Research Misconduct: Frequently Asked Questions

FAQ — Definitions?

Does the definition of “research record” include medical records?
The definition of “research record” in VHA Handbook 1058.02, Paragraph 5.n., is taken from the Federal Policy on Research Misconduct.  A “medical record” is not specifically included as an example of research records in the definition.  However, the list of examples is not exhaustive.  If, in fact, a medical record contains data or results that “embody the facts resulting from scientific inquiry,” then such a medical record constitutes a research record for purposes of Handbook 1058.02.

FAQ — Notifications?

When should the Office of Research Oversight (ORO) be notified of a research misconduct allegation?
In accordance with the provisions of Paragraph 12.b and Appendix B of VHA Handbook 1058.01, ORO Central Office must be notified as soon as possible (preferably by telephone or email) about any allegation of research misconduct.  Subsequent written notification must be provided as specified by ORO.

In accordance with VHA Handbook 1058.02, ORO Central Office must be further notified:

if an Inquiry determines that the case should be closed without further Investigation (par. 14.g.(2));
when an Investigation is initiated (par. 15.c.);
at the end of an Investigation (par. 15.h.(3));
when interim actions are taken in response to certain events, e.g., harm to research subjects, serious violations of animal welfare requirements, research safety compromises, etc. (par. 12.e.(1)).

FAQs — RIOs?

Does the Research Integrity Officer (RIO ) have to be the Associate Chief of Staff (ACOS) for Research, the Research Coordinator, or the Research and Development Committee Chairperson?
No.  Those positions are listed only as examples of existing staff positions to which the medical center Director may assign the additional duties of Research Integrity Officer.  The RIO may be “another similar individual within the research program who has sufficient institutional authority and experience to be able to fulfill the required duties.”  VHA Handbook 1058.02, Paragraph 7.a.

Does the ACOS for Research have an inherent conflict of interest as the RIO?
As the person responsible for managing the success of a VA medical center’s research program, one could suspect that the ACOS/R acting as RIO might have an inherent bias towards downplaying any incident of research misconduct at the facility. Several procedural features of the Handbook, however, ensure that procedural objectivity is properly maintained:

The RIO must promptly notify the Director of all research misconduct allegations received, regardless of merit.  VHA Handbook 1058.02, Paragraph 13.c.(3).

For allegations that the RIO determines to be deficient (fails to meet the required threshold), a notification of that determination must be sent to the VISN Director and retained for at least 3 years. Paragraph 13.f.(2).

ORO reviews all allegations of research misconduct for procedural conformance, including those for which the RIO or Inquiry Committee finds the evidence to be insufficient to open an Investigation. Paragraphs 14.g. and 17.
Given these procedural checks and balances, the medical center Director may appoint the ACOS/R to be the facility’s RIO if the Director believes that that person can demonstrate objectivity in carrying out the duties of a research integrity officer.

May a VA medical center (VAMC) with a small research program rely on the RIO of another VAMC instead of appointing its own RIO ?
A number of VAMCs with smaller research programs have established a Memorandum of Understanding (MOU) with a larger VAMC to use the latter’s IRB and Research and Development Committee for oversight of the smaller VAMC’s protocols.  Regardless of these arrangements or the size of a VAMC’s research program, VHA Handbook 1058.02, Paragraph 7.a., requires that each VA medical center with research involvement designate a permanent RIO position responsible for overseeing misconduct allegations at that facility.

There are important reasons for having an on-site RIO at each facility.  For one, potential informants at each facility should have a point of contact that is readily accessible so that making an allegation of research misconduct is not overly burdensome.  If misconduct does arise at a medical center, such a case would best be handled by a RIO housed at that facility who has the appropriate authority and familiarity with the facility in order to administer the proceedings effectively.  Also, the RIO is responsible for overseeing his/her medical center's general compliance with the research misconduct procedures.  An off-site RIO would not be able to accomplish this oversight responsibility as effectively as an on-site RIO .

In certain limited circumstances where appointing a permanent on-site RIO would be administratively untenable, a facility may designate a RIO who is located at another VAMC if the two facilities otherwise share research resources.  Procedures should be instituted to ensure that the concerns outlined in the above paragraph are addressed.  These arrangements should be discussed with ORO before making such appointments.

FAQ — Education and Training

What are the education/training requirements for a RIO ?
VHA Handbook 1058.02, Paragraph 7.b.(3), states that RIOs are responsible for “receiving initial and continuing education and training in the handling of research misconduct allegations.”  The Handbook does not provide further details on the nature of this educational requirement.  The most important step for a newly appointed RIO is to become familiar with the provisions of Handbook 1058.02.  Secondarily, RIOs should review VA Handbook 0700 (Administrative Investigations).  Beyond that, ORO will send out periodic announcements about further training opportunities.  Examples of possible training include:

Attendance at conferences and meetings at which Handbook 1058.02 is presented by ORO staff;

Attendance at Employee Education System (EES) training on Administrative Investigation Boards (AIB).  (Course #311);

View and Self-certify Completion of TMS Course number VA 7083 "Administrative Investigation Board (AIB) Video Concept" at https://www.tms.va.gov/; 

Review of these FAQs which will be updated periodically; 

Individual consultation with ORO staff in particular research misconduct cases.