Overview
This document outlines the compliance changes occurring for Institutional Biosafety Committee (IBC) Approval, as well as updates to Export Controls/Classified Research, effective with the following eRPM releases:
- Version 8.0 - July 21, 2025
- Version 7.9 - April 28, 2025
- Version 5.3 - May 6, 2019
In the Proposal Approval Form (PAF), changes are reflected in Section 5 - Research Activity, the PAF Summary, and in the Update Research Activity.
In Unfunded Agreements (UFAs), changes are reflected in the Material Transfer Agreements (MTAs) and Other, and in the UFA Summary.
PAF Section 5. Research Activity Questions
Biosafety questions
Prior to May 6, 2019, biosafety questions and applicable sub-questions were all required. As of May 6, 2019, you can answer a high-level question, then only answer applicable sub-questions. If any of the sub-questions are answered “Yes”, the additional detail questions display. You can link to an IBCA or indicate that an application is not yet submitted/pending.
Existing questions were revised and new questions were added, causing a renumbering of questions.
Does the proposed activity involve any of the following?
- 5.1 Human research?
- 5.2 Use or derivation of human induced pluripotent stem cells (iPSC) or human embryonic stem cells (hESC)?
- 5.3 Use of vertebrate animals, including custom antibody production?
- 5.4 Does this project involve research in a U-M laboratory with biological materials?
- 5.4.1 Use of recombinant or synthetic nucleic acid molecules (rDNA or SNA)?
- 5.4.2 Use of transgenic animals?
- 5.4.3 Use of human-derived substances (including cell lines, blood/body fluids, or unfixed tissues)?
- 5.4.4 Use of cells, tissues, fluids, or other substances from any wild animal, non-human primates, ruminants, swine, chickens, or fowl?
- 5.4.5 Use of non-recombinant infectious agents (i.e., bacteria, viruses, parasites, fungi, prions)?
- 5.4.6 Use of biological toxins (i.e., toxic substances produced by bacteria, fungi, protozoa, insects, animals, or plants)?
- 5.4.7 Will you be doing research with any Risk Group 3 (RG3) or higher pathogens, or any agents on the Federal Select Agents and Toxins List, including at amounts below the Permissible Toxin Amounts?
- 5.4.8 Could your research with Risk Group 2 (RG2) or higher pathogens involve manipulations that would be reasonably anticipated to result in one or more of these experimental outcomes or actions:
- Enhance transmissibility of the pathogen in humans
- Enhance the virulence of the pathogen in humans
- Enhance the immune evasion of the pathogen in humans such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity via immunization or natural infection
- Generate, use, reconstitute, or transfer an eradicated or extinct pathogen with pandemic potential (PPP), or a previously identified pathogen with enhanced pandemic potential (PEPP).
- 5.4.9 Indicate the IBC Application(s) that cover the use of biological materials above in questions 5.4.1 - 5.4.8:
- Not yet submitted/Pending [checkbox] OR
- [Add] button
When completing the PAF, it is possible (and acceptable) to answer the high-level question “Yes” yet answer “No” to all the sub-questions. If so, no IBCA is expected.
An approved IBCA will be required at the time of Award or Award Modification if the rDNA/SNA question is answered “Yes” for all Biosafety Levels (BSL). See the Award and Award Modifications section below.
Export Controls, Controlled Unclassified Information, Controlled Substance, and other questions
- 5.5 Restrictions on openness of research?
- 5.6 Does the research project involve possible export controls or delivery of a physical item, such as a product or material, including models and prototypes?
- 5.7 Are there any enhanced security requirements for this project (e.g., CUI, FISMA, or classified research)?
- If "Yes" or "Unsure", then a request will be sent to the U-M Security Officer for review when the PAF moves to the “Negotiation in Progress” or “Processing Award” states.
- 5.8 Use of radioactive materials for (non-human) research?
- 5.9 Use of unbound engineered nanoscale particles or nanofabrication technology?
- 5.10 Use of a controlled substance (as defined by the federal Controlled Substances Act) or Propofol in a U-M research laboratory?
- 5.11 Are there any non-financial agreements (e.g., material transfer, data use, software license, non-disclosure, confidentiality, export control, or teaming agreements) in place related to this proposal?
- 5.12 Is there any existing innovation (e.g. technology, software, research tool, or some other form of intellectual property) disclosed in a U-M Innovation Partnerships invention report that is expected to be used in this project?
- 5.13 Will anyone perform a significant portion of this project outside of the United States?
Update Research Activity
PAF
PI & Project Team personnel can use Update Research Activity on the PAF workspace to complete the required compliance questions and/or add associated HUMs, PROs, and/or IBCAs.
The Update Research Activity is available in states where the PAF is not editable for changes before ORSP creates an Award.
Award and Award Modifications
An IBCA will be required if the existing rDNA question is answered "Yes".
The Compliance Status meter will display red/stop (on hold) until IBC Approval is given, yellow/triangle (caution) if the IBC will be in the future, and green/circle (approved) for all other biosafety conditions.
