IACUC ORIENTATION PART 19 POSTAPPROVAL ANNUAL RENEWAL AND APPLICATION

1 FORM IACUC 00305 AMERICAN UNIVERSITY OF BEIRUT
13 FORM IACUC 00105 AMERICAN UNIVERSITY OF BEIRUT INSTITUTIONAL
2 FORM IACUC 00505 AMERICAN UNIVERSITY OF BEIRUT

7 FORM IACUC 00405 AMERICAN UNIVERSITY OF BEIRUT
ADDITIONAL PERSONNEL FORM PRINCIPAL INVESTIGATOR IACUC
EKU IACUC FORM W ANIMAL WORKER QUESTIONNAIRE PAGE 2

IACUC Orientation Part 1.9 Post-Approval


IACUC ORIENTATION PART 19 POSTAPPROVAL ANNUAL RENEWAL AND APPLICATION

Annual Renewal and Application Continuation

There are two types of renewals. First, all approved applications must be updated and reviewed annually. This process is called Annual Renewal. Second, after two annual renewals (at the end of the three–year approval period), the Investigator must either continue or terminate an application. To continue the project, federal regulations require that the IACUC perform a ‘de novo” review of the project. The UNC-CH IACUC requires the PI to submit a full Animal Care Application (ACAP) and the IACUC must review the application.

The Investigator completes the Annual Renewal form, available on ACAP, to submit the annual renewal. The annual renewal serves to renew an existing application for an additional year, yet does not account for any new procedures or changes in the protocol—this requires an Amendment (see below). Approved applications must be renewed annually. Failure to renew an active application will result in termination of the application and submission of a report to the Institutional Official (IO) and the investigator’s funding agency and possible suspension of animal privileges. At the end of three years, if a continuation application is required, the Investigator must submit a new ACAP for review and approval. In the appropriate section of the form, the Investigator should indicate “continuation application” as opposed to “new application.” Because the application review process can be lengthy, the IACUC recommends that investigators submit applications a month early, especially if there are agency deadlines or animals “in-house” covered by the expiring application.



It is important for the IACUC to have an accurate record of current individuals in the laboratory who will work with animals as part of the application. Please accurately account for personnel on the application and annual renewals. New individuals must be added to the application, must have completed all required training and certifications, and must obtain IACUC approval before they handle animals. Please account for all students rotating through your laboratory. Because the completion of training requirements takes considerable time, we encourage PIs to have their students start begin the process well before they will need to perform experiments. Likewise, please delete relevant personnel from your application as part of the annual renewal process. You can also send an electronic mail notification to [email protected] to inform the office that an individual has left the laboratory. Indicate the individual’s name, PID, and all applications from which the individual should be removed.


Summary of Animal Care Application (ACAP) and Annual Renewal



Expiring Applications w/ Animals in House and the IACUC Hold Application


Since various offices are involved in the review of an IACUC protocol (IACUC, EHS, IBC, veterinary reviewers, and volunteer committee members) the application review process can take several months. If an application is time sensitive or animals ‘in-house’ are covered by an expiring application, the IACUC encourages investigators to submit their applications a month early if possible. Due to the extended approval process, there is the possibility that an investigator’s application may expire before the continuation application is approved. If the investigator still has animals in-house after the application expires and before the continuation application is approved, the animals will be transferred to a temporary IACUC Holding Application. The IACUC Holding Application is only a temporary measure and investigators must work with the IACUC and OACU to secure timely approval of their application. Experimental animal work is not allowed on the IACUC Holding Application. Please note that NIH funding cannot be used to pay any associated animal costs, including per diems, during this IACUC Holding period. Other funding agencies may follow NIH guidelines on this topic. Continuing animal work on an expired application is a violation of federal and University policy and would result in IACUC notification of this occurrence to the Office of Laboratory Animal Welfare (OLAW) and the funding agency.


Amendments

Before an investigator may use new procedures and agents or allow new personnel to work under an IACUC protocol, the IACUC must first review and approve any changes to an approved application. Investigators are responsible for requesting application changes or addition of new personnel through the formal process of amending the application. Performing unapproved procedures or allowing unapproved personnel to participate on an IACUC-approved application is considered non-compliance with federal policy and is reportable to OLAW (NIH).



The following are some examples of changes requiring an amendment:



The amendment must include all pertinent details of the requested change. The following are examples of some of those details: adequate justification for additional animals; indication of potential adverse effects the animals may experience as a result of administration of new agents or procedures; details of new anesthetic and/or analgesic agents to be administered; and new administration routes. The specific details of the amendment should provide the Committee members with all the information they need to make an informed decision.

The IACUC handles most amendments by designated member review. Investigators must submit amendments electronically through the ACAP system. Amendments are distributed electronically to all IACUC members and any member can request a full IACUC review. Request for a full review of an amendment necessitates review of the amendment at the next convened IACUC meeting. The following types of amendments, by default, require review at a convened meeting: requests for an Exception to Policy; animals in Pain Category E; and pain studies.

If the proposed change is comprehensive, significantly changes the original content of the application, or involves new surgical procedures, an amendment may not be acceptable. The IACUC will review each amendment on a case by case basis and may require submission of a full application rather than an amendment. Full applications receive Committee review at a convened IACUC meeting.

The minimum time for an amendment to be approved is usually eight business days. On a case-by-case basis, depending on the circumstances, the Committee will consider a 24-48 hour turn around.


Title and Funding Changes

Investigators may wish to change the title of their project or provide evidence of IACUC approval to multiple funding agencies. Although a title or funding change does not allow application content changes, it requires IACUC approval. If an Investigator wishes to change titles, he/she must submit a Title/Funding change form through ACAP and receive IACUC approval. The additional title exists only as a title, with no additional animals attached. Annually, at the time of renewal of the original project, the Investigator must also renew the additional project titles - no matter when the title change is initiated during the three-year approval period. Thus, for example, a title change approved two months before the related protocol is due for renewal would have to be renewed after two months, and then annually. Please note: a title change serves as an additional title ONLY. It does not replace or eliminate the original title. If an investigator does not wish to continue with a particular title, he/she should terminate that title at the time of the application annual renewal.



Ending Note Quotes

“Virtually every medical achievement of the last century has depended directly or indirectly on research in animals. In order to continue the privilege of utilizing animals in research and teaching, it is important to understand and fulfill the regulations pertaining to animal use.”

“In fact without animal research we would medically speaking - be stuck in the Dark Ages. Animal research has contributed to 70 per cent of Nobel prizes for physiology or medicine. Antibiotics, insulin, vaccines for polio and cervical cancer, organ transplantation, HIV treatments, heart-bypass surgery - it reads like an A to Z of medical progress. But these major advances have something in common: they were all developed and tested using animals.”

“No one chooses to use animals where there is no need. It gives no one any pleasure, and it is time consuming, expensive and - quite rightly - subject to layers of regulation. Yet it is still the best way of finding out what causes disease, and of knowing whether new treatments will be safe and effective.”


“Medical research is an arduous process. By the time a therapy reaches the patient, it is easy to forget just how important animals were in its development. Patients might not know that the powerful new drugs were developed after research on mice.”


Acknowledgements: Institutional Animal Care and Use Committee Guidebook 2nd Edition, 2002 (ARENA, OLAW); Animal Welfare Information Center; UNC-CH Daily Tar Heel; US Public Health Service

IACUC ORIENTATION PART 19 POSTAPPROVAL ANNUAL RENEWAL AND APPLICATION IACUC ORIENTATION PART 19 POSTAPPROVAL ANNUAL RENEWAL AND APPLICATION

Animal Welfare Act Governmental Act administered by the USDA, which determines fair use and treatment of laboratory animals.

AWIC The Animal Welfare Information Center is a page of the Agriculture Network Information Center on the Internet. This site features databases, recommendations for animal alternatives, resources, and more information relevant to animal researchers.

Division of Laboratory Animal Medicine provides veterinary care and husbandry services for animal users at UNC-CH.

Environment Health and Safety handles the use of hazardous materials at UNC-CH. This committee must approve Appendix C: The Use of Hazardous Materials in Animals and the Addendum to the Laboratory Safety Plan before the IACUC can approve the animal application.

Guide for the Care and Use of Lab Animals This link accesses the Guide, providing standards of animal care and use from the AALAC.

IACUC Homepage The home page for the Institutional Animal Care and Use Committee at UNC-CH This page provides links to classes, reporting forms, links, Training and Compliance information, Standard Operating Procedures and information concerning the use of animal research at UNC-CH.

Johns Hopkins Animal Care and Use: Alternatives to Pain and Distress offers a narrative on alternatives to animal research and guidelines in doing so. This site also examines some of the legal implications in research and policies in place regulating animal research.

2007 AVMA Guidelines on Euthanasia A document listing all the approved methods of euthanasia. This is an important document to review before writing an IACUC application.

United States Department of Agriculture (USDA) One of the federal offices that governs the use of animals used in research. The USDA governs though application of the Animal Welfare Act.

University of California at Davis Center for Animal Alternatives Provides numerous web resources dealing with the use of animals in research and alternatives thereof. Also is an aid to online searching on alternatives and policies relating to specific animal research.


Network of Laboratory Animal Coordinators Website provides a quick overview of the most current IACUC useful information and related links.



IACUC ORIENTATION PART 19 POSTAPPROVAL ANNUAL RENEWAL AND APPLICATION

IACUC ORIENTATION PART 19 POSTAPPROVAL ANNUAL RENEWAL AND APPLICATION

IACUC

Phone: 966-5569

Fax: 966-8429

CB # 7193 Chapel Hill, NC 27599-7193

[email protected]

http://research.unc.edu/iacuc/



Please contact the Office of Animal Care and Use at 966-5569 or at [email protected] with any questions, comments or problems with the online orientation

Part 1.9 Post-Approval -- Page 7 of 7 -- IACUC Online Orientation -- September 2009



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