Institutional Annual Reporting Requirements

Transcription

1 Institutional Annual Reporting Requirements ANNA HAMPTON DVM, DACLAM, CPIA ASSOCIATE DIRECTOR DUKE UNIVERSITY OFFICE OF ANIMAL WELFARE ASSURANCE What is required? Are you USDA Registered? Are you PHS Assured? Are you AAALAC International Accredited? What is required? Are you USDA Registered? Are you PHS Assured? Are you AAALAC International Accredited? An annual report is required for each of these now lets look at the details 1

2 Animal Welfare Act What: All research registrants must file an Annual Report of Research Facility (APHIS Form 7023 and 7023A) Where: Animal Care Regional Office When Report period is fiscal year (October 1 September 30) Due date is December 1 Who Did not hold or use animals? YES Registration terminated or canceled? YES Let s look at the report 2

3 The simple stuff 1-3 The meat and potatoes USDA Covered Species Live or dead dog, cat, NHP, guinea pig, hamster, rabbit, or any other warm blooded animal which is being used. Dog: all dogs including hunting, security, or breeding Use common names on form EXCLUDES Birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research Horses not used for research Other farm animals used in agriculture research (food, fiber, animal nutrition, breeding, management, or production) 3

4 USDA Pain and Distress Categories Category B* Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used... NOTE: These are not counted in F Category C Animals upon which teaching, research, experiments, or test were conducted involving no pain, distress, or use of pain-relieving drugs Category D Animals upon which teaching, research, experiments, or test were conducted involving accompanying pain or distress to the animal for which appropriate anesthetics, analgesics, or tranquilizing drugs were used Category E** Animals upon which teaching, research, experiments, or test were conducted involving accompanying pain or distress to the animal for which appropriate anesthetics, analgesics, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the activity Category F: Total number of animals USED *Category B Not counted in Category F, total number USED Count if They were on the census on September 30 th of fiscal year They were held but died during the fiscal year NOTE: Euthanasia is USE Breeding colonies: Breeding animals and offspring NOTE: Genotyping is USE Animals present at facility used in the previous years but not used in the current year (retired) Don t count if Not on your facility September 30 th and didn t die at your facility The facility which POSSESSES them on September 30 th reports them Category C, D, and E ALL used reported, even if they are no longer at the facility Reported every year Reported in the highest category of use for that year 4

5 Registration number Number of animal used Species (common name) Description/explanation/ purpose of study Scientific or regulatory justification for withholding analgesics, anesthetics, or tranquilizing drugs Federal regulation that required this procedure: Agency, CFR number, and section number **Category E Assurance Statement 1) The facility cared for the animals appropriately 2) Each PI considered alternatives to painful procedures 3) The facility is following the AWA (AWA, AC Policies, etc.) and any exceptions to standards and regulations were explained and approved by the IACUC* 4) The attending vet has appropriate authority to care for animals 3) There is always a * Any exceptions to standards and regulations were explained and approved by the IACUC.* Include a summary of The IACUC approved exceptions Brief explanation of the exception Species Number of animals affected 5

6 The go to jail person USDA Annual Report the other items Only one report can be submitted per facility Animals used in more than one protocol are counted in the most painful/distressful category Report wild rodents Do not report lab rats, lab mice, birds, reptiles or other exempt animals Category E: Death as an endpoint or LDxx studies must be well documented and justified 6

7 OLAW What: All facilities with a PHS Assurance Where: Office of Laboratory Animal Welfare When Report period is the calendar year (January 1 December 31st) Due date is January 31st Annual Report to OLAW: Section 1 Program Changes Yes or no Need to look at Assurance and select the appropriate change AAALAC accreditation Program for animal care and use I.O. IACUC membership Annual Report to OLAW: Section 2-3 Section 2: Semiannual evaluations This one is easy Program evaluation dates Facility inspections dates Assurance that reports of evaluation and inspections have been submitted to the I.O. with departures form the Guide and reason, deficiencies (significant or minor) identified, and plan for correction Section 3: Minority Views IACUC reports and recommendations If there were any, attach them 7

8 Annual Report to OLAW: Section 4-5 Section 4: Signatures IACUC Chairperson I.O. Section 5: Change in I.O. Section 6: Change in IACUC membership Annual Report to OLAW: Section 6 Change in IACUC membership Name or code Degree/credential Position title/occupational background PHS policy membership requirements Who must be named? Chairperson DVM IACUC Requirements Health Research Extension Act of 1985 DVM Non-affiliated Minimum number? Three PHS Policy DVM (with training and experience with direct or delegated authority), Scientist (Practicing with animal research experience), Non-scientist (concerns are non-scientific), and Non-affiliated (cannot be immediate family) Minimum number? Five Guide DVM (with training and experience with direct or delegated authority), Scientist (Practicing with animal research experience), Non-scientist (concerns are non-scientific), and Non-affiliated (cannot be immediate family) Minimum number? Five AWA/AWR Attending Veterinarian or delegate, Non-affiliated, and Chairman Minimum number? Three 8

9 AAALAC What: All AAALAC International accredited facilities Where: Animal Care Regional Office When Reporting period: You pick (USDA or calendar year is encouraged). Must include an entire year. Due date: You pick Why? AALAC uses this information to maintain records between AAALAC site visits What do they want to know? 1. AAALAC contact person at the facility 2. I.O. information 3. Attending veterinarian information 4. IACUC Chairperson 5. Animal support areas information Building number Outdoor areas Total square footage Number of sites 9

10 What do they want to know? 6. Addition and deletion of use areas 7. Plan to phase in 8 th edition of the Guide (Sept. 1, 2014) 8. SFI update 9. Changes in organizational structure 10. Suspended protocols and reason 11. Adverse events Investigations by national oversight bodies and/or serious incidents or concerns identified by them that negatively impact animal wellbeing (AAALAC should be promptly notified, this is a clean-up), with details Self identified serious deviations (care and use program or policies) with details Items reported to OLAW What do they want to know? 12. Approximate animal numbers Used What animals? All vertebrate animals consider non-vertebrates Random source dogs Random source cats 13. Key personnel changes 14. Others are just questionnaires name posted, comments, area of expertise 10

11 Question 1 The OLAW Assurance Annual Report includes reporting all but A. Minority views of IACUC members B. Dates that the Animal Care and Use Program was reviewed by the IACUC C. Number and species of vertebrate animals used D. Changes in the IACUC Chairperson Question 2 What is the reporting period for the USDA Annual Report? A. January 1st December 31 st B. October 1 st September 30 th C. You get to pick as long as it is a year Question 3 Which animals would need to be included in your USDA annual report? A. Field study to collect bear feces from the ground at national parks B. Client owned dogs being used in a non-invasive behavioral study C. Wild caught mice placed in a fenced University preserve to see where they go D. Non-human primates housed at another USDA registered facility but supported solely by a PI at your facility 11

12 Question 4 Protocol suspensions should be report on A. The USDA Annual Report B. The OLAW Annual Report C. The AAALAC Annual Report D. All E. None Question 5 You own a biotech that only uses laboratory mice to test novel compounds. You receive no external funding and are not AAALAC accredited. Who must be in your IACUC A. A veterinarian B. A non-affiliated member C. A non-scientist D. A scientist E. None of the above Question 6 Who must be identified by name on the OLAW Annual Report? A. The I.O. B. The Veterinarian C. The IACUC Chair D. All of the above 12

13 Question 7 If an institution reports on their OLAW Annual Report that their AAALAC status has changed form accredited to non-accredited, what else should they do? A. Nothing you have reported it B. Provide a detailed description as to why you no longer are accredited and your plan to be reaccredited C. Submit the most recent semiannual report of the IACUC evaluation D. File for renewal of your OLAW assurance Question 8 A researcher tags sharks with radio transmitters off the cost of North Carolina and Mexico. Over the last reporting year he has tagged 4 sharks in NC and 8 sharks in Mexico. How many should you report on your USDA report? none Question 9 A researcher tags dolphins with radio transmitters off the cost of North Carolina and Mexico. Over the last reporting year he has tagged 4 dolphins in NC and 8 dolphins in Mexico. How many should you report on your USDA report? none 13

14 Question 10 A researcher tags dolphins with radio transmitters off the cost of North Carolina and Mexico. Over the last reporting year he has tagged 4 dolphins in the international waters off NC and 8 dolphins in Mexico. How many should you report on your USDA report? none Question 11 A PI used a rabbit in a surgical procedure in January 2012, since then the rabbit has not be used or bred and is now considered the lab pet (housed in the vivarium of course). How should this rabbit be reported this year. A. 1 animal in category B B. 1 animal in category C C. 1 animal in category D D. 1 animal in category E E. Not reported Question 12 A PI used a rabbit in a surgical procedure in January 2012, since then the rabbit has not be used or bred and is now considered the lab pet (housed in the vivarium of course). The rabbit was given to another facility on June 15 th, How should this rabbit be reported this year. A. 1 animal in category B B. 1 animal in category C C. 1 animal in category D D. 1 animal in category E E. Not reported 14

15 Question 13 A PI used a rabbit in a surgical procedure in January 2012, since then the rabbit has not be used or bred and is now considered the lab pet (housed in the vivarium of course), but they say they took blood to be a control. A. 1 animal in category B B. 1 animal in category C C. 1 animal in category D D. 1 animal in category E E. Not reported 15