PHS questions Flashcards
Health Research Extension Act of _____
1985
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?
IRAC
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
