University of Pennsylvania

Biomedical Graduate Studies
Responsible Conduct of Research (RCR) and Scientific Rigor and Reproducibility (SRR)

Use of Animals in Research

Preface

Animal experimentation is an essential component of biomedical research. As important this form of experimentation might be, however, researchers must be grounded in the moral and ethical implications of what they do. And it goes without saying that they must also adhere to all regulations built upon those implications and that otherwise govern the practicalities of experimentation.

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Background

The primary rationale for the use of animals in biomedical experimentation is the production of basic and applied knowledge that promotes human health and well being. That it can provide for general animal welfare is a benefit as well.1 One must assume in using animals that they have moral value, a status if you will, that obliges us to treat them humanely and to balance, ever so carefully, that value with what we consider to be the value of humans. Legislation that speaks to this obligation includes the Animal Welfare Act, the Public Health Service Policy on the Humane Care and Use of Laboratory Animals, and the Guide for the Care and Use of Laboratory Animals. A good discussion of how these link together is provided by Macrina.2  The Guide for the Care and Use of Laboratory Animals is, in terms of practical value, most essential to scientists and caretakers, as it provides quite detailed, species-specific information on how animal research should be carried out. All three mandate an Institutional Animal Care and Use Committee (IACUC) at each institution. The responsibility of this committee is to assure safety, maintenance, care, and use of vertebrate animals and to comply with federal, state, and local laws.

1Responsible Conduct of Research, Shamoo and Resnik, Oxford University Press, 3rd Edition
2Scientific Integrity, Macrina, ASM Press, 4th Edition

 

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Policies and Guidelines

The University requires all coursework and research projects involving vertebrate animals to be reviewed and approved prior to initiation by the IACUC. This policy applies, to all biomedical, behavioral, teaching, training, and clinical research, regardless of the source of funding, involving vertebrate animals performed by faculty, staff, and students of the University.

Penn’s Office of Regulatory Affairs provides the following guidelines and policies for the use of animals: http://www.upenn.edu/regulatoryaffairs/index.php?option=com_content&task=view&id=10&Itemid=7.

Greg Reinhardt, Director of the Office of Animal Welfare for the University, provides this as general information for those leading the case-studies in this module:

"The IACUC protocol covers a number of important items, not only how the study is performed but possible issues and how they will be addressed. It carefully addresses pain and distress issues. It requires careful attention to endpoints in which a study is stopped. The protocol should also include provisions for addressing adverse events. A protocol is like a contract that must be followed.  For example, if an animal dies under anesthesia and it is not considered as a possibility in the protocol, then the person needs to notify the IACUC and the attending Veterinarian.  Most likely the Vet will review the procedures and determine if any changes are needed and the protocol amended."

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Case Studies

Access to case studies requires a PennKey. They are available here.

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Comments/Resources

Two textbooks provide excellent discussions of data acquisition and management. Both are electronically accessible through the Biomedical Library. These are:

Scientific Integrity, F.L. Macrina, 4th ed.
Responsible Conduct of Research, A.E. Shamoo and D.B. Resnick, 3rd ed.

The following monograph provides case studies with answers on a variety of RCR topics, including animal subject research. It can be obtained in PDF: Ethical Dilemmas in Research, J. Brigham, A.B. Chausmer, K.S. Fraiser, C.E. Gutkin, G.D. Marshall, S. Spilman, and H.W. Tyrer, 2004.

Here are some websites of note:

Penn’s IACUC site, which includes links to guidelines, policies, and training: http://www.upenn.edu/regulatoryaffairs/index.php?option=com_content&task=view&id=2&Itemid=7

Guide for the Care and Use of Laboratory Animals, 8th ed., 2011. http://www.nap.edu/catalog/12910/guide-for-the-care-and-use-of-laboratory-animals-eighth

The USDA’s Animal Welfare Handbook can be found here: https://awic.nal.usda.gov/government-and-professional-resources/federal-laws/animal-welfare-act

The Public Health Service Policy on the Humane Care and Use of Laboratory Animals can be found here: https://grants.nih.gov/grants/olaw/references/phspol.htm

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