Applications for Research

The mandate of the Institutional Animal Care and Use Committee (IACUC) is to ensure that studies involving the use of vertebrate animals are conducted ethically, humanely and comply with federal law and regulations. No studies involving vertebrate animals, including pilot and intra-mural projects, can be initiated without prior IACUC approval.

1. IACUC APPLICATIONS FOR RESEARCH INVOLVING VERTEBRATE ANIMALS

A. IACUC Applications and forms

1. 1. IACUC forms
      Prior to initiating a study involving vertebrate animals, Principal Investigators (PI) must submit to the IACUC an application entitled Vertebrate Animal Study. In such application, the PI is required to describe the scientific aims of the study and provide a detailed description of the intended use of experimental animals. If the study involves hazards (biological, chemical, radiological), genetically altered animals, major surgery or production of antibodies, additional forms and appendices are also required. These are:
      
      • Biosafety Risk Assessment
      • Appendix A: Genetically Modified Animals
      • Appendix B: Surgery
      • Appendix C: Antibody Production

   The PI and co-investigators of Program Projects and Center Grants are required to submit a separate Vertebrate Animal Study form and
  appendices for each of the subprojects.

2. Standard procedure forms
   A special form entitled Standard Procedures is also available. This form is a shortened version of the Vertebrate Animal Study form and may be used by PIs as convenient package to describe animal procedure used routinely in their laboratory (e.g. organ transplantation, bone marrow transplantation, major surgeries, behavioral testing, etc). Once approved, a single Standard Procedures form can be referred to in multiple Vertebrate Animal Study forms (related to multiple extramural grant applications), thereby avoiding the need for repeated descriptions of the same procedures. It should be noted that the Standard Procedures form does not authorize the use of animals; only Vertebrate Animal Study forms can be used to obtain approval for the use of animals.

B. Where to find IACUC application and appendices
All IACUC forms and appendices are electronic documents available on-line via the InfoEd portal at https://eresearch.mssm.edu/login.asp. These documents are completed, submitted, managed and reviewed entirely on-line via the InfoEd portal.

C. Access to the InfoEd portal
In order to access the InfoEd portal, users must obtain an ID and a password by contacting the MSSM IT department at infoed@mssm.edu. The IT department will respond promptly to inquiries.

D. Training for the use of the InfoEd portal
The use of the portal requires training. Information on training seminars may be obtained by contacting the IT department at infoed@mssm.edu. Training provides instructions on items such as:

• • • Use of the portal
    • Access to IACUC forms and appendices
    • How to complete and submit forms, iv) how to finds protocols in the database
    • How to respond to IACUC requests for modification
    • How to file progress reports and addenda

Additional training instructions are available at http://eolas.mssm.edu/e-learn by clicking on the "Lab Animal Module" link. The IACUC office also offers limited ad hoc training (x48955).

E. Where to find help for problems with the InfoEd system
Users encountering problems in completing or submitting IACUC forms via the InfoEd system should contact immediately the IT department at infoed@mssm.edu. Help may also be obtained by contacting the IACUC office at 212-241-8955 or by e-mail at IACUC@mssm.edu.

F. Review of IACUC Applications

1. 1. Review methods
      Once submitted, IACUC applications are reviewed by either one of the two methods required by federal regulations:
      1. Designated Review. One (or more) IACUC member is selected by the Chairperson and/or the IACUC coordinator to conduct designated reviews. Designated reviewers have the authority to approve, require modification, or request a full Committee review of the proposed research. Generally, study protocols involving minimal pain and/or distress to animals are reviewed by designated review.
      2. Full Committee Review. The full Committee reviews the following categories of protocols at a convened meeting:
         1. Studies requiring major or multiple survival surgeries (in any species)
         2. Studies involving procedures or treatments that may induce painful or distressful conditions (e.g. injection of toxic materials, cancer cells, irradiation etc)
         3. All protocols involving species covered by the Animal Welfare Act
         4. Studies involving the use of hazardous substances in vivo (biological, infectious, chemical, radiological)
            
            Committee members have on-line access to all applications and any IACUC member may request a review of any protocol by the full Committee.
            
   2. Additional levels of review
      1. Review of protocols involving biological, chemical and radiological hazards
         PIs proposing to use hazardous agents in their studies are required to complete Biological Risk Assessment forms and to develop specific SOPs (with guidance from the Biosafety Officer) for the use of such agents in the laboratory and in vivo (e.g., teratogens, toxins with LD50<500 mg/kg in mammalian species, carcinogens, infectious agents, recombinant DNA etc). The Institutional Biosafety Officer (IBO) reviews the Biological Risk Assessment forms and presents its findings to the IACUC. The IBO also determines if studies involving recombinant DNA molecules, genetic modification of animals, and development of genetically modified organisms fall under the purview of the Institutional Biosafety Committee (IBC). In such cases, the IACUC will not review the application until the IBC has rendered a final decision on the protocol.
      2. Veterinary review of surgical procedures
         Studies involving major surgical procedures in any species require the submission of Appendix B: Major Surgery. PIs are strongly advised to consult with the veterinarians (Drs. Reginald Miller and Gregg Goldschlager, x43008) regarding surgical procedures, anesthetics, analgesics and pre- and post-operative care before submitting the IACUC forms and the surgery appendix.
         
   3. Review of protocol modifications requested by the IACUC
      Applications amended upon a request of the IACUC are generally reviewed by designated review, unless otherwise determined by the IACUC at a convened meeting.

G. Final approval
Final approval of a protocol is granted after all reviews have been completed and the PI has adequately responded to all requests for modifications of the protocol. The review processes may take from one to 6 weeks, depending on factors such as Committee meeting schedules and how promptly a PI responds to requests for modifications. Approval letters are issued by the IACUC office and forwarded to the PI. The Chair, Deputy Chair or the IACUC Administrator are all authorized to sign approval letters.

H. Approval periods
All study protocols are approved for a period of three years. For the second and third year of the project, PIs are only required to submit a Progress Report. The Progress Report form is also available on line via the InfoEd portal. At the expiration of the three-year approval period, PIs must submit a new set of IACUC forms. Information on how to file a Progress Report may be obtained from the IACUC office at ext 48955.

I. IACUC Meeting Schedule
IACUC meetings are held approximately every three weeks throughout the year. A meeting can be held only when a quorum of members (half of the membership plus one) is in attendance. At such meetings, approval of a protocol requires a majority vote of the quorum present. When raised, minority opinions are recorded in the minutes.

J. Guidelines on Fellowships and IACUC applications

1. Fellow will conduct an independent research project
   If the fellow will receive fellowship funds for salary and for the specific purchase of animals and supplies to pursue independent research in a sponsor's laboratory, he/she must file an IACUC application to cover the project.
2. Fellow will conduct research covered by a mentor's approved project
   

•     Case 1                                                                
  1. The fellow will participate in a mentor's research project
  2. The fellow will receive a salary from a mentor's grant
  3. The fellow's part of the research project is fully covered by a mentor's approved protocol
     
     
  4. In such case, the fellow does not need to file an IACUC application. However, the name of the fellow and his/her experience must be included in the personnel list of the pertinent mentor's IACUC application.
     
•     Case 2                                                                
  1. The fellow will participate in a mentor's research project
  2. The fellow will receive a salary from a fellowship grant, but no research money
  3. The fellow's activities in the research project are completely covered by a mentor's approved protocol
     
     
  • In such case, the fellow does not need to file an IACUC application. However, the name of the fellow and his/her experience must be included in the personnel list of the pertinent sponsor's IACUC application. The mentor must also provide to the IACUC a written assurance that the fellow's activities are covered by a mentor's approved protocol. In addition, the IACUC will conduct a comparative review of the fellow's extramural application and of the mentor's protocol to ensure that no discrepancies exist between the mentor's project and the research described in the fellowship application.
    
•     Case 3                                                                
  1. The fellow will participate in a mentor's research project
  2. The fellow will receive a salary and some research money from a fellowship grant,
  3. The fellow's activities in the research project are completely covered by a mentor's approved protocol.
  • 
    In such case, the fellow does not need to file an IACUC application. However, the name of the fellow and his/her experience must be included in the personnel list of the pertinent mentor's IACUC application. The mentor must also provide a written assurance that the fellow's activities are covered by a mentor's protocol. In addition, the IACUC will conduct a comparative review of the fellow's extramural application and the mentor's IACUC application to ensure that no discrepancies exist between the mentor's project and the research described in the fellowship grant application. Lastly, the research money from the fellowship grant should not be used for purchasing animal.