eRAM Release 3.1.36
10/31/2016
The following changes will be included in the 3.1.36 release:
Protocol Changes to questions:
- change to Procedures Summary - Species page (4 reworded and 2 moved)
See the Protocol Updates page for more details.
ABSL Changes
PI/Lab Personnel, OSEH, ULAM, and ACUO
Procedure Details -Hazardous Agents
Over 40 Human or Animal related Hazardous Substances will be retired. In their place, 2 new simpler Hazardous Substances - Human Derived and Animal Derived, will be added.
Over the next several months, the ACUO's RCA will assist Protocols to change over to the 2 new substances via Amendments (AMEs). |
Procedure Details - Hazardous Agents, Update Substance/Agent
There will be 2 new Hazardous Agents added - Human Derived and Animal Derived. These agents will each have 2 new questions added. These questions will help clarify what ABSL level of housing will be required. The Yes/No questions will be:
For Human Derived:
- Are any of the Human substances: blood, blood products, primary cell lines, or non-primary cell lines? Note: ABSL-2 housing is required, unless an exception is approved (exceptions are granted at the individual substance level, see ULAM page for details.
- Are any of the Human substances: unfixed cadavers, body parts, body fluids, substances, visibly contaminated with blood, and/or all body fluids in situations where it is difficult or impossible to differentiate between body fluids, or unfixed human tissue or organ (include tumors and xenografts)? Note: ABSL-2 housing is required.
In the case of some Human Derived Substances, an exemption can be made so only ABSL-1 is required. This is explained more on the U-M Guidance for Animals Administered Human-Derived Substances page.
For Animal Derived:
- Are any of the Animal substances: blood, body substances, or cells from NOT Nonhuman primates? Note: ABSL-1 housing is sufficient.
- Are any of the Animal substances: blood, body substances, or cells from Nonhuman primates? Note: ABSL-2 housing is required.
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PI/Lab Personnel
PI/Lab Personnel can use the new Request or Maintain ABSL 2 Exemptions activity for Approved Protocols. Click Add or Update to enter exemption information.
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A new tab will be added to the Protocol workspace - ABSL 2 Housing Exemptions. It will list the following exemption information:
- Agent
- Derived Substance Name
- Derived Substance Identifier
- Derived Substance Note
- Test Results Document
- Housing Level
- RCA Review Note
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