Appropriate Use of Recovery Groups in Nonclinical Toxicity Studies: Value in a Science-Driven Case-by-Case Approach

2011 ◽  
Vol 49 (2) ◽  
pp. 357-361 ◽  
Author(s):  
K. Pandher ◽  
M. W. Leach ◽  
L. A. Burns-Naas
Keyword(s):  
Laboratory Animal ◽  
Prolonged Exposure ◽  
Recovery Phase ◽  
Regulatory Requirements ◽  
Appropriate Use ◽  
Toxicity Studies ◽  
Animal Use ◽  
Antidrug Antibodies ◽  
Recovery Group ◽  
Recovery Groups

A recovery phase—a nondosing period that follows the main dosing phase of a study—is sometimes included in nonclinical toxicity studies, and it is designed to understand whether toxicities observed at the end of the dosing phase are partially or completely reversible. For biopharmaceuticals with long half-lives, the inclusion of recovery arms can be helpful in understanding effects of prolonged exposure and assessing antidrug antibodies. This commentary discusses when to include recovery groups in nonclinical toxicity studies, the number of recovery groups to include in a given study, the number of animals to include in each recovery group, and the duration of the recovery phase. In general, the inclusion of recovery arms should follow a case-by-case approach that values rational scientific design and reflects the development needs and regulatory requirements applicable to individual nonclinical programs to ensure appropriate guidance for human studies while minimizing laboratory animal use.

Putting the Ethical Principles into Practice

2020 ◽  
pp. 69-78
Author(s):  
Rebecca Dresser
Keyword(s):  
Policy Change ◽  
Laboratory Animal ◽  
Social Benefit ◽  
Core Values ◽  
Animal Research ◽  
Scientific Quality ◽  
Scientific Review ◽  
Committee Membership ◽  
Animal Use ◽  
Research Studies

Beauchamp and DeGrazia introduce a framework of core values and principles for animal research studies that is more comprehensive than the leading alternative—Russell and Burch’s Three-Rs scheme of replacing, refining, and reducing laboratory animal use. Beauchamp and DeGrazia’s principles flesh out both social benefit requirements and animal welfare values. I recommend changes that would make their framework a real force in the conduct of animal research. One positive change would be a requirement to increase the diversity of institutional committee membership. A better scientific review system would substantially improve assessments of the justification of research studies. Existing government provisions on animal research direct committees to consider scientific quality but fail to provide the tools for doing so. Setting limits on the number of animals allowed in research is another needed policy change.

Training for Reduction in Laboratory Animal Use

2004 ◽  
Vol 32 (2_suppl) ◽  
pp. 65-67 ◽  
Author(s):  
Timo Nevalainen
Keyword(s):  
Laboratory Animal ◽  
Animal Use

The Fourth EC Report on the Statistics of Laboratory Animal Use: Trends, Recommendations and Future Prospects

2005 ◽  
Vol 33 (4) ◽  
pp. 417-426 ◽  
Author(s):  
Christina Grindon ◽  
Nirmala Bhogal
Keyword(s):  
Laboratory Animal ◽  
Reporting System ◽  
Transgenic Animals ◽  
The European Union ◽  
Future Prospects ◽  
Member States ◽  
Fourth Report ◽  
Animal Use ◽  
The Uk ◽  
First Time

At the beginning of 2005, the European Commission published its fourth report on the statistics of the number of animals used for experimental and other scientific purposes. A total of 10.7 million animals were used within the Member States of the European Union (EU) in 2002, an increase of almost a million animals since the 1999 report. France, Germany and the UK continue to be the largest users of animals for scientific purposes, and mice, rats, fish and birds remain the most commonly-used animals. For the first time, all 15 Member States used the standardised “EU tables”, as had been agreed in 1998. This has made it easier to identify areas on which Three Rs initiatives should be focused. Nevertheless, the reporting system still has a number of serious deficiencies. In particular, there are insufficient data on the numbers of animals that are kept or bred for research purposes, the numbers of transgenic animals, and the severity of procedures that are applied.

scholarly journals 341 How the IACUC uses the Ag Guide to ensure the best care

2020 ◽  
Vol 98 (Supplement_4) ◽  
pp. 72-72
Author(s):  
Kelly D Heath
Keyword(s):  
Guidance Document ◽  
Regulatory Requirements ◽  
Funding Mechanism ◽  
Land Grant Institutions ◽  
Care Processes ◽  
Short Video ◽  
Animal Use ◽  
The University ◽  
Animal Care

Abstract All Institutional Animal Care and Use Committees (IACUC) are all subject to the same regulatory requirements. Membership requirements (Scientist, Nonscientist, Attending Veterinarian, Public Members, and Chairperson) are established by the regulatory agencies and appointed by the Institutional Official (IO). Today we will review the basic role of the IACUC: reviewing animal use protocols, inspecting animal facilities and procedure areas, evaluating the program of animal care, investigating allegations of non-compliance, making recommendations to the institutional official about needed changes, and utilizing the Ag Guide as a guidance document. The role of the IACUC at Land Grant Institutions is confounded often by the variety of research that is conducted. At the University of Nebraska, we have traditional food and fiber, biomedical and wildlife research, which requires a diverse set of committee members to adequately review the animal care and use. All IACUC protocols, regardless of the species or funding mechanism, are required to address several common questions. As a principal investigator, you can help yourself tremendously by providing all the required information in a transparent, logical and organized manner. If you can anticipate your audience and provide key information in multiple formats, it will help streamline the review process. Based on membership requirements, most committee members will not come from agriculture backgrounds, so it is imperative you help the committee to understand standard agriculture practices. You can best accomplish this with standard operating procedures, herd management protocols, disaster plans, and veterinary care processes and provide photographs or short video clips of your proposed activities. Additionally, if you are asked to serve on this committee, be willing to proactively educate your peers on what is considered appropriate management, housing, experimental and humane endpoints. By acting as your own advocate, you can ensure good animal care as well as achieve timely approvals.

The Modern Politics of Laboratory Animal Use

BioScience ◽  
1984 ◽  
Vol 34 (10) ◽  
pp. 621-625
Author(s):  
Thomas H. Moss
Keyword(s):  
Laboratory Animal ◽  
Modern Politics ◽  
Animal Use
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