IACUC Quick Start

New Principal Investigators (PIs) or anyone new to animal research

Who needs to submit a Protocol?

The use of all live or dead vertebrate animals or collection of their byproducts (fur/feathers, tissues, blood, secretions) in research or teaching must be IACUC-approved prior to the start of the activity. Usually, the individual who is responsible for the activity (PI for research or instructor for teaching) submits the Protocol.

Examples of animal use include:

  • Any research activity involving live animals
  • Collection of any byproduct (fur/feathers, tissues, blood, secretions) from a living animal
  • Collection of tissues post-mortem for research or teaching
  • Field trapping of animals
  • Handling of animals as part of a UA course or teaching activity
  • Observational field studies
  • Production of custom antibodies
  • Routine care and use of livestock

Activities that do not require IACUC oversight:

  • Teaching or research involving invertebrate species (arachnids, crustaceans, insects, mollusks, nematodes, etc...)
  • Purchase of commercially available antibodies (i.e., antibodies that were not produced specifically for the Protocol) 
  • Purchase of commercially available vertebrate animal blood, cells or tissue does not fall under the purview of the IACUC. (Commercially available means that the PI has not influenced any procedures performed on the animal.) However, there are ethical issues and risks associated with the use of vertebrate animal blood, cells or tissue. Anyone using these should undergo the minimal IACUC training for inclusion on a Protocol.

Who needs to be listed on a Protocol?

Research-based Protocols

Anyone involved in the animal activity, including the PI, should be listed as participating personnel. As a general rule, do not include personnel who will not handle the animals or their tissues/by-products directly.

Everyone listed on the Protocol must successfully complete the appropriate IACUC training before they can perform animal work.

An administrative protocol contact can be added, if desired, though their lack of animal handling must be noted on the protocol submission form (Animal Work? field).  These individuals must successfully complete the CITI Working with the IACUC training module to be added to the Protocol. 

Similarly, internal (UA) or external (non-UA) collaborators can be added, if desired, but no animal use should be noted and CITI Working with the IACUC training module completed. If an internal collaborator will have animal contact, they should be added to the Protocol as participating personnel. If an external collaborator will have animal contact, seek advice from the IACUC Office before submitting the Protocol. 

Teaching-based Protocols

The course instructor, graduate teaching assistants and preceptors, but not enrolled students, should be listed as participating personnel.

Everyone listed on the Protocol must successfully complete the appropriate IACUC training before they can perform animal work.

What types of Protocols are there?

Currently, there are two types of Protocols:

  • Protocol Form - for all work involving live animals, whether for teaching or research
  • Bio-Products Protocol Form - for bio-products (when live animals will not be used), cadavers and/or custom antibody production only 

If your only animal activity is euthanasia for tissue harvest, you must complete a Protocol Form, as live animals will be used.

If you will not be using live animals, complete the Bio-Products Protocol Form. Please note that if you are having custom antibodies produced by a company, a Bio-Products Protocol must be approved before starting the work.

What is the timeline for submission and review of a Protocol?

New and renewal protocol submissions, on average, take two to three months from the date of submission to approval, but this depends on the complexity of the Protocol and whether the PI has previous experience submitting Protocols. One of the issues that lengthens the approval process is a delay in responding to IACUC questions. Prompt PI responses allow for the shortest approval time.

Primate protocols average three to four months for approval given the more complex nature of the review process.

Amendments, on average, are approved within 3-5 weeks, unless there is a delay in the PI response to IACUC questions or if they are particularly complex. In addition, consider whether the proposed amendment can be handled via an informal email rather than through a formal Amendment. Details are available here.

Additional details on Protocol submission can be found here.

Step-by-step guides for completing a Protocol

A detailed description of how to complete Protocol Forms can be found here.

I have questions, who do I contact?

Student researchers

Are you doing animal research?

Are you on the appropriate protocol?

Your PI may have a number of Protocols, some of which may have overlapping research activities. Confirm with your PI that you are listed on all the protocols for which you perform research, before the research begins. It is a good idea to read each Protocol so that you understand what research activities have been approved by the IACUC.

Have you completed the appropriate training?

The Training and Certification page lists all the required training.

Note that all training and certification must be completed before any animal work commences.  This includes completion of the Risk Assessment Questionnaire process with Occupational Health.

Why is this important?

The Graduate College requires that you and your advisor certify that you are aware of Responsible Conduct of Research compliance regulations when completing your Plan of Study and Committee Appointment forms. The responsible conduct of animal research includes the need to have appropriate animal research training and certification and to be listed on the appropriate protocol(s), before the research begins.

Please note, you do not need any specific IACUC letter or form to confirm your participation on an animal protocol when you submit your thesis or dissertation.

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Subcontractors

What is a subcontract?

When a portion of the animal work is conducted off-site under the direction of a third party, usually another University or Company, this is considered a subcontract for the purposes of the IACUC.

Examples of research activities that are not subcontracts:

  • Purchase of animals from a vendor (i.e., a company that provides essentially the same product or service to any customer without any customization). An example of this would be purchase of thymectomized mice from an approved animal vendor.
  • Where a UA investigator performs animal research and shares data with a collaborator

What to do before you start

If you think your animal activity may involve a subcontract, contact the IACUC Office at 621-9305 for advice on the process.

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IACUC members

How to review a Protocol document

A detailed description of how to review a Protocol can be found here.

How to conduct a Semi-Annual Inspection

A detailed description (Word document) of how to conduct a Semi-Annual Inspection can be found here.

An on-line training on how to perform inspections produced by the US Department of Health and Human Services, Office of Research Integrity and Wake Forest University can be found here.