USDA Intramural Research Misconduct Policies and Guidelines

U.S. DEPARTMENT OF AGRICULTURE

WASHINGTON, D.C. 20250

DEPARTMENTAL REGULATION

Number:

2401-001

SUBJECT

USDA Intramural Research Misconduct Policies and Guidelines

DATE:

June 18, 2008

OPI:

Research, Education and Economics

1. BACKGROUND

On December 6, 2000, the National Science and Technology Council, Office of Science and Technology Policy of the Executive Office of the President (OSTP) published in the Federal Register (65 FR 76260) the Federal Policy on Research Misconduct (OSTP Policy) as a final, government-wide policy addressing research misconduct. The purpose of the policy was to establish: (1) uniformity among the Federal agencies’ definition of research misconduct, and (2) consistency in their processes for responding to allegations of research misconduct. The OSTP Policy defines research misconduct and establishes basic Federal guidelines for the conduct of fair and timely investigations of alleged or suspected infractions, and provides instruction on agency administrative actions when research misconduct is found. The OSTP Policy covers both intramural and extramural research.

2. PURPOSE

This Departmental Regulation (DR) sets forth U.S. Department of Agriculture (USDA or the Department) policy for implementation of the OSTP Policy applicable to intramural research, such that the Department and all its agencies will comply with OSTP Policy requirements. The Department has a separate rule, 7 CFR Part 3022, on research misconduct related to extramural research.

The OSTP Policy defines “research misconduct” as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results”. USDA hereby accepts and endorses OSTP’s definition of research misconduct.

3. APPLICABILITY AND SCOPE

This DR applies to:

a. The USDA and any and all agencies thereof that engage in research, as defined in Appendix A (hereafter referred to as “USDA Agencies”).

b. All allegations of research misconduct by employees of the USDA who are performers or reviewers of research as well as research managers.

4. DEFINITIONS

Adjudication. The stage in response to an allegation of research misconduct when the outcome of the investigation is reviewed, and appropriate corrective actions, if any, are determined. Corrective actions generally will be administrative in nature, such as termination of an award, debarment, discipline, award restrictions, recovery of funds, or correction of the research record. However, if there is an indication of violation of civil or criminal statutes, civil or criminal sanctions may be pursued.

Agency Research Integrity Officer (ARIO). The individual appointed by a USDA Agency that conducts research and who is responsible for overseeing Agency responsibilities and activities related to research misconduct.

Allegation. A disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement, or by other means of communication to an institutional or USDA official.

Assistant Inspector General for Investigations. The individual in the Office of Inspector General (OIG) that carries out the OIG's domestic and foreign investigative operations through a headquarters office and the seven regional offices.

Extramural research. Research conducted by any research institution other than the Federal Agency to which the funds supporting the research were appropriated. Research institutions conducting extramural research may include Federal research facilities.

Fabrication. Making up data or results and recording or reporting them.

Falsification. 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.

Finding of research misconduct. The conclusion, proven by a preponderance of the evidence, that research misconduct occurred, that such research misconduct represented a significant departure from accepted practices of the relevant research community, and that such research misconduct was committed intentionally, knowingly, or recklessly.

Inquiry. The stage in the response to an allegation of research misconduct when an assessment is made to determine whether the allegation has substance and whether an investigation is warranted.

Intramural Research. Research conducted by a Federal Agency, to which funds were appropriated for the purpose of conducting research.

Intramural Research Institution. All USDA organizations, including intramural Federal research laboratories, conducting research.

Investigation. The stage in the response to an allegation of research misconduct when the factual record is formally developed and examined to determine whether to dismiss the case, recommend a finding of research misconduct, and/or take other appropriate remedies.

OIG. The Office of Inspector General of the United States Department of Agriculture.

OSTP. The Office of Science and Technology Policy of the Executive Office of the President.

Plagiarism. The appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

Preponderance of the evidence. Proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.

Research. All basic, applied, and demonstration research in all fields of science, engineering, and mathematics. This includes, but is not limited to, research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals regardless of the funding mechanism used to support it.

Research Misconduct. Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.

Research Record. The record of data or results that embody the facts resulting from scientific inquiry, and includes, but is not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles.

USDA. The United States Department of Agriculture.

USDA Research Integrity Officer (USDA RIO). The individual designated by the Office of the Under Secretary for Research, Education, and Economics (REE) who is responsible for overseeing USDA and its research agencies development and implementation of research misconduct policies and procedures.

5. POLICY

Consistent with the objective of the OSTP Policy to ensure public trust in USDA-conducted research and USDA Agencies’ support for research, all USDA Agencies that conduct intramural research shall either:

a. Establish procedures to respond to allegations of research misconduct and remedy findings of research misconduct, consistent with applicable laws, regulations, the OSTP Policy, and the guidelines established by this DR;

b. Initiate and sign a standing Memorandum of Understanding (MOU) between the agency and the Office of the Under Secretary of Agriculture for Research, Education, and Economics to have another USDA agency act on its behalf in lieu of developing its own research misconduct procedures.

6. ASSIGNMENT OF RESPONSIBILITIES

a. Responsibilities of the Office of the Under Secretary of Agriculture for Research, Education, and Economics (hereafter REE):

(1) Delegation: REE is hereby delegated oversight authority for research misconduct proceedings within the Department. REE will oversee and monitor USDA agencies’ implementation of this policy. REE must:

(a) Ensure that procedures are developed by USDA Agencies to address research misconduct, that these procedures are consistent with the guidelines established by this DR and that USDA Agencies adhere to their procedures when processing allegations of research misconduct;

(b) Ensure allegations of research misconduct that are reported through the USDA Office of Inspector General (OIG) Hotline complaint system are assigned to the appropriate USDA agency; and

(c) Maintain a status report of research misconduct cases across USDA as a means of monitoring the progress toward resolution.

(2) Assignment of Coordinating Person or Group: REE will designate a USDA Research Integrity Officer (RIO). This USDA RIO will be responsible for:

(a) Overseeing USDA agency responses to allegations of research misconduct;

(b) Ensuring that USDA Agencies comply with this DR by developing research misconduct procedures consistent with the guidelines set forth in this DR; or signing standing MOUs, if more appropriate, to permit the USDA RIO to assign research misconduct proceedings to an appropriate USDA agency;

(c) Ensuring that USDA Agencies comply with their own implementation procedures and process allegations of research misconduct promptly and fairly. Instances of any intramural research institution failing to comply with this DR shall be referred for resolution to the USDA RIO.

(d) Receiving and assigning allegations of research misconduct reported by the public or through OIG;

(e) Developing Memoranda of Understanding with USDA Agencies that elect not to develop their own research misconduct procedures;

(f) Monitoring the progress of all research misconduct cases and reporting such progress to OIG; and

(g) Notifying the Assistant Inspector General for Investigations of all allegations of research misconduct reported to the USDA RIO.

(h) Criminal or potentially criminal behavior: If at any point the research misconduct proceedings reveal any criminal or potentially criminal behavior involving USDA conducted research, the USDA RIO shall immediately report the potentially criminal behavior to OIG and coordinate with the appropriate USDA agency to ensure that all records, documents or other materials relating to the research misconduct allegation are provided to OIG. If OIG accepts the case for criminal investigation, it will assume responsibility for conducting the criminal investigation into the allegation.

In situations where there is an ongoing criminal investigation, USDA RIO shall cooperate with the criminal investigation.

(i) The USDA Research Integrity Officer will provide a copy of the report to the Chief Financial Officer if the misconduct includes fraud, a breach in internal controls, or a management override of financial or program policy.

(3) Providing Contact Information: REE shall provide contact information for the USDA RIO on its website and any other appropriate medium. The USDA RIO may be reached at:

USDA Research Integrity Officer

214W Whitten Building

Washington, DC 20250

Telephone: 202-720-5923

Email: researchintegrity@usda.gov.

b. Responsibilities of USDA Agencies Conducting Research

(1) Reporting of Allegations: USDA Agencies conducting research shall report all allegations of research misconduct reported to them to the OIG, using any of the methods described in subsection 7(1), and to the USDA RIO. The USDA agency will provide all records, documents and other materials relating to a research misconduct allegation to OIG when requested. A USDA agency responding to allegations of research misconduct will provide status reports to the USDA RIO during each of the separate phases (i.e., inquiry, investigation, and adjudication, as defined in Appendix A) of its response to the allegation.

(2) Development of Implementation Procedures: USDA Agencies that conduct research shall:

(a) Develop implementation procedures to comply with the OSTP Federal Research Misconduct Policy and this DR. Implementation procedures shall include, at a minimum, the requirements listed in Sections 8 and 9 of this DR. Once adopted, each USDA agency will handle reported research misconduct allegations according to its implementation procedures;

(b) In lieu of developing its own implementation procedures to comply with the OSTP policy, a USDA agency may initiate a Memorandum of Understanding (MOU) with REE. Under the MOU, the USDA RIO shall assign another USDA agency to act on behalf of the USDA agency that has not developed an OSTP-compliant policy, with respect to research misconduct.

(3) Department-wide Consistency of Implementation Procedures: USDA Agencies electing to adopt implementing procedures shall consult with the USDA RIO while drafting implementation procedures to ensure that procedures are consistent with this DR and with other USDA Agencies that elect to adopt implementing procedures. The USDA RIO must concur with individual USDA Agencies’ implementing procedures prior to final adoption. A copy of the procedures shall be provided to REE.

(4) Adherence to Procedures/MOU: Each USDA agency will handle reported research misconduct allegations in accordance with its own USDA RIO-approved implementation procedures or through a MOU with REE to have another agency act on its behalf.

(5) Other Resources: The USDA Agencies may use any available resources to respond to allegations of misconduct, including the Office of the Inspector General (OIG), Office of General Counsel (OGC), the Office of Ethics (OE) and expert consultants. To ensure a consistent and appropriate response to allegations of research misconduct by USDA intramural research institutions, the USDA agency must first notify the USDA RIO of its intent to consult OIG, OGC, OE or other outside parties.

(6) Notice of Procedures/MOU: Upon completion of its implementation procedures or completion of its MOU with REE, a USDA agency must publish its implementation procedures or MOU on its website (intranet, internet, or both, as appropriate), and make reasonable efforts to notify any and all interested parties and relevant stakeholders of the agency’s procedures for handling allegations of research misconduct.

(7) Reporting Research Misconduct: An intramural research institution shall announce and make available the name and contact information of the Agency Research Integrity Officer (ARIO) and the appropriate contacts at OIG. Intramural research institutions shall also announce that research misconduct should be reported to OIG (see subsection 7(1)). Intramural research institutions shall make the preceding announcements through standard agency communication channels.

(8) Referral to REE: If an allegation does not involve the agency to which it was reported, a USDA agency shall refer the allegation to REE for reassignment.

(9) Designation of Agency Research Integrity Officer: Each USDA agency shall appoint an ARIO in their implementation procedures, and shall name an ARIO within 30 days of completing its procedures.

(a) Responsibilities of ARIO in USDA Agencies with Implementation Procedures:

1 Receive and process allegations of research misconduct as assigned by the USDA RIO;

2 Inform the OIG and the USDA RIO of allegations of research misconduct reported to the USDA agency;

3 Ensure that any records, documents and other materials relating to a research misconduct allegation are provided to OIG when requested;

4 Oversee proceedings to address allegations of research misconduct at intramural research institutions.

5 Determine which level of the USDA agency is capable of conducting an independent, unbiased, and equitable process, assign responsibilities for research misconduct proceedings to the appropriate individuals or office within the agency, and ensure that the individuals assigned such responsibilities are capable of carrying out an inquiry, investigation, and adjudication in an independent, unbiased, and equitable process;

6 Immediately notify OIG and the USDA RIO if behavior that is or may be criminal in nature is discovered at any point during the inquiry, investigation, or adjudication phases of the research misconduct proceedings;

7 Document the dismissal of the allegation, and ensure that the name of the accused individual and/or institution is cleared (this includes making the information public through available and appropriate means)if an allegation of research misconduct is dismissed at any point during the inquiry or investigation phase of the proceedings; and

8 Other duties relating to research misconduct proceedings as assigned, including additional duties of the ARIO with respect to extramural research.

(b) Responsibilities of ARIO of USDA Agencies with MOU:

1 Inform the OIG and the USDA RIO of allegations of research misconduct reported to the USDA agency;

2 Provide any records, documents, and other materials relating to a research misconduct allegation to the agency assuming responsibility for processing the allegation.

3 Ensure that any records, documents and other materials relating to a research misconduct allegation are provided to OIG when requested;

4 Immediately notify OIG and the USDA RIO if behavior that is or may be criminal in nature is discovered at any point during the inquiry, investigation, or adjudication phases of the research misconduct proceedings;

5 Document the dismissal of the allegation, and ensure that the name of the accused individual and/or institution is cleared if an allegation of research misconduct is dismissed at any point during the inquiry or investigation phase of the proceedings;

6 Other duties relating to research misconduct proceedings as assigned, including additional duties of the ARIO with respect to extramural research.

7. REPORTING ALLEGATIONS OF RESEARCH MISCONDUCT

a. Contact Information: Anyone who suspects that intramural researchers or intramural research institutions performing research may have engaged in research misconduct is encouraged to make a formal allegation of research misconduct to OIG. Suspected research misconduct may be reported to OIG using any of the following methods:

Via the OIG Hotline:

Telephone: (202) 690-1622

(800) 424-9121

(202) 690-1202 (TDD)

E-mail: usda_hotline@oig.usda.gov.

U.S. Mail: United States Department of Agriculture

Office of Inspector General

P.O. Box 23300

Washington, DC 20026-3399.

b. Required Information when Making an Allegation: To the extent known, the following details should be included in any formal allegations made to the OIG:

(1) The names of involved individuals and research projects,

(2) Sources of funding;

(3) Important dates;

(4) Any documentation that bears upon the allegation; and

(5) Any other potentially relevant information.

c. Reporting Chain: Should a member of the public make a formal allegation of research misconduct to a USDA ARIO or the USDA RIO, the following process shall apply:

(1) All allegations of research misconduct received by the ARIO must be reported to the USDA RIO and the OIG. The ARIO will then proceed according to the USDA agency’s research misconduct procedures.

(2) All allegations of research misconduct received by the USDA RIO must be reported to the Assistant Inspector General for Investigations, and assigned by the USDA RIO to the appropriate ARIO to handle the allegation. The ARIO will then proceed according to the USDA agency’s research misconduct procedures.

Usually, allegations of research misconduct received by the OIG will be forwarded to the USDA RIO. The USDA RIO will then assign it to the appropriate USDA ARIO to handle the allegation.

8. PROCEDURES

a. Minimum requirements for USDA Agencies Conducting Intramural Research: USDA Agencies’ implementation procedures for intramural research institutions shall include:

(1) Inter-agency Procedures. When a USDA Agency provides funding for research conducted at another Federal Agency (within or outside USDA) or a USDA research institution conducts research funded in whole or in part by another Agency (within or outside USDA) ordinarily the research institution where the research misconduct is alleged to have occurred bears primary responsibility for inquiry, investigation, and adjudication of the research misconduct allegation.

(a) Two or more Agencies within USDA. If an allegation of research misconduct is made regarding research conducted at a USDA research facility and that research is funded in whole or in part by a different USDA agency, the research institution will ordinarily be responsible for inquiry, investigation, and adjudication of the allegation or research misconduct. The process for determining which USDA Agency should conduct the research misconduct proceedings should permit the ARIO of the Agency conducting the research and the ARIO of the Agency funding the research to confer to determine which Agency will conduct the inquiry, investigation, and adjudication of the allegation of research misconduct. If the relevant ARIOs cannot agree on which Agency shall conduct research misconduct proceedings, then the allegation shall be referred to the USDA RIO. The USDA RIO shall then assign the allegation to one of the relevant Agencies, and shall determine the level of the Agency at which the research misconduct allegation shall conduct inquiry, investigation, and adjudication.

(b) Research conducted by USDA Agency and funded by Agency outside USDA. Ordinarily, the USDA Agency conducting the research funded by a non-USDA Agency will initiate and carry out the inquiry, investigation, and adjudication of research misconduct allegations at the USDA Agency research facility, in accordance with the OSTP Policy. It is assumed that other, non-USDA Federal Research Agencies will also have research misconduct procedures in place to implement the OSTP Policy, and that these research misconduct procedures will be similar to those implemented by the USDA Agency. When conducting the research funded by other, non-USDA Federal Agencies, USDA Agencies shall adhere to the research misconduct procedures, requirements, and/or procedures set by the funding Agency, and any relevant terms and conditions of the grant, agreement, or funding arrangement.

(c) Extramural research conducted by non-USDA Federal Agency and funded by USDA Agency. It is presumed that all Federal research Agencies will have research misconduct procedures in place to comply with the OSTP Policy. A USDA Agency supporting extramural research conducted by a non-USDA Federal research institution may rely on the procedures in place at the other Federal research institution to conduct inquiry, investigation, and adjudication of allegations of research misconduct.

(2) Responsibilities for handling each phase of the response to an allegation of research misconduct: inquiry, investigation, and adjudication. These responsibilities shall be assigned to organizations and officials that

(a) Understand the research and the research environment;

(b) Can ensure objectivity;

(d) Reach a timely resolution.

The responsibilities for adjudication shall be separate from those for inquiry and investigation. Adjudication responsibilities may be assigned to individuals at higher levels within the same research institution’s organization, or to a part of the research institution other than that which conducted the inquiry and investigation. An individual involved in the investigation must be certified through the training program offered by OIG and USDA Departmental Administration (i.e., a credentialed USDA investigator).

(3) The circumstances, if any, under which the ARIO shall determine that the headquarters level of the USDA agency should respond directly to an allegation. These may include, but are not limited to:

(a) A determination that it is in the public interest for the headquarters level of the USDA agency to conduct the inquiry and investigation; or

(b) A determination that the allegation involves a small organization or an individual that cannot reasonably be expected to respond.

(4) Responsibilities for, and the form and timing of, notifying an individual that an allegation of research misconduct involving him or her has been made and its disposition.

(5) A requirement that the research institution immediately notify the ARIO and provide an explanation of the circumstances if:

(a) The public health or safety is at risk;

(b) The research institution’s resources or interests are threatened or at risk.

(d) Action to protect the interests of those involved in the inquiry into or investigation of the allegation is required from the headquarters of the USDA agency;

(e) A premature public disclosure of the inquiry into or investigation of the allegation may compromise the process;

(f) The research community or public should be informed; or

(g) There is a possible violation of civil or criminal law. If research misconduct proceedings reveal behavior that may be criminal in nature at any point during the proceedings, the USDA RIO and the Assistant Inspector General for Investigations must be notified immediately.

(6) Agency implementation procedures shall allow the ARIO to reassign the research misconduct proceedings. If information revealed during research misconduct proceedings indicates that the organization, group, or level of the intramural research institution or agency to which research misconduct proceedings were originally assigned is not capable of conducting an independent, unbiased, and equitable inquiry, investigation, and adjudication process, then the ARIO shall reassign the proceedings.

(7) A requirement that the intramural research institution report the outcome of all investigations to the ARIO after completing the investigation. Agency implementation procedures shall also include a requirement that the research institution report to the ARIO the outcome of the adjudication, if an investigation results in a finding of research misconduct, and the ARIO delegates the authority to adjudicate the finding of research misconduct to the research institution. This reporting of adjudication shall contain the following, as available:

(a) A copy of the evidentiary record;

(b) The investigative report;

(d) A summary of the findings;

(e) Any action taken including disciplinary action; and

(f) Any other materials that bear on the allegation, finding, or adjudication.

(8) Required documentation for each phase of the response to an allegation of misconduct and requirements related to document retention, storage, handling, and dissemination. At a minimum, the documentation should include the following:

(a) The allegation;

(b) Methods and procedures used to gather information and evaluate the allegation during inquiry and investigation stages;

(d) For findings of research misconduct, any recommended or imposed institutional sanctions, and any recommended corrective actions, including but not limited to recapture of funds, or disciplinary actions.

When research misconduct is found, documentation shall also include evidence to support each element of a “finding of research misconduct”; that is,

(e) There is a significant departure from accepted practices of the relevant research community;

(f) The misconduct be committed intentionally, or knowingly, or recklessly; and

(g) Proof of the allegation by a preponderance of the evidence.

The research institution must retain the documents specified in this section for 3 years following the final decision. Disposition of the Agency’s records should follow the Agency’s Records Disposition Schedule.

(9) Procedures to protect the rights of those who make allegations of research misconduct to promote a climate where the informant does not fear retribution. Protections for those alleging research misconduct should include protection against retaliation or harm to their positions or reputations, if the allegation was made in good faith.

(10) Fair and objective procedures for the examination and resolution of allegations at the research institutions.

(11) Procedures to protect the rights of those who are alleged to have engaged in research misconduct in order to instill confidence that the individuals shall be treated in an impartial and professional manner. Protections for subjects of allegations of research misconduct should include the following, at a minimum:

(a) Providing subjects a description of substantial allegations made against them;

(b) Giving subjects of allegations reasonable access to data and other supporting evidence related to the allegation; and

(12) Procedures intended to ensure confidentiality during the inquiry, investigation, adjudication, and if necessary, administrative action processes. To the extent possible, consistent with a fair and thorough investigation and as allowed by law, the procedures shall limit knowledge about the identity of subjects and informants to those directly involved with the inquiry, investigation, adjudication, or administrative action, the ARIO and USDA RIO, and OIG. The procedures shall be in compliance with the Freedom of Information Act (FOIA) and the Privacy Act.

(13) Time frames for completing each phase of the response to an allegation of research misconduct: inquiry, investigation, adjudication, and administrative action.

(14) The authority to which an appeal of a finding of research misconduct may be made. This must not be an office or individual directly involved in the inquiry, investigation, or adjudication of an allegation of research misconduct. “Office” means that organizational component with formal responsibility for one or more phases of the response to an allegation of research misconduct. The organizational level to which appeals may be made may be defined by the USDA agency, as long as there is an adequate separation of responsibilities and there is no appearance of bias, inequity, or conflict of interest. Agencies may utilize their currently-existing appeals procedures to process appeals of findings of research misconduct.

b. Appeals: The USDA agency procedures must include provisions for appealing findings of research misconduct. A USDA agency may use its existing administrative appeals process to address findings of research misconduct provided the process includes reasonable time limits. The administrative appeals process is to be separate from the USDA administrative grievance system.

c. Remedies: USDA Agencies must identify within their implementation procedures administrative actions that the agency may use to remedy findings of research misconduct. These administrative actions must include the recovery of funds as a potential sanction from an intramural research institution or any research institution conducting federally-funded research where a finding of research misconduct has been made. USDA Agencies may also include other administrative actions to remedy findings of research misconduct, including correction of the research record, letters of reprimand, debarment or suspension from non-procurement activities of the researcher(s) that engaged in the research misconduct, proper attribution, or any other administrative action that the USDA agency deems appropriate to remedy the instance(s) of research misconduct.

In determining the appropriate administrative action, the appropriate agency should consider the seriousness of the misconduct, including, but not limited to, the degree to which the misconduct was knowing, intentional, or reckless; was an isolated event or part of a pattern; or had significant impact on the research record, research subjects, other researchers, institutions, or the public welfare.

d. Existing Procedures: The USDA Agencies may use their existing procedures for processing research misconduct allegations so long as they comply with the minimum requirements of this DR. Nothing in this DR is intended to supersede current USDA personnel management authorities.

9. RELATIONSHIP TO OTHER REQUIREMENTS

Research covered under this DR that is also subject to requirements of other Agencies or funding sources must be conducted in compliance with all applicable requirements of this DR. USDA Agencies may include in their implementation procedures a process for deferring to or collaborating with other Agencies when a research institution receives funding or support from multiple sources and would, therefore, be subject to multiple research agencies’ research misconduct procedures.