eRAM Protocol Updates

To simplify Animal Use Protocols, the Animal Care & Use Office and eRAM are making changes that should relieve some administrative burden on Principal Investigators and their labs. In the first phase, protocol questions will be deleted, reworded, moved to, or combined with other pages. These changes will be made along with the normal eRAM bi-weekly releases.

Summary of Changes by Release Number and Date

3.1.39 December 19, 2016
Page Changes
General Information

Reworded question -
Old: Explain in non-scientific terms the long-term or overall scientific goals of the proposed work (the ultimate question this project will address).
New: Briefly explain the overall scope of the study and why the study is important to human or animal health, the advancement of knowledge, or the good of society. This section should be clearly written in language that a layperson can easily understand.

Reworded question -
Old: Explain why animals must be used to accomplish your proposed work. Further explain why cell or tissue culture, isolated organ preparations, or computer simulations cannot be used.
New: Explain why animals must be used to accomplish your proposed work. For each species selected in this protocol, describe why it was chosen for this project. Explain the physical and/or physiological characteristics of the species that makes it ideal for this research, and explain why a lesser sentient species cannot be used. Further explain why non-animal models (cell or tissue culture, isolated organ preparations, computer simulations, etc.) cannot be used.

Reworded question -
Old: Describe how personnel (investigator, staff, students) will be protected from applicable exposures, specifically animal bites and scratches, West Nile Virus, rabies, tularemia, etc. while conducting the field study.
New: Describe how personnel (investigator, staff, students) will be protected from injury (animal bites or scratches) and/or exposure to zoonotic infection (West Nile Virus, rabies, tularemia, etc.) while conducting the field study.

Reworded question -
Old: Describe the procedures that will be performed in the event that personnel (investigator, staff, students) sustain injury (bite, scratch) resulting from animal handling and/or exhibits symptoms and signs consistent with a zoonotic infection due to animal exposure while conducting the field study.
New: Describe what will be done if personnel (investigator, staff, students) sustain injury (animal bites, scratches) and/or exhibits symptoms or consistent with a zoonotic infection while conducting the field study.

Reworded question -
Old: Describe your relevant experience related to the specific fieldwork proposed in this application (e.g., environments, conditions, countries (if applicable), species).
New: Describe the PI’s relevant experience related to the specific fieldwork proposed in this application (e.g., environments, conditions, countries (if applicable), species).

Reworded and relocated question -
Old: Provide the agency name, permit number, and expiration date for all required federal, state, and local permits.
New: Does this project require local, state, or federal permits?

Relocated question -

  • Indicate the types of animal use proposed in the application. (Check all that apply).

Removed questions -

  • Explain in non-scientific terms the long-term or overall scientific objectives of the proposed work, should be specific to the proposed work.
  • Explain in non-scientific terms the ways the proposed animal use might benefit human or animal health, the advancement of knowledge, or the good of society.
Species

Reworded question -
Old: Other Description
New: Species Name

Reworded question -
Old: Will any of the animals used, generated, or acquired for this protocol be transgenic or genetically modified?
New: Will any of the animals used, generated, or acquired for this protocol be transgenic or genetically modified? (Note: For core service protocols and holding protocol, please select “no”. Transgenic animals used on these protocols should be captured under the original PI’s IBC registration.)

Reworded question -
Old: Confirm that animals will be reported at least monthly using the Non-traditional Animal Acquisition form.
New: Confirm that animals will be reported at least monthly using the “Report Non-Traditional Animal Acquisition” use form.

Reworded question -
Old: Will personal vehicles be used to transport animals?
New: Will personal vehicles be used to transport animals? (Note: Personal vehicles used for transport must be inspected semi-annually by the IACUC.)

Reworded question -
Old: Justify using a personal vehicle.
New: Justify using a personal vehicle as opposed to an approved ULAM transport vehicle.

Reworded question -
Old: Will animals be group housed?
New: Will any animals be singly housed for experimental reasons? (Note: Single housing of animals due to fighting, veterinary treatment or post-op recovery, attrition, or separation of breeders does not need to be indicated here.)

Reworded question -
Old: Provide scientific or veterinary justification for singly housing animals.
New: Provide scientific justification for singly housing animals.

Reworded question -
Old: Will you be providing enrichment?
New: Will you be withholding enrichment from any animals for scientific reasons?

Reworded question -
Old: Justify circumstances where animals will not be provided enrichment.
New: Provide scientific justification for withholding enrichment.

Removed questions -

  • Justify species selected and indicate why a lesser sentient species cannot be used.
  • Will Transportation Guidelines be followed when animals are transported through public areas or outside of buildings?
  • Describe the deviation(s) from the Transportation Guidelines.
  • Describe how the vehicle will be sanitized.
  • Will ULAM Quarantine and Conditioning protocols be followed?
  • Describe the quarantine and conditioning protocols that will be followed.
  • Will animals be habituated/conditioned to routine husbandry or experimental procedures prior to initiation of the study?
  • Explain why no prior habituation/conditioning will be initiated.
  • Describe enrichment that will be provided (e.g., toys, treats, bedding material, etc...).
3.1.38 December 5, 2016
Page Changes
Adverse Consequences

Reworded question -
Old: Describe how you have refined experimental procedures to minimize pain and distress (e.g., early endpoints, use of analgesics, techniques that reduce stress, etc.).
New: Describe how you have refined experimental procedures to minimize pain and distress and enhance animal well-being. Examples of refinement include, but are not limited to, use of anesthetics and analgesics, supportive care, acclimation to procedures, techniques that reduce stress, using less-invasive routes of administration or blood collection, modifying surgical procedures, replacing a surgical model with a non-surgical one.

Reworded question -
Old: Describe expected adverse physical and/physiological consequences (including genetically modified animals and their specific phenotypes) or adverse effects on well-being that the animals may experience as a result of the procedures.
New: Describe any expected or possible severe adverse physical and/physiological consequences or adverse effects on well-being that the animals may experience as a result of the procedures. Include adverse phenotype expression in genetically-modified animals and death as a result of euthanasia.

Reworded question -
Old: Describe how the consequences or events stated above will be monitored. Include criteria for premature euthanasia.
New: Describe how the consequences or events stated above will be monitored and alleviated. Include criteria for premature euthanasia (euthanasia due to reaching a humane endpoint prior to a planned experimental endpoint)

Removed questions -

  • List severe complications that the animals may experience as a result of the procedures.
  • Will the policy for End-Stage Illness and Humane Endpoints be followed?
  • Describe the deviations from the policy.
  • Would analgesics be provided in human medicine for any of the procedures described?
  • Will analgesics be provided to the animals for procedures?
  • Justify why analgesics will not be provided.
  • Will ULAM Veterinary staff be consulted if pain or distress goes beyond the level anticipated in the protocol?
  • Provide justification for why the veterinary staff will not be consulted.

Relocated questions -

  • Will non-ULAM veterinary staff be utilized at any time during this project?
  • Provide justification for using non-ULAM veterinary staff.
  • Provide the name(s), degrees/credentials, and contact information for each non-ULAM veterinary staff member.
Alternative

Reworded question -
Old: Indicate the keywords or search strategy used.
New: Indicate the keywords or search strategy used. Keywords should indicate you’ve searched for alternatives to painful and distressful procedures in this project, as well as for alternatives to using animals.

Textboxes were resized to reduce scrolling.

Use Justification

Reworded question -
Old: Enter the total number of animals requested for each of the Use Categories for the next 3 years.
New: Enter the total number of animals requested for each of the Use Categories for the entire approval period.

Reworded question -
Old: Justify the number of animals needed to achieve the scientific aim(s) of the project. Animal numbers should be justified by statistical analysis whenever possible.
New: Justify the number of animals needed to achieve the scientific aim(s) of the project. Numbers justification should include the following:

  1. For experimental animals: Calculations illustrating how you arrived at the total needed per experiment. Calculations should include the number of animals per experimental group, number of groups (experimental and control), number of repeats, and any extras needed to cover experimental failure, attrition, etc.
  2. For breeding animals: Calculations that break down your breeding scheme, including number of adult breeders and replacements, number of breeding cages, average number of pups expected per litter, number of matings, and progeny both wanted and unwanted.
  3. For field studies: Calculations that include number of collection sites, number of collections, and average number of animals expected to be collected each time.
  4. For teaching courses: Calculations should include number of courses taught, average number of students per course, and number of animals per student.
  5. For all study types: Explanation for how you determined the number of animals per group/collection/student is necessary. This should be based on statistical or power analysis whenever possible. If based on previous studies or literature, please provide references. If based on statistical or power analysis, please describe the parameters used in your analysis.

Reworded question -
Old: Provide specific scientific justification, including references if possible, for why animals must experience pain/distress, cannot receive analgesics, or why death must be used as an endpoint.
New: Provide specific scientific justification, including references if possible, for why animals must experience unrelieved pain or distress (e.g., why anesthetics or analgesics cannot be used or why death as an endpoint must be utilized).

3.1.37 November 14, 2016
Page Changes
Funding

Reworded question -
Old: Will this project be sponsored externally?
New: Will this project be fully or partially funded through one or more external sources?

Reworded question -
Old: External Sponsor/Funding [Add]
New: External Sponsor/Funding Sources [Add]

Reworded question -
Old: External Sponsor/Funding Documents [Add]
New: Supporting Documents (Optional) [Add]

Reworded question -
Old: Will this project be sponsored internally?
New
: Will this project be fully or partially funded through one or more internal sources?

Reworded question -
Old: Internal Sponsor/Funding [Add]
New: Internal Sponsor/Funding Sources [Add]

Reworded question -
Old: Internal Sponsor/Funding Documents [Add]
New: Supporting Documents (Optional) [Add]

Removed question -
Has this project undergone peer review?

Location

Reworded question -
Old: Will ULAM provide daily care?
New: Will the laboratory provide daily husbandry care instead of ULAM?

Removed question -
Select who will be responsible for meeting Animal Care Standards at the University of Michigan.

Relocated question -
Will euthanasia be conducted in this location?

Reworded question -
Old: Will non-recovery surgery be conducted in this location?
New: Will non-recovery surgery be conducted in this location? (Note: Euthanasia procedures are not considered non-recovery surgery.)

PI Assurance

Reworded question with new link -
Old: Acknowledgment. I acknowledge responsibility for this project...
New: Acknowledgment.
I acknowledge that as Principal Investigator I am responsible for this project and all work performed by personnel listed on this protocol.
I have read the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training and certify that this project will be conducted in compliance with those principles.

I confirm that I have read all IACUC policies and guidelines pertaining to this project.

I assure that I will not initiate new procedures or modifications to existing procedures without IACUC approval.

I confirm that this project does not unnecessarily duplicate previous research or instructional projects.

I assure that I have made every effort to refine this project to reduce animal pain and distress and to look for alternatives to painful or distressful procedures.

I verify that all personnel working with animals on this project are qualified or will be fully trained to conduct the project in a humane and scientific manner. I will maintain training records for personnel who are trained on procedures by myself or other personnel working on this project.

I understand that this project is approved for up to three years and that renewal of the project after the expiration date will require re-submission for a complete de novo review by the IACUC.

I understand that failure to comply with IACUC policies and guidelines will jeopardize the University of Michigan’s Animal Welfare Assurance agreement with OLAW, USDA registration, and AAALAC International accreditation status. I understand that serious and continuing noncompliance may lead to suspension of this project or revocation of my privileges to conduct animal research at the University of Michigan.

By checking this box, I confirm the above statements and submit my electronic signature.

3.1.36 October 31, 2016
Page Changes
Procedures Summary - Species

Reworded question -
Old: Describe in narrative form all experimental or instructional procedures in the order they will be performed on the animals, including procedures on anesthetized animals.
New:
1. Provide an outline for each proposed experiment, including pertinent timepoints and endpoints.
2. Provide a complete description of each procedure performed on live animals, including euthanasia. Do not describe procedures done post-euthanasia or in vitro work.

Reworded question with new link moved to 1-
Old: Will substances be administered to the animals in the course of experimentation that are reagent-grade (i.e.,purchased from Sigma, drugs in development obtained from manufacturers) rather than commercial pharmaceutical product?
New: Will non-pharmaceutical grade (reagent-grade) substances be administered to the animals? (Note: Pharmaceutical-grade substances are those approved by the FDA for human or veterinary use.)
Examples of non-pharmaceutical grade substances:

  • Stock chemicals and compounds purchased from vendors such as Sigma.
  • Experimental compounds currently in development.
  • Dilutions or compounds created from FDA-approved pharmaceutical products.
  • USP-grade chemical or substance used to formulate a needed dosage.
Additional Information for Investigators on the Use of Non-Pharmaceutical Grade Drugs

Reworded question -
Old: Justify why a reagent-grade of these substances is used rather than an approved pharmaceutical product. Note that USDA and OLAW do not consider expense an appropriate justification for their use.
New: List each reagent-grade drug and provide justification for its use. Justification must be based on unavailability of an acceptable veterinary or human pharmaceutical-grade compound or on scientific necessity. (Note: USDA and OLAW do not consider expense an appropriate justification for use of reagent-grade substances.)

Reworded question moved to 3 -
Old: Describe the steps that will be taken to ensure sterility when preparing non-pharmaceutical/reagent grade substances (e.g., use of filter, sterile diluents, sterile container), the proposed shelf life/use by date, and storage and safe preparation method.
New: Describe the steps that will be taken to ensure stability, potency, and sterility when preparing each non-pharmaceutical grade substance:
1. How will you ensure sterility (e.g., use of sterile container, sterile diluents, 0.2 um filter)?
2. What is the shelf life/use by date for each substance, and how was it determined?
3. How will stock and working solutions be stored (e.g., in freezer or refrigerator, at room temperature). Include the temperature and duration of storage.

3.1.35 October 17, 2016
Page Change
Principal
Investigator (PI)
Reworded Appointment Information link -
Old: Update Appointment
New: Add or Update Appointment
PI Reworded question on Update Appointment -
Old: Future Appointment Effective Date
New: Effective Date
PI
Personnel
Find button field name change -
Old: User Name
New: Last Name or Uniqname
PI
Personnel
Reworded question -
Old question: List degrees and describe experience and qualifications for handling animals.
New question: List degrees and briefly describe animal handling experience and qualifications relevant to the species selected for this particular study. Note: This text field contains information relevant to all approved protocols this individual is listed on. Do not delete information relevant to species and procedures on other animal use protocols.
Personnel Removed question -
Send system email notifications to Principal Investigator only?
Personnel Reworded question -
Old: Use current UM employee contact information?
New: Change contact information?
Personnel Relocated question -
Will ULAM Technical Services (IVAC, ASOR, ULAM Breeding Colony Management) be utilized? (Note: This refers to paid services, not routine husbandry, clinical care, or training)
Procedures -
Breeding
Removed question -
Will ULAM Breeding Colony Management services be used?
Procedures

Removed procedures
-Amputation
-Behavior Modification/Operant Conditioning
-Cardiac Puncture
-Gavage
-Food/Water Manipulation
-Immunosuppression
-Implant
-Injection
-Inoculation, Experimental
-Obesity, Experimentally Induced
-Sepsis Induction/Infection
-Stress, Experimentally Induced
-ULAM Tech Services

Combined procedures
-Food/Water Manipulation combined with Food/Water Restriction and renamed "Food/Water Manipulation/Restriction"
-Immunization, Experimental combined with Inoculation, Experimental and renamed "Immunization/Inoculation"
-Inflammation, Experimentally Induced combined with Sepsis Induction/Infection and renamed "Sepsis Induction/Inflammation"

Renamed procedures
-Organ/System Failure/Dysfunction, Experimentally Induced becomes "Organ/System Failure/Dysfunction"
-Paralysis, Experimentally Induced becomes "Paralysis"
-Tissue Collection for Genotyping and Identification Methods becomes "Genotyping"
-Tumor Growth, Experimentally Induced becomes "Tumor Growth"