Animal Research in a Global Environment Meeting the Challenges: Proceedings of the November 2008 International Workshop (2011) / Chapter Skim
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CHALLENGES IN OUTSOURCING STUDIES
CHALLENGES IN OUTSOURCING STUDIES
Pages 232-248
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From page 232... ...
That foreign component is usually executed through a subaward or subcontract. A foreign component is defined as performing a significant element of the project outside the United States.
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From page 233... ...
It is essentially a one-page document with three major components: a statement that the institution must comply with whatever the local regulations are; the institution needs to be guided by the International Guiding Principles for Biomedical Research Involving Animals issued by the Council for International Organizations of Medical Sciences (CIOMS) , which are very similar to the US Government Principles; and the institution has to make a reasonable effort to ensure that the people doing the work understand the regulations and their responsibilities.
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From page 234... ...
Once an institution enters into an agreement to perform animal research at a foreign site, there needs to be a risk assessment to determine what the institution needs to do for monitoring and oversight. What kind of oversight is there?
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From page 235... ...
The FDA has put out new standards for the conduct of clinical trials. The new standards mandate that foreign clinical trials must now have an independent ethical committee and must be in compliance with the FDA's good clinical practice.
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From page 236... ...
Most of the monkey breeders are in southern China; almost all the Chinese rhesus colonies or breeders are to the southwest. The area north of Vietnam is where many of the breeders of cynomolgus monkeys are located.
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From page 237... ...
It has been amazing how quickly things have progressed. In 2003 I visited Nanning and we were able to convince some local business people and the local government to put in some modest investment to rent a space on the second floor of a building beside a breeder, a big monkey farm.
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From page 238... ...
An additional suggestion is that people coming from abroad should work with the Chinese government, which, at the local or federal state level, is very receptive to advice from abroad and is also receptive to collaborations. In the last few years we were able to convince a major science funding agency in China to add requirements for major grants, mandating that facilities doing animal studies must comply with international standards, either by AAALAC accreditation or adherence to the Guide.
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From page 239... ...
. It is important to remember that almost 27,000 monkeys came into the United States in 2007.1 Even though there is a financial crunch and there is not as much money for research and fewer carriers are flying animals, there were still 27,000 monkeys that came into this country -- and I am still worried about transporting animals.
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From page 240... ...
This also raises the issue of having the workers wear personal protective equipment. Ideally, they should, but doing so might raise concerns among the public who see them.
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From page 241... ...
The number of animals and the number of procedures differ slightly because some animals are used in more than one procedure and are thus counted more than once. The statistics indicate that 87% of animals used are in regulatory toxicology and about 13% in basic or applied research, which was the area of greatest interest to the authors of the Weatherall report; thus I will not say much about regulatory toxicology.
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From page 242... ...
The sponsors of the report were the Royal Society, which is somewhat the equivalent of the National Academies, the UK Academy of Medical Sciences, the Wellcome Trust, and the Medical Research Council, the last two being the major funders of basic and applied research involving primates. It was focused on hypothesis-driven research in academia and looked at the use of primates in communicable disease research, neuroscience, and reproductive biology.
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From page 243... ...
The third recommendation is that major specialist organizations should regularly collate information involving their fields, and the information should be disseminated to funding bodies, ethics committees, and regulatory agencies. Fourth, the major funding organizations should undertake a systematic review of the outcome of all research using nonhuman primates supported over the last decade.
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From page 244... ...
Some question whether it is necessary to develop new centers of excellence rather than have existing centers become better networked together. The national primate strategy will also look at things like training and sourcing, which were not addressed in the Weatherall report but are nevertheless very important.
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From page 245... ...
The Future of the Use of Nonhuman Primates in the UK 245 Those are just some of the issues that come with the fact that the use of primates in research is not only a highly sensitive issue but also something that has global impact. My conclusion is that this is an ideal opportunity for global collaboration and harmonization, so that we are not competing for use of these animals but truly ensuring that this global resource is being used as effectively as possible.
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From page 246... ...
Text of Joseph Kemnitz's Slides on the Proposed International NHP Plan Background First primate plan developed in 1978 by the Interagency Primate Steering Committee established by the Director of the National Institutes of Health (NIH)
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From page 247... ...
. • Emphasized pressure on Indian rhesus monkey supply • Encouraged use of alternative species • Develop a comprehensive plan to preserve and expand resources for biomedical research using NHP models Rationale for a New Plan • Increasing need for human disease research and testing • Disease threats that compromise quality and supply of NHP • Globalization of research • Need for conservation • Need for renewed investment in infrastructure Overall Scope To address the current and future needs of NHP supply and use in biomedical research on a global level with consideration of multiple issues Scope 1.
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From page 248... ...
6. Transportation issues specific to NHP, including the control of microenvironment of the animals during shipping, transport of biological samples from NHP, and current international regulatory obstacles to importation and transportation of animals.
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