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Training

Effective August 10, 2012, Virginia Tech implemented the new provisions of the Individual Conflicts of Interest policy 13010 which requires all investigators to complete initial and periodic training on Conflicts of Interest that includes; informing investigators of the new regulations, the Institution’s FCOI policy, and of the Investigator’s disclosure responsibilities that meet or exceed the regulatory requirements. 

Target Audience:  Individuals required to complete training include, but may not be limited to; principal investigators, co-investigators, project directors, postdoctoral associates, graduate students and any other person deemed responsible for the design, conduct, or reporting of research.  For the purposes of the Individual Conflicts of Interest Policy 13010, research includes outreach and service awards if there is a research component to the project.   

All investigators with existing awards will need to be trained, see special requirements for Public Health Service awards below.  As of August 10, 2012, investigators for all other awards must be trained within 30 days of project start-up.   

Public Health Service (includes NIH, CDC, and more)
Federal regulations require all Public Health Service (PHS) investigators to complete training prior to expending funds, therefore, all PHS awards will be held until all individuals named in the proposal are trained. For all current, active PHS awards, investigators should be trained as soon as possible. All investigators with pending PHS proposals will need to be trained before award setup. Anyone added to PHS projects after award setup will have 30 days to complete the training. No work should be performed on the PHS project until training has been completed. Research administrators who support faculty members in proposal development or award management are encouraged to attend.

Retraining

Initial and periodic training concerning applicable university policies and state and federal law and the investigator’s responsibilities for disclosure is required for all faculty engaged in sponsored research. 

Retraining related to conflict of interest is required every four years and/or whenever there is significant change in university policy related to investigator responsibilities. Any investigator found to be in non-compliance with disclosure requirements will also be required to complete immediate training.

The Office of Research has established the following options for satisfying the new PHS requirement:

Face-to-Face and Synchronous Online Instruction

Individuals can register for face-to-face sessions through www.training.vt.edu.  Login in using your VT PID and password and select "view by alpha" and scroll down to the courses whose titles start with “OVPR.”  Click on the course titled "OVPR: Individual Conflicts of Interest and Commitment" and select the preferred session date/time.  You will receive an email confirmation of enrollment.

Face-to-face sessions will be offered monthly through out the semester and as needed thereafter.   These sessions will also include a live online option if you are not able to attend in person.  

For questions about courses or enrollment, please contact Vicky Ratcliffe at vratcliffe@vt.edu or Quinn Steen at qsteen@vt.edu

Asynchronous Online Training (CITI course)

Individuals can access an asynchronous on-line course created by the Office of Research and maintained by the Collaborative Institutional Training Initiative (CITI), a nationally-recognized source for research-related training.  After the learners complete and pass the appropriate modules, they will be able to print a completion report.
 

Failure to comply with this policy by any required participants within the specified time frame may result in freezing the account of the project supporting these personnel.

For more information:

  • Technical issues regarding content delivered on the CITI website should be addressed to citisupport@med.miami.edu or to 305-243-7970.
  • Questions regarding COI training requirements should be addressed to Linda Bucy, Assistant VP for Finance and Controls, at coi@vt.edu or 540-231-7964 or Vicky Ratcliffe, Manager of Research Education and Development, at vratcliffe@vt.edu or 540-231-7964

Research Integrity Training Tracking System

The Research Integrity Training Tracking System is available so that principal investigators and department staff, who have authorization, can view the training status of those required to complete responsible conduct of research or conflict of interest training. 

Public Health Service (PHS) investigators can also submit their required travel disclosures via this system.   To learn more about the travel disclosure required for PHS (NIH, CDC, etc.) investigators please go to the disclosure section.

This system will allow you to view:

  • Individuals who have been added through payroll to a grant level sponsored project associated with your organization and is required to complete training  
  • Individual RCR and COI training status
  • Training notification e-mails that were sent  to the individual  
  • Individuals within your organization who  have been trained in RCR or COI but are not currently on a sponsored project   

The link to the system is https://secure.research.vt.edu/rcr/ (requires PID/Password).

 

Learn more about conflict of interest:

FAQ’s

  1. No, the policy and the federal regulations require that investigators are trained on institutional specific conflicts of interest policy.  

  2. Retraining related to conflict of interest is required every four years and/or whenever there is significant change in university policy related to investigator responsibilities. Any investigator found to be in non-compliance with disclosure requirements will also be required to complete immediate training.

  3. Individuals required to complete training include, but may not be limited to; principal investigators, co-investigators, project directors, postdoctoral associates, graduate students and any other person deemed responsible for the design, conduct, or reporting of research.  For the purposes of the Individual Conflicts of Interest Policy 13010, research includes outreach and service awards if there is a research component to the project.   

     

  4. There are several triggers to consider in determining whether a student – undergraduate or graduate – needs to be trained in conflict of interest:

    • Is the student participating in a sponsored research project?
      • Participation in research managed through Sponsored Programs is one trigger, whether or not the student is being paid from the project. 
      • Students who are conducting research as an independent study or senior design project for credit, but not as part of a sponsored project, would not require training.
    • Does the student’s role in the research meet the definition of “investigator”?
      • “Investigators” are those “responsible for the design, conduct or reporting of research” regardless of title.
        • Participation in taking measurements, collecting data or samples, conducting tests or performing tasks under the supervision of another do not usually rise to the definition of investigator.  Investigators would typically add analysis or interpretation of the data, extrapolate from observations, build models, and so on, thereby making an original contribution to the research.
      • Many undergraduates, or even high school participants, are involved in research but often their work is not sufficiently independent to trigger the definition of “investigator.”  One exception may be students funded on a sponsored project REU (Research Experience for Undergraduates) in which the REU application specifies that the student will have some independent responsibility for the research.  In such cases, students would be subject to the COI training requirement.
        • The National Council on Undergraduate Research offers this definition:  Undergraduate research is an inquiry or investigation conducted by an undergraduate student that makes an original intellectual or creative contribution to the discipline
        • Note the intent in this definition to have students make an original contribution to the research.
      • Graduate students funded on a sponsored project and conducting research related to a thesis or dissertation would almost always meet the definition of “investigator” and hence should be trained in conflict of interest. 
      • Many other graduate students may be functioning independently in the design or conduct of a sponsored research project, or be involved in writing up and reporting the findings even if the research is not part of their dissertation or thesis.  COI training would be required in these cases as well.

    Additional considerations about student involvement in research:

    • University policy provides protections for students involved in research funded by a faculty member’s company or consulting.  Please see the relevant sections of policy 13010 and the related form, “Research Agreement for Students and Postdoctoral Associates.”  Faculty members are required to disclose student involvement with their private business or consulting so that appropriate steps can be taken to inform the student about the potential risks, avenues for redress if needed, and the scope of work/research and any restrictions on publication of the findings.
    • Caution should be exercised if a class project appears to serve the interests of a faculty member’s outside company or consulting.  Disclosure of a faculty member’s interest in the class project is important so that the risks and benefits can be assessed and the appearance of using student labor for personal gain can be mitigated.  When possible, such a project may be better handled as part of a university sponsored project with the student supervised by another uninvolved faculty member.