IBC protocols and forms are submitted through the NuRamp electronic research administration system. NuRamp is a secure electronic research administration system developed by the Office of Research and administered by Bolero, Inc., to help University of Nebraska-Lincoln faculty, staff and administrators manage research projects. Access to NuRamp is granted by using your UNL TrueYou credentials.
NuRamp
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Protocol Development and Maintenance
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Preparing a New Protocol
You will need the following information prior to beginning an IBC form in NuRamp:- Research Description. This should be a summary of proposed research, using non-scientific terminology. A copy of an abstract is usually not a substitute for a research description. Information entered in the protocol should be referenced in the research description.
- List of any applicable grants or permits. These should be available for reference in NuRamp.
- List of any laboratory staff or collaborators, These individuals will be directly involved with the proposed research.
- List of related protocols from other research compliance committees. This includes any IACUC, RSC, SROC, or IRB protocols.
- Specific sections of the NIH Guidelines indicated. The PI must indicate which section(s) of the NIH Guidelines apply to the experiments to be conducted under the protocol.
- List of all microorganisms to be manipulated. All microbes and their traits such as pathogenicity and host range that are part of the protocol must be listed. This includes proposed host vectors.
- List of all genes to be manipulated. If the list includes multiple genes which share the same function (e.g., decarboxylase enzyme), you may list the genes by function.
- List of plasmids to be manipulated. As with genes, you may group these if from the same host (e.g., pBR322, K12 derived).
- List of organs, tissues, cells and cell lines, body fluids and byproducts to be manipulated.
- List of research organisms. These refer to animals (including invertebrates) or plants used in research. Human research participants are generally not included in this section.
- Facilities used for the research. Include core facilities and field sites.
- PPE, SOPs, and risk assessment information.
- Disinfection/ decontamination/ disposal methods and procedures.
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Protocol Pre-review
- After initial submission, IBC protocols are pre-reviewed to assure accurate and complete description of proposed research in addition to correctly referenced NIH Guidelines. In the event the referenced NIH Guidelines are incorrect, the PI will be notified and corrective action will be taken if needed (cessation of work, etc.).
- It is advisable that the PI respond to any discrepancies in the protocol as soon as possible to facilitate a timely committee review.
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IBC Review
- As indicated in the NIH Guidelines and the university Biosafety Guidelines, the IBC is charged with reviewing the submitted protocol, establishing final biosafety containment as applicable, and helping ensure compliance with the NIH Guidelines. The PI is responsible to address any questions, concerns, or other issues promptly. PIs will be notified of the meeting date at which their protocol will be reviewed.
- PIs are strongly encouraged to attend IBC meetings when their protocols are being reviewed to answer any questions posed by the committee.
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Laboratory Safety & Compliance Surveys
New PIs are required to have a "preapproval" safety and compliance survey to ensure the lab space is adequate for the proposed research. Results of safety surveys are reported to the IBC during protocol review
PIs with approved IBC protocols will receive an annual safety and compliance survey of their laboratory spaces, administered by EHS, to ensure compliance with biosafety guidelines in addition to applicable safety regulations (OSHA, NFPA, etc.). -
Protocol Maintenance
- At the university IBC protocols do not have a termination date, but Annual Update Forms are required to be submitted each year after approval of a New Protocol Form.
- Major changes to a protocol after initial approval must be reviewed and approved by the IBC through submission of
an Amendment Form. Amendments can be submitted at any time after a protocol is approved. They also
supersede the requirement for an Annual Update Form is submitted within 60 days of the Annual Update due date.
- For details about what constitutes a "Major Change," consult Section 5.5.2 of the university Biosafety Guidelines.
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Minor Modifications
- Changes to a protocol that are considered "Minor" in nature can be requested through submittal of a Minor
Modification Form through NuRamp. This form can be submitted at any time after initial approval. Below is a
list of the categories of changes that are considered "Minor" by the IBC. The Minor Modifications Forms are reviewed and
can be approved by the BSO without full committee review:
- Changes to personnel (except the PI; this change requires a full Amendment)
- Changes to facilities (Facility inspection by the BSO is required)
- Changes to funding
- Changes to decontamination/disinfection or disposal procedures
- The Minor Modification Form does not replace the requirement for submission of the Annual Update Form.
- Changes to a protocol that are considered "Minor" in nature can be requested through submittal of a Minor
Modification Form through NuRamp. This form can be submitted at any time after initial approval. Below is a
list of the categories of changes that are considered "Minor" by the IBC. The Minor Modifications Forms are reviewed and
can be approved by the BSO without full committee review:
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Protocol Terminations
- When projects that require IBC approval are terminated or a faculty member leaves the university, the IBC protocol must be terminated by submitting a Termination Form. This form asks about the final disposition of the biological materials, samples and specimens used in the project. Submission of this form must be completed immediately upon project completion and prior to faculty leaving the university.
- If a faculty member is leaving the university and shutting down his/her lab, other requirements for lab decommissioning apply and are detailed in the EHS SOP Laboratory Decommissioning.
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Preparing a New Protocol
Post-approval Monitoring (PAM)
- To help PIs maintain compliance with biosafety and NIH guidelines, an informal visit will be conducted by members of the EHS biosafety team. This visit is separate from the annual safety and compliance surbeys and is designed to discuss any future research plans of the PI and assist in submitting any applicable IBC forms if needed. Post-approval monitoring is conducted on a variety of timelines (annual, biannual), at the discretion of EHS and the IBC.
- All PIs with new IBC protocols will receive a PAM visit approximately 6 months aafter protocol approval. This visit will function mainly as a means of providing lab start up assistance to the PI related to safety procedures and practices and to offer assistance with lab personnel training as requested by the PI.