eRAM Release 3.1.36

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:

  1. 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.
  2. 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:

  1. Are any of the Animal substances: blood, body substances, or cells from NOT Nonhuman primates? Note: ABSL-1 housing is sufficient.
  2. Are any of the Animal substances: blood, body substances, or cells from Nonhuman primates? Note: ABSL-2 housing is required.

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.
Request or Maintain ABSL 2 Housing Exemptions window

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