-
Institutional Biosafety Committee (IBC). This U-M entity is responsible for the biological safety review and approval of the research use of recombinant DNA, synthectic nucleic acid molecules, infectious agents, biological toxins, federally-regulated select agents, and more.
- Additional Practices - BL2 An explanation of the additional safety practices that may be assigned to research requiring Biosafety Level 2 (BL2) containment.
- Biosafety Considerations for Research with Lentiviral Vectors Guidance from the NIH Office of Biotechnology Activities (OBA) Recombinant DNA Advisory Committee (RAC)
- CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
- Changes to BL2+ Containment An explanation of the new BL2 with additional practices designation.
- COVID-19 Research Laboratory Biosafety Guidelines Guidance describing the types of research activity, appropriate biosafety levels, and contacts for questions and institutional approvals required for University of Michigan researchers working in laboratories during the COVID-19 pandemic. Last updated: 05/03/2021.
- Environment, Health & Safety (EHS) - Topics A-Z
- Environment, Health & Safety (EHS): Research & Clinical Safety - Biological U-M's EHS guidelines, SOPs, etc. for laboratories conducting research with rDNA, bloodborne pathogens, and other potentially hazardous biological materials.
- Federal Select Agent Program CDC web site that provides a complete listing of specific Select Agents and detailed information about the regulations addressing them.
- IBC Application Overview Orientation to the features and functions of the online IBC Application (IBCA) form in the IBC tab of the eResearch Regulatory Management (eRRM) system
- IBC Application Tasks A guide to accessing and viewing your IBC Application (IBCA) in eResearch during the submission, amendment, or renewal processes. Provided by ITS.
- IBC Application: Applicant's Guide to Common Areas of Improvement Lists common issues applicants encounter when completing an IBCA and provides fixes and tips to improve the accuracy and detail of the application information. Last updated: July 2024
- IBC Approval Needed for Research Involving E. coli Strains (PDF) Lists of exempt, not exempt non-pathogenic, and not exempt pathogenic E. coli strains that require IBC approval prior to use in research per NIH Guidelines III-F-8 appendix, III-E, and III-D respectively.
- IBC FAQs Series of frequently asked questions covering the range of IBC processes, including information about the IBC registration, submission and renewal processes, and EHS- or animal-related IBC requirements. (PDF) Last updated: 04/28/2022.
- IBC Policy for U-M Managed Research Cores Defines and describes the guidelines that U-M Core Research Facilities must follow to comply with the University of Michigan's Insitutional Biosafety Committee (IBC) regulations for the safe handling of potentially hazardous biological materials.
- IBC Recommendations for Animal Housing Containment A chart listing the applicable animal biosafety level for types of animal research. (PDF) Last Updated: 07/13/2022
- My LINC Link to U-M training resources
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules HTML version of NIH Guidelines for rNDA/sNA research, April 2024.
- NIH Guidelines, Appendix C: Exemptions Lists the types of experiments exempt from IBC oversight under Section III-F-8 ("not a significant risk to health or the environment") of the NIH rDNA/SNA guidelines and exceptions to those exemptions.
- NIH Guidelines, Appendix G: Containment Provides information about biosafety level containment requirements, best practices, equipement and more.
- NIH Guidelines, Appendix M Information regarding physical and biological containment for recombinant or synthetic nucleic acid molecule research involving animals.
- NIH Guidelines, Section III-D-4: Experiments Involving Whole Animals
- NIH Guidelines, Section III-F Lists the categories of experiments exempted from IBC oversight per the NIH rDNA/SNA research guidelines.
- Retrovirus/Retroviral Vectors: SOPs Joint EHS/UMOR guidance on the safe use and handling of retrovirus and retroviral vectors.
- Reviewing an IBC Application eResearch instructions for IBC Members to locate, view, and submit their review for an IBC Application (IBCA)
- SOP for Working with Adenovirus (EHS) Joint EHS/UMOR guidance on the safe use and handling of adenovirus and adenoviral vectors.
- Spill and Exposure Response Procedures Guide for reporting spills of or exposures to BSL1/BSL2 etiological agents or recombinant DNA (rDNA).
- Submitting an IBC Application eResearch system instructions to submit a completed IBC Application (IBCA) for committee review
- U-M Biosafety Manual Link to download the U-M EHS required Biosafety Manual (for U-M laboratories).
- U-M EHS Biological Safety Designated Standards for U-M Laboratories An explanation of the expected features and practices of BL1 and BL2 laboratories at U-M.
- U-M IBC Adverse Event Reporting Requirements for Human Gene Transfer Clinical Trials
- U-M Life Sciences Dual Use Research of Concern Policy University of Michigan policy that outlines U-M's oversight requirements for life science research that may be considered to be "dual use research of concern" (DURC) and subject to the federal DURC policy.
- University of Michigan Institutional Biosafety Committee BSL3 Subcommittee Charge Outlines the charge for the University of Michigan's IBC Biosafety Level 3 Subcommittee, which provides oversight for research with federally regulated Select Agents and Toxins and other research that requires BSL3 containment.
- University of Michigan Institutional Biosafety Committee Charge Updated 09/15/2015
- Viral Vector Containment Guidelines Chart that lists the risk group, biosafety level, and recommendations for working with common viral vectors in research labs at U-M.
Enterprise
Enterprise
As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.
The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.
ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.
Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).
eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).
Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.
