NIH Guidelines

The NIH Guidelines provide scientifically based practices for the safe construct and handling of recombinant or synthetic nucleic acids, and cells, organisms and viruses containing them. The NIH Guidelines also include information on biosafety and biocontainment requirements for human subjects, animals, plants and insects participating or used in research involving recombinant/synthetic organisms. The NIH Guidelines address the responsibilities of institutions, investigators, and Institutional Biosafety Committees for biosafety oversight. Compliance with the NIH Guidelines is a condition for grants from the National Institutes of Health and other Federal agencies.

Biosafety in Microbiological and Biomedical Laboratories (BMBL)

The Biosafety in Microbiological and Biomedical Laboratories is a guidance document developed by the CDC and the NIH.  The BMBL provides guidance on protecting laboratory workers and the public from exposure to infectious biological materials and regulated biological toxins that pose various levels of risk to human health, and the containment of biological hazards within the laboratory. The BMBL is considered the code of practice, authoritative reference, and de facto standard of operations for U.S. laboratory biosafety and biocontainment principles, practices, and procedures. Adhering to the BMBL is a requirement for certain research grants related to the US Department of Human Health and Services.

Other Biohazard Controls & Safety Compliance

Risk Management collaborates with the IBC to manage and control biohazardous waste at CSUMB at large through Environmental Health & Safety. Your research will likely involve interaction with EHS staff if your activity involves IBC oversight.

 

What requires IBC review?

The use of infectious or potentially infectious or toxic agents in research and teaching requires prior review and approval by the IBC. The CSUMB IBC has oversight of agents such as: microorganisms, bloodborne pathogens, use of cell lines, NIH recombinant DNA, transgenic plants and animals, select hazardous agents or toxins, nanomaterials, and human gene transfer.

More information on when IBC review is required

IBC Submission Process

All submissions to the IBC will now be processed via Cayuse Hazard Safety.

Step 1: Review guidance

  • Review the activities that might require IBC review and read the IBC Charter to better understand the roles and responsibilities of the committee and Principal Investigator.
  • Request access to Cayuse Hazard Safety – email ibc@csumb.edu
  • Have student research assistants request Cayuse access – email ibc@csumb.edu
  • Document what materials and/or chemicals will be used, the locations where they will be stored, procedures will take place, and plans of disposal. 

Step 2: Complete HSR training via CSU Learn

IBC Training for Researchers via CSU Learn

The IBC will require all study personnel to have completed IBC training prior to approval. IBC training is valid for 3 years and offered via CSU Learn. Additional courses are available based on safe lab practices and additional training may be required commensurate with the project, as determined during the IBC review.

Step 3: Start your Cayuse Animal Oversight submission

Prepare Your Protocol

  • Review the sections of the IBC application in Cayuse.
  • Document what materials and/or chemicals will be used, the locations where they will be stored, procedures will take place, and plans of disposal. 
  • If working with animals or humans subjects, secure additional compliance reviews and approvals. 

Manage Your Approved Study

Once your study is approved, you can manage it through Cayuse:

  • Modifications: Request changes to your approved protocol.
  • Annual Reviews: Submit a brief annual reviews for ongoing protocols.
  • De Novo Reviews: After 3 years, the IBC is required to conduct a thorough review to keep the protocol open.

Step 4: Review Process and Timelines

The IBC typically meets each month if there are applications to review. It is difficult to predict the turnaround time for a specific application because it depends upon the complexity of the project, current number of applications under review, and other factors. We recommend submitting an application at least one month before research begins.

Need help?

Email us at ibc@csumb.edu 

Come to Office Hours – Monday and Thursday 10-11am: https://csumb.zoom.us/j/89660256793 

Bloodborne Pathogens

All studies involving materials derived from humans or non-human primates, including unfixed tissues, primary cells, and established cell lines must be regarded as potentially biohazardous and are regulated under the California OSHA Bloodborne Pathogens (BBP) Standard (https://www.dir.ca.gov/title8/5193.html). These materials must be manipulated under BSL-2 containment conditions and are regarded as “potentially infectious materials” under the BBP Standard. Laboratories using human and primate-derived materials need to register with the IBC.

 Transgenic Plants

Transgenic plants created and maintained in the laboratory and greenhouse environment are subject to provisions of NIH Guidelines and are part of the IBC purview. Transfer of transgenic plants or receiving of transgenic plants from other approved institutions is exempt from NIH guidelines. Field releases, however, are not covered by NIH Guidelines because the release of those organisms is subject to notification and permit requirements under the USDA. To effectively manage releases in accordance with the provisions of USDA notification or permit, all CSUMB personnel and units associated with the work must be informed of these provisions and restrictions, even if the CSUMB PI is not the responsible person on the notification or permit. Failure to do so may result in accidental environmental release, which can lead to sanctions for CSUMB and the holder of the notification or permit.

 Transgenic Animals

The creation of transgenic rodents and other animals must be registered with and approved by the IBC. The creation of transgenic animals includes direct gene delivery (i.e. transformation) and/or the crossing of two different transgenic strains (or a transgenic strain crossed with a non-progenitor wild-type strain). The purchase or transfer of transgenic rodents for experiments that require only BSL-1 containment are exempt from NIH Guidelines.

Select Agents and Toxins

CSUMB does not support the use of select agents or toxins at this time 3/6/2026.

Infectious agents and toxins that are considered by the Department of Health & Human Services (DHHS) or USDA to have the potential to pose substantial harm or a severe threat to human, animal or plant health, or plant products are regulated as ‘select agents’. The current select agent list (https://www.selectagents.gov/SelectAgentsandToxinsList.html) and this process includes a significant security clearance component, conducted by the Federal Bureau of Investigation, for the facility and all who will have access to the select agent or toxin.

Dual Use

CSUMB does not support research that involves Dual Use Research of Concern at this time 3/6/2026.

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. Additional information is available at: https://osp.od.nih.gov/biotechnology/dual-use-research-of-concern/. 

Get Support for Your Biosafety Activities

We’re here to help you navigate requirements, clarify next steps and move your work forward.

Cheryl Logan, PhD

IBC Chair

Michelle Burgett-Moreno

Research Integrity and Compliance Officer