eIACUC

The eIACUC underlying coding structure requires the definition/description of "Research Teams," "Substances," "Procedures" and "Experiments," in that order. Substances and Procedures are fundamental components (building blocks) for the subsequent completion of the eIACUC section entitled "Experiments."

Definitions:

I) The term "Research Team" refers to the group of persons participating in the study.

II) The term "Substance" in eIACUC encompasses the wide range of compounds or biologic materials that may be administered to or injected into animals during the course of a study (see Note below for more examples).

III) The term "Procedure" refers to techniques, methods, and tests applied to experimental animals.

IV) The term "Experiment" is defined as "a set of procedures, methods and techniques performed to test specific hypotheses." It is important to keep in mind that "Procedures" and "Experiments" are distinct entities in eIACUC. Thus, simply describing procedures in the Experiments, or in the Study Design sections of the forms would not capture all the relevant information about a study. This lack of information would require amendments of the forms and approval delays. Furthermore, not keeping this distinction may result in overestimations of the numbers of animal needed for a study, in clear violation of the 3Rs regulatory principle (Reduce, Refine, Replace).

Note: Examples of "Substances" administered to animals are: chemical compounds, drugs, carcinogens, organ-toxic agents, bone marrow cells, cell lines, tumor cells, tumor tissue fragments, viruses, infectious agents, nanoparticles, recombinant DNA, therapeutics agents, food or water additives, biologics, normal cells, etc.

See the PDF guide here for detailed instructions on how to complete experiments in eIACUC. 

Introduction

The IACUC has worked with Research Administration IT (RAIT) to archive obsolete IACUC standard procedures. Archived procedures will be replaced by updated standard procedures located in the eIACUC Standard Library.

Historically in eIACUC, study teams use IACUC standard procedures across multiple protocols. Now that obsolete procedures will be archived, users will see the term "Archived" next to the procedure. It is an indication that an archived procedure must be substituted with the updated IACUC procedure via the submission of an Amendment.

View instructions for updating archived procedures

According to Federal regulations and the 3Rs principle (1) the number of experimental animals used in a biomedical study should be the minimum necessary to obtain scientifically valid result.

The IACUC recommends that, whenever possible, the calculation of animal numbers be based on statistical methods. When appropriately described prior experience with specific experimental models may also be an acceptable justification.

See the PDF here for instructions for updating archived procedures.

Breeding

The numbers justification for breeding requires a description of:

• The breeding colony that will be used to produce the number of animals needed for experimental use and to maintain one or more lines,
• The total number of animals produced, including those pre- or post-weaning not genotypically useful, and
• The disposition of animal that do not have the desired genotype.

Regardless of how an animal generated by breeding will be used (i.e. in experiments or future breeding), all animals are to be counted only once when estimating the total number of animals generated by breeding.

See the PDF here for instructions for writing breeding justifications.

Newly hired Principal Investigators (PIs) can be provided the ability to access the eIACUC system to begin creating their research protocols. The IACUC requires that, as long as the PI has undergone the Human Resources (HR) and Employee Health Service (EHS) vetting processes, obtained a Mount Sinai Health System life number and email, a ticket can be submitted to https://osticket.mssm.edu. Research Administration IT will then assign them the study staff role.  As a pre-requisite, all PIs and research personnel must take the required CITI Program training (see sections "Mandatory Institutional and IACUC Training Requirements" and "Update User Profiles" below).

Within the eIACUC protocol workspace, the PI can assign a “Proxy” (delegate) to work on a protocol on their behalf. The Proxy has create, edit, view and submit authority. Proxy roles are protocol specific and must be assigned before a new iteration of a protocol is created.

Effective August 1, 2019, all Principal Investigators and their research personnel must take the following courses in CITI Program. Failure to show completion will result in delay of review of the protocol:
Principal Investigators - Rigor and Reproducibility and Ethical Behavior in Biomedical Research
Principal Investigators and their research personnel - Species Specific Module

Visit the CITI Program website

If you need to create a new account:

1. Click Log In (top right of the window)
2. Click "LOG IN THROUGH MY INSTITUTION"
3. Scroll and select “Icahn School of Medicine at Mount Sinai"
4. Type in your Mount Sinai Email Address and Password
5. Select "I don't have a CITI Program account and I need to create one."
6. Click "Create a New CITI Program Account"

If you already have a CITI account:

1. Click Log In (top right of the window)
2. Click "LOG IN THROUGH MY INSTITUTION"
3. Scroll and select “Icahn School of Medicine at Mount Sinai"
4. Type in your Mount Sinai Email Address and Password
5. Select "I already have a CITI Program account."
6. Enter your existing Username and Password to link your account to your Mount Sinai credentials.

To add the new, required course:
On your Profile page, in the "My Learner Tools for Icahn School of Medicine at Mount Sinai" section:

1. Click "Add a Course"
2. Scroll to select the course: Rigor, Reproducibility and Ethical Behavior in Biomedical Research
3. Scroll to select the species specific course related to your research (e.g., Working with Mice in Research)
4. Click "Submit"
5. Take course

To ensure accurate transfer of training and certifications data to eIACUC please update your profiles in the following areas:

1. CITI Program
   Log on > Profile > Update Institutional Profile > Employee ID #> Enter Your Mount Sinai Life #
2. eIACUC.mssm.edu > Top Right Side go to my Profile > Edit Experience
3. Update profile on Sinai Central
   Use Mount Sinai email only as your PRIMARY email. Do not use personal email accounts as your primary email.
   Log on > Personal Profile > Sinai1 Profile

*Note: Certificates of training may also be attached to the protocol record as “Supporting Documents” within the eIACUC protocol.