• COMPLETE WEB TRAINING:  Visit the OESO (safety office) web site at: http://www.safety.duke.edu/.  Select the link on the left ‘On-line Training.’  Enter your NetID and Password.  Select ‘Courses Available On-Line.’  All animal users must complete Animal Handlers I and Animal Handlers II.  If you are working with rodents and will use CO2 for euthanasia, you must also complete ‘CO2 Euthanasia of Rodents.’  You may complete any of the other courses you feel are appropriate or may be necessary.  The IACUC, OESO, or EOHW may require specified web courses (e.g. biosafety work may require completion of the biosafety web module) during the protocol review. 

PROTOCOL SUBMISSION:

• PRE-REVIEW:  To assist researchers with protocol development, the Office of Animal Welfare Assurance (OAWA) provides a pre-review service.  Just complete your protocol as best you can, and Email it to IACUC@DUKE.EDU.  An OAWA veterinarian will review your protocol and offer suggestions for improvement. 

• SUBMISSION FOR IACUC REVIEW:  When ready, submit all protocols to IACUC@DUKE.EDU.  Once a protocol is submitted, DO NOT revise the protocol, only reply to Emails.  Emails become part of the protocol file.  A revised protocol will require re-review and may delay protocol approval.

o        ADMINISTRATIVE REVIEW:  You will receive a confirmation from one of the Protocol Specialist that your protocol has been added to the IACUC’s agenda.  The Protocol Specialist will also perform an ‘Administrative Review’ and may suggest enhancements (e.g. missing contact information, missing housing or procedure location, etc.).  Please reply by Email with the information requested.

o        VETERINARY REVIEW:  All protocols receive a review by a Duke veterinarian prior to going to the IACUC.  This review will include the entire protocol, but will focus on animal care, anesthesia, analgesia, and other animal care activities.  The reviewer may identify specific concerns and offer suggestions to reconcile the concern.  Please reply to the Email with the information requested.

o        OESO / EOHW REVIEW: All protocols and amendments are reviewed by OESO and EOHW to assure compliance with Duke requirements for a safe workplace.  You will receive an Email notice from OESO/EOHW concerning any issues that require attention.  Please do not delay in responding to OESO/EOHW.  Animal protocols may be reviewed by the IACUC, but the approval will not be granted until PROTOCOL CLEARANCE has been received from OESO and EOHW.  

o        PRIMARY IACUC MEMBER REVIEWER:  A member of the IACUC will be assigned as the PRIMARY REVIEWER.  A few days before the IACUC meeting you may receive an Email from the PRIMARY REVIEWER requesting clarification of certain points.  Please reply to the Email with the information requested. The PRIMARY REVIEWER will be your advocate at the IACUC meeting.

o        NOTICE OF IACUC REVIEW:  Within 3 business days of the IACUC meeting you will be advised of the outcome of the Committee’s review.  If approved, you will be given a protocol registry number and instructions on annual reporting of your animal use activity.  If additional clarifications are required to secure approval, you will receive a point by point breakdown of necessary actions to secure approval.

o        COPY OF PROTOCOL OR RELATED DOCUMENTS:  You may request a copy of your protocol file, which includes a PDF version of your protocol and all related correspondence (e.g. protocol, amendment, communications, approvals) at any time by submitting a request to IACUC@DUKE.EDU The pdf file will be sent to the PI listed on the protocol.  

• QUESTIONS OR PROBLEMS:  Call the Office of Animal Welfare Assurance at 919.668.6720 or Email ron.banks@duke.edu.

PROTOCOL MAINTENANCE:

•  ANNUAL PROTOCOL REPORT:  A request for an annual report of your animal use activities will be sent via Email during the 10^th month of the protocol.  You must complete the report, return the report, and the report must be approved prior to the protocol approval anniversary date, or the protocol may be suspended by the IACUC.   

• USDA REPORT:  The Duke animal program must report animal use to the USDA annually.  A request for your animal numbers used will be sent via Email each fall.  Please reply as soon as possible.

• AMENDMENTS TO APPROVED ACTIVITY:  Any change of research direction, addition of new procedures or personnel, or changes in approved procedures must be IACUC approved prior to performing the changed activity.  The Amendment form is available on the animal program website under ‘FORMS AND REPORTS.’  Depending upon the nature of the change, amendments may take up to 14 business days for approval.

• DE NOVO REVIEW:  According to NIH/PHS Policy, all protocols have a life cycle of 3 years. Projects continuing beyond 3 years must have a new protocol approved by the IACUC.  At the 33^rd month of your protocol life cycle, we will alert you by Email that you should submit a new protocol.  Please reply promptly.

• POST APPROVAL MONITORING:  Duke has an active program of Post Approval Monitoring (PAM).  Compliance Liaisons will occasionally monitor animal procedures and confirm that the laboratory practices are as described in the approved protocol.  Most laboratories will receive one visit per year, but depending upon the type of research, more monitoring sessions may be required.  Researchers should view this process as partnering with the IACUC assuring program integrity.  Deficiencies noted will be addressed quickly and in a collegial manner.

• QUESTIONS OR PROBLEMS:  Call the Office of Animal Welfare Assurance at 919.668.6720 or Email ron.banks@duke.edu.

GUIDELINES AND EXAMPLES FOR WRITING GOOD PROTOCOLS:  Please consider the links below for examples of well written protocol paragraphs.  These are not actual protocols, but examples of what has been considered by the IACUC as well written and incorporating the required regulatory language:

• Animal Numbers Justification:  An important aspect of writing a good protocol is to provide the IACUC with a clear and sound basis for the numbers of animals required to achieve the goal.  The Duke Animal Program provides the following information for protocol development: 

  • Click here for a primer on performing statistical assessment on animals. 

  • There are a number of useful web addresses for statistically validating the numbers requested, one such site is Animal Numbers Justification. 

• Species Justification:  An important requirement for an animal use application is a clear and accurate argument on the use of the species required for the proposed study.  Click here for a discussion on how to provide a response that the IACUC will approve.   

• Lay Language (non technical synopsis):  A common problem area with new protocols is writing certain aspects of the protocol in lay language, or language that is understandable by the public. Another method of defining the non-technical synopsis is to consider this as 'newspaper' language.  Do not use scientific or highly technical terms that one would not find in a newspaper article. Click here for a review of examples for non-technical synopsis.

• Guidelines and Recommendations for Animal Use: If you are needing a recommendation about how to perform a specific task or fill in a specific part of the protocol, check out these links:

  • Anesthesia / Analgesia Recommendations

  • Euthanasia

  • Techniques for Rabbit

  • Techniques for Rodents     

•   Literature Searches:   The Animal Welfare Act requires that the principal investigator provide assurance that alternatives to the use of animals were considered in planning these research activities. What is the justification for using live animals rather than alternative means of achieving the research goal? For help with available literature search engines, click here.   

• Occupational Health & Safety Program (OHSP):  The OHSP program at Duke consist of two Offices:

  • Occupational and Environmental Safety (OESO):  This Duke Office reviews all animal protocols and manages the safety aspects on animal use on campus. In certain cases, a further review by the Institutional Biosafety Committee (IBC) may be required prior to granting safety 'clearance' for animal work.  You are encouraged to discuss concerns with Dr. Joan Catignani (the animal program's primary contact at OESO) even before submitting your protocol for the IACUC's review.

  • Employee Occupational Health & Wellness (EOHW):  This Duke Office reviews all animal protocols and manages the safety aspects on animal use on campus. To begin this process, download the form titled: " Placement Health Review for Animal Handlers."  Once you have completed the form, send it to  Terri Weddle for the animal handler health review.  You can also call Terri at 919.681.0555.

NOTE:  All personnel on the protocol MUST BE 'cleared' by OESO and EOHW before the IACUC will grant approval for the new protocol or amendment.  It is critically important to check your training records and assure you are current with all Duke safety and health requirements.

NOTE:  PIs can have access to the training status of their laboratory members.  Please contact Cackie Joyner to arrange for access.

If you need further clarification of the requirements or the process, you can contact our the Director, Office of Animal Welfare Assurance (Dr. Ron Banks) by clicking this link.

• Animal Program Training:  You will need training prior to working with animals at Duke.  

  • One requirement for ALL new animal users at Duke are the web training modules 'Animal Handler I' and 'Animal Handler II.' 

  • If you will be on a protocol where rodents are euthanized with CO2 (Carbon Dioxide), then you will also be required to complete the 'CO2 Training' web module.  You can take this training at any time with your Duke Unique ID and your password. Click here to get started.

  • Access to AALAS Learning Library:  The Duke Animal Program has campus wide access to the training modules in the AALAS Learning Library.  This resource keeps track of your training history and your scores on the modules. It allows you to progress through a large number of modules at your pace.  All you need is your Duke Unique ID and be associated with an animal protocol.  Contact Ron Banks (ron.banks@duke.edu) for the access codes and passwords for the AALAS Learning Library.  

  • It may be determined by the IACUC (Duke's animal use committee) that you may need additional training.  While this decision is a Committee decision, you may wish to click this link to ask the Director, Office of Animal Welfare Assurance if he thinks the Committee may require training (and how you can get a head start on the training).

• Facility Access:  Duke has a number of facilities holding and using animals.  Your access to an animal holding facility is dependent upon:

  • Having an approved protocol;

  • Being enrolled in the OHSP;

  • Having completed the required training.

Click here for more information on completing the steps for facility access.  Once you have completed all three requirements for facility access, you can Email the Operations Manager, Division of Laboratory Animal Resources to obtain access rights to the facility.

• Veterinary Authority with Duke Owned Animals:  Duke is serious about assuring animal welfare and well being.  Click here to review the institution's formal position on when the veterinary staff will provide care for research animals in the absence of investigator approval.  
   

• Common Vendors Used by Duke Researchers:  While not intended on either including or excluding vendors, this link provides a list of commonly used vendors by Duke researchers.  Click here to access the page.