The Institutional Animal Care & Use Committee (IACUC), supported by the Animal Care & Use Office (ACUO), ensures that the highest animal welfare standards are maintained along with the conduct of accurate, valid scientific research through the supervision, coordination, training, guidance, and review of every project proposed to include the use of vertebrate animals at the University of Michigan. Learn more at animalcare.umich.edu. This committee was formerly called the University Committee on Use and Care of Animals (UCUCA).
The Institutional Animal Care and Use Committee. IACUC approves any use of vertebrate animals in U-M research and education. It advises University research officials on matters related to the use of animals in research and education. See: http://www.ucuca.umich.edu/.
Institutional Biosafety Committee (formerly the Biological Research Review Committee). 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 practices that may be assigned to BL2 work
- 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 Manual OSEH requirements for maintaining a Biosafety Manual. This page includes a link for downloading a template you can use to create a Biosafety Manual for your laboratory.
- BL2 with Additional Practices A list of additional practices that may be assigned to BL2 work, depending on the nature of the work being conducted.
- Bloodborne Pathogens Detailed information about maintaining an Exposure Control Plan for bloodborne pathogens; provides links to annual required training.
- CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
- Changes to BL2+ Containment An explanation of the new BL2 with additional practices designation.
- 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.
- FAQ: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- Federal Select Agent Program CDC web site that provides a complete listing of specific Select Agents and detailed information about the regulations addressing them.
- Human Gene Transfer Clinical Trials
- 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.
- My LINC Link to U-M training resources
- NIH Guidance on Informed Consent
- NIH Guidelines, Appendix G NIH Guidelines, Appendix G: Containment
- NIH Guidelines, Appendix Q Information regarding physical and biological containment for recombinant or synthetic nucleic acid molecule research involving animals.
- NIH Guidelines, Section IIID-4: Experiments Involving Whole Animals
- 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.
- NIH/OBA Recombinant DNA Advisory Committee, Schedule of Meetings Currently scheduled meetings for the RAC
- Retrovirus/Retroviral Vectors: SOPs
- 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 (OSEH)
- 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 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.
Non-monetary cost sharing, often consisting of equipment which is donated or loaned for a project.
Also known as Facilities and Administrative (F & A) Costs or overhead. These are the real costs of university operations which are not readily assignable to a particular project.
The costs of operations that generally cannot be assigned to specific projects, such as electricity and central administrative services.
These costs are determined by federal auditors under the guidelines of the Uniform Guidance, 2 CFR Part 220, "Cost Principles for Educational Institution," (formerly OMB Circular A-21). Also known as Facilities and Administrative Costs. The costs of operations which generally cannot be assigned to specific projects, such as electricity and central administrative services (sometimes referred to as "overhead").
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.
- ICOI Committee & Schedule
- Institutional Conflicts of Interest (ICOI)
- Policy for Institutional Conflicts of Interest in Research Effective July 1, 2018. 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.
Potentially legally protectable knowledge, technology, ideas, and information often resulting from performance of sponsored activity.
- U-M Standard Practice Guide 201.30-5
- 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.
Instituational Review Board - Health Sciences & Behavioral Sciences
- Continuing Review Process
- Data Security Guidelines
- Decision Trees: Exempt Human Subjects Research Decision trees displaying the criteria and potential review paths, including self-determination, for exempt categories 1 - 4, 7 & 8 under the 2018 Common Rule.
- Incident Reporting (AE/ORIO)
- Informed Consent Guidelines & Templates
- IRB Amendment Process
- IRB Application Process
- IRB Health Sciences and Behavioral Sciences (HSBS)
- 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 Aid See "Respository Application" under Proecedure Documents & Tips on the eResearch website for step-by-step instructions to create and submit an REP, amend an REP, file a continuing review, and terminate an REP.
- IRB Review Process
- IRB-HSBS Blue Full Board Roster
- IRB-HSBS Education
- IRB-HSBS Maize Full Board Roster
- 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.
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.