Subpart 2C - Research Facilities Flashcards
Which research facilities must register? Who do they register with? Who is the form provided and filed by?
Each research facility, other than a Federal research facility. Registers with Secretary. Form furnished by DA and filed with DA.
When a school or department of a university or college uses live animals for research, tests, experiments, or teaching, what is considered the research facility? What is an exception? Who must sign the registration form?
University or college, instead of the school or department, is considered the research facility. Except in cases in which a school or department of a university or college demonstrates to the Secretary that it is a separate legal entity and its operations are independent. Official who has legal authority to bind the parent organization signs the registration form.
Does the subsidiary of a business corporation or the parent company register? Exception?
Subsidiary registers, unless the subsidiary is under such direct control of the parent corporation that the Secretary determines that it is necessary that the parent corporation be registered to effectuate the purposes of the act.
How do research facilities acknowledge regulations and standards?
APHIS supplies a copy with each registration form. Research facility acknowledges receipt and agrees to comply with regulations and standards by signing a from and filing it with the DA.
How many days does a research facility have to notify the DA in writing of any change in the name, address, or ownership, or other change in operations affecting its status as a research facility?
10 days after making such change.
What are the two ways in which a registration can be cancelled?
- Written request by research facility to DA.
- DA has sufficient evidence showing that a research facility has ceased to function, can cancel registration on their own without a written request from the facility.
If a research facility plans to resume regulated activity, it must re-register at least how many days prior to resuming work? What is the fee?
10 days prior. No fee.
Who appoints the IACUC?
CEO
IACUC membership must include how many people? What makeup?
At least a Chairman and two additional members. One must be a vet with training or experience on LAM who has direct or delegated program responsibility for activities involving animals at the research facility. At least one must be unaffiliated with the facility, including being an immediate family of a person affiliated with the facility, and represent general community interest.
If the Committee consists of more than three members, not more than how many shall be from the same administrative unit?
Three
How often must the IACUC review the research facility’s program for humane care and use of animals? Inspect all aspect of the research facility’s animal facilities, including animal study areas? What is excluded in inspecting animal study areas? What must the IACUC do with this information?
At least once every 6 months. Excludes free-living wild animals in their natural habitats. Must prepare reports of its evaluations and submit the reports to the IO of the research facility.
Who decides the best means of conducting evaluations of the research facility’s programs and facilities?
IACUC
Can the IACUC exclude members from participating in any inspection? How many members must go on inspections? What additional people can join? Who remains responsible for inspections?
No. Subcommittees of at least two Committee members and may invite ad hoc consultants. IACUC remains responsible.
Who must signs IACUC reports? What must the report include?
Signed by a majority of IACUC members and include any minority views.
How often are the reports updated? Who maintains the reports? To who must they be available.
At least once every 6 months upon completion of the semiannual evaluations. Reports maintained by research facility and made available to APHIS and officials of funding Federal agencies for inspection and copying upon request.
The report must describe what?
The nature and extent of the research facility’s adherence to this subchapter. Must identify specifically and departures from Act and state the reason for each departure. Must distinguish sig. deficiencies from minor.
What is a significant deficiency?
One that, in the judgement of the IACUC and IO, is or may be a threat to the health of safety of the animals.
If program or facility deficiencies are noted, the report must contain what? What if this fails?
A reasonable and specific plan and schedule with dates for correcting each deficiency. Any failure to adhere to the schedule that results in a sig deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC, through the IO, to APHIS and any Federal agency funding that activity.
Which group makes recommendations to the IO regarding any aspect of the research facility’s animal program, facilities, or personnel training?
IACUC
What are the three outcomes of protocol proposal or proposed sig changes?
Approve, require modifications in to secure approval, or withhold approval
In order to approve proposed activities or proposed sig. changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this Act except for:
Field studies
IACUCs reviewing proposed activities or sig. changes in ongoing activities must determine that they meet what requirements regarding pain and euthanasia?
- Procedures involving animals will avoid pain or minimize discomfort, distress, and pain to animals
- PI has considered alternative to procedures that may cause more than momentary or slight pain or distress and has provided a written narrative of the methods and sources used to determine no alternatives
- Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved with euthanized after or during procedure
- Methods of euthanasia used must meet requirements in Act, unless a deviation is justified for scientific reasons, in writing, by investigator
What are the requirements for surgical procedures? Survival? Major? Non-major? Field sites?
Activities involving surgery include appropriate pre- and post-op care in accordance with established vet med and nursing practices. All survival surgery performed using aseptic procedures, including sterile gloves, masks, sterile instruments, and aseptic techniques. Major operative procedures on animals other than rodents and birds conducted only in facilities intended for that purpose which shall be maintained under aseptic conditions. Non-major and all surgery on rodents and birds do not require a dedicated facility, but must be aseptic. Field site procedures need not be performed in dedicated facilities, but must be performed using aseptic procedures.
In what situation may an animal undergo more than one major operative procedure from which it is allowed to recover?
Justified for scientific reasons, in writing, by PI
Required as routine vet procedure or to protect health and well-being or animal as determined by AV
In special circumstances as determined by Administrator on individual basis. Written requests and supporting data sent to APHIS
What must the IACUC ensure is covered in proposed or sig. changes to approved protocols regarding housing, veterinary care, training, and duplication of work?
Animals living conditions will be appropriate for their species and contribute to health and comfort. Housing, feeding, and nonmedical care will be directed by AV or other scientist trained and experienced in proper care, handling, and use of species. Medical care for animals will be available and provided as necessary by a qualified vet
Personnel conducting procedures will be appropriately qualified and trained in those procedures
PI has provided written assurance that the activities do not unnecessarily duplicate previous experiments
If procedures will cause more than momentary or slight pain or distress to the animal, what must occur?
- Be performed with appropriate sedatives, analgesics, or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, and will continue for only the necessary period of time; 2. Involve in their planning, consultation with the AV or their designee; 3. Not includes the use of paralytics w/o anesthesia
What must be provided to all members of the IACUC prior to review?
A list of proposed activities to be reviewed. Written descriptions of all proposed activities that involve the care and use of animals available to all IACUC members.
What members of the IACUC can call a protocol to FCR?
Any member of IACUC
If a protocol is not called to FCR, who reviews the protocol? What do they have the authority to do?
At least one member of the IACUC, designated by the chairman, and qualified. Authority to approve, require modifications in, or request FCR
What occurs if FCR is requested after an initial DMR?
Approval of activity may be granted only after review at a convened meeting of a quorum of the IACUC, and with the approval vote of a majority of the quorum present.
How can members of the IACUC with conflicts not participate in review of an activity? How can they?
Cannot review or approve of an activity or contribute to the constitution of a quorum. Can provide information requested by the IACUC.
Can consultants assist in the review of proposed activities?
Yes, but they may not approve or withhold approval or vote (unless they are also members of the IACUC)
Who and how does the IACUC notify regarding decisions to approve or withhold approval for protocols? If the IACUC withholds approval, what does it include in its written notice?
Notifies PI and research facility in writing. If withheld, includes in written notice the reason for decision and vies PI an opportunity to respond in person or writing. IACUC may reconsider decision.
How often shall the IACUC conduct complete reviews of activities? What should the IACUC be provided at the end of the term?
At appropriate intervals as determined by IACUC, but not less than every 3 years. IACUC provided a written description of all activities that involve the care and use of animals for review and approval at the end of the term.
