TABLE OF CONTENTS If product development proceeds without regard to general ethical principles and the specific checks and balances described here (and in Box 4.5) and in Section 4.16 the company can face negative consequences, including a complete halt of all product development activities.
Ethics considerations formally enter the NPD process at the time of pre-clinical testing of the drug or device and continue through the clinical development and post-approval stages of development. Specific embodiments of these considerations are described in the following sections.
IACUC resources are available online at: http://grants.nih.gov/grants/olaw/references/outline.htm.
The Animal Welfare Act has provisions to regulate and ensure that animals used in research, for exhibition, or as pets receive humane care and treatment. Regulatory authority is vested in the secretary of the US Department of Agriculture (USDA) and implemented by USDA s Animal and Plant Health Inspection Service (APHIS). Rules and regulations pertaining to implementation are published in the Code of Federal Regulations, Title 9 (Animals and Animal Products), Chapter 1, Subchapter A (Animal Welfare), available from Regulatory Enforcement and Animal Care, APHIS, USDA, Unit 85, 4700 River Road, Riverdale, MD 20737-1234. File Name 9CFR93.
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals was updated in 1996 and contains guidelines on what constitutes humane and ethical treatment and care of animals used in research. Information concerning the policy can be obtained from...
