Oversight | OHSU

The Oregon National Primate Research Center, as one of the NIH-supported National Primate Research Centers, has both external and internal oversight to assure the dual necessity for the highest quality ethical care for animals and the most outstanding scientific research. The Center maintains accreditation and is subject to continuous oversight from federal and non-federal organizations that regulate how and where animal research is performed. We are proud that we have maintained a clean bill of health and accreditation for the last 33 years.

"OHSU's primate center has an outstanding record of animal care," explained Peter Barr-Gillespie, Ph.D., Senior Vice-President for Research. "Twice a year the federal government conducts unannounced inspections. These inspections repeatedly demonstrate the hard work and dedication of our animal care staff. Our employees truly care about these animals and the records show this year after year."

Because nonhuman primates are highly regulated in the United States, any experiment that a scientist proposes to conduct with monkeys must be approved by the Institutional Animal Care and Use Committee (IACUC) at the Institution where the scientist works before the research can begin. There are five key elements to this approval process.

The scientist must describe in detail the specific procedures that he or she plans to use on the animals, such as any behavioral testing, surgical procedures, or experimental substances like drugs or vaccines that the animals might receive.
There must be an explanation of whether any of the procedures are likely to cause an animal pain or distress, and if so, details must be presented describing all steps the scientist will take to minimize or eliminate pain or distress.
The scientist must provide a justification for why the proposed research must be conducted with monkeys rather than some other animal; whether there are any alternative ways that the scientist can find to answer his or her question (for example, by studying cells rather than whole monkeys); and why the scientist needs to study the specific number of animals that he or she is proposing to study in the research.
In addition, the scientist must indicate that the proposed research does not unnecessarily duplicate research that has already been conducted, and must describe the sources he or she used to determine that the study has not already been done.
Finally, the scientist must list all personnel who will be involved in the project, and must be able to document the training that those individuals have had with respect to the procedures to be employed and the animals to be used.

All of the research at the Center, whether an animal study or a basic laboratory study, must be peer-reviewed for scientific justification. Once a year, our external Scientific Advisory Board visits the center and reviews all of the research in detail, providing oral and written external critique for each of the scientists. The Center, in collaboration with its host institution the Oregon Health & Science University, maintains internal committees that must approve studies before they commence. These committees assure that the research is conducted in a manner consistent with all regulations for biohazards (including radiation), safety, and fair access to resources, including animal resources. These committees are all appointed by the Director in consultation with the Associate Directors and Heads of the Research Divisions.

Institutional Animal Care and Use Committee (IACUC)

The IACUC is composed of individuals from the institution and the community, and they review (and must approve) all proposed research projects involving live vertebrates. As noted above, IACUC approval is mandated for all research sponsored by funding from the U.S. government. The IACUC also conducts inspections of animal facilities every six months. The West Campus IACUC is administrated by the OHSU Research Integrity Office staff which assists the research staff in the completion and submission of IACUC protocols, and provides advice on regulatory matters. The IACUC meets monthly to review all animal protocols for the West Campus and works in close consultation and collaboration with the OHSU Office of Integrity and the Main Campus IACUC via shared membership.

Animal Utilization Advisory Committee (AUC)

This committee meets quarterly to address policies and procedures for determining long-range and short-term plans and needs for NHPs/animals and to resolve issues related to all aspects of NHP/animal use in research programs. It also serves to educate about policy decisions related to use of NHPs in research protocols. The committee is broad-based and has representation from the following areas: scientists in all research divisions, the veterinarians, lab animal medicine staff and administrative staff.

OHSU Institutional Biosafety Committee (IBC)

This committee evaluates all research that is conducted with recombinant DNA (rDNA), synthetic nucleic acid molecules, infectious agents, and biologically derived toxins regardless of funding, to ensure compliance with NIH Guidelines. The committee routinely reviews and makes recommendations for all research projects performed at the ONPRC and VGTI.

Campus Safety Committee

This committee educates and trains to protect the safety and health of employees. The goal is to reduce potential for injuries and illnesses due to hazards in the workplace. The committee evaluates incidents, summarizes information and makes recommendations for corrective action and is responsible for overseeing the adherence to local, state and federal workplace health and safety guidelines. More specifically, the committee defines actual or potential occupational risk, promotes accident prevention, helps identify and define employee safety training needs and utilizes accident investigation resources in the event of an incident.

West Campus Radiation Safety Committee

The new committee, established in 2001, integrates the West Campus—ONPRC/OHSU, VGTI and OGI. The ONPRC license will change from a Broad Scope B Radioactive Materials License from the State of Oregon to a Broad Scope A License to include all institutions on campus. New radiation policies and procedures were developed in the fall of 2001 and are updated as needed.

West Campus Operations Committee

All division and unit heads meet to discuss, review and develop Center policies; issues regarding scientific program planning, facilities/property, primate/animal resources, information technology, environmental health and safety, administrative services and public relations/information are addressed. Minutes of meetings are available to Center staff.

Promotions Committee

The promotions committee evaluates candidates, including scientific staff and veterinary staff, for promotion according to procedures described in the Promotions Policy. All employees participate in the annual OHSU personnel evaluation process.

Research Integrity Office

ONPRC also has a Research Integrity Office which has the responsibility to assure compliance with all regulations related to animal research, staff training and safety on the West Campus. The Research Integrity Office works closely with the IACUC, the Institutional Biosafety Committee (IBC), the West Campus Attending Veterinarian, the IACUC chair, the Biosafety Officer and the Occupational Health nurse. The Research Integrity Office also works closely with Animal Resources & Research Services to assure proper training of animal technicians and research staff.

Federal oversight

There are four agencies that regulate the use of animals in research.

1. One is the Public Health Service (PHS), which issues the PHS Policy on Humane Care and Use of Laboratory Animals. The recommendations in this policy statement have the force of law under the Health Research Extension Act (PL99-158) passed in 1985. Among other things, both the Health Research Extension Act and the PHS Policy require the existence of an Institutional Animal Care and Use Committee (IACUC) at each institution that conducts research with funds from federal sources. The IACUC is composed of individuals from the institution and the community, and they review (and must approve) all proposed research projects involving live vertebrates. They also conduct inspections of facilities.

2. The Institute of Laboratory Animal Resources (ILAR) of the National Research Council, National Academy of Sciences writes the ILAR Guide for the Care and Use of Laboratory Animals, which is published by the National Academy Press. The Guide was updated and revised in 2011 as the 8^th Edition. The National Institutes of Health (NIH) funds ILAR to write the document. Investigators that receive funds from PHS (including NIH and the Centers for Disease Control and Prevention) for research involving live vertebrates, must adhere to these guidelines which address the day-to-day aspects of caring for laboratory animals.

3. The United States Department of Agriculture (USDA) Animal Plant and Health Inspection Service (APHIS) is responsible for enforcing the Animal Welfare Act, the second principal law governing the use of animals (Title 7, Sections 2131 et seq. of the U.S. Code, amended in 1985 by PL99-198). The Act was created in response to public concern about animal welfare, and covers species such as cats and dogs, as well as primates. The Animal Welfare Act does not cover laboratory rats (genus Rattus) and mice (genus Mus), nor does it cover agricultural uses of farm animals. The Animal Welfare Act requires that APHIS perform at least one compliance inspection per year on each research facility that uses animals in experimentation. USDA sets the same minimum for all regulated entities that use animals, including research facilities (i.e., hospitals, universities, diagnostic laboratories, and private firms in the pharmaceutical and biotechnology industries), dealers, exhibitors, and in transit carriers (e.g., airlines). Compliance inspections are unannounced, meaning that the institution to be inspected is not given advanced notice that an inspection is planned. (Reference: Report of the Secretary of Agriculture to the President of the Senate and Speaker of the House of Representatives. Animal Welfare Enforcement, Fiscal Year 1994. USDA, APHIS 41-35-034).

4. The U.S. Food and Drug Administration (FDA) has regulations pertaining to Good Laboratory Practices (GLP). These regulations address animal care issues and apply to safety studies of any food additive, drug, or medical device intended for humans that use animals, and require highly detailed records of all aspects of study. FDA requires adherence to the ILAR Guide.

American Association for the Accreditation of Laboratory Animal Care (AAALAC)

Finally, one independent, non-Federal organization that is involved in animal welfare is AAALAC, International. Institutions voluntarily submit for accreditation by AAALAC which site-visits facilities every three years. Institutions that meet the highest standards of animal care may then be accredited by AAALAC and are allowed to proudly display their accreditation status. The Oregon National Primate Research Center is an AAALAC accredited institution. Visit the AAALAC website to learn more about the accreditation program.

Scientific Advisory Board

The Scientific Advisory Board provides advice and guidance to the Principal Investigator and Center Director on planning and strategic initiatives.

The ONPRC is fortunate to have as its board a group of investigators who are widely acknowledged as outstanding, internationally recognized scientific experts in their fields. Members were appointed by the Director in 2018 for a five-year term. The board meets yearly to advise Drs. Jacobs, Barr-Gillespie, and Haigwood concerning plans for scientific strategic initiatives. Drs. Fazleabas and Clark serve as advisors to the Developmental and Reproductive Sciences Division. Dr. Levitt provides guidance to the Neuroscience Division. Dr. Roberts serves as an advisor to Animal Resources & Research Services. Drs. Gale and Walker serve as advisors to the Pathobiology & Immunology Division. Dr. Scherer advises the Cardiometabolic Health Division. Dr. Cox provides guidance regarding genetics.

The care of animals at the Oregon National Primate Research Center is overseen locally and nationally by a variety of external and internal organizations including the OHSU Institutional Animal Care and Use Committee, a university/ public body. The National Institutes of Health requires very high standards in order to obtain and retain federal health research dollars. The primate center also maintains voluntary accreditation that requires an institution to exceed the country's animal welfare laws. However, the most well-known law regarding oversight is the Animal Welfare Act. The act is a very lengthy and detailed set of federal guidelines that are updated regularly to ensure that animals in captivity are well cared for. The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service is responsible for enforcing the Animal Welfare Act.

USDA inspectors visit ONPRC approximately twice a year and sometimes more often. During their visit, they view animals, facilities, food supplies medications, and records. In effect, inspectors can go wherever they want and see whatever they wish to ensure that the animals at ONPRC are receiving excellent care. If problems are found, a research institution can be fined and in an extreme case, animals can be confiscated -in effect closing a research facility down.

Below are links to all of the primate center's inspections in the past years. By clicking each link you can see the full report along with background information when necessary.