Chapter 2 - Program Oversight Flashcards
What is the IACUC’s responsibility?
Oversee and routinely evaluate the Program
Who’s responsibility is it to provide suitable orientation, background materials, access to appropriate resources, and specific training (if necessary) to assist IACUC members in understanding their roles and responsibilities?
Institution
IACUC Committee membership must include:
- DVM either certified or with training and experience in lab animal science and medicine or in the use of the species.
- One practicing scientist experienced in research with animals
- One member with a nonscientific background drawn from inside or outside the institution
- Public member to represent general community interests
Public members SHOULD not be what? Can they be compensated?
Should not be a lab animal user, affiliated with the institution, or members of the immediate family of a person affiliated with the institution. May receive compensation for participation and ancillary expenses, but amount SHOULD be sufficiently modest that it does not become a substantial source of income and thus risk compromising the member’s association with the community and public at large.
No more than how many vomiting members SHOULD be associated with a single administrative unit? What determines the number of members of the committee and their terms of appointment?
- Size of institution and nature and extent of Program
What do the oversight functions of the IACUC include?
- Review and approval of proposed animal use and of proposed significant changes
- Regular inspection of facilities and animal use areas
- Regular review of Program
- Ongoing assessment of animal care and use
- Establishment of mechanism for receipt and review of concerns involving the care and use of animals at the institution
How often MUST the committee mee? What SHOULD be retained?
MUST meet as often as necessary to fulfill its responsibilities. Records of committee meetings and results of deliberations should be maintained.
How often SHOULD program review and facilities inspections occur? What SHOULD be provided afterwards and to who?
Should occur at least annually, or more often as required by other policies. Written report (including minority views) should be provided to the IO about status of the Program.
What topics SHOULD be considered in preparation of a protocol by the researcher and its review by the IACUC?
- Rationale and purpose of proposed animals
- Sequential description of procedures involving the use of animals
- Availability or appropriateness of the use of less invasive procedures, other species, isolated organ prep, cell or tissue culture, or computer stimulation
- Justification of species and number proposed, with statistical justification when possible
- Unnecessary duplication
- Nonstandard housing and husbandry requirements
- Impact of proposed procedures on animals’ well-being
- Appropriate sedation, analgesia, and anesthesia
- Conduct of surgical procedures, including multiple operative procedures
- Postprocedural care and observation
- Description and rationale for anticipated or selected endpoints
- Criteria and process for timely intervention, removal from study, or euthanasia if painful or stressful outcomes are anticipated
- Method of euthanasia or disposition of animals, including planning for care of long-lived species after study completion
- Adequacy of training and experience of personnel in the procedures used and roles of responsibilities
- Use of hazardous materials and provision of safe working environment
SHOULD IACUC evaluate the scientific merit of the protocol? What outside source may be necessary? What can IACUC request?
Scientific merit review normally lies outside the IACUC, but committee members should evaluate scientific elements of the protocol as they related to welfare and use of animals. For certain questions, input from outside experts may ne necessary. In the absence of evidence of a formal scientific merit review, IACUC may consider conducting or requesting such a review.
What MUST IACUC members named in protocols or those with conflicts do?
Recuse themselves from decisions concerning these protocols.
What SHOULD be done with procedures that have not been previously encountered or have the potential to cause pain or distress that cannot be reliably predicted or controlled? What can be proposed and what do they evaluate?
Relevant objective information should be sought. If little is known, limited pilot studies designed to assess the procedure’s effect on animals and the skills of the research team and conducted under IACUC oversight are appropriate.
What protocols may require special consideration during the IACUC review process?
Those with unrelieved pain or distress or other animal welfare concerns.
IACUC is obligated to weight what in evaluating studies?
Weigh objectives of study against potential animal welfare concerns.
What is an experimental endpoint? A humane endpoint?
Experimental - When the scientific aims and objectives have been reached.
Humane - Point at which pain or distress in an experimental animal is prevented, terminated, or relieved
Humane endpoints SHOULD be:
Relevant and reliable, humane and scientifically sound
Which studies commonly require special considerations of their endpoints?
Tumor models, infectious diseases, vaccine challenge, pain modeling, trauma, production of monoclonal antibodies, assessment of toxicologic effects, organ or system failure, and models of cardiovascular shock.
Determination of humane endpoints SHOULD include what people and SHOULD be defined when?
PI, vet, and IACUC. Should be defined when possible before start of study
What information is critical to the IACUC’s assessment of appropriate endpoint criteria?
Precise definition of the humane endpoint, frequency of observation, training of personnel for assessment and recognition, and response required on reaching endpoint
What three factors can aid the PI and IACUC when considering or developing proposed endpoints?
- Understanding of preemptive euthanasia
- Behavioral or physiologic definitions of the moribund state
- Use of study-specific animal assessment records
When information for an alternative endpoint is lacking, what can be performed? What should occur during and after this period?
Pilot study. System for communication to IACUC should be in place both during and after such studies
Why could GMAs have an increased monitoring?
Inherent potential for unanticipated phenotypes, which could result in unexpected outcomes.
What MUST be weighted when considering human endpoints?
- Model
- Species (Sometimes strain or stock)
- Animal health status
- Study objectives
- Institutional policy
- Regulatory requirements
- Scientific literature
What SHOULD occur with the first offspring of a newly generated GMA line? What SHOULD happen if something is noted?
Carefully observed from birth into early adulthood for signs of disease, pain, or distress. When initial characterization of a GMA reveals a condition that negatively affects animal well-being, this SHOULD be reported to the IACUC and more extensive analysis may be required.
What is physical restraint?
Use of manual or mechanical means to limit some or all of an animal’s normal movement for the purpose of examination, collection of samples, drug administration, therapy, or experimental manipulation.
Restraint devices SHOULD be suitable in size, design, and operation for what?
To minimize discomfort, pain, distress, and the potential for injury to the animal and research staff.
Prolonged restraint, including chairing of nonhuman primates, SHOULD be avoided unless:
It is essential for achieving research objectives and is specifically approved by the IACUC.
