The Personnel Information section of the application records the University of Minnesota faculty, staff, students, and volunteers that will be associated with the IBC application. All personnel associated with the IBC application require an x500 login, which will match their eProtocol user ID. Collaborators (including volunteers or visiting scientists from outside institutions) that will be performing IBC related work should be accounted for as personnel on the application. If a non-UMN collaborator requires access to eProtocol, they can be added by having the PI complete an eProtocol Access Request form. Please contact the IBC office at firstname.lastname@example.org or (612) 626-2161 for assistance with this.
The Personnel Information section of the application is used by the IBC to verify that all required online training courses have been completed by the individuals listed on the application. This section of the application can also be helpful to the Principal Investigator since Co-Investigators and a Lab Admin Contact can be designated. The Co-Investigator and Lab Admin Contact roles in eProtocol have greater access to the application which allows for editing and application submission abilities as described below.
Other than the PI, the decision to add a Co-I or PI Lab Admin Contact should be decided by the power granted to that person from the possible actions the person can take related to the IBC application.
Principal Investigator (PI)
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):
- 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.
- Submit annual continuing reviews to maintain approval.
- Submit amendments to update/change research activities, personnel, or funding associated with the application.
- Submit a renewal application if work will continue 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.
- Maintain responsibility for all aspects of the IBC research project including the actions of their staff and the lab spaces associated with the application.
- The actions of the laboratory staff are the responsibility of the PI. This includes ensuring that lab members/staff receive all IBC required training.
- Report incidents involving activities subject to IBC oversight to the IBC. Please note, some incidents reported are subject to additional reporting by the IBC to the NIH Office of Science Policy with conditions set forth in the NIH Guidelines. Some incidents require PI reporting to the NIH OSP (serious adverse events associated with human gene transfer clinical studies to all regulatory entities involved).
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.
PI Lab Admin Contact
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.