What’s coming down the road? (or: “You’ll never know what hit you”)

Note: To see the answers to the survey questions, you must view this as a PowerPoint slide show. There are no “correct” answers for this presentation. This was a poll. There is no way to verify the accuracy of the answers given.

Has your facility received at least one research misconduct allegation in the past 10 years? 1. Yes 2. No 3. Don’t Know

For those who have received an allegation, was that allegation reported to the Office of Research Oversight? 1. Yes 2. No 3. Don’t Know

For those who have received an allegation, was the allegation investigated? 1. Yes 2. No 3. Don’t Know

For the allegations that were investigated, were they investigated under the procedures of VHA Handbook ? 1. Yes 2. No 3. Don’t Know

For allegations that were investigated under VHA Handbook , did the investigation result in a finding of research misconduct? 1. Yes 2. No 3. Don’t Know

Has your facility appointed a Research Integrity Officer (RIO)? 1. Yes 2. No 3. Don’t Know

Are you appointed as your facility’s RIO? 1. Yes 2. No 3. Don’t Know

How many of you have read VHA Handbook (“Research Misconduct”)? 1. Yes 2. No 3. Don’t Know

Research Misconduct Defined Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Federal Policy on Research Misconduct 65 Fed. Reg (2000)

Fabrication is making up data or results and recording or reporting them. 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. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion. Federal Policy on Research Misconduct 65 Fed. Reg (2000)

¶ 12d(1). Inquiry and Investigation by a Local VA Medical Center. In most instances, the local VA medical center that receives a research misconduct allegation is responsible for conducting an Inquiry, and if warranted, a further Investigation. The Investigation Committee’s findings and recommendations for corrective actions, if applicable, are set forth in an Investigation Report. ¶ 12d(3). Adjudication by VISN Director. The appropriate VISN Director reviews the final Investigation Report and renders a decision regarding the findings and recommendations for corrective actions. ¶ 12d(5). Appeal to the Under Secretary for Health. The Respondent may appeal a finding of research misconduct and proposed corrective actions (including debarment, if applicable) to the Under Secretary for Health [who] makes a ruling on the Respondent’s appeal which constitutes VA’s final agency action. VA Policy and Procedures for Handling Research Misconduct Allegations VHA Handbook Sequence of Review

Proposed Revisions: VHA Handbook Considerations Strict consistency with the Federal Policy on Research Misconduct Overall consistency with VA Handbook 0700 (Administrative Investigations) Overall consistency with other VHA policies, including VHA Handbook (Debarments for Research Impropriety) Overall consistency with PHS Policies on Research Misconduct Practical considerations based on 7 years of implementing the current VHA Handbook Feedback from the field

Proposed Revisions: VHA Handbook Current “If a matter involves both research misconduct and non-research misconduct issues, a single administrative investigation may be convened to review all of the related issues in order to promote administrative efficiency. NOTE: If a consolidated administrative investigation is convened, the investigation procedures must be consistent with the specifications of this Handbook and must contain a distinct recommendation regarding the research misconduct issue(s). VHA Handbook § 4b Proposed Only research misconduct allegations shall be processed under the VHA Handbook procedures.

Proposed Revisions: VHA Handbook Current (no provision) Proposed At the direction of other Government oversight bodies including OIG, a research misconduct proceeding may be temporarily suspended.

Proposed Revisions: VHA Handbook Current “If the final outcome involves a debarment recommendation, ORO Central Office issues a notice of proposed debarment to the Respondent on behalf of the Under Secretary for Health. Such a notice is prepared according to the requirements of 38 CFR sec , and specifies the length and terms of the proposed debarment.” VHA Handbook §17c(3) Proposed Incorporate the procedures of VHA Handbook (“Debarments and Suspensions based on Research Impropriety in VA Research,” 2008) into VHA Handbook

Proposed Revisions: VHA Handbook Current (no provision) Proposed VA may publish findings of research misconduct, including name of Respondent and corrective actions; e.g., on ORO’s Web site. May also notify Respondent’s current employer and academic affiliate.

Proposed Revisions: VHA Handbook Current (no provision) Proposed ORO may schedule in-person meetings with the RIO and/or Investigation Committee to provide in-depth instruction and guidance.

Proposed Revisions: VHA Handbook Current “In exceptional cases as determined by ORO Central Office within its discretion, an ORO Ad Hoc Committee consisting of ORO staff … and outside experts, as needed, may investigate a misconduct allegation in lieu of the local VA medical center. Such cases may include, but are not limited to, instances in which the local VA medical center is not prepared to handle the allegation in a manner consistent with these procedures….” VHA Handbook § 12d(2) Proposed If, as determined by ORO, the responsible VA facility is unable to satisfactorily complete the Handbook requirements, the VISN shall appoint an alternate VA facility to assume the responsibilities.

Proposed Revisions: VHA Handbook Current “The position of RIO must be administratively assigned to either the Associate Chief of Staff (ACOS) for Research, the Research Coordinator, the Research and Development Committee Chairperson, or another similar individual within the research program….” VHA Handbook § 7a Proposed The RIO will be the Research Compliance Officer (RCO) appointed by the facility Director. The RIO position is changed to provide administrative management and support only.

Proposed Revisions: VHA Handbook Current “The RIO must promptly notify the VA medical center Director of all research misconduct allegations received.” VHA Handbook §13 c(3) Proposed Within one (1) day of receiving an allegation, the RIO must notify the facility Director, ACOS/R, Regional Counsel, and ORO.

Proposed Revisions: VHA Handbook Current “Upon receipt of a research misconduct allegation, the RIO must determine whether the allegation contains all of the threshold requirements for opening an Inquiry.” VHA Handbook §13e Proposed ORO determines whether a research misconduct Inquiry must be initiated.

Proposed Revisions: VHA Handbook Current “Wherever possible, the VA medical center and the non-VA agencies or entities with concurrent jurisdiction are encouraged to perform a joint Inquiry, and if warranted, a joint Investigation.” VHA Handbook §12c(3) Proposed If a non-VA institution has joint jurisdiction with VA over a research misconduct allegation, each institution shall conduct separate Inquiries.

Proposed Revisions: VHA Handbook Current “Inquiries may be conducted by either the RIO or an Inquiry Committee appointed by the VA medical center Director.” VHA Handbook §14e(2) “ For every case in which an Inquiry is initiated, the RIO, or Inquiry Committee if applicable, must produce an Inquiry Report ” VHA Handbook §14f Proposed The VA facility Director must appoint an individual (excluding the RIO) to conduct the Inquiry. A short Inquiry Memorandum is required.

Proposed Revisions: VHA Handbook Current “The Investigation Review (including final Investigation Report) normally must be completed within 90 days from the initiation of the Investigation.” VHA Handbook §15f(1) Proposed The research misconduct Investigation must be completed within 120 days from the Investigation’s initiation.

Proposed Revisions: VHA Handbook Current “The Investigation Report must be provided to the Respondent, and the portions of the Investigation Report related to the initial Informant’s role and testimony must be provided to the Informant, for their responses. Written comments must be submitted to the Committee within 7 days.” Proposed The Respondent and Informant must be given no less than 30 days to provide any comments on a draft of the Investigation report. The draft Investigation report must also be sent to ORO and Regional Counsel for their review and comment.

Proposed Revisions: VHA Handbook DIALOGUE