The one big CPIA set exam study guide verified 100%

The one big CPIA set exam study guide verified 100% Name the group that wrote/administers each: 1. Animal Welfare Act 2. PHS Policy 3. The Guide 4. Ag Guide 5. Directive 3216.1 6. Handbook 1200.07 - 1 USDA 2 OLAW 3 National Research Council 4. Federation of Animal Science Societies 5. DOD 6. VA Name the law that provides authority for the following: 1. AWA 2. PHS Policy 3. The Guide 4. Ag Guide - 1. 9 CFR, Statute 7 USC 2. Health Research Extension Act of 1985 3. Required by PHS Policy 4. Endorsed by PHS policy Name the animals covered by each: 1. AWA 2. PHS policy 3. The Guide 4. Ag Guide 5. DoD 6 VA - 1. Any live or dead warm-blooded animals used in research, teaching, testing, experimentation, except birds, rats of the genus "Rattus", mice of the genus "Mus", bred for use in research. 9 CFR 1.1 2. Any live, vertebrate animal used or intended for use in research, research training, experimentation or biological testing or for related purposes. Policy III.A. 3. Any vertebrate animals, ag animal, wildlife, aquatic species, produced or used for research, testing, or teaching Ch. 2 4.Ag animals NOT used for research, testing, or teaching (food/fiber) 5. Any live vertebrate animal including larvae; eggs after hatching; any dead animal that is killed for the purpose of conducting research development testing evaluation, etc 3216.01 Part II 6. Same as PHS Policy. 1200.07 .3.c What are the registration/sign-ups required to comply with each? 1. USDA 2. OLAW 3. DoD/ONR 4. VA - 1. USDA Registration every 3 years with annual inspection and annual report 2. Assurance at least every 5 years, with Annual Report 3.DFARS clause (i.e. will abide by DoD rules), USDA Registration, AAALACi Accreditation 32.16.01 3.2 4. MOU in place (can be standing MOU) Who is the IO under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. VA - 1. The individual authorized to legally commit on behalf of the research facility that requirements will be met. 2. The individual who has authority to and who signs the Assurance (legally committing on behalf of the institution that requirements will be met). 3. Representative of a senior administrator who bears ultimate responsibility for the program, including resource planning and aligning program goals with institution mission 4. VA official responsible for ensuring that the program has resources and support necessary to comply with all regs; point of contact for all regulatory correspondence. Typically the medical director of the VA. Who appoints the IACUC members under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA - 1. CEO 2. CEO; may delegate (per FAQ) 3. Not stated 4. CEO or responsible administrative official of IACUC 5. Most senior official (CEO/commander) 6. Medical Director Describe the minimum IACUC makeup under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA - 1. 3 members, 3 roles (Chair, AV, unaffiliated) 2. 5 members, 4 roles (AV, practicing scientist with animal research experience, nonscientist, unaffiliated) 3. 4 members, 4 roles (Lab animal vet, practicing scientist with animal research experience, nonscientist, unaffiliated), *no more than 3 from the same department* 4. 5 members, 5 roles (Large animal vet, scientist with ag research/teaching experience, animal/dairy/poultry scientist, nonscientist, unaffiliated) 5. 5 members, 4 roles (chair, DVM, nonscientist, nonaffiliated) 6. 5 members, 5 roles (Chair, AV, scientist with research experience, unaffiliated, lay member) *unaffiliated cannot be lay member, Senior admins can't be on IACUC, need 1 member from R&D committee* What is a quorum as defined by each set of regulations? - 1. A majority of voting members What does the PHS policy say about the qualifications of the IACUC chair? - Shouldn't be anyone with a conflict of interest (AV, IO, etc) How often should the IACUC meet under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA - 1. shall conduct continuing reviews of activities regular intervals determined as appropriate by the IACUC but not less than annually (refers to protocols but by extension meetings) 2. shall conduct continuing review...at appropriate intervals as determined by the IACUC (refers to protocols but by extension meetings) 3. As often as necessary to fulfill responsibilities 4. at regular intervals as appropriate 5. Not stated 6. Not stated Describe the allowed use of electronic communications for the IACUC meeting under each set of regulations? 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA - 1. Same as PHS 2. Ok as long as everyone is given notice, everyone has documents prior to meeting, everyone can fully participate in real time; only votes in real time count, need minutes 3. Not specified 4. Ok if in real time and interactive 5. no info 6. no info Describe the semiannual program review and inspection schedule/requirements for each of the following: 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA - 1. Program review and inspections due every 6 months 2. Program review and inspections due every 6 months, written report needed 3. Program review and inspections due at least annually, written report SHOULD be provided to IO 4. Inspections at least twice a year, provide written report to IO 5. No clue, but we were told every 6 mo by someone? 6. written report of semiannual inspections Describe what should be in the semiannual report for the following: 1. USDA 2. PHS Policy 3. The Guide 4. Ag Guide 5. DoD 6. VA - 1: Semiannual inspection findings with deficiency correction timetable, program review findings, departures from title 9 (?) 2. Semiannual deficiencies and correction schedule/plan, departures from the guide 3. Report of semiannual findings 4. Report regarding compliance with the guide 5. n/a 6. n/a Under the USDA regulations, how long to institutions have to report failure to correct significant deficiencies? - 15 days- to APHIS and funding sources What needs to be in the written annual report according to the USDA vs PHS? - 1. assurance of accep