AGENDA

1. AGENDA • Background • Overview of VHA Handbook 1058.2* • Handling Allegations of Research Misconduct* • Q & A * Refer to VHA Handbook 1058.2 for complete policy

2. I. Background VA Policy (1993) – M-3, Pt. I, Ch. 15 §15.04 DEFINITION “Misconduct” is defined as: a. Serious deviation, such as fabrication, falsification, or plagiarism, from accepted practice, in carrying out research, or in reporting the results of research; or b. Material failure to comply with Federal requirements affecting specific aspects of the conduct of research e.g., the protection of human subjects and the welfare of laboratory animals.

3. I. Background Federal Policy on Research Misconduct (2000) • Applies to all federally-funded research • Uniform definition of research misconduct • fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results • Procedural requirements and guidelines • e.g., clear separation of Inquiry/Investigation, Adjudication, and Appeal phases

4. I. Background VHA Handbook 1058.2 (2005) • Effective May 4, 2005 • VHA Manual M-3, Part I, Chapter 15 rescinded • Developed by ORO, with input from ORD, OGC, OIG, and field representatives • Implements Federal Policy on Research Misconduct • All VHA facilities are required to follow the new Handbook for research misconduct allegations

5. II. Overview of VHA Handbook 1058.2 Paragraph 1. Purpose • To establish procedures for reporting, investigating, and resolving allegations of misconduct involving VA research

6. II. Overview of VHA Handbook 1058.2 Paragraph 2. Background • The procedures in the Handbook • protect the public’s confidence in the integrity of VA research by • minimizing the incidence of research misconduct; • providing a fair and timely manner of responding to allegations. • maintain appropriate safeguards for Respondents and Informants • RESEARCH MISCONDUCT IS PROHIBITED • The Handbook conforms to the Federal Policy on Research Misconduct (2000)

7. II. Overview of VHA Handbook 1058.2 Paragraph 3. Definition of Research Misconduct • Fabrication, Falsification, or Plagiarism in proposing, performing, or reviewing research, or in reporting research results • 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 • Plagiarism: the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit

8. II. Overview of VHA Handbook 1058.2 Paragraph 3. Definition of Research Misconduct • Research misconduct does not include honest error or differences of opinion • To constitute research misconduct, the behavior must: • represent a significant departure from accepted practices of the relevant research community; and • be committed intentionally, knowingly, or with reckless disregard for the integrity of the research • The allegation must be proven by a preponderance of the evidence(i.e., MORE LIKELY THAN NOT TO BE TRUE)

9. II. Overview of VHA Handbook 1058.2 Paragraph 4. Scope • Applies to all VA employees • includes WOC, contractors, IPA personnel engaged in VA research • scientists, trainees, technicians, students, collaborators, etc. • Other ethical improprieties are not covered by Handbook • Special examples: • Misrepresentation of one’s qualifications in a merit review application falls within definition of research misconduct • Authorship disputes other than plagiarism do not fall within definition of research misconduct

10. II. Overview of VHA Handbook 1058.2 Paragraph 5. Definitions Informant. The person who makes an allegation or cooperates with an Inquiry or Investigation of research misconduct. Respondent. The person against whom an allegation of research misconduct is directed or whose actions are the subject of an Inquiry or Investigation. Research Record. The record of data or results that embody the facts resulting from scientific inquiry, including, but not limited to, research proposals, physical and electronic laboratory records, abstracts, theses, oral presentations, internal reports, and journal articles. VA Research. All research (1) funded in whole or in part by VA; (2) conducted by VA employees within the scope of their VA employment; and/or (3) using VA facilities, equipment, personnel, or patients.

11. II. Overview of VHA Handbook 1058.2 Paragraph 6. The Office of Research Oversight • ORO Central Office oversees VHA’s research misconduct program in general • ORO Central Office reviews all research misconduct cases

12. II. Overview of VHA Handbook 1058.2 Paragraph 7. Research Integrity Officers (RIOs) • Each VAMC with research involvement must have a RIO • The RIO is responsible for overseeing all research misconduct allegations at that facility • The RIO may be: ACOS/R&D, Research Coordinator, R&D Committee Chair, or similar individual within the research program with sufficient institutional authority and experience to fulfill the required duties • Responsibilities: • Receiving and reviewing research misconduct allegations, overseeing all Inquiries and Investigations, maintaining files of all documents and evidence, ensuring the confidentiality and security of those files, acting as a liaison with ORO; • Maintaining safeguards for Respondents and Informants; • Providing education and training to Inquiry/Investigation Committee members; • Informing VAMC staff of Handbook procedures and overseeing compliance; • Demonstrating objectivity in carrying out RIO duties • Conflicts of Interest: If the RIO has a COI in a particular case (significant relationship with Respondent, Informant, project or investigator), an acting RIO must be appointed

13. II. Overview of VHA Handbook 1058.2 Paragraph 8. Informants • VA employees have a responsibility to report suspicions of research misconduct if they honestly and reasonably believe there is credible evidence • VAMC authorities must make diligent efforts to protect good faith Informants from retaliation • Informants may provide testimony and be informed of the general outcome of a case, but do not otherwise have a right to participate in the determination of the case

14. II. Overview of VHA Handbook 1058.2 Paragraph 9. Respondents • Respondents must be given timely, written notification of allegations made against them • Respondents must have the opportunity to be interviewed and present evidence • Respondents are required to cooperate in good faith with any Inquiry or Investigation • Respondents may obtain the advice of legal counsel or a personal advisor, but such advisor may not speak on behalf of the Respondent during the Inquiry or Investigation • Respondents are prohibited from retaliating against good faith Informants • Respondents may appeal any finding of research misconduct • Respondents who are not found guilty of research misconduct must be given reasonable assistance in restoring their reputations

15. II. Overview of VHA Handbook 1058.2 Paragraph 10. Privacy and Confidentiality • All nonpublic information must be kept confidential • Nonpublic information should only be made available to persons specifically authorized to review the research misconduct allegation • Case files must be stored in a secure location

16. II. Overview of VHA Handbook 1058.2 Paragraph 11. Record Retention and Access • All research records related to a misconduct allegation may be inspected and sequestered by the RIO, Inquiry or Investigation Committee, or ORO, without notice • Respondents may be given supervised access to or copies of original data to continue their research prior to completion of a misconduct proceeding • After a case is closed, the RIO must retain all research misconduct records until the retention period has ended* * 7 year retention period has been proposed

17. II. Overview of VHA Handbook 1058.2 Paragraph 12. General Procedures • Joint Jurisdiction • Other non-VA entities (e.g., academic affiliates) may have concurrent jurisdiction over the same research project • Perform joint Inquiry/Investigation with representatives from both institutions • Negotiate which entity will take the lead • Single set of recommendations • Each entity follows own procedures for adjudication and appeals • Interim Actions • Follow 38 CFR §§ 1.200 – 1.205 for reporting criminal matters • Refer to VA Inspector General or other appropriate investigative body • Admissions • An admission of guilt by itself is not grounds for terminating a case. Additional investigation may be necessary to discover the full extent of misconduct • Admissions must be in writing and signed by the Respondent and a witness • Employment Status • Termination of a Respondent’s VA employment does not preclude an Investigation

18. II. Overview of VHA Handbook 1058.2 Paragraph 13. Allegations • Allegations of research misconduct must be made in good faith and must be reasonable: • The informant must believe in the substance of his/her allegation; and • The allegation must be one which a person in the Informant’s situation could reasonably make. • An allegation is not made in good faith nor reasonable if made with reckless disregard for or willful ignorance of facts that would negate the allegation.

19. II. Overview of VHA Handbook 1058.2 Paragraph 13. Allegations • Informants are not required to prove good faith in order for an Inquiry to be opened. • However, an allegation that is not made in good faith may result in the waiver of certain protection privileges (i.e., protection from retaliation).

20. II. Overview of VHA Handbook 1058.2 Paragraph 14. Inquiry • Sole purpose: to determine whether sufficient evidence exists to open a formal Investigation.

21. II. Overview of VHA Handbook 1058.2 Paragraph 15. Investigation • Purpose: to determine • whether and to whatextent research misconduct has occurred; • who is responsible; and • what corrective actions are appropriate.

22. II. Overview of VHA Handbook 1058.2 Paragraph 16. Adjudication • VA determination based on recommendations from the Investigation • Adjudication by the Network Director • review of Investigation Report and all supporting documents • may consult with ORO, ORD, OGC • May adopt all, some, or none of the Investigation’s recommendations

23. II. Overview of VHA Handbook 1058.2 Paragraph 17. Departmental Review • ORO CO reviews each case for procedural conformance: • Timeliness • Objectivity • Preservation of safeguards • Thoroughness • Competence

24. II. Overview of VHA Handbook 1058.2 Paragraph 17. Departmental Review ORO Disposition: • Inquiry/Investigation and adjudication substantially adhered to procedures Uphold Network Director’s decision • Inquiry/Investigation did not substantially adhere to procedures so as to materially affect outcome of the case Reopen VAMC Investigation, or open ad hoc ORO Investigation

25. II. Overview of VHA Handbook 1058.2 Paragraph 18. Corrective Actions • Examples: • Government-wide debarment • Removal from a particular project or suspension/ termination of an active award • Restitution of funds or civil penalties • Prohibition from receiving VA research funds for a period of time • Correction or retraction of published article • Monitoring or supervision of future work • Required certification of data or sources • Remedial education and/or mentoring

26. II. Overview of VHA Handbook 1058.2 Paragraph 18. Corrective Actions • Considerations: • Extent of the misconduct (amount, duration, scope) • Degree to which misconduct was knowing, intentional, or reckless • Presence or absence of pattern of misconduct • Consequences of the research misconduct • Respondent’s position and responsibility • Cooperation of Respondent • Likelihood of rehabilitation • Type of corrective actions imposed in past cases

27. II. Overview of VHA Handbook 1058.2 Paragraph 19. Appeals • All final research misconduct findings and proposed corrective actions may be appealed • Only named Respondents may appeal • Reviewed by the Under Secretary for Health • Must appeal within 30 days of receiving notice • Document review only • Exception: Debarment hearing (38 CFR 44, Subpart H) • Final decision: uphold, reverse, or modify

28. II. Overview of VHA Handbook 1058.2 Paragraph 20. References • Federal Policy on Research Misconduct (65 FR 76260) • Administrative Investigations (VA Handbook 0700) • Employee/Management Relations (VA Handbook 5021) • Whistleblower Protection Act of 1989 (5 USC §1201) • Governmentwide Debarment/Suspension (38 CFR Part 44) • Criminal Referrals (38 CFR §§1.200-1.205)

29. III. Handling Allegations of Research Misconduct ALLEGATION • Good faith and reasonable • In writing, if possible • Submitted to Respondent’s supervisor • Forwarded to RIO (or direct submission) • May be anonymous • Required Threshold

30. III. Handling Allegations of Research Misconduct REQUIRED THRESHOLD • Before an Inquiry is opened, the RIO must determine that the allegation meets all of the following requirements: • The allegation involves VA research • The allegation is of research misconduct • The allegation on its face contains the elements of a finding of research misconduct: • Significant departure from accepted practices • Committed intentionally, knowingly, or with reckless disregard • Deficient Allegations • Notify Informant of the particular threshold requirement(s) that the allegation fails to meet

31. III. Handling Allegations of Research Misconduct INQUIRY • VAMC Director convenes within 5 days after allegation received • Written notification to Respondent, Informant, VISN, ORO CO • Sequestration of physical evidence • Inquiry conducted by RIO or an Inquiry Committee • Interview Respondent and Informant • Written transcripts • Inquiry Report (summary format) • Determine whether sufficient evidence exists to open Investigation • Complete within 30 days

32. III. Handling Allegations of Research Misconduct OPENING AN INVESTIGATION • Evidence that would raise a significant suspicion of research misconduct to a reasonable person is sufficient to justify opening a formal Investigation • Termination of VA Case • Available evidence is insufficient to justify opening an Investigation • Retain case file for authorized retention period • Forward Inquiry Report VISN, ORO CO • If VAMC Director disagrees, must open an Investigation

33. III. Handling Allegations of Research Misconduct INVESTIGATION • VAMC Director convenes Investigation Committee within 10 days of recommendation to open Investigation • Written notification to Respondent, Informant, VISN, ORO CO • Sequestration of physical evidence • Administrative Investigation Board procedures (VA Handbook 0700) • (Except where Handbook 1058.2 has contrary provision) • Interview Respondent and Informant; other relevant witnesses • Written transcripts • Determine whether, what extent research misconduct has occurred, who is responsible, and what corrective actions are appropriate • VAMC Director sends Investigation Report to Network Director, with any added recommendations and proposed disciplinary actions • Complete within 90 days

34. III. Handling Allegations of Research Misconduct INVESTIGATION COMMITTEE • May be a standing or ad hoc Committee • Composed of 3 to 5 individuals • Members of Inquiry Committee may serve • Members selected by the VAMC Director • Chair must be VAMC employee with 5/8ths or greater appointment, involved in VA research • Representative of agency/entity with concurrent jurisdiction • No actual or apparent conflict of interest • Respondent and Informant may submit objections to Committee membership based on COI, but Director makes final decision

35. III. Handling Allegations of Research Misconduct INVESTIGATION REPORT • VA Handbook 0700, Chapter 6 • Standard Format • Appendix N • Investigation Report summarizes • the allegation • the evidence reviewed • Recommendation about whether research misconduct occurred, the type/extent of misconduct, who is responsible, corrective actions • Draft reviewed and commented on by • Respondent • Informant (only the portion related to Informant’s role and testimony)

36. III. Handling Allegations of Research Misconduct ORO Investigation • Conducted in lieu of a VAMC investigation in exceptional circumstances • as determined by ORO CO within its discretion • Exceptional circumstances: • the VAMC is not prepared to handle the allegation in a manner consistent with Handbook 1058.2 • the VAMC cannot complete an investigation for any reason • ORO involvement is needed to protect the public interest

37. IV. Questions and Answers ?