Office of Research Integrity. and Outreach. Animal Study Proposal. Instructions:

Transcription

1 and Outreach Office of Research Integrity Animal Study Proposal Instructions: De Novo Review: The Institutional Animal Care and Use Committee (IACUC) is required under federal law to perform a complete re-review of the entire protocol every three years. Please contact the Research Integrity Administrator at or usmorio@maine.edu with questions. A. Administrative Information Q1 Principal Investigator Role Organization Department Q2 If applicable: Undergraduate Student Graduate Student Course: Q3 If applicable, Faculty Advisor: Name: Title: Department:

2 Contact information: Q4 Primary Address Primary Telephone Primary Fax Primary B. Project Information Q5 Project Title Q6 Submission Type Initial Submission De Novo (3rd year) If De Novo, IACUC Number: Duration: Start and End Dates Q7 Funding Funding Source Funding Level Next section: C. Personnel Training and Experience Information C. Personnel Training and Experience Information There is space for up to 7 personnel. Hence forward, narrative boxes accommodate 200 characters and spaces. Q8 Training: List all personnel, including Primary Investigator(s) Personnel Name (1)

3 Date Occupational He lath Survey Who trained them? Q9 Q10 Add Another Personnel Go to next section: Animal Requirements Training, Experience and Background Personnel Name (2) Date Occupational He lath Survey Who trained them? Q11 Q12 Add Another Personnel Go to next section: Animal Requirements Training, Experience and Background Personnel Name (3) Date Occupational He lath Survey

4 Who trained them? Q13 Q14 Add Another Personnel Go to next section: Animal Requirements Training, Experience and Background Personnel Name (4) Date Occupational He lath Survey Who trained them? Q15 Q16 Add Another Personnel Go to next section: Animal Requirements Training, Experience and Background Personnel Name (5) Date Occupational He lath Survey Who trained them?

5 Q17 Q18 Add Another Personnel Go to next section: Animal Requirements Training, Experience and Background Personnel Name (6) Date Occupational He lath Survey Who trained them? Q19 Q20 Add Another Personnel Go to next section: Animal Requirements Training, Experience and Background Personnel Name (7) Date Occupational He lath Survey Who trained them? Next Section: D. Animal Requirements D. Animal Requirements

6 Pain and Distress Categories: Examples: Q21 Animal Information Common Name1 Genus Species Number of Individuals Sex Age, Weight, Size Are the animals trangenic? Source Pain Category Q22 Q23 Add Another Animal Go to next section: Rationale for Animal Use Animal Information Common Name2 Genus Species Number of Individuals Sex Age, Weight, Size Are the animals trangenic? Source Pain Category

7 Q24 Q25 Add Another Animal Go to next section: Rationale for Animal Use Animal Information Common Name3 Genus Species Number of Individuals Sex Age, Weight, Size Are the animals trangenic? Source Pain Category Q26 Q27 Add Another Animal Go to next section: Rationale for Animal Use Animal Information Common Name4 Genus Species Number of Individuals Sex Age, Weight, Size Are the animals trangenic? Source Pain Category

8 Q28 Q29 Add Another Animal Go to next section: Rationale for Animal Use Animal Information Common Name5 Genus Species Number of Individuals Sex Age, Weight, Size Are the animals trangenic? Source Pain Category Next: Rationale for Animal Use Rationale for Animal Use (the text boxes do not expand; 4000 characters/spacing limit) Q30 (a) Please justify your rationale for animal use Q31 (b) Please justify the appropriateness of the species you intend to use

9 Q32 (c) Please justify the number of animals to be used Q33 (d) Please explain why non-animal models (such as computer simulation, in vitro studies, etc) cannot be used: Next: Transportation and Literary Search Transportation Q34 Describe how animals will be transported, with specific details on the methods, containment and care that will be utilized. Literary Search Q35 Does the protocol unnecessarily duplicate previous experiments? Yes No Include at least two of the databases searched [list the database used, data of the search, date range and keywords used]. Next Section: E. Animal Study Information

10 E. Animal Study Information Q36 (1) Describe the animal housing or holding location, locations where manipulation will be conducted, all equipment needed, and how animals will be cared for during the holding/housing. Q37 Q38 (2) Does this project require any permit (such as Maine Dept. of Inland Fisheries and Wildlife Scientific Collection Permit)? Yes No Permits Permits Required1 Permitting Agency Which species or circumstances require permits? Under whose name is the permit held? Date that permit was obtained? Q39 Permits, if applicable Per mist Required2 Permitting Agency Which species or circumstances require permits?

11 Under whose name is the permit held? Date that permit was obtained? E. Animal Study Information, cont Q40 (3) Does the study: a) Involve an invasive procedure? b) Harm the animal in any way? c) Materially alter the behavior of the animal? Yes No Q41 (4) Does the study involve an Endangered or Protected Species? Yes No If yes, provide justification Q42 (5) Provide a Detailed Description of the Safeguards in Place for: Zoonotic Disease Environmental Hazards Equipment Hazards Other Hazards applicable to this study E. Animal Study Information, cont

12 Q43 (6) Study objective: Explain the purpose of this study, including why it is important to human or animal health, the advancement of knowledge, or the good of society. Q44 (7) Experimental Design and Animal Procedures: Explain the experimental design and all animal procedures. This description should allow the IACUC to understand the experimental course of an animal from beginning to end. Q45 (8) Method of Anesthesia and/or Analgesia: Specify the anesthetics and analgesics that will be used, including the name of the agent(s), the dosage, route of administration, and whether it a DEA controlled substance. Q46 (9) Method of Euthanasia: Detail the proposed method of euthanasia, including whether it is consistent with the AVMA guidelines, the dosage and route of administration (if using a chemical agent), the taken on properly performing the euthanasia, and method of carcass disposal. Q47 (10) Chemicals and Other Materials: Have all research personnel listed in Section C reviewed the Material Safety Data Sheets for all chemical or biological agents used, and do they understand the appropriate safety precautions and first -aid procedures? Yes No

13 Last Section: F. PRINCIPAL INVESTIGATOR CERTIFICATIONS AND AGREEMENT F. PRINCIPAL INVESTIGATOR CERTIFICATIONS AND AGREEMENT (1) I certify that I have determined that the research proposed herein is not unnecessarily duplicative of previously reported research. (2) I certify that the individuals listed as research personnel are authorized to conduct procedures involving animals under this proposal, will participate in the USM Occupational Health and Safety program, have attended the institutionally required investigator course, and received in: the biology, handling, and care of this species; aseptic surgical methods and techniques (if necessary); the concept, availability, and use of research or testing methods that limit the use of animals or minimize distress; the proper use of anesthetics, analgesics, and tranquilizers (if necessary); and procedures for reporting animal welfare concerns. (3) I certify that I have reviewed the pertinent scientific literature and the sources and/or databases as noted above and have found no valid alternative to any procedures described herein which may cause more than momentary pain or distress, whether it is relieved or not. (4) I certify that I will obtain approval from the IACUC before initiating any changes in this study. (5) I certify that I will notify the IACUC regarding any unexpected study results that impact the animals. Any unanticipated pain or distress, morbidity or mortality will be reported to the attending veterinarian and the IACUC. (6) I certify that I am familiar with and will comply with all pertinent institutional, state, and federal laws and policies. Q48 By checking the box below, I, the Faculty Instructor named above, accepts responsibility for the ethical conduct of students conducting the classroom projects described above. I understand that if it is determined that individual student projects constitute research involving human subjects, or will be used for thesis or Thinking Matters students will be REQUIRED to submit a formal application for review with the ORIO or IRB. The USM Assurance for the Protection of Human Subjects prohibits the start of any research involving human subjects (including recruitment of subjects) that has not been reviewed and approved or exempted by the IRB or its designee. I agree