Updates and Reminders
The latest insights from the AALAS National Meeting 2022 focusing on VA Programs of Research with Animals. Dive into the significance of signatures, JIT processing in eRA, certifications, and more key topics discussed during the event. Gain valuable information about IACUC approvals, SOP development, and protocol evaluations. Stay informed about crucial aspects in animal subjects research and the upcoming AVAVMO/VMU meeting.
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AALAS National Meeting 2022 VA Programs of Research with Animals 25 October 2022 Updates and Reminders What s All the Fuss About Signatures? Alice Huang, ScB, PhD Deputy for IACUC Guidance Office of the CVMO Alice.Huang@va.gov
Not Just Hassle What s the Point? What s the Timing? What Counts? 25 October 2022 2 AVAVMO/VMU meeting at AALAS National Meeting
JIT Processing in eRA Animal Subjects Research Review NOTHING to submit directly into eRA for this JIT area Keep in touch with the people managing eRA for your station Email me the IACUC-approved protocol When the secondary review process is complete, I will approve the JIT area in eRA 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 3
ACORP Item Z Certifications Main Body Appendix 1 (local) Appendix 2 (antibodies) Appendix 3 (biosafety) Appendix 4 (antemortem samples) Appendix 5 (surgery) Appendix 6 (special procedures) Appendix 7 (patient care equipment or spaces) Appendix 8 (explosives) Appendix 9 (departures) 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 4
Item Z.1 Main Body Certification by PI I certify that this ACORP is complete and accurate, and the work will be performed as described and approved Certification by AV and Chair We certify that we, with the IACUC, have evaluated this ACORP The IACUC has approved the protocol Written minority opinions are included 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 5
Appendix 3 Biosafety PI , AV, and Chair We certify that SOPs will be developed and approved All personnel will be informed of possible risks and properly trained Biosafety Official I certify that each agent has been properly identified use of each of the agents .. is documented as required in Appendix 3 use of each of these agents have been approved Radiation Safety Official I certify that (For radioactive agents) 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 6
Needing More Than Just IACUC Approval Sequential or parallel processes OK Each committee can only approve what it oversees Signatures on ACORP help to document that all approvals are in place before work begins Establish consistent local policy/procedures You ve Been Approved to Wait (Lab Animal 9/2022) https://www.nature.com/articles/s41684-022-01036-6 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 7
Appendix 5 Surgery Certification by PI Work will be done as approved Contact information for research staff will be available to VMU staff Appropriate post-op medical records to be maintained Animal IDs Daily post-op documentation for each animal All meds and treatments For the duration of post-op period Signature or initials of author 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 8
Appendix 7 Patient Care Equipment/Space Certification by PI work will be done as approved Certification of approval for patient care equipment to be moved to space where work is done with animals and used for animals IACUC Chair Whoever is responsible for the equipment Certification of approval to use equipment in patient care space IACUC Chair AV Whoever is responsible for the safety of the space for patients 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 9
Appendix 8 Explosive Agents PI Certification Work will be done as approved Appropriate precautions will be taken Certification of approval to use explosive agents IACUC Chair AV Facility Safety Officer ACOS/R&D (VISN Regional Safety Officer) 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 10
ACORP Item Z Certifications PI, Chair, AV Main Body Appendix 1 (local) Appendix 2 (antibodies) Appendix 3 (biosafety) Appendix 4 (antemortem samples) Appendix 5 (surgery) Appendix 6 (special procedures) Appendix 7 (patient care equipment or spaces) PI, Chair, AV PI, Chair, AV PI Appendix 8 (explosives) Appendix 9 (departures) PI, Chair, AV 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 11
Not Just Hassle What s the Point? What s the Timing? What Counts? 25 October 2022 12 AVAVMO/VMU meeting at AALAS National Meeting
Valid Signatures Wet scanned Digital per VA Handbook 6510, "a specific electronic signature technology that allows the recipient to prove the origin of the document and to protect against forgery." On clearly identified pages 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 13
ACORP What s the Point? Document agreement with the certification statements What s the Timing? Before work begins, after IACUC grants approval What Counts? Verifiable, hard to forge, associated with the certification statements 25 October 2022 14 AVAVMO/VMU meeting at AALAS National Meeting
USDA APHIS Annual Report What s the Point? Certifies that the numbers and Assurance statements are true What s the Timing? After form is filled out What Counts? Online submission by eAuthorized personnel with access code 25 October 2022 15 AVAVMO/VMU meeting at AALAS National Meeting
Reporting Noncompliance What s the Point? Signature certifies that report documents what IACUC determined happened and requires as corrective action What s the Timing? After report is complete What Counts? Verifiable, hard to forge, associated with the report 25 October 2022 16 AVAVMO/VMU meeting at AALAS National Meeting
Preliminary Notification of Potential Noncompliance What s the Point? Heads up for CVMO office to be able to respond to inquiries What s the Timing? As soon as it would be useful What Counts? No signature required anyone known by CVMO office to be part of the local program 25 October 2022 17 AVAVMO/VMU meeting at AALAS National Meeting
1200.07 Current version: VHA Handbook 1200.07 (23 November 2011) Next version: VHA Directive 1200.07 (now in pre-concurrence) Directive specific to enforceable policy established by this document Companion Guidance to provide integrated guidance on implementation 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 18
For More Information Slides will be posted at https://www.research.va.gov/programs/animal_res earch/meetings.cfm Email me at Alice.Huang@va.gov Questions? 25 October 2022AVAVMO/VMU meeting at AALAS National Meeting 19
