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The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety is used to protect from harmful incidents. Many laboratories handling biohazards employ an ongoing risk management assessment and enforcement process for biosafety. Failures to follow such protocols can lead to increased risk of exposure to biohazards or pathogens. Human error and poor technique contribute to unnecessary exposure and compromise the best safeguards set into place for protection.
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is one of the institutes and centers that make up the National Institutes of Health, an agency of the United States Department of Health and Human Services (HHS).
The Virginia–Maryland College of Veterinary Medicine is a state-supported college of two states, Virginia and Maryland, filling the need for veterinary medicine education in both states. Students from both states are considered "in-state" students for admissions purposes.
The regulation of science refers to use of law, or other ruling, by academic or governmental bodies to allow or restrict science from performing certain practices, or researching certain scientific areas.
The Animal Welfare Act was signed into law by President Lyndon B. Johnson on August 24, 1966. It is the main federal law in the United States that regulates the treatment of animals in research and exhibition. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimally acceptable standard for animal treatment and care. The USDA and APHIS oversee the AWA and the House and Senate Agriculture Committees have primary legislative jurisdiction over the Act. Animals covered under this Act include any live or dead cat, dog, hamster, rabbit, nonhuman primate, guinea pig, and any other warm-blooded animal determined by the Secretary of Agriculture for research, pet use or exhibition. Excluded from the Act are birds, rats of the genus Rattus, mice of the genus Mus, farm animals, and all cold-blooded animals.
The Joint Commission is a United States-based nonprofit tax-exempt 501(c) organization that accredits more than 22,000 US health care organizations and programs. The international branch accredits medical services from around the world. A majority of US state governments recognize Joint Commission accreditation as a condition of licensure for the receipt of Medicaid and Medicare reimbursements.
Institutional Animal Care and Use Committees (IACUCs) are centrally important in applying laws about animal research in the United States. Similar systems operate in other countries, but generally under different titles; for example, in Canada a typical title would be the University Animal Care Committee (UACC), while in the United Kingdom it would be the Animal Welfare and Ethical Review Body (AWERB).
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pets or companion animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.
Veterinary education is the tertiary education of veterinarians. To become a veterinarian, one must first complete a veterinary degree in Doctor of Veterinary Medicine.
M. Krishnan Nair was an Indian oncologist. He was the founding director of the Regional Cancer Centre, Thiruvananthapuram, a director of the S.U.T. Institute of Oncology, and Trivandrum Cancer Center(TCC), part of SUT Royal Hospital in Thiruvananthapuram (Trivandrum) and a professor at the Amrita Institute of Medical Sciences & Research in Kochi. The Government of India awarded him the fourth highest civilian award of the Padma Shri, in 2001 for his contributions in the cancer care field.
The American Animal Hospital Association (AAHA) is a non-profit organization for companion animal veterinary hospitals. Established in 1933, the association is the only accrediting body for small animal hospitals in the U.S. and Canada. The association develops standards for veterinary business practices, publications, and educational programs. Any veterinary hospital can join AAHA as a member, but must then pass an evaluation in order to receive AAHA accreditation.
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).
Animal testing regulations are guidelines that permit and control the use of non-human animals for scientific experimentation. They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
Public Responsibility in Medicine and Research (PRIM&R) is a 501(c)(3) nonprofit organization based in Boston, Massachusetts. The organization was formed in 1974 by a group of researchers who sought to ensure that the concerns and experiences of those working in biomedical research would be reflected in the growing body of federal regulations governing the field.
A glossary of terms used in clinical research.
The NIH Intramural Research Program (IRP) is the internal research program of the National Institutes of Health (NIH), known for its synergistic approach to biomedical science. With 1,200 Principal Investigators and over 4,000 Postdoctoral Fellows conducting basic, translational, and clinical research, the NIH Intramural Research Program is the largest biomedical research institution on earth. The unique funding environment of the IRP facilitates opportunities to conduct both long-term and high-impact science that would otherwise be difficult to undertake. With rigorous external reviews ensuring that only the most outstanding research secures funding, the IRP is responsible for many scientific accomplishments, including the discovery of fluoride to prevent tooth decay, the use of lithium to manage bipolar disorder, and the creation of vaccines against hepatitis, Hemophilus influenzae (Hib), and human papillomavirus (HPV). In addition, the IRP has also produced or trained 21 Nobel Prize-winning scientists.
The European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, sometimes simply referred to as the animal experimentation convention or laboratory animals convention, is an animal welfare treaty of the Council of Europe regarding animal testing, adopted on 18 March 1986 in Strasbourg, and effective since 1 January 1991.
References
- ↑ "Welcome to the CCAC". Canadian Council on Animal Care. Archived from the original on 2009-08-22. Retrieved 2009-10-18.
- ↑ "The Canadian Council on Animal Care's Code of Ethics: A Critical Evaluation". Medical Research Modernization Committee. Retrieved 2009-10-18.
- 1 2 3 4 Ernest D. Olfert, DVM; Brenda M. Cross, DVM; A. Ann McWilliam (1993). Guide to the Care and Use of Experimental Animals. Vol. 1 (2nd ed.). Canadian Council on Animal Care.
- ↑ Wong, James (1997). "Laboratory Animal Care Policies and Regulations". Ilar Journal. Archived from the original on May 16, 2008. Retrieved 2009-10-18.
