Minneapolis VA Health Care System Research Service
New Investigator Orientation: Investigator Responsibilities
Investigator Orientation: Overview | Required Information | Research Approval | Investigator Responsibilities | Research Funding | Hiring Personnel
Personnel serving as Principal Investigator (PI) for a research project must accept responsibility for all staff working on the project under their supervision. Investigators are responsible for ensuring that they and all staff under their supervision follow all applicable rules and regulations, complete required training, and respond to administrative requests in a timely manner.
The investigator is ultimately responsible for the conduct and continued approval of all of their research projects, even if specific duties are tasked to a study coordinator or other assistant. If you are unwilling to ensure that annual review or renewal paperwork is filed for your studies, you should not initiate any studies as the lead investigator. Likewise, if you are not willing to ensure staff complete all required training, you should not accept responsibility for supervising any personnel.
If an investigator or their staff do not adhere to these expectations, our research administration will intervene to address deficiencies. Repercussions for continued noncompliance may include (but are not limited to) placing administrative holds on active studies, adminstrative removal of personnel from studies, or even administrative closure of studies. Our program can in extreme circumstances refuse to accept or approve new research protocols for individual investigators, or to allow an investigator to supervise paid or unpaid personnel.
All VA research personnel have mandatory training requirements. Training mandated for VA employees is assigned in TMS. Additional training requirements for personnel engaged in human subjects research, animal subjects research, or research that includes laboratory work is assigned through the CITI Program.
Most training required in VA research must be renewed on a recurring basis. TMS trainings are primarily annual; CITI human and animal subjects training must be completed triennially. Because individual CITI training modules are used across many institutions, completion of this training for VA will generally partly satisfy requirements at our academic affiliate, if you link your CITI account to both institutions. Instructions for doing so can be found in CITI Training Information and Guidance.
As with other investigator responsibilities, the lead investigator on a study is reponsible for ensuring all required training is completed for all persons participating in the project. If you are not willing to ensure personnel participating in your studies complete all required training, you should not accept responsibility for adding these personnel to your research projects.
We recognize that in many cases personnel on your projects are colleagues, not subordinates. It can be very difficult to pressure a peer to complete lapsed training. Remember that while you are responsible for the project, all VA personnel are expected to remain current on their own required training. You can refer lapses in training to our office to address deficiencies, or in extreme cases, you can request an amendment to remove individuals from your project.
You should keep in mind that for personnel hired to perform clinical care duties, the research office is only charged with ensuring that required research training is completed. Clinical staff will have additional training assigned by the facility. Lapses in required clinical care training will be addressed by the facility Privacy Officer or Information Systems Security Officers.
Scope of Practice
Each member of the research team, including clinicians with a functional statement/privileges, must have a research "Scope of Practice" statement listing what tasks they are allowed to do. The scope of practice is approved by the individual's PI or immediate supervisor and the ACOS or Deputy ACOS. Each individual is only required to have one scope of practice. It is the responsibility of the individual and their immediate supervisor or PI(s) to update their scope of practice any time duties are added or removed.
The Scope of Practice form should be completed and submitted via email to the Research Office (VHAMINResearchOffice@va.gov) after the employee and supervisor sign the form.
Publications and Presentations
You do not need permission from VA to present your work at a conference, or to publish a manuscript. However, you do need to request clearance in advance from the Minneapolis VA Public Affairs Specialist for media presentations or interviews.
VA researchers who publish or present on their projects are required to include a disclaimer stating that the views expressed are theirs alone, and do not represent the official view of the VA or of the U.S. Government.
Investigators must also acknowledge VA support for their work. The Office of Research & Development created a checklist to assist researchers in citing VA support appropriately.
Publications resulting from VA-approved research must be reported by the lead VA investigator using the VA PubTracker Intranet site at http://vaww.pubtracker.research.va.gov/PubTracker/default.cfm (copy and paste this link into your browser). For guidance, refer to the instructions in Submitting a Research Publication or Presentation in VA PubTracker.
Remember that all publications resulting from VA-approved research must also follow NIH open access guidelines. Use the NIHMS Manuscript Submission System to ensure compliance.
Invention Disclosure and Intellectual Property
Any invention made by a VA employee (including personnel on WOC or IPA appointment) must be disclosed to VA through submission of an Invention Disclosure and Invention Certification statement for each applicable invention. Disclosures and certifications are made using the VA Technology Transfer Program (TTP) Sophia Online Portal. Links and instructions can be found on the VA TTP website. Investigators must ensure that they and their study team understand these obligations and ensure that disclosures and certifications are properly filed. Submissions use the Investigators should consult with the Field Technology Transfer Specialist at our facility, Nicholas Cilz, for guidance and assistance with invention disclosure and other issues related to intellectual property.
Securing and Archiving Data
Research project personnel are responsible for securing and maintaining records for active projects. When initiating a project, a secure study data folder must be created on the VA network (R drive) at R:\Data. The folder in which data are placed must be named using the approved project protocol number, and must be secured to prevent access for any persons other than approved study personnel. All study records and data must be stored in this folder. Access to the folder can be managed by the study team using instructions outlined in Adding or Removing Personnel in SFFX.
Note: Some research groups or centers (CCDOR or MADE) maintain study data in alternate locations approved by the Research Office. These folders are secured and access-restricted using the same process as folders in R:\Data. When in doubt, contact the Research Office for guidance.
Once a project is closed, the PI must provide all paper and electronic study records and data for archiving. Please note that once a project closes, the research team is not allowed to retain copies of records containing PHI/PII. For specific details and guidance on records management and records destruction, refer to the Records Management FAQ.
Applicable policy and guidance:
- RDC-002 "Presentation of Research Results"
- RDC-004 "Research Investigator Responsibilities"
- RDC-008 "Scopes of Practice"
- RDC-009 "Administrative Expectations for Personnel Conducting Research"
- RDC-010 "Required Research Training"
- RDC-016 "Research Data Requirements"
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