The Institutional Animal Care & Use Committee (IACUC), supported by the Animal Care & Use Office (ACUO), is ultimately responsible for approving, requiring modification of, or prohibiting the use of vertebrate animals in research, teaching, and/or testing activities at the University of Michigan. This includes supervision, coordination, training, guidance, and review of every project proposed to include the use of vertebrate animals.
Learn more at animalcare.umich.edu.
Internet Assisted Review (a report handled in eRA)
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.
- Adenovirus/Adenoviral Vectors: Standard Operating Procedure Provides detailed information about working with adenoviruses, including the required containment level and registration, precautions, lab practices, and decontamination procedures.
- 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.
- eResearch UM application for registering research with the IRB and the IBC.
- 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 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.
- 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 2019.
- 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 Q 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.
- NIH Human Gene Transfer Review Process (4/27/16) Link to NIH document (PDF) containing information about the revised (April 27, 2016) NIH review process for HGT trials.
- 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 adenoviralvectors.
- 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.
Indirect Costs/Facilities & Administrative
Investigational Device Exemption
Non-monetary cost sharing, often consisting of equipment which is donated or loaned for a project.
Generally a single project or series of closely related projects under the direction of a single investigator.
An institutional conflict of interest is a situation in which a financial interest of the university (e.g., investments held by the university in a company) or a Covered Official has the potential to bias, or appear to bias, research conducted by its employees or students.
- Policy for Institutional Conflicts of Interest in Research Office of the President policy outlining the criteria and processes for the identification, review, and management of conflicts of interest arising when U-M, as an institution, has financial interests that may affect or appear to affect the design, conduct, reporting, review, or oversight of research. Revised October 2020 - all sections in effect except for Section 3.C.2, which will be effective as of February 1, 2021.
Per U-M Technology Transfer, intellection property (IP) means inventions, processes, compositions, life forms, computer software, copyrighted works, mask works, research tools and data, certain defined trade and service marks, Tangible Materials, and the legal rights to the same. IP often results from the performance of sponsored activity.
- U-M Standard Practice Guide, section 201.30-5 on Federal Intergovernmental Personnel Agreements.
- IPA Process for U-M and Veterans Affairs (Med School Site)
- GSA Form 69 (pdf)
- IPA Form for VA agreements
- Veterans Affairs (VA) Memorandum of Understanding (MOU) - A Memorandum of Understanding (MOU) must be completed when a U-M faculty member with a Veterans Affairs (VA) appointment is identified on a Federal grant or contract application. MOUs are active for one year and must be updated annually.
A copy of the most recent VA MOU must be submitted to ORSP at the time of proposal submission and with each non-competing renewal application and at the time the just-in-time material is requested for NIH applications.
Including but not limited to:
- U-M affiliated investigators conducting research outside the U.S.
- Funded and unfunded collaborations with investigators who are doing
research outside the U.S.
- Appointments at, and affiliations with, foreign institutions (paid and unpaid)
- Foreign sources of other support (monetary and non-monetary)
- Visitors from foreign institutions
An Institutional Review Board (IRB) is a federally mandated independent committee responsible for the oversight of human subjects protections in research conducted by university units and affiliates. At U-M there is more than one IRB, with jurisdiction determined by type of research (e.g., biomedical, social-behavioral).
For IRB Office contact information, see U-M IRB Contacts.
Multi-year U-M project to redesign the current IRB application ("the HUM") and the IRB Review processes in order to improve efficiency, reduce redundancy, and maintain the high quality compliance review of human subjects research at U-M.
Institutional Review Board - Health Sciences & Behavioral Sciences
- Decision Trees: Exempt Human Subjects Research Decision trees displaying the criteria and potential review paths, including system generated determination, for exempt categories 1 - 4, 7 & 8 under the 2018 Common Rule.
- Introduction to Human Research Protection: A Guide for Student Investigators Last Updated: March 2019
- IRB Repository Application Supplement Template that outlines the information necessary for IRB review of a U-M data/biospecimen repository. Complete and upload to the IRB Repository Application within the eResearch Regulatory Management System (eRRM).
- IRB Repository Application: eResearch Job Aids Webpage with links to step-by-step instructions to create and submit an REP, amend an REP, file a continuing review, and terminate an REP. Provided by ITS.
- IRB-HSBS Exempt Protocol Template A suggested brief template for exempt protocols.
- IRB-HSBS: Key Changes to the Common Rule IRB-HSBS general session presentation (updated 10/12/2017) explaining key changes in the 2018 Common Rule (Regulations for the Protection of Human Subjects ~ 45 CFR 46)
- OHRP Repository Guidance Issues to Consider in the Research Use of Stored Data or Tissues (1997)
- Tip Sheet: Exemption #1 Provides the full definition and explanation of exemption category #1 (educational exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #2 Provides the full definition and explanation of exemption category #2 (surveys, interviews, educational tests, and observations of public behavior exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #3 Provides the full definition and explanation of exemption category #3 (benign behavioral intervention) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
Five Medical School IRBs (collectively referred to as IRBMED)
International Traffic in Arms Regulation
Information Technology Management Reform Act
Information and Technology Services is an umbrellla unit of the merged general and administrative computing at the University of Michigan. ITS manages the administrative systems, such as M-Pathways and e-Research. It also provides technology and communications services for U-M Ann Arbor's academic and research needs.