PHS policy Flashcards
What act established the PHS policy?
Health Research Extension Act
When was the Health Research Extension Act passed?
1985
How many IACUC members required by Health Research Extension Act?
3
What IACUC members required by Health Research Extension Act?
DVM, unaffiliated member
Responsibilities of the IACUC?
review care and treatment program semiannually, keep records, and file report with the NIH after review
What must be included in the report from the IACUC to the NIH?
(1) minority views from committee members
(2) assurances
(3) reports of violations
(4) certification that review was performed
When can the NIH revoke a grant?
(1) conditions for animal care aren’t met
(2) A notification was given by the NIH Director with an opportunity to make a correction
(3) No correction was made
What is US Govmt Principle I?
Animal use, care, and transport follows Animal Welfare Act
What is US Govmt Principle II?
Animal research is for the good of society
What is US Govmt Principle III?
Appopriate species, number for the results; alternatives considered.
What is US Govmt Principle IV?
Pain or distress in humans = pain or distress in animals
What is US Govmt Principle V?
Give analgesia/anesthesia when indicated.
What is US Govmt Principle VI?
Euthanasia in the face of unalleviated pain or distress
What is US Govmt Principle VII?
Appropriate husbandry directed by a vet
What is US Govmt Principle VIII?
Investigators should be trained
What is US Govmt Principle IX?
IACUC review and approval of procedures
What is US Govmt Principle X?
There is none
Who does PHS policy apply to?
Anyone using PHS money at their institution
What is an animal in the PHS policy?
live vertebrate animal
How long must an animal be housed in a facility before it is considered a satellite facility for PHS?
24 hours
What is required to be given to PHS before any animal work can be conducted?
Assurance
Where are PHS Assurances sent?
To OLAW
Who signs the PHS assurance?
IO
What is the longest period of time for which a PHS Assurance is valid?
5 years
What has to be included in the program description for PHS?
every branch and component of the institution to be included, lines of authority in the program, veterinarians in the program, list of members, procedures IACUC follows, occ health program, synopsis of training, square footage of each facility with animals used there
What is a Category 1 assurance?
Accredited by AAALAC at all facilities and inspected q6mo by the IACUC
What is a Category 2 assurance?
Facilities evaluated by IACUC q6mo
Who appoints the IACUC?
CEO
Number of IACUC members required by PHS Policy?
5
What type of members are required by IACUC policy?
practicing scientist, DVM, unaffiliated member, nonscientist
How often do inspection reports need to be sent from the IACUC to the IO?
Every 6 months after facility inspection and program review
What is a significant/major deficiency?
One that affects animal health or safety
What must be included with a list of deficiencies?
Reasonable and specific plan + schedule for correctign each deficiency
What must be evaluated by the IACUC for each PHS-funded project?
(1) procedures minimize pain/distress/discomfort
(2) appropriate analgesia/anesthesia is used when indicated
(3) euthanasia in the face of unalleviated pain/distress
(4) appropriate husbandry
(5) medical care available and provided by vet
(6) appopriate training
(7) appropriate euthanasia
Who can request full committee review of a protocol?
any IACUC member
When designated member review is used, who chooses the member to review each project?
IACUC chair
How should an investigator be notified of a n IACUC decision?
In writing
What must be provided if the IACUC withholds approval for an activity?
Statement of reasons for decision, investigator has to be given a chance to respond
How often does the IACUC need to do a complete activity review?
At least q3y
How does an IACUC suspend an activity?
Majority vote of a quorum of the committee ; full report must be submitted to OLAW
What has to be included on a PHS activity proposal?
species and number of animals, rational for use, description of use, description of procedures designed to reduce pain/distress, description of euthanasia
How long do records need to be kept?
3 years
What needs to be reported in the Annual Report to OLAW?
change in program/facilities that would change assurance category, change in the description of animal program, changes in IACUC membership, dates that semiannual inspections were performed
What does the IACUC need to promptly report to OLAW?
serious/continuing noncompliance with PHS Policy; serious deviations from the Guide, IACUC suspensions
If an assurance isn’t on file when an application for PHS funding is submitted, how do they get funding?
OLAW negotiates an assurance with the institution before funding is released
Does PHS policy apply to production of custom antibodies?
yes if you provide or request specific antibodies- and whoever you buy them from needs to have them too
Does PHS policy apply to purchase of surgically modified animals?
yes if the surgery was done in response to a request for you
When an awardee has a surgical model created at another facility for use at their home institution, who has the primary responsibility for PHS compliance?
the awardee
Does custom antibody production at another facility need to be on an IACUC protocol?
Yes
Is euthanasia for tissue collection covered by PHS policy?
YEs
Is terminal surgery covered by PHS policy?
Yes
Is use of clinically euthanized rodents for a teaching lab covered by PHS policy?
No- they weren’t specifically manipulated or euthanized for research
When does PHS policy apply to embryonated eggs?
After they hatch- parents must be covered
Are larval amphibians and fish covered by PHS policy?
yes!
What information must be provided to the IACUC for field studies?
where the activity is, what procedures will happen, and how those procedures will affect the biology and ecology of animals; assurance that regs will be followed and permits obtained before the work starts
When does a field study need IACUC approval?
When it alters or influences the activity of study animals or other species in the area
Does PHS policy apply to privately owned animals?
Yes
What are the qualifications for the IACUC DVM position?
direct or deligated program authority and responsibility for animal related activities
If an IACUC member who is in a required position leaves, can they still conduct official business?
No, only when a new member is appointed by the CEO
Can an IACUC alternate represent more than one member?
No
Can more than one IACUC alternate be specified?
Yes, as long as they fulfill the specifci membership requirement
When is an IACUC quorum needed?
To conduct full committee review and to suspend an activity
If there are 5 IACUC members and 4 are present but 2 abstain from a vote, is it still a quorum?
Yes but a majority vote is still needed to pass the item
An IACUC is just barely at quorum and one member recuses themselves due to a conflict of interest. Is the IACUC still at quorum?
No
Can the IACUC suspend an animal activity it didn’t approve?
Yes and it needs to be reported to OLAW as a serious noncompliance
Can the IO unilaterally halt an approved activity?
yes
Can the IO unilaterally approve an activity that hasn’t been approved by the IACUC?
no
Do significant changes that require IACUC approval need to be reported to OLAW?
Not unless the activities were changed prior to IACUC approval
