PHS

Question 0

PHS

Who enforces it?

Answer 0

OLAW, not regulatory…oversite

Question 1

The 1966 laboratory animal welfare act was renamed what and when?

Minimum standards, principally about dogs

Answer 1

1970 animal welfare act

Required annual report from research facilities
Defined adequate care
Extended to warm blooded species, exhibition and wholesale pet trade

Question 2

What makes up the PHS policy?

Answer 2

HREA of 1985
US Gov principles…9
Policy itself

Question 3

What is the law that mandates the PHS policy?

Who establishes the guidelines governing animal care?

Answer 3

HREA

Secretary acting through the director of NIH

Question 4

Who is the PHS policy applicable to?

Answer 4

PHS supported research in us
Foreign institutions doing PHS funded work
Individuals doing funded work
Must also comply with local policies and AWA

Question 5

What is the animal definition for PHS?

Answer 5

Live vertebrate used or intended use in research, research training, experimentation or biological testing

Question 6

What are the two categories of assurance by the PHS policy?

Answer 6

Cat 1- aaalaci accredited and iacuc inspected every. 6 mo

Cat 2- not aaalaci accredited, iacuc inspections

Question 7

How many iacuc members according to HREA and PHS?

Answer 7

HREA…3…vet…appointed in writing by CEO

PHS…5…vet, scientist, non-scientist, non-affiliated, may fill more than one role

Question 8

Which regulation requires significant and minor deficiencies (departures from the guide)?

Answer 8

PHS

Significant= threat to health or safety of animals

Question 9

Housing for how many hours outside of the core facility designates a study area as a satellite facility?

Answer 9

24 hours

Question 10

What are the PHS agencies that provide funding for animal research?

Answer 10

CDC, FDA, NIH, BARDA

Question 11

what is the exception..has a PHS assurance even if they have no PHS funding?

Answer 11

The VA

Question 12

The animal is defined as any live vertebrate used or intended for use in research, experimentation, biological testing, research training

Answer 12

PHS

Question 13

Who is the over site body for PHS funded research?

Answer 13

OLAW

Question 14

If a company conducts research using their own money on Mus bred for research, what regulations do they need to comply with?

Answer 14

State and local laws only

Question 15

What are the PHS policy standards for animal care and use?

Answer 15

The Guide, AWA, US gov principles, AVMA guidelines on euthanasia, as applicable by species used

Question 16

What is an animal welfare assurance?

Answer 16

Contract with federal gov, description of the institutional program, documents institutional commitment, principal method for compliance oversight. PHS
Cliff notes if aaalaci program description

Question 17

Can animal work start without an assurance in place?

Answer 17

No

Question 18

Can u get an assurance without a grant? Without being named on the grant?

Answer 18

No

Question 19

What are the 3 types of animal assurances exist?

Answer 19

Domestic, inter-institutional, foreign

Question 20

How long is an animal assurance valid for?

Answer 20

PHS-up to 5 yr

OLAW- 4 years

Question 21

What is described in a domestic assurance?

Answer 21

Iacuc, veterinary care program, facilities, personnel training, implementation of PHS funding, last semi annual inspection if not aaalaci accredited

Question 22

What type of assurance is required if the entity controls its own animal facility and has PHS funding?

Answer 22

Domestic assurance

Signed by IO

Grants management office verifies this is in place prior to giving out $

Question 23

Why would an inter-institutional assurance be negotiated?

Answer 23

Grantee doesn’t have an animal care facility, work will be done at an assured facility (performance site) approved for the life of the grant

Question 24

What are the IACUC responsibilities according to PHS?

Answer 24

Semi annual program evaluation and facility inspection; prepare the reports and submit to IO; investigate AWIs; makes recommendations to the IO about the animal program; facilities, personnel training; review and approve, require modifications to secure approval, or withhold approval of protocols; authorized to suspend animal activities if non compliance with policy

Question 25

Is aaalaci accreditation necessary to do PHS funded work?

Answer 25

No, the institution can be granted a category 2 assurance

Question 26

Who is held responsible for research conducted at a foreign institution?

Answer 26

The primary grantee (may be domestic of foreign awardee)

Question 28

How long is a foreign assurance awarded for? What standards are they held to? Can foreign institution be a prime awardee?

Answer 28

5 years, no renewal unless funding is continued, must meet international guiding principles for biomedical research involving animals (CIOMS) and local laws, not requirement for iacuc approval for a direct award ( prime awardee)...yes they can be a prime awardee

Question 28

What is CIOMS and what do they do?

Answer 28

Council for International Organizations of Medical Sciences; makes international guiding principles for biomedical research involving animals

Question 29

If a domestic primary awardee contracts out work at a foreign institute, what minimal assurances are needed, who is responsible for animal work conducted at the foreign institute, does there need to be an iacuc approved protocol?

Answer 29

Domestic primary awardee needs a domestic or inter-institutional assurance; foreign assurance needed for foreign institute; primary grantee is ultimately responsible and culpable for animal work done no matter where it is done; if the primary grantee is domestic an iacuc approved protocol is necessary; if the primary awardee is the foreign institute no iacuc protocol is required

Question 30

What is grant congruence and who is responsible for it?

Answer 30

Ensuring that what work listed in the grant is covered in the protocol...what is listed must be in the protocol at a minimum or the primary grantee has to pay the money back; primary grantee can approve the over arching protocol... performance sites can use that overarching protocol...create their own...how do u handle institutional differences? Up to the primary grantee

Question 31

Who requests the negotiation of a PHS assurance for a performance site?

Answer 31

Grants Management of PHS will contact OLAW to negotiate the assurance; OLAW will contact the institution

Question 32

How often must projects be reviewed by the IACUC according to PHS?

Answer 32

Triennial De novo review

Question 33

What is OLAW's authority of assurances?

Answer 33

Request, negotiate, approve, disapprove assurance Limit effective period of approval Restrict, condition, or withdraw approval Review, approve, disapprove waivers to PHS policy OLAW is responsible for administration and coordination of PHS policy

Question 34

Who is the person legally responsible for the animals and the use of the PHS grant?

Answer 34

The IO

Question 35

What is the PI responsible for by accepting a PHS grant?

Answer 35

The research, compliance with the animal care and use program, they do sign and accept responsibility for the scientific conduct of the project, must follow all terms and conditions of the grant

Question 36

Are goats used for antibody production covered by PHS? Is an assurance needed if surgery models are produced without pi request...out of a catalog?

Answer 36

Yes-if a specific antigen is used/supplied for specific antibody production only upon the request of the PI No- if antibodies are produced and able to be purchased out of a catalog...produced anyway without PI request Same for surgical manipulations

Question 37

What are the five points to address in the vertebrate animal section (VAS) if a PHS grant application?

Answer 37

Animal info-species, strains, age, sex, # Justification of use, species, and # Veterinary care to include performance site Procedures to minimize pain and distress...limited to that which is unavoidable, description of anesthesia and analgesia Describe methods of euthanasia