Personnel Information

Who can be listed as a PI in eProtocol?

• The PI must be a University of Minnesota employee who is primarily responsible of all aspects of the research project or who is primarily responsible for and in charge of their teaching laboratory.
• The criteria necessary to serve as the PI are:
  • Regular or emeriti faculty member OR
  • Term and non-regular faculty and other academic employees (such as P&A employees) OR
  • Individuals with graduate student/professional training status OR
  • Employees with non-academic titles, in unusual circumstances
• Non-UMN entities seeking IBC approval must collaborate with an eligible UMN PI who will serve as the PI on the application.
• Only one PI can be listed on an IBC application.
   

Responsibilities of the PI (as summarized from IBC policy 700, the NIH Guidelines, and University-wide Administrative Policy):

• Apply for approval for any research projects or teaching activities involving potentially hazardous biological materials (infectious agents, biological toxins) or recombinant/synthetic nucleic acid molecules (r/sNA) with the IBC.
  • Comply with the NIH Guidelines in the conduct of r/sNA research.
  • Conduct research in compliance with safety requirements established by the CDC/NIH publication, “Biosafety in the Microbiology and Biomedical Laboratories” (BMBL) and the conditions set by the IBC.
  • Work involving r/sNA molecules, infectious agents, or biologically-derived toxins may not be initiated until final approval has been granted by the IBC.
• Maintain the IBC application by:
  • Submitting annual continuing reviews to maintain approval.
  • Submitting amendments to update/change research activities, personnel, or funding associated with the application.
    • When a research project changes from one PI to another, because of resignation or retirement, the change in PI responsibility must be approved by the IBC through submission of an amendment.
  • Submitting a renewal application if work continues past the initial 3 year approval period.
• For all projects involving either human gene transfer or administration of infectious agents/toxins to human subjects, the PI must obtain informed consent from human subjects participating in research studies and have IRB approval.
• Maintain responsibility for the lab spaces associated with the application (lab inspections, equipment maintenance).
• The PI should be adequately trained in good microbiological techniques.
• The actions of the laboratory staff are the responsibility of the PI. The PI should therefore:
  • Ensure that lab members/staff receive all IBC required training.
  • Inform their staff and students of the potential risks posed by agents used in their research or teaching laboratories.
  • Prepare a safety plan for any research or teaching activities under their direction, which must include a description of the emergency and/or accident response procedures to be followed in the event of a spill, personnel contamination, or loss of containment.
  • Correct work errors and identify defective work conditions which could result in personal injury and/or loss of containment, and emphasize the importance of accident prevention among staff and students
• Comply with shipping requirements for r/sNA molecules.
• Report incidents involving activities subject to IBC to the IBC, NIH OSP, and other appropriate authorities (if applicable) within 30 days. Typically, the IBC Administration performs the reporting to the NIH OSP, so if the PI performs this, then they should let the IBC Administration know.
  • Report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses.
     
    

eProtocol actions that can be performed by the PI:

• Create, edit, view, print, and submit the initial application and all subsequent submissions including amendments, incident reports and continuing review forms.
• The PI may also respond to comments from IBC staff or reviewers.
• Check the PI assurance tab.

Who should be listed as a Co-Investigator in eProtocol?

• Any UMN faculty, staff, or student that the PI desires to have the same eProtocol access/capabilities to the protocol as the PI (even though the PI takes responsibilities for all actions)
• We do not recommend that the Co-Investigator be any of the following:
  • An accountant or office manager.
  • An individual with their own lab who is listed as a Co-Investigator on a grant application with the PI submitting the IBC application. 
    • If an individual with their own lab staff is added as a Co-Investigator it should be understood that the PI listed on the application will be solely responsible for all personnel, training, lab spaces, and incident reports associated with this application.
• Multiple Co-Investigators may be added to the application, however, the designation of a Co-Investigator is not required. 

eProtocol actions that can be performed by the Co-Investigator:

• The Co-Investigator may create, edit, view, print and submit the initial application and all subsequent submissions. 
  • Of note: the PI assumes responsibility for any edits or protocol submissions that a Co-Investigator makes to the application. 
• Co-Investigators may also respond to comments from the IBC admin staff and IBC. 

Who should be listed as the PI Lab Admin Contact in eProtocol?

• A lab manager or other individual directly involved in the research activities on the application.
  • Administrative office staff such as accountants are not recommended to be listed as the PI Lab Admin Contact on the application. These types of individuals are not relevant to the IBC application since the goal of the personnel section is to record the individuals that will be performing IBC related work and their necessary laboratory training records.
• Only one PI Lab Admin Contact may be designated on an application, but the inclusion of a PI Lab Admin Contact is not required. 
   

eProtocol actions that can be performed by the PI Lab Admin Contact:

• Edit, view, and print the application and subsequent submissions.
• The PI Lab Admin Contact may also respond to comments from IBC staff and reviewers.
• Personnel in this role can initiate amendments and continuing reviews to edit the application but the final submission must be performed by the PI.

Who should be listed as Additional Staff in eProtocol?

• Individuals that will be performing any of the research activities described in the IBC application.
• Each application may have multiple people listed as Additional Staff but there is no requirement to add Additional Staff to an application.
• For teaching activities, all teaching/laboratory assistants should be part of the application. It is not expected that enrolled students are part of the application, but training should be provided to students related to the required training for personnel on the application. 
   

eProtocol actions that can be performed by Additional Staff:

• View or print the protocol. This role does not allow individuals to edit, submit, or initiate changes to the protocol.