Animals, COI, Export Control and Intellectual Property Flashcards
Nuremburg Code, 1947
The Nuremberg Code (German: Nürnberger Kodex) is a set of research ethics principles for human experimentation created by the U.S. v Brandt court as one result of the Nuremberg trials at the end of the Second World War.
Office of Laboratory Animal Welfare (OLAW) Responsibilities
> Provides general administration and coordination of the PHS Policy for research conducted or supported by any component of the PHS
> Coordinates PHS regulations, policies, and procedures within the PHS and with other Departments and Agencies of the Federal Government
> Negotiates Animal Welfare Assurances with institutions engaged in PHS-conducted or -supported research using animals
> Evaluates reports of noncompliance with PHS Policy and conducts compliance oversight of PHS-supported animal care and use programs
> Provides clarification and guidance for both the Federal and non-Federal sectors with respect to the use of animals in research
> Provides final review and decision making (PDF) on behalf of NIH on actions involving PHS Policy
> Directs the development and implementation of educational and instructional programs and generates educational resource materials
> Evaluates the effectiveness of PHS policies and programs for the humane care and use of laboratory animals through site visits of awardee institutions
> Serves as liaison to Presidential, Departmental, Congressional, interagency, and non-governmental Commissions and Boards established to examine issues pertaining to laboratory animal welfare in research and exercises leadership in identifying and addressing such issues
The Guide for the Laboratory Animal Facilities and Care, 1963
Main guidance document used by OLAW (PHS Office of Lab Animal Welfare) and AAALAC (Assoc. for Assessment and Accreditation of Lab Animal Care International)
- Used to be voluntary, now mandatory
- Has 5 chapters (performance standards):
> Key concepts
> Program (policies and responsibilities)
> Environmental housing and management
> Vet Care
> Physical Pain
- Incorporates all vertebrate species
- Some regulations (housing) are more stringent that AWA
- Guidelines are similar to AWA
Laboratory Animal Welfare Act / Animal Welfare Act (AWA), 1966 - THE BASICS
- Regulates the care and use of animals in many areas, including animal research.
- Original version had only 6 species under the definition of regulated species: dogs, cats, rabbits, hamsters, guinea pigs, nonhuman primates
- The Act has been modified and updated several times since its adoption in 1966, and currently covers all warm-blooded animals except rats, mice and birds, and farm animals used in food and fiber research.
- The Animal and Plant Health Inspection Service (APHIS), a division of the United States Department of Agriculture (USDA), was responsible for drafting AWA Regulations
- Changes in 1970 Amendment:
> Name officially “Animal Welfare Act”
> Other mammalian species added but still excludes mice, rats, birds, agriculture animals
> Animals now covered before, during, after use. Previously just during. - 1985 Amendment - “The Improved Standards for Laboratory Animals Act”
> One of several changes is requirement that each research facility establish an Institutional Animal Care and Use Committee (IACUC) to approve and monitor all research involving animals. - 2011 Amendment
> Adds agricultural animals used in biomedical research
AWA Mandated Training Requires Instruction on…
- the humane practice of animal maintenance and experimentation
- research or testing methods that mimize the use of animals or limit pain and/or distress
- methods to conduct literature searches to determine the availability of alternatives and to assure that duplication doesn’t occur
- methods for reporting deficiencies in animal care and treatment
AWA Mandatory IACUC Composition
The IACUC membership must consist of at least 5 members and includes:
> 1 veterinarian with training or experience in laboratory animal science and medicine, who has direct or delegated authority and responsibility for activities involving animals at the institution;
> 1 practicing scientist experienced in research with animals;
> 1 member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, member of the clergy); and
> 1 member who is not affiliated with the institution other than as a member of the IACUC.
IACUC Responsibilities (general)
IACUC responsibilities include:
Review research protocols and conduct evaluations of the institution’s animal care.
Evaluations include inspections of all animal use facilities every six months.
IACUC reports to the NIH Office of Laboratory Animal Welfare (OLAW) annually, and is issued an animal welfare assurance number by OLAW without which no federally funded use of animals in research may occur.
IACUC is required to report significant noncompliance with animal use protocols and actions taken by IACUC to address
IACUC Protocol Review
Each protocol must include:
- The species and approx. number of animals to be used
- A rationale for using animals
- A complete description of the euthanasia method
- A description of procedures designed to minimize discomfort to animals
Annual review of ongoing projects must be performed
At least once every 6 mos the IACUC must…
- Review the research facility’s program for humane care and use of animals
- Inspect all of the animal facilities, including animal study areas
- Prepare reports of its evaluations conducted, and submit the reports to the IO of the research facility
- Make recommendations to the IO regarding any aspect of the research facility’s animal program, facilities, or personnel training
Federal Health Research Extension Act, 1985
The Health Research Extension Act of 1985 (Public Law 99-158) provides the legislative mandate for the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy). It directs the Secretary of Health and Human Services to establish guidelines for the proper care and treatment of animals used in research, and for the organization and operation of animal care committees. The law requires that the guidelines address appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia, and appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals.
In its review of protocols, IACUC must ensure that the proposed work falls with OLAW Animal Welfare Assurance and that which 6 points are covered?
a. Procedures with animals will avoid or minimize discomfort, distress, and pain
b. Procedures will be performed with appropriate sedation, analgesia, or anesthesia
c. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
d. The living conditions of animals will be appropriate for their species and contribute to their health and comfort.
e. Medical care for animals will be available and provided as necessary by a qualified veterinarian.
f. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
g. Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia (PDF), unless a deviation is justified for scientific reasons in writing by the investigator.[5]
In the mid-1970s, the United States sought to gain jurisdiction over known arms dealers and enacted this set of regulations
International Traffic in Arms (ITAR) regulations
Export control requirements address/focus on the following (x4):
> An item’s technical characteristics
> The intended or anticipated end use of the item
> The destination of that item (country or entity)
> The end-user of that item
Two agencies of the federal government are primarily responsible for promulgating and enforcing the export control regulations
Department of Commerce
- Bureau of Industry and Security (BIS) manages the Export Administration Regulations (EAR)
Department of State
- Directorate of Defense Trade Controls (DDTC) manages the International Traffic in Arms Regulations (ITAR)
Export Control Classification Number (ECCN)
five-digit number identifying items based on:
- categories
- groups
- reasons for control
e.g. “3 A001”
3 - Category (electronics)
A - Product Group (systems, equipment, components)
001 - Reasons for Control (chemical & biological weapons)
