Potential U.S. Federal Government Shutdown: Research Continuity Guidance

Regulated Biological Materials Frequently Asked Questions

Frequently asked questions about the IBC, r/sNA, biohazards, ESCRO, human embryonic stem cells, Dual Use Research of concern and other materials involved in research.

This page consists of a series of Frequently asked questions about materials used in research that require additional reviews for safety and compliance with Federal regulations. 

IBC Process and Function

​​​​​​​New applications must be submitted by the second Tuesday of the month prior to the month of desired approval to accommodate review and meeting schedules (Ex. For anticipated March approve, the application would need to be submitted by the second Tuesday of February). Amendments are reviewed and approved on a rolling basis. Please check the submission schedule for specific dates.

​​​​​​There could be multiple reasons which include but are not limited to: the application needs to be reviewed at the monthly IBC meeting, your application is still being reviewed by the committee, the committee is waiting on clarification from you. To get a status update please reach out to cu_ibc@cornell.edu for the most up to date information on the status of your application.

The IBC meets on a monthly basis. Check the meeting schedule for important dates. 

​​​​The IBC staff are happy to talk with you about your research and figure out what regulations apply and help with the next steps. Reach out to cu_ibc@cornell.edu to set up a meeting with the IBC staff.

​​​​​The IBC is charged with reviewing and approving research activities for safety and compliance with Federal and State regulations. The IBC is comprised of a group of professionals and faculty who have expertise in practices and procedures that promote safety. The committee is requesting clarification or a modified practice as these increase the safety of research personnel, the environment, or align with regulatory requirements. If you have questions about requested revisions or need clarification in what a requested revision is asking, please reach out to cu_ibc@cornell.edu

NIH Guidelines for r/sNA

The NIH Guidelines for r/sNA  are Federal requirements established by the National Institute of Health. They require institutions conducting or sponsoring research using recombinant or synthetic nucleic acid molecules (r/sNA) adhere to practices that promote the safety of individuals working with these materials and prevent the spread of these materials to the environment. This document also requires that institutions form an Institutional Biosafety Committee (IBC) and charge that committee with the oversight responsibilities for research that falls within the guidelines.

​​​​​​Yes, though the term used is guidelines, they are required as a term and condition of receiving NIH funding. Violations of the NIH guidelines or lack of adherence to them can result in an institutions loss of all NIH funding and any future opportunities for it.

The NIH Office of Science Policy is charged with overseeing and answering questions regarding the NIH guidelines for r/sNA. Their website contains a series of important Frequently Asked Questions.

Human Embryonic Stem Cells (hESC) in Research

​​​​​Research involving pluripotent stem cells derived from early stage human embryos, up to and including the blastocyst stage that are capable of dividing without differentiating for prolonged periods of time in culture and are known to develop into cells and tissues of the three primary germ layers.

​​​​​​Cornell has established an Embryonic Stem Cell Research Oversight (ESCRO) committee to oversee the review and adherence to of research activities involving human embryonic stem cells.

The ESCRO process consists of a separate application that collects information about the research activities involving hESC. The research activities are reviewed by a committee of individuals with expertise in regulation and the science of hESCs. This committee will determine if the proposed research is allowed within the regulations and will propose any modifications needed to adhere to these requirements. For more information please refer to our ESCRO website.

​​​​​Please reach out to the IBC administrator at cu_ibc@cornell.edu for questions about hESCs or ESCRO.

    1. No, there are multiple cell lines that are considered stem cells that do not fall within hESC regulations. Human Induced Pluripotent Stem Cells (iPSCs) and all other animal stem cells do not qualify as hESCs.

Dual Use Research of Concern (DURC)

​​​​​​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.

Cornell handles potential DURC research through a combination of review by our IBC and our Institutional Review Entity (IRE). Our IBC will identify research with infectious agents that may fall with DURC and then refer these projects to our IRE for further review and compliance the USO DURC policy. For further information about our procedure please go to our Cornell DURC website.

​​​​​If you believe your research constitutes DURC or a funding agency has identified your work as DURC, please contact cu_ibc@cornell.edu. The IBC administrator will get you started on working through the DURC process.

​​​​​​The best place to start is with an IBC administrator at cu_ibc@cornell.edu