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Regs > PHS > Flashcards

PHS Flashcards

0
Q

PHS

Who enforces it?

A

OLAW, not regulatory…oversite

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1
Q

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

Minimum standards, principally about dogs

A

1970 animal welfare act

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

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2
Q

What makes up the PHS policy?

A

HREA of 1985
US Gov principles…9
Policy itself

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3
Q

What is the law that mandates the PHS policy?

Who establishes the guidelines governing animal care?

A

HREA

Secretary acting through the director of NIH

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4
Q

Who is the PHS policy applicable to?

A

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

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5
Q

What is the animal definition for PHS?

A

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

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6
Q

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

A

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

Cat 2- not aaalaci accredited, iacuc inspections

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7
Q

How many iacuc members according to HREA and PHS?

A

HREA…3…vet…appointed in writing by CEO

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

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8
Q

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

A

PHS

Significant= threat to health or safety of animals

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9
Q

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

A

24 hours

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10
Q

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

A

CDC, FDA, NIH, BARDA

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11
Q

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

A

The VA

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12
Q

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

A

PHS

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13
Q

Who is the over site body for PHS funded research?

A

OLAW

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14
Q

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

A

State and local laws only

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15
Q

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

A

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

16
Q

What is an animal welfare assurance?

A

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

17
Q

Can animal work start without an assurance in place?

A

No

18
Q

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

A

No

19
Q

What are the 3 types of animal assurances exist?

A

Domestic, inter-institutional, foreign

20
Q

How long is an animal assurance valid for?

A

PHS-up to 5 yr

OLAW- 4 years

21
Q

What is described in a domestic assurance?

A

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

22
Q

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

A

Domestic assurance

Signed by IO

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

23
Q

Why would an inter-institutional assurance be negotiated?

A

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

24
Q

What are the IACUC responsibilities according to PHS?

A

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

25
Q

Is aaalaci accreditation necessary to do PHS funded work?

A

No, the institution can be granted a category 2 assurance

26
Q

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

A

The primary grantee (may be domestic of foreign awardee)

28
Q

How long is a foreign assurance awarded for?

What standards are they held to?

Can foreign institution be a prime awardee?

A

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

28
Q

What is CIOMS and what do they do?

A

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

29
Q

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?

A

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

30
Q

What is grant congruence and who is responsible for it?

A

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

31
Q

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

A

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

32
Q

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

A

Triennial De novo review

33
Q

What is OLAW’s authority of assurances?

A

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

34
Q

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

A

The IO

35
Q

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

A

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

36
Q

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?

A

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

37
Q

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

A

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

Regs (6 decks)

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