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Flashcards in PHS questions Deck (25)
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Health Research Extension Act of _____



Responsibilities of Animal Care Committees under Health Research Extension Act

- review program at least semiannually
- keep appropriate records
- file with the director of NIH at least annually: certification that the review has been conducted, report violations to guidelines, assurances
- Include minority views


requirements for an Assurance

- applicant meets the requirements of this Act
- Facility has a animal care committee
- Personnel have training available to them


who has the power to suspend or revoke grants or contracts if animal care, treatment, and use does not meed quidelies and the entity does not correct problems?

Director of NIH


Who published the US Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, REsearch and Training?

Interagency Research Animal Committee


What are the US Government Principles

1) transportation in accordance with AWA
2) reserach is relevant to human or animal health
3) species and animal numbers are appropriate
4) avoidance or minimization of discomfort, distress, and pain
5) appropriate sedation, analgesia, or anesthesia
6) euth animals in severe or chronic pain or distress
7) living conditions are appropriate
8) personnel are appropriately qualified
9) exceptions are approved by IACUC


definition of animal under PHS policy

live, vertebrate animal


List the 8 organizations under PHS agencies

1) Agency for Health Care Research and Quality
2) Agency for Toxic substances and disease registry
3) CDC
4) FDA
5) Health Resources and Services Administration
6) Indian Health Service
7) NIH
8) Substance Abuse and Mental Health Services Administration


definition of field study under PHS

actvity alters or influences the activities of the animals that are being studied. (ie anything other than observational, photographs, collection of feces, etc)


definition of animal facility and satellite facility

any and all buildings, rooms or areas that are used for animal confinement, maintenance. Area outside of the core where animals are kept for >24hrs


definition of Institutional Official

has the authority to sign the institutions assurance, has the authority to commit to the assurance on behalf of the institution


What 9 things must be included in the Assurance program description

1) list of every branch and major component of the institution
2) lines of authority and responsibility for administering the program
3) qualifications, authority, and responsibility of the veterinarian and the percent of time each will contribute to the program
4) the membership list of the IACUC
5) procedures which the IACUC will follow to fulfill the requirements
6) health program for personnel who work with laboratory animals
7) synopsis of training or instruction in the humane practice of animal care and use
8) gross square footage of each animal facility (including satellite facilities), species housed, and average daily inventory
9) any other pertinent information requested by OLAW


What is a Category 1 institution

all of the institutions programs and facilities are accredited by AAALAC, and all facilities have been evaluated by the IACUC and will be reevaluated by the IACUC at lease once every six months


What is a Category 2 institution

evaluated by the institution. All of the institutions programs and facilities for activities involving animals have been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months. ie not all programs are AAALAC accredited


Who appoints the IACUC according to the PHS policy

CEO or their designate


Whose names must be inlcuced in the assurance

Chairperson and veterinarian only, rest can use numbers/symbols


what is the required composition of the IACUC under PHS policy?

5 members total
1) DVM with LAM training and has program authority
2) Practicing scientist using research animlas
3) member whose conserns are non-scientific
4) a member who is not affiliated with the institution directly or whose immediate family member is not affiliated with the institution.


List the 8 functions of the IACUC

1) review at least every six months the institutions program
2) inspect animal facilities at least once every 6 months
3) prepare reports of the IACUC evaluations conducted, and submit reports to IO
4) review concerns involving the care and use of animals
5) make recommendations to the IO regarding any aspect of the program
6) review and approve, require modification or withhold approval of PHS conducted activities
7) review and approve, require modification or withhold approval of proposed significant changes to ongoing animal use activities
8) be authorized to suspend an activity involving animals


What must be in the semiannual report to the IO?

1) results of semiannual evaluations
2) nature and extent of the institutions adherence to the Guide and Policy and identify any departures and reasons for each departure
3) distinguish significant deficiencies from minor
4) contain a reasonable and specific plan and schedule for correcting each deficiency


What is required to approve a protocol?

Must be available to all members. Any member may call for FCR but if not, any one member can review the proposal.


what is required to suspend an activity?

reviewed at a convened meeting (quorum present) and a majority of the quorum in favor of suspension


when a protocol is suspended, what are the next steps?

notify and consult with the IO, take corrective action, report these details to OLAW


What must be inlcuded in the annual report to OLAW?

1) any change in accreditation status
2) any change in description of the institutions program
3) any changes in IACUC membership
4) notice of dates of semiannual evaluations
5) minority opinions


Who is responsible for ensuring that employees are appropriately trained and qualified?

the institution


for institutions that do not have an assurance, when should they submit the assurance to OLAW?

upon IACUC approval of those components of the application or proposal