Congress passed the Health Research Extension Act in 1985. The Act mandated that HHS establish processes to review reports of research misconduct. In 1993, the National Institute of Health Revitalization Act delegated the responsibility of dealing with research misconduct to the Office of Research Integrity (ORI). ORI policies were revised in 1999 by the HHS Secretary to adopt a government-wide definition of research misconduct, require institutional training in responsible conduct for research staff, and protect whistleblowers in research misconduct cases. The ORI released new research misconduct regulations in 2005, which added more specific guidelines on the proper handling of research misconduct within an institution receiving PHS funding.

B. NSF

In 1950, Congress created the National Science Foundation (NSF) “to initiate and support basic scientific research and programs to strengthen scientific research . . . and science education programs,” Among other objectives. NSF has authority to prescribe rules and regulations to govern its organization. In 2002, NSF updated the regulations regarding research misconduct to be more consistent with federal policy. On December 1, 2012, the Office of Inspector General (OIG) within NSF sent out a Dear Colleague Letter outlining specific policies and procedures regarding the handling of inquiry, investigation, findings, and actions pertaining to research misconduct.

III. APPLICABILITY TO BYU–Hawaii

To the extent that BYU–Hawaii applies for or receives PHS or NSF funding for research, the university must establish and implement policies and procedures for addressing allegations of research misconduct, take appropriate steps to respond to and report allegations of research misconduct, and fulfill other requirements mandated by federal research misconduct regulations, as summarized below. The PHS research misconduct regulations apply to “[e]ach institution that applies for or receives PHS support for biomedical or behavioral research, research training or activities or activities related to that research or training.” The NSF research misconduct regulations apply to any research misconduct that occurs “in proposing or performing research funded by NSF, reviewing research proposals submitted to NSF, or in reporting research results funded by NSF.” While the two sets of regulations overlap significantly, each set has some differences in its level of detail and required procedures.

IV. REQUIREMENTS

A. Definition of Research Misconduct

Research misconduct is defined as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research.” Fabrication is recording made up data or results. Falsification is the misrepresentation of research by changing or excluding data or results, or manipulating materials, equipment, or processes. Plagiarism is taking credit for another’s “ideas, processes, results, or words.” Research misconduct does not include an “honest error or differences of opinion.”

To establish a finding of research misconduct, (a) there must be a significant departure from accepted research practices; (b) the misconduct must “be committed intentionally, knowingly, or recklessly;” and (c) the allegation must be proven by a preponderance of the evidence.

B. General Institutional Responsibilities

Any institution applying for or receiving PHS or NSF funding is required to have written policies and procedures for addressing allegations of research misconduct. The institution must take all reasonable and practical steps to protect the positions and reputations of those coming forward with allegations of research misconduct within the institution. All persons involved in any research misconduct investigation must be provided confidentiality to the extent that the law requires.

Additional general responsibilities apply to institutions that apply for or receive PHS funding. Specifically, the PHS rules require an institution to foster a research environment that promotes responsible research practices while discouraging misconduct. Also, each allegation of research misconduct for which the institution is responsible must be dealt with fairly and objectively. A PHS funded institution also must provide PHS with an assurance of compliance to receive PHS funding. The responsible institutional official must maintain and adhere to written policies and procedures for investigating research misconduct and provide them upon request to the ORI, HHS, or members of the public.

All institutional research members involved in PHS supported research must be informed of the institution’s policies and procedures for responding to allegations of research misconduct. The ORI may decide that a PHS funded institution is noncompliant if the institution shows disregard for, or inability or unwillingness to implement and follow federal guidelines. In making this decision, the ORI may consider, but is not limited to, the following factors:

  • failure to establish and comply with institutional policies and procedures;
  • failure to respond appropriately to allegations of research misconduct;
  • failure to report all investigations and findings of research misconduct to the ORI; and
  • failure to cooperate with ORI’s review of research misconduct proceedings.

C. Policies and Procedures

Required policies and procedures for addressing allegations of research misconduct can be divided into two areas: inquiry and investigation. Inquiry involves determining whether or not the allegations merit a full investigation, whereas investigation involves a complete examination of the evidence to determine whether research misconduct actually occurred. In general, PHS mandates more detailed policies and procedures than NSF. Unless otherwise noted below, procedures for investigating alleged research misconduct generally may be applied to both NSF- and PHS-funded research. If ORI and NSF are investigating the same allegation of research misconduct, NSF may follow the same procedures as other entities.

1. Inquiry into Research Misconduct

An inquiry is warranted if the allegation falls within the definition of research misconduct and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The alleged perpetrator of research misconduct—the respondent—must be notified in writing when the inquiry begins. The institution must then seize and secure all evidence needed to conduct the research misconduct proceeding. After the evidence is initially examined, the institution must prepare an inquiry report based on initial findings. The respondent must be provided an opportunity to review and comment on the inquiry report, which must include a copy of or refer to the institution’s policies and procedures regarding research misconduct. The person who came forward with the allegation—the complainant—also may be notified if an investigation is found to be warranted and may receive and comment on relevant portions of the report.

The institution must then determine if an investigation is warranted. An institutional investigation is warranted if (a) there is a reasonable basis that the allegation falls within the definition of research misconduct and (b) the inquiry shows that the allegation is substantial. For NSF-funded projects, NSF may send an inquiry letter to the respondent seeking information about the allegations, or NSF may d[e]fer its inquiry until the institution has completed its own inquiry and has provided an inquiry report to NSF.

For PHS-funded projects, if the institution finds that an investigation is warranted, the institution must notify ORI within thirty days. Specifically, the institution must provide the ORI with the written finding by the responsible institutional official and a copy of the inquiry report. The report must include the name and position of the respondent, a description of the allegations, PHS support amounts, the basis for recommending that an investigation be conducted, and any comments on the report by the respondent or complainant. If the institution decides not to conduct an investigation, documentation from the inquiry must be kept for at least seven years and provided upon request to the ORI. The inquiry must be concluded within sixty days from its initiation. The ORI must be notified of any decision to conduct an institutional investigation.

2. Investigation of Research Misconduct

An investigation is consists of the formal development, examination, and evaluation of a factual record to determine whether research misconduct occurred, and if so, to assess its seriousness and take appropriate action. The investigation procedures for PHS-funded research differ somewhat from NSF-funded research.

a. Investigations of PHS-funded research

The institution must begin an investigation into the research misconduct within thirty days after determining the investigation is warranted. The institution must take reasonable steps to ensure an impartial, fair, and unbiased investigation. All parties involved, including the respondent, complainant, and any witnesses must be interviewed as part of the investigation. The recording or transcript of each interview must be provided to the interviewee for correction, and each recording or transcript should be included in the record of the investigation.

The investigation must be completed within 120 days from its initiation. With the completion of the investigation, the institution must draft a report detailing the results of the investigation. The respondent must receive a copy of the draft investigation report and the evidence upon which the report is based. The institution must then create a final investigation report. This report must be in writing and include all of the following:

  1. The nature of the allegations of research misconduct
  2. PHS support amount
  3. Institutional charge describing the specific allegations of research misconduct being considered
  4. Policies and procedures, if not already included in the ORI inquiry report
  5. Research records and evidence
  6. A statement of findings identifying whether research misconduct occurred for each allegation. If research misconduct occurred, the institution must include in the statement
  • “whether the research misconduct was falsification, fabrication, or plagiarism, and if it was intentional, knowing, or in reckless disregard;
  • summarize the facts and analysis . . . and consider the merits of any reasonable explanation by the respondent;
  • identify specific PHS support;
  • identify whether any publications need correction or retraction;
  • identify the person(s) responsible for the misconduct; and
  • list any current support or known proposals for support the respondent has pending with non-PHS federal agencies.”

7. Any comments made by the respondent or complainant

At the conclusion of the investigation, the institution must provide the ORI with the investigation report, the final institutional action, findings, and institutional administrative actions taken against the respondent.

If the institution plans to close a case early at the inquiry or investigation stage on the basis that the respondent has admitted guilt, or a settlement has been reached, or for any other reason, the institution must inform the ORI. At this point, the ORI may approve the closure of the case, direct the institution to complete the entire process, refer the matter to HHS for further investigation, or take compliance action. As with the inquiry stage, all records of research misconduct proceedings must be kept for at least seven years after the completion of the proceedings.

b. Investigations of NSF-Funded Research

Before OIG conducts an investigation, typically NSF asks the institution to conduct its own investigation and provide OIG with evidence and conclusions. The institution has 180 days to conduct an investigation and report its findings to OIG. The report must include a description of the allegation, the curriculum vita for each investigator, the methods and procedures for gathering and evaluating information, a summary of the records compiled, a statement of findings with the reasoning and evidence supporting those conclusions, and a description and explanation of any actions recommended and/or imposed by the institution.

Once OIG receives the institution’s investigation report, OIG either accepts the report in whole or in part, or conduct its own independent investigation. If OIG finds research misconduct did not occur, OSF will close the case and notify the respondent and complainant. If OIG finds that research misconduct did occur, OSF prepare its own investigation report with proposed findings and actions, and submits that report to the Deputy Director of NSF for final decision.

3. Special Circumstances

At any time during a research misconduct proceeding, an institution must immediately notify ORI and/or OIG if the institution has reason to believe that any of the following conditions exist:

a) health or safety of the public is at risk;
b) HHS or NSF resources or interests are threatened
c) research activities should be suspended;
d) there is reasonable indication of possible violations of civil or criminal law;
e) federal action is required to protect the interests of those involved in the research misconduct proceeding;
f) the institution believes the research misconduct proceeding may be made public prematurely so that HHS may take the appropriate steps to safeguard evidence and protect the rights of those involved; or
g) the research community or public should be informed.

V. PENALTIES

ORI or HHS may take any of the following actions in connection with research misconduct that involves PHS-funded research:

  1. issue a letter of reprimand;
  2. direct that research misconduct proceedings be handled by HHS;
  3. place the institution on special review status;
  4. place information on the institutional noncompliance on the ORI website;
  5. require the institution to take corrective actions;
  6. require the institution to adopt and implement an institutional integrity agreement; and/or
  7. recommend that the entity be suspended or debarred.

OIG may recommend, and NSF may take, any of the following actions in connection with research misconduct that involves NSF funded research:

  1. issue a letter of reprimand;
  2. recommend that the institution be suspended or debarred;
  3. require that an individual or institution obtain special prior approval of particular activities as a condition of an award;
  4. require an institutional officer to certify the accuracy of reports generated under the award;
  5. require a correction to the research record;
  6. suspend or restrict an active award for the specified period of time;
  7. terminate an award; and/or
  8. require special reviews for all requests for funding from an affected individual or institution to prevent future misconduct.

VI. COMPLIANCE CALENDAR

Any institution subject to the PHS research misconduct regulations must file an annual report with the ORI detailing the institution’s compliance with federal regulation. Along with this report, the institution must send upon request any information regarding institutional research misconduct proceedings.