PHS questions

Question 1

Health Research Extension Act of _____

Answer 1

1985

Question 2

Responsibilities of Animal Care Committees under Health Research Extension Act

Answer 2

• 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

Question 3

requirements for an Assurance

Answer 3

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

Question 4

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?

Answer 4

Director of NIH

Question 5

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

Answer 5

IRAC

Interagency Research Animal Committee

Question 6

What are the US Government Principles

Answer 6

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

Question 7

definition of animal under PHS policy

Answer 7

live, vertebrate animal

Question 8

List the 8 organizations under PHS agencies

Answer 8

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

Question 9

definition of field study under PHS

Answer 9

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

Question 10

definition of animal facility and satellite facility

Answer 10

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

Question 11

definition of Institutional Official

Answer 11

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

Question 12

What 9 things must be included in the Assurance program description

Answer 12

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

Question 13

What is a Category 1 institution

Answer 13

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

Question 14

What is a Category 2 institution

Answer 14

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

Question 15

Who appoints the IACUC according to the PHS policy

Answer 15

CEO or their designate

Question 16

Whose names must be inlcuced in the assurance

Answer 16

Chairperson and veterinarian only, rest can use numbers/symbols

Question 17

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

Answer 17

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.

Question 18

List the 8 functions of the IACUC

Answer 18

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

Question 19

What must be in the semiannual report to the IO?

Answer 19

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

Question 20

What is required to approve a protocol?

Answer 20

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

Question 21

what is required to suspend an activity?

Answer 21

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

Question 22

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

Answer 22

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

Question 23

What must be inlcuded in the annual report to OLAW?

Answer 23

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

Question 24

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

Answer 24

the institution

Question 25

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

Answer 25

upon IACUC approval of those components of the application or proposal