Protocol Form Update 2016

Transcription

1 Protocol Form Update 2016

2 Updated Protocol Form 2016 Updated forms footer: 2016 Minor word changes/layout changes for clarification Major updates to Assurances/Narrative and Training & Qualifications documentation sections Updated forms available for use October 2015 Beginning January 2016 ALL submission must be on updated forms

3 Assurances Potentially Painful or Distressful Procedures New section: List each potentially painful or distressing procedure included in this protocol: To comply with Policy #12, investigators are required to conduct literature searches using two different search engines (see below) addressing each of the procedures listed above. Specific procedures listed may be utilized as key terms. Additional assistance may be obtained by contacting the Rowland Medical Library reference desk at ext Also see IACUC Guidance on Minimizing Pain and Distress in Animals and Searching for Alternatives

4 Search for Alternatives New table to document search focusing on the 3 R s Indicate which mandate each search addressed Name of the database Date of search Period of years covered by the search Potentially painful or distressing procedures addressed Key words and/or search strategy used Replacement of animals Reduction in numbers of animals used Refinement to minimize pain or distress Lack of unnecessary duplication

5 Developing a Search Strategy The key to conducting a search for alternatives is to focus on alternatives to the potentially painful or distressful procedures used in the study, not only on alternatives to the topic or purpose of the research. When developing a search strategy, identify the experimental techniques or procedures in the study that have the potential to cause pain or distress in animals. Alternatives for each potentially painful or distressing procedure must be considered. Choose descriptive search keywords specific for the techniques or procedures in the study. Include the animal species to be studied and select a database appropriate for the area of study. The use of the term alternatives in the search is usually not very productive. Also see IACUC Guidance on Minimizing Pain and Distress in Animals and Searching for Alternatives

6 Examples A study proposing retro-orbital blood collection from mice. Search keywords could include: blood collection, method, and mouse. Search results would provide alternative sites or methods for blood collection such as the tail artery, saphenous vein, and submandibular vein. The investigator must then consider how much blood may be obtained with each method, whether or not repeated blood collection is require, and the potential for pain and distress with each method. A study involving intra-cerebral injections in rats. Search keywords could include: drug, administration, method, and rat. Search results would provide other administration routes such as intravenous or subcutaneous injections, oral gavage, and subcutaneous implants. The investigator must then consider if another method of administration meets the requirements of the experiment. For example, if the drug needs to cross the blood-brain barrier in a certain time frame, intra-cerebral injection might be the only possible route. The investigator will need to address this in the refinement section of the protocol form.

7 Pain Categories UMMC uses pain categories corresponding to the USDA categories. Category B: Animals being bred, acclimatized, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes. Category C: Animals that are subject to procedures that cause no pain or distress, or only momentary or slight pain or distress and do not require the use of pain relieving drugs. Category D: Animals subjected to potentially painful or stressful procedures for which they receive appropriate anesthetics, analgesics, tranquilizing drugs, and/or humane endpoints to avoid pain, distress, or discomfort. Category E: Animals subjected to potentially painful or stressful procedures that are not relieved with anesthetics, analgesics and/or tranquilizer drugs. Withholding anesthesia/analgesia must be scientifically justified in writing and approved by the IACUC. Procedures classified in categories D or E require consideration of alternatives.

8 Training and Qualifications Assurances includes documentation of training and qualifications of PI and personnel PI Name Animal research experience Qualifications to perform specific procedures Specific procedure(s) Experience with each procedure in the species described in this that the PI will perform Protocol personally Other research personnel (copy the lines below for each individual listed as personnel on protocol) Name Animal research experience Qualifications to perform specific procedures Specific procedure(s) Experience with each procedure in the species described in this that this individual will Protocol perform

9 Experience and training should be addressed for each person listed on the protocol (including the PI) and each procedure the person will perform When a procedure is new to the lab, a description of training should be included

10 Appendices Appendix A: Title changed to Non-Human Primate Environmental Enhancement/Enrichment Appendix B: Question 1b split to provide a description of separation plan when trio or harem breeding is used. Appendix C: Formulary table lists pre-operative and post-operative analgesics separately; questions added to address non-pharmaceutical-grade compounds; removed question on experience/training as it now addressed in the main protocol form and modification form

11 Appendices Appendix D: Questions added to address nonpharmaceutical-grade compounds Appendix F: Questions added to address nonpharmaceutical-grade compounds Appendix M: Removed; non-pharmaceutical-grade compounds now addressed in Appendices C, D, & F

12 Modification Form For addition of procedures, 2 questions added: Who will conduct the procedure? Describe experience/training. For procedures that may cause more than momentary pain and/or distress, a literature search must be conducted. Search documentation and Narrative section added.

13 Questions? Contact the Office of Animal Welfare