I. EFFECTIVE DATE OF VHA HANDBOOK 1058.02 (“RESEARCH MISCONDUCT”)
A. What is the issuance date of the version of VHA Handbook 1058.02 (“Research Misconduct”) that is currently in effect?
The version of VHA Handbook 1058.02 that is currently in effect was issued on February 7, 2014. This version of the Handbook replaced a previous version that was issued on November 16, 2012.
B. If an updated version of VHA Handbook 1058.02 (“Research Misconduct”) is issued while a research misconduct proceeding is already in progress, which version of the Handbook must be followed?
The applicable policies and procedures of the version of VHA Handbook 1058.02 that was in effect at the time a formal allegation of research misconduct was received by the RIO must be followed for the duration of that particular research misconduct case. For example, if a formal allegation of research misconduct was received by the RIO after November 16, 2012, and prior to February 7, 2014, all subsequent procedural stages (e.g., inquiry, investigation, adjudication, and appeal) associated with the case would be subject to the requirements of the version of the Handbook issued on November 16, 2012. If a formal allegation of research misconduct was received by the RIO on or after February 7, 2014, all subsequent procedural stages (e.g., inquiry, investigation, adjudication, and appeal) associated with the case would be subject to the requirements of the current version of the Handbook issued on February 7, 2014. NOTE: If additional allegations arise during the course of an ongoing research misconduct case and the allegations are incorporated into the ongoing case, the additional allegations must be handled in accordance with the version of the Handbook applicable to the case that is already in progress (i.e., the initial and additional allegations should both be handled in accordance with the version of the Handbook that was in effect on the date the initial allegations were received by the RIO).
II. VHA HANDBOOK 1058.02 POLICY AND PROCEDURAL CHANGES
A. What changes have been incorporated into the version of VHA Handbook 1058.02 (“Research Misconduct”) that is currently in effect?
Numerous substantive changes were incorporated into the current version of the Handbook. The current Handbook retains the fundamental, procedural structure (e.g., inquiry, investigation, adjudication, and appeal) that conforms with the Federal Policy on Research Misconduct and that has been included in previous versions of VHA Handbook 1058.2/1058.02. The current Handbook addresses common procedural challenges that were not addressed in previous versions, and implements more robust and efficient procedures for responding to allegations of research misconduct.
III. VA FACILITY POLICIES AND PROCEDURES
A. Are VA facilities required to develop facility-specific policies and procedures for responding to allegations of research misconduct?
No. VHA Handbook 1058.02 provides detailed policies and procedures that alleviate the need for facilities to develop local policies and procedures for responding to allegations of research misconduct. However, facility personnel may, at their discretion, develop supplemental procedures to implement the Handbook at the local level provided that the local procedures are compliant with those in the current Handbook.
IV. ORO NOTIFICATION OF RECEIPT OF AN ALLEGATION
A. When should the Office of Research Oversight (ORO) be notified that an allegation of research misconduct has been received?
Within one (1) business day of receipt of a formal allegation of research misconduct, ORO Central Office must be notified of the allegation (see VHA Handbook 1058.02 §14d(1)).
V. RESEARCH INTEGRITY OFFICERS (RIOs)
A. Does the Research Integrity Officer (RIO) have to be the Associate Chief of Staff (ACOS) for Research and Development (R&D), the Deputy ACOS/R&D, the Administrative Officer (AO)/R&D, or the Research Compliance Officer (RCO)?
No. VHA Handbook 1058.02 §10a stipulates that the individual appointed as RIO must have previous experience conducting research and/or providing research administrative oversight, and sufficient institutional authority to be able to fulfill the required responsibilities of the position. Section 10a(1) of the Handbook provides additional factors that the VA facility Director should consider when selecting an individual to serve as RIO. The positions referenced in the FAQ are listed in the Handbook only as examples of staff who might possibly be qualified to serve as RIOs.
B. Does an individual serving in an administrative position within the Research Service have an unmanageable conflict of interest in serving as the Research Integrity Officer (RIO) by virtue of his/her position?
Not necessarily. See VHA Handbook 1058.02 §10a(2). Several procedural requirements of the Handbook adequately manage any apparent conflict of interest and ensure that procedural objectivity is properly maintained, including:
(i) The RIO must promptly notify ORO and the VA facility Director of all formal allegations of research misconduct that are received (see VHA Handbook 1058.02 §14d(1)).
(ii) If a RIO has a conflict of interest that cannot be appropriately managed with respect to the research, the respondent, the informant, or other key witnesses in a particular research misconduct case, the Director must appoint another individual to serve as an acting RIO for the case (see VHA Handbook 1058.02 §10d).
(iii) ORO, not the RIO, makes the determination as to whether a research misconduct inquiry must be initiated (see VHA Handbook 1058.02 §14e).
(iv) The VA facility Director and ORO both have the authority to require that an investigation be convened in instances where an inquiry recommended that a case be closed without an investigation (see VHA Handbook 1058.02 §19a(1)(b)).
(v) ORO conducts a procedural review of all research misconduct cases that involve an investigation and provides the outcome of its review to the VISN Director who adjudicates the case (see VHA Handbook 1058.02 §23c).
Given these procedural checks and balances, the VA facility Director may appoint an individual who serves in an administrative role within the Research Service to also serve as RIO.
C. Is there a requirement for an appointment letter to be issued for the individual who serves as the Research Integrity Officer (RIO)?
Yes. VHA Handbook 1058.02 §10a states that “[t]he Director of each VA facility with an active research program must appoint, in writing, an individual, who is employed by that facility, to serve as RIO.”
D. Are Research Integrity Officer (RIO) personnel changes required to be reported to ORO?
Yes. VHA Handbook 1058.02 §10b requires RIO personnel changes to be reported to the ORO Research Misconduct Officer within 30 days of the change being made.
E. May a VA facility with a small research program rely on the Research Integrity Officer (RIO) of another VA facility instead of appointing its own RIO?
A number of VA facilities with smaller research programs have established a Memorandum of Understanding (MOU) with a larger VA facility to use the latter’s Institutional Review Board (IRB) and Research and Development Committee (R&DC) for oversight of the smaller VA facility’s protocols. Regardless of these arrangements or the size of a VA facility’s research program, VHA Handbook 1058.02 §10a requires the Director of each VA facility with an active research program to appoint an individual, who is employed by that facility, to serve as RIO.
There are important reasons for having an on-site RIO at each VA facility that is engaged in research. First, potential informants at each facility should have a point of contact who is readily accessible so that making an allegation of research misconduct is not overly burdensome. Second, if a research misconduct case does arise at a facility, the case is often best handled by a RIO who has the appropriate authority and familiarity with the facility (by virtue of being employed there) to oversee the proceedings effectively. Also, because the RIO is responsible for overseeing the VA facility’s general compliance with the research misconduct procedures, an off-site RIO may not be able to provide this oversight as readily or effectively as an on-site RIO.
In rare circumstances where appointing a permanent on-site RIO would be administratively untenable, the facility must contact ORO to explore possible alternative arrangements before appointing a RIO.
F. What are the education/training requirements for a RIO?
VHA Handbook 1058.02 §10e stipulates that RIOs must become familiar with the policies and procedures established in the Handbook. RIOs may, at their discretion, consider availing themselves of additional applicable training including:
(i) Training on VA Administrative Investigations (e.g., VA Employee Education System (EES) in-person training on Administrative Investigation Boards (AIB) (course #311), and/or VA TMS Web-based training, titled "Administrative Investigation Board (AIB) Video Concept" (course # 7083) available at https://www.tms.va.gov/);
(ii) In-person and Web-based training on research misconduct and the role of the RIO (see http://ori.hhs.gov/content/rio-boot-camp and http://ori.hhs.gov/video-role-rio); and/or
(iii) Participation in teleconferences and other forums where ORO personnel present information related to VHA Handbook 1058.02.
VI. AVAILABLE RESOURCES
A. What resources are available to promote compliance with the requirements of VHA Handbook 1058.02?
ORO provides remote training for Inquiry Committees and on-site training for Investigation Committees. In addition, ORO has developed notification templates and checklists that can be used by VA RIOs and facility personnel to facilitate compliance with the requirements of the Handbook. ORO is also available for individual consultation with regard to particular issues that may arise during the course of a research misconduct proceeding. VA facility RIOs are encouraged to contact the ORO Research Misconduct Officer to learn more about the specific resources that are available.