FAQs: Prior to Submission
Who can create or edit a protocol?
Only the Principal Investigator (PI) can create a new protocol.
Once the PI designates an Alternate Responsible individual(s), either the PI or any of the Alternate Responsible individuals can edit and submit the protocol for review.
Who can submit the protocol?
Either the Principal Investigator or Alternate Responsible can submit a protocol application in RIO.
The PI can designate more than one Alternate Responsible for a protocol.
Who can be listed as Principal Investigator (PI)?
Academic appointees in the following title groups are eligible for PI status, provided that their paid appointments are at 50% or more:
- Professor, Associate Professor, Assistant Professor, and Instructor;
- Professor In Residence series;
- Professor of Clinical X series;
- Adjunct Professor series;
- Clinical Professor series;
- Professional Research series;
- Librarian series;
- Emeritus Professors (This group is exempt from the 50% appointment rule)
To Request PI Status:
Individuals who are not eligible for PI status by virtue of their appointments may contact [email protected] to request an exemption.
How are the personnel roles in RIO defined?
Principal Investigator (PI)
The Principal Investigator is the person who has primary responsibility for the design, execution, and management of a research or teaching project and is involved in the project in a significant manner. The PI is also responsible for ensuring the proper care and use of vertebrate animals and adherence by all research or teaching personnel to IACUC requirements, as well as applicable university policies, state statutes, and federal regulations.
The PI can create, edit, submit and view protocols on which they are listed as PI.
Alternate Responsible
The Alternate Responsible is the person primarily responsible for managing all the day-to-day research operations. This is generally a lab manager, senior staff researcher, or senior postdoctoral fellow.
Anyone designated as Alternate Responsible will receive all IACUC communications regarding the protocol. The PI can designate more than one Alternate Responsible for a protocol.
The Alternate Responsible can edit the protocol and submit applications for IACUC review.
Emergency Contact
IACUC protocols require at least two lab members to be designated as emergency contacts. The emergency contacts will receive email/phone notifications from LARC regarding animal health issues.
A researcher with this role should be available to respond to LARC communications, and should have the authority to make decisions about animals on study.
Correspondence To
A researcher with this role will receive all IACUC communications about the protocol, but is not the PI or Alternate Responsible.
This role does not allow the user to edit or submit applications for IACUC review; this user would not receive health check information from LARC.
Authorized Purchaser
A researcher with this role can order animals for studies described on their approved IACUC protocol.
This role does not allow the user to edit or submit applications for IACUC review, and the user would not receive most IACUC communications about the protocol.
User
Participates in animal studies described on a specific IACUC protocol.
This role does not allow the user to order animals, edit or submit applications for IACUC review, and the user would not receive most IACUC communications about the protocol.
What does it mean to categorize animals as C, D, or E? How do I know which category my experimental animals fall into?
The animal numbers section of the IACUC protocol application will ask you to categorize your animals as C, D, or E. These categories help the IACUC determine whether the benefit of the study outweighs the costs of potential pain or distress to experimental animals.
When reviewing your protocol, our IACUC will follow the USDA’s definition of a painful procedure: any procedure that would cause more than momentary pain or distress in a person.
Category C: Animals undergo procedures that cause no more than momentary or slight pain or distress, with no need for anesthesia or pain-relieving drugs.
- Examples of Category C procedures:
- Observational studies
- Injections (intravenous, parenteral) of non-irritating agents
- Blood collections from peripheral vessels
- Euthanasia followed by tissue collection
Category D: Animals undergo procedures that may cause more than momentary pain or distress. Pain and/or distress are relieved by appropriate anesthetics or analgesics, or by euthanasia.
- Examples of Category D procedures:
- Blood collection, imaging performed under anesthesia
- Survival surgeries conducted with anesthesia and post-surgical analgesia
- Non-survival/Acute surgeries performed under anesthesia
- Animals that undergo infection or tumor implantation procedures, but are treated or euthanized at early stage of disease
Category E: Animals undergo procedures in which pain or distress is NOT relieved by anesthetics, analgesics, or euthanasia.
- Examples of Category E procedures:
- Models of severe human clinical conditions: late-stage metastasis, sepsis
- Drug withdrawal models
- Pain research where analgesics would interfere with pathway being studied
If you have any questions about which category your animals should be placed into, please contact the IACUC office ([email protected]).
What other authorizations will I need before starting my animal work?
Biological Use Authorization (BUA): infectious agents (including some viral vectors), primary human cells or human tissue, biological toxins, carcinogens. This application can be submitted in RIO and linked to your IACUC protocol.
https://ehs.ucsf.edu/laboratory-safety
Controlled Substances Authorization (CSA): anesthetics/medications regulated by federal or state Drug Enforcement Administration (DEA). This application can be submitted in RIO and linked to your IACUC protocol.
Radiation Use Authorization (RUA): radioactive chemicals or drugs, including radioisotopes. This application can be submitted in RIO and linked to your IACUC protocol.
Human Tissue: use of cells or tissues collected from humans may also require review by the Human Research Protection Program (HRPP)/Institutional Review Board (IRB), depending on tissue source and identification. This application can be submitted in iRIS, the IRB’s electronic application system.
Human Stem Cells: use of certain types of human stem cells may require review by the Human Gamete, Embryo, and Stem Cell Research (GESCR) committee. This application can be submitted in iRIS, the IRB’s electronic application system.
How do I request housing space in an animal facility?
Send an email with the following information to [email protected]:
- Species
- Number of cages needed at start, and number of cages expected at 1 year
- Any special needs (ABSL 2 work, non-standard light/dark cycle, etc)
- Location of your lab
- Home department and department chair (or other contact)
LARC (Laboratory Animal Resource Center) will follow up with you about space assignments.
I need to transfer animals to UCSF from another institution. How do I start this process?
Please refer to LARC’s page on importing rodents: http://larc.ucsf.edu/importing-rodents
Is there a way to see what strains of mice other labs at UCSF are using?
Yes!
Contact [email protected] or search the UCSF Mouse Inventory Database: https://mousedatabase.ucsf.edu/mouseinventory/about.jsp (UCSF network access required).
Do I need an IACUC protocol if I am only working with cells or tissue?
The IACUC strongly encourages investigators to use the Tissue Sharing Program (link available in RIO under IACUC>Collaboration Tools) whenever possible. If you are unable to obtain needed tissues through the Tissue Sharing Program and must euthanize live animals to collect tissue, then an IACUC protocol is required.
What resources are available to help researchers with IACUC protocols?
We are glad you asked! Here are a few of our favorites:
Search for alternatives: our resources tab lists places where you can search for alternatives
Standard procedures – these are established, IACUC approved procedures (mostly for mice) that can be added into your protocol by checking a box in RIO.
LARC veterinarians - can provide advice on choice of animal model, appropriate anesthesia, analgesia, and monitoring parameters for your model and species, and can train lab staff in many types of surgical procedures. Please email [email protected] to request a veterinary consult.
The LARC website also offers some written references that you can customize for your lab:
LARC Veterinarians’ Guidance on Pain Management
Anesthesia/Surgery Record templates
Collaboration tools - RIO has a feature on the IACUC tab, under Collaboration Tools > Keyword Search, that allows you to find text from other approved UCSF protocols.
IACUC office – We keep track of about 500 active protocols, so we have a pretty comprehensive knowledge of models used at UCSF, as well as IACUC expectations for animal care. We’ve also got a nice library of sample protocols that other investigators have volunteered to share.
CTSI – Biostatisticians can help plan out your studies before you start your animal protocol. A well-designed study with appropriate sample size calculations can save you several weeks of review time, and of course helps us in our commitment to reduce animal numbers.