IV. Protocol Review Process

Laboratory Animal Services has developed a Word97 (for Windows) version of the March 1998 Animal Use Protocol Review Form.   This version has hyperlinks to line-by-line instructions, context-sensitive links to relevant documents, and formats your input so that it stands out from the text of the form. 

Word97 version of March 1998 Animal Use Protocol Review Form (Internet Explorer users)
Word97 version of March 1998 Animal Use Protocol Review Form (Netscape users)
Line-by-line instructions for the Animal Use Protocol Review Form

Introduction / Review Procedure / Amendments / Term of Approval / Renewal / Significant Changes / Obtaining Forms / Submitting Forms / Assistance / Funding Agency Notification / Field Studies / Questions

According to the Animal Welfare Policy for Rutgers University (October 11, 1994), before any work with live vertebrate animals commences, all procedures using live vertebrate animals whether new or on-going, or proposed for funding, and irrespective of source or present funding, whether conducted at the University or elsewhere by faculty in the discharge of their University duties and responsibilities must be reviewed by the Animal Care and Facilities Committee. This shall include use of animals for research, instruction, or demonstration purposes (with the exception of farm animals utilized for demonstration purposes by Rutgers Cooperative Extension).

Procedures described in the protocol must conform with those prescribed by the U.S. Public Health Service Policy (PHS), Animal Welfare Act Regulations, The Guide for the Care and Use of Laboratory Animals and the University’s Assurance.

A. Review Procedure

All Animal Use Protocol Review forms are examined and approved at a monthly meeting of the Animal Care and Facilities Committee (ACFC). In order to obtain approval, the ACFC conducts a review of procedures involving animals and determines whether the activities are in accord with the University and Federal policies. The ACFC determines whether the activity conforms with the University’s Assurance and meets the following criteria set forth in, and excerpted herein, the U.S. Government Principles Regarding the Care and Use of Animals:

  1. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et seq.) and other applicable Federal laws, guidelines, and policies.
  2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
  3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. The use of statistical models and proper experimental design can help determine the numbers of subjects needed to produce required statistical power. Following such good scientific practice might actually increase the total number of animals used in a project. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
  4. Proper use of animals, including the avoidance or minimalization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures which cause pain or distress in human beings may also cause pain or distress in other animals.
  5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.
  6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure, or if appropriate, during the procedure.
  7. The living conditions of animals should be appropriate-for their species and contribute to their health and comfort. Normally, the housing, care, feeding, and care of all animals used by biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.
  8. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
  9. Where exceptions are required in relation to the provision of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle 2, by the Animal Care and Facilities Committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

B. Amendments

It is the nature of the research process that experiments often raise more questions than they answer. It is not reasonable to expect that an investigator can anticipate every procedure he or she might need to perform during the 3 year period for which some projects are approved by the ACFC.

However, federal law and University policy require that all procedures be reviewed by the ACFC prior to initiation of the procedures. For this reason, any significant changes (see below) require approval by the ACFC.

In cases of an amendment to a previously approved protocol, an investigator should submit a letter detailing the change. In describing the amendment, the animal protocol review form should be used as a guide to discuss species, number of animals, surgery, anesthesia, analgesia, prolonged restraint, pathological conditions, death as an endpoint, dietary manipulations, experimental stress, final disposition and use of hazardous agents.

C. Notification of Approval

Investigators will be notified in writing of the committee’s decision concerning their protocol.

D. Term of Approval

The period of approval will be for one to three years from the date of approval, or the expected ending date of the project, whichever is shorter, unless otherwise specified by the ACFC.

E. Renewal

Investigators with approved animal use protocols will be sent a renewal form one to two months prior to the expiration of the approval period. Significant changes (see below) should be noted and the renewal form returned to the committee. Following approval the ACFC will notify the investigator in writing of the new expiration date.

F. Significant Changes

Significant changes to approved projects using animals must be approved by the ACFC prior to initiation of new procedures. The following is a list of changes that are considered significant.

For the purpose of ACFC approval, the following changes would not be considered significant changes.

G. Obtaining Forms

Laboratory Animal Services has developed a Word97 (for Windows) version of the March 1998 Animal Use Protocol Review Form.   This version has hyperlinks to line-by-line instructions, context-sensitive links to relevant documents, and formats your input so that it stands out from the text of the form. 

Word97 version of March 1998 Animal Use Protocol Review Form (Internet Explorer users)
Word97 version of March 1998 Animal Use Protocol Review Form (Netscape users)
Line-by-line instructions for the Animal Use Protocol Review Form

Animal Use Protocol Review Forms may be obtained from the following sources. When using paper forms, be sure that you have the most up-to-date version.

Office of Research and Sponsored Programs
        Rutgers, The State University
        Administrative Services Building Annex II
        58 Bevier Road Piscataway, New Jersey 08854-8010
        732-445-2880

Laboratory Animal Services
        Room D108
        Nelson Biological Laboratories
        Busch Campus
        732-445-4168

Departmental Business Offices

              The ACFC provides the protocol form and instructions as downloadable documents in several word processor formats.

H. Where to Submit Completed Forms

Completed Animal Use Protocol Review forms should be submitted to:

Sponsored Programs Administrator
        Office of Research and Sponsored Programs
        Rutgers, The State University
        Administrative Services Building Annex II
        58 Bevier Road Piscataway, New Jersey 08854-8010
        732-445-2880
       http://info.rutgers.edu/orsp/shtml

I. Assistance

For further information on completing the animal protocol review form, planning of alternatives, modification of protocols or for discussion of problems arising in particular studies contact Robert L. Harris, D.V.M. or Stephen Curtis, D.V.M., Office of Laboratory Animal Services, Phone: (732) 445-41 68. Contact Karen M. Janes, Office of Research and Sponsored Programs, Phone: (732) 445-2883, for information on administrative matters.

J. Notification to Funding Agencies

Investigators who wish to have ACFC approval communicated to funding agencies will complete the form which accompanies the Notice of Approval.

Information needed when completing grant applications

K. Guidelines For Field Studies

In many cases, animal experiments carried out in the field are subject to the same jurisdiction as animals in the laboratory. While the Guide does not cover field studies, there are a number of professional organizations that have developed their own gudelines for field-animal use.

Amphibians and Reptiles
Guidelines For Use of Live Amphibians And Reptiles in Field Research
Compiled by: The American Society of Ichthyologists and Herpetologists, The Herpetologists League, and The society for the Study of Amphibians And Reptiles.
The document is available on-line and in The Journal of Herpetology. Supplement, Volume 4, pp. 1-14, 1987.

Wild Birds
Guidelines For the Use of Wild Birds in Research
Compiled by: The American Ornithologists Union and The Wilson Ornithological Society
The document is available in the supplement to "The Auk" Volume 105, Number 1, January, 1988.

Fishes
Guidelines For Use of Fishes in Field Research
Compiled by: The American Society of Ichthyologists and Herpetologists, The American Fisheries Society, and The American Institute of Fisheries Research Biologists.
The document is available on-line and in the Copeia Supplement, pp. 1-12, 1987.

Wild Mammals
Guidelines For the Capture, Handling and Care of Mammals
Compiled by: The American Society of Mammologists

L. Commonly asked questions about Protocol Review

Q My project is not funded by PHS. Do I need ACFC approval?

A Yes. Rutgers policy requires that all projects, regardless of funding source, if any, be reviewed and approved prior to initiating work with animals.

Q Since rats, mice and birds are excluded from the Animal Welfare Act, must I have approval for my rat study?

A Yes. Rutgers policy requires that all projects, regardless of species be reviewed and approved prior to initiating work with animals.

Q My project is a collaborative study. The animal work will be done at another institution. Do I need to have the project reviewed by the Rutgers ACFC?

A Yes. All projects using animals performed by Rutgers faculty must be reviewed and approved, regardless of where the work is performed.

Q I will be conducting field research involving fish. I will not house any animals in animal facilities. Are field studies reviewed?

A Yes. NSF and University policy require review of field studies. The committee uses guidelines for field studies developed by various professional organizations (see above).

Q Does my work with marine invertebrates require ACFC review?

A No. Only projects involving vertebrates are reviewed.

Q I will be using preserved fetal pig cadavers for a laboratory course. Must this be reviewed?

A No. Only projects involving animals purchased live require committee approval.

Q I have received a new grant. The new grant will involve new laboratory procedures, but the work involving animals is the same as that already approved for a previous project. Must I seek a modification of my approval?

         A No. Approval of projects involving animals is specific with respect to
                    the animal work, not with respect to source of laboratory procedures.

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