Animal Welfare Act for Lab Animal Science

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Questions and Answers

What is the primary duty of the animal welfare officer in the establishment?

  • To manage the finances of the establishment
  • To conduct animal experiments personally
  • To ensure the animals are fed daily
  • To inform about technical and scientific developments (correct)

Which of the following is NOT a requirement for the animal welfare officer's position?

  • To receive regular further training
  • To make suggestions to the competent body
  • To be under direct supervision at all times (correct)
  • To be free from instructions in their duties

Who must be included in the animal welfare committee?

  • Only the scientific members of the establishment
  • The financial officer and administrative staff
  • Consultants from external organizations
  • Animal welfare officers and responsible supervisors (correct)

What is one of the tasks of the animal welfare committee?

<p>To develop programs for animal welfare monitoring (C)</p> Signup and view all the answers

In the animal welfare committee, who holds the position of chair?

<p>The animal welfare officer (C)</p> Signup and view all the answers

What must be included in the application for approval of an experimental project?

<p>A written or electronic submission to the competent authority (B)</p> Signup and view all the answers

Which authority is responsible for authorising animal experiments conducted under institutional auspices?

<p>The competent authority linked to the institution (D)</p> Signup and view all the answers

What is an important aspect of the authorisation procedure mentioned in the content?

<p>It includes regulations on the content of the permit notice (A)</p> Signup and view all the answers

What can be a consequence of changes to the essential facts underlying the approval?

<p>There may be an obligation to notify or approve such changes (C)</p> Signup and view all the answers

Who must carry out the animal experiments if authorized by a university?

<p>Persons employed by the institution or authorized with agreement (D)</p> Signup and view all the answers

What aspect of authorisations can the Federal Ministry regulate?

<p>The limitation of the duration of authorisations (C)</p> Signup and view all the answers

In the animal experiment approval process, what is one responsibility of the competent authority?

<p>To assess with a level of detail appropriate for the trial project (A)</p> Signup and view all the answers

What information is essential regarding the applicant in the experimental project proposal?

<p>Name and address of the applicant (D)</p> Signup and view all the answers

Which of the following is NOT required when describing the experimental project?

<p>Commercial viability of the experiment (A)</p> Signup and view all the answers

What must be detailed about the conduct of the proposed animal experimentation?

<p>Proposed use of anaesthesia or pain relief (A)</p> Signup and view all the answers

What is required if animals are planned to be euthanized during the experimentation?

<p>The procedure to be followed for killing the animals (A)</p> Signup and view all the answers

Which of the following components addresses the welfare of the animals throughout their lifecycle during experimentation?

<p>Measures to alleviate suffering from birth to death (D)</p> Signup and view all the answers

What kind of information regarding the experimental project timeline is necessary?

<p>Date of commencement and expected duration (C)</p> Signup and view all the answers

Which piece of information is required concerning the individuals involved in the experimentation?

<p>The name and qualifications of all individuals involved (B)</p> Signup and view all the answers

What aspect of the experimental design must be included to minimize animal numbers?

<p>Experimental and monitoring strategies, and statistical design (D)</p> Signup and view all the answers

Which factor regarding animal acclimatization is necessary in the proposal?

<p>Planned training programs suitable for the animals (B)</p> Signup and view all the answers

What is the initial time frame for the competent authority to notify the applicant of the result of their examination on the application?

<p>15 working days (A)</p> Signup and view all the answers

Under what conditions can the competent authority extend the initial notification period?

<p>If the examination is complex (B)</p> Signup and view all the answers

What information must be included in the acknowledgement of receipt issued to the applicant?

<p>The timeline for notification of the final decision (A)</p> Signup and view all the answers

Which subsection determines whether a retrospective assessment is performed?

<p>§ 35 (C)</p> Signup and view all the answers

What is the maximum duration for which the competent authority can extend the examination period?

<p>10 working days (A)</p> Signup and view all the answers

What does paragraph 4 mandate the competent authority to check immediately upon receipt of an application?

<p>The completeness of the application (B)</p> Signup and view all the answers

What parameters must be reviewed to determine the examination requirements according to § 8?

<p>Specific letters and numbers in the statute (B)</p> Signup and view all the answers

When must the applicant be notified of any extensions to the application decision period?

<p>By the expiry of the initial period (A)</p> Signup and view all the answers

Which of the following is NOT considered a requirement to assess under § 8 subsection 1?

<p>The applicant's previous experience (C)</p> Signup and view all the answers

What must happen after the competent authority receives an application?

<p>They must provide an acknowledgement of receipt without delay (D)</p> Signup and view all the answers

What is a condition under which primates may be authorized for use in animal experiments?

<p>If it is scientifically established that their use is essential. (D)</p> Signup and view all the answers

Which of the following is NOT a valid purpose for conducting animal experiments with primates?

<p>Studying animal behaviors in non-threatening environments. (C)</p> Signup and view all the answers

What must be scientifically established regarding the purpose of the animal experiment for primates?

<p>It cannot be achieved by the use of other animal species. (B)</p> Signup and view all the answers

In what situation are great apes allowed to be used in animal experiments?

<p>When it is crucial for species conservation research. (C)</p> Signup and view all the answers

Which paragraph identifies conditions under which primate experiments may deviate from the normal regulatory requirements?

<p>Paragraph 4 (A)</p> Signup and view all the answers

What is explicitly excluded from the justification process for primate usage in experiments?

<p>Experiments that serve basic research. (B)</p> Signup and view all the answers

What type of research might include a valid purpose for primate experiments based on the content?

<p>Research aimed at diagnosing human diseases. (A)</p> Signup and view all the answers

Which regulation discusses the use of primates in animal experiments?

<p>Regulation (EC) No 338/97 (A)</p> Signup and view all the answers

What constitutes a life-threatening condition for the purposes of using primates in research?

<p>Conditions that reduce physical or mental functioning. (D)</p> Signup and view all the answers

What must an experiment focusing on disease treatment establish regarding its participants?

<p>It must confirm the necessity of primates for its goals. (A)</p> Signup and view all the answers

Flashcards

Record Keeping for Animal Experiments

The act of maintaining records related to animal experiments, in accordance with specific legal requirements.

Competent Authority's Assessment

An assessment conducted by the responsible authority to evaluate an animal experiment proposal based on its specific characteristics and potential risks.

Personnel Requirements for Animal Experiments

Individuals performing animal experiments must be formally affiliated with the institution or authorized to use its facilities with the agreement of the head.

Federal Ministry's Regulatory Power

The Federal Ministry, in collaboration with the Ministry of Education and Research, has the authority to create regulations governing various aspects of animal experiments.

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Application for Animal Experiment Approval

The application for approval of an animal experiment project must be submitted in writing or electronically to the designated authority.

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Content of Animal Experiment Application

The application for approval of an animal experiment project must include details about the individuals responsible for the experiment, the project's purpose, and the animal species involved.

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Submitting an Animal Experiment Application

The application for approval of an animal experiment project must be submitted to the designated authority, with specific information about the experiment, the individuals involved, and the animal species used.

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Scientific Justification of the Experimental Project

A detailed explanation of the scientific purpose of the experiment, including the aims and objectives.

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Scientific Justification of the Animal Species

An explanation of why the chosen animal species, their origin, age, and estimated number are suitable for the experiment.

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Nature and Conduct of the Animal Experimentation

A detailed description of the steps involved in the experiment, including the use of anesthesia, pain relief, and criteria for removing animals from the experiment.

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Location, Start Date, and Duration

The location where the experiment will take place, the start date, and the estimated duration of the experiment.

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Personnel Involved in the Experiment

The names, addresses, qualifications, and roles of all individuals involved in planning, conducting, and caring for the animals used in the experiment.

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Euthanasia Procedure

A plan detailing the method for euthanizing animals used in the experiment.

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Measures to Alleviate Animal Suffering

A summary of the measures taken to minimize animal suffering throughout the experiment, from birth to death.

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Experimental and Monitoring Strategies

Strategies and statistical designs used to minimize the number of animals, pain, suffering, and adverse environmental impact during the experiment.

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Acclimatization and Training Programs

Plans for acclimating and training animals for the specific procedures and duration of the experimental project.

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Legal Basis for Animal Experiments

The legal authorization to conduct an animal experiment, outlined in § 8a(1), first sentence, number 1 of the Animal Protection Act.

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Competent Authority

The designated authority responsible for reviewing and approving applications for animal experiments.

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Animal Experiment Application

A written or electronic request submitted to the competent authority seeking approval for an animal experiment project.

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Examination of Application

The process where the competent authority examines the application to ensure it meets all the required criteria for animal experiment approval.

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Retrospective Assessment

This assessment determines if the experiment aligns with the ethical guidelines and animal welfare standards required by the law.

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Initial Review Period

A period of up to 15 working days for the competent authority to inform the applicant about the outcome of their application's review.

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Final Decision Period

A period of up to 20 working days for the competent authority to provide a final decision on the application.

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Acknowledgement of Receipt

A formal confirmation that the application has been received by the competent authority.

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Extension Notification

An official document outlining the reasons for an extended review period.

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Completeness Check

An immediate inspection of the application to verify if all necessary information and documents are included.

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Essential Use of Primates

Using primates in experiments is permitted only when scientifically proven necessary to achieve the research's objective.

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Primate Use for Human Health

Animal experiments using primates for preventing, diagnosing, or treating diseases, suffering, or disorders in humans are allowed.

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Scientific Justification for Animal Experiments

The specific purpose of the animal experiment must be clearly stated and scientifically justified.

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Annex A Primates in Animal Experiments

Primates listed in Annex A of Regulation (EC) No 338/97 can be used in specific animal experiments if certain criteria are met.

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Basic Research vs. Annex A Primate Use

Experiments serving basic research are excluded from the exceptions allowing the use of primates listed in Annex A.

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Great Ape Use in Animal Experiments

The competent authority can authorize using great apes in animal experiments if specific criteria are met.

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Alternatives Before Primate Use

The use of animals other than primates must be considered and assessed before using primates.

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Permitted Primate Use in Research

Animal experiments using primates can be permitted under specific conditions for research related to human health or species conservation.

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Annex A Primate Use in Human Health Research

Research involving the development, production, and testing of substances or products affecting human health can use Annex A primates.

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Annex A Primate Use in Conservation Research

The use of Annex A primates is permitted for conservation research when other animal species cannot achieve the desired research objectives.

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Animal Welfare Officer's Freedom

The Animal Welfare Officer is free from instructions in their duties and must not be disadvantaged while working.

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Animal Welfare Committee

A special group of people, including the animal welfare officer, responsible for overseeing animal welfare in a facility involved in animal experiments.

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Responsibilities of the Animal Welfare Committee

This committee helps animal welfare officers with their tasks, monitors animal experiments and their effects, and advises on programs to improve animal welfare.

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Why is the Animal Welfare Officer Important?

The Animal Welfare Officer's role involves advising on the best practices for animal experiments, ensuring humane treatment, and staying up-to-date on scientific developments.

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Role of the Animal Welfare Officer in the Committee

The animal welfare officer is the point of contact for the Animal Welfare Committee and ensures they have the information to carry out their tasks effectively.

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Study Notes

Animal Welfare Act (Relevant Parts for Lab Animal Science)

  • Principle §1: No one may inflict pain, suffering, or harm on an animal without a justifiable reason.
  • Animal Husbandry §2: Anyone caring for animals must provide appropriate food, care, housing, and meet species-specific needs. Movement restrictions causing pain or avoidable suffering are prohibited. The caregiver must have the necessary knowledge and skills.
  • Detailed Animal Husbandry Requirements §2a: The Federal Ministry is authorized to provide more specific details regarding animal care, particularly for animals used in experiments. These details can be found in the Laboratory Animal Welfare Ordinance (TierSchVersV).
  • Animal Protection Transport Ordinance (TierSchTrV): Regulates the transport of animals, including those used in experiments.
  • Killing of Animals §4: Vertebrate animals must be killed with effective analgesia (stunning), in a state of unconsciousness and insensibility. Methods to avoid pain and suffering should be followed.
  • Killing Methods §4b: Methods of killing are regulated, with specific requirements for certain animals (e.g., those used in specific experiments). The use of the least stressful methods is preferred.

Design and Performance of Animal Experiments

  • Existing Legislation: Existing legislation regarding animal experimentation is to be followed.
  • Ethics: Considerations of the ethical relationship between humans and animals, and the justification of animal use in research are to be addressed.
  • Biology: Appropriate species-specific biological knowledge is crucial (anatomy, physiological characteristics, breeding, genetics, and genetic modification)
  • Behavior and Husbandry: Animal behaviors and husbandry, including enrichment of their environment, must be considered.
  • Species-Specific Pain and Suffering: Understanding how various species respond to pain and suffering is important; knowledge of appropriate species-specific handling and testing methods
  • Painless Endpoints: Endpoints for animal experiments which minimize pain and suffering are to be used.
  • Planning and Implementation: Appropriate planning and implementation of experimental procedures are needed.
  • Experimental Procedures: Experimental methods and surgical procedures must be relevant.
  • Alternative Methods: Researchers must explore alternative methods to animal testing where possible.
  • Anaesthesia and Pain Relief: Appropriate anaesthesia and pain relief methods need to be used.
  • Biometric statistics: Data collection and analysis for experiments.

Interventions on Animals

  • Anaesthesia §5: Painful procedures on vertebrates must be performed under anaesthesia.
  • Stunning/Pain Avoidance §5(2): Stunning is not required in certain situations (e.g., if comparable human procedures don't use anaesthesia or when stunning is considered infeasible by a veterinarian) and pain must be reduced or avoided in all feasible ways.
  • Labeling: Methods of labelling (e.g. ear-punching, tattooing) can be used to identify animals.
  • Specific Measures§5(4): The Federal Ministry is authorized to exempt some measures from the stunning obligation if compatible with general animal care.
  • Animal Experimentation §7: Protection of animals intended for use in experiments or organs for experiments; pain, suffering and harm, number of animals in experiments, specifics about the used species, limiting the species-specific ability of animals to experience the effects of a test.

Specifics of Killing Animals and Methods

  • Killing Methods Annex 2: A table categorizing killing methods for various animals.

Additional Regulations and Procedures

  • Authorizations §8-§12: Requires and regulates the design of experiments and the permission needed by the competent authority.
  • Review and Approval of Animal Experiments: The competent authority reviews experimental proposals. Detailed information about the experiment must be in the application. The authority can ask for adjustments to experiments.
  • Animal Experiment Commissions §15, §16, §15a, §16c: Regulations on commissions involved in animal welfare, review and approval of experiments. Establishments must have Animal Welfare officers and associated committees to ensure animal well-being is adequate in research facilities.
  • Ethical Concerns in Animal Experiments: The need for consideration of scientific justification for using certain methods when performing animal experiments, including avoiding unnecessarily prolonged pain or suffering .
  • Specific Regulations §17, §11, §11b, §20, §19, §21, §22, §23, §23, §24, §25: More detailed rules pertaining to the use and treatment of animals in experiments

Implementation of the Act

  • Responsibility of Authorities §15: Authorities responsible for the implementation of the animal welfare act and regulations.
  • Special Records §40: Authorisation, review, and maintenance of records associated with various animal experiments.

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