Section Three
IMPORTANT UNIVERSITY POLICIES
ADMINISTRATIVE PANELS
This discussion includes:
Stanford University is committed to safeguarding the rights and welfare of all human research subjects, ensuring the humane care and use of laboratory animals, and protecting the safety of personnel and the general public in the areas of biosafety and radiological safety. These safeguards apply regardless of whether the research project is sponsored by an external agency or not.
The Office of the Dean of Research provides support to the seven administrative Panels discussed in this section. They are:
- Three Administrative Panels on Human Subjects in Medical Research
- Administrative Panel on Human Subjects in Nonmedical Research
- Administrative Panel on Laboratory Animal Care (A-PLAC)
- Administrative Panel on Biosafety (APB)
- Administrative Panel on Radiological Safety (APRS)
Review and approval by these Panels certifies to our sponsors that Stanford is in compliance with all applicable laws and regulations.
The purpose of this section is to provide a brief overview of the compliance issues and Panel reviews that are required of any research or teaching activity involving the use of human subjects, laboratory animals, biohazards, or radiological hazards.
For more information, please see:
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Human Subjects in Research
Definitions of Human Subject, Research, and Minimal Risk are taken from the Federal Policy for the Protection of Human Subjects: Notices and Rules, as published in the Federal Register, June 18, 1991, and are:
- Human Subject: A living individual about whom an investigator obtains
- data through physical procedures, interpersonal communication or interaction with the individual, or
- identifiable private information, which may include behavioral observance that the individual is unaware of, or confidential information (i.e., medical records).
- Research: A systematic investigation including research development, testing, and evaluation designed to contribute to generalizable knowledge.
- Minimal Risk: The probability of harm or discomfort is not greater than that ordinarily encountered in daily life or during the performance of routine examinations or tests.
- Protocol: The name of the application document which is submitted to the Administrative Panel(s) describing the plan of a scientific experiment or treatment.
Stanford's Assurance to the Department of Health and Human Services (DHHS), as revised in 2001, states that the University will comply with applicable federal regulations regarding the use of human subjects in research.
At Stanford, these regulations apply to all research (sponsored and unsponsored) involving human subjects. The review process is carried out before a research activity begins by one of four institutional review boards: 1) three Administrative Panels on Human Subjects in Medical Research, and 2) the Administrative Panel on Human Subjects in Nonmedical Research. The Panels are appointed annually by the Vice Provost and Dean of Research and Graduate Policy and are charged with the responsibility to review all research and teaching activities involving the use of human subjects in accordance with Stanford's policies and external regulations.
Any researcher (faculty, staff, student, or other) who will work with human subjects MUST complete a tutorial on this topic. This tutorial is online (http://www.stanford.edu/dept/DoR/hs).
For further information about the Administrative Panels on Human Subjects in Medical Research, visit http://humansubjects.stanford.edu/medical. For further information about the Administrative Panel on Human Subjects in Nonmedical Research, visit http://humansubjects.stanford.edu/nonmedical.
Student Research Involving Human Subjects
Stanford University is unusual in the number of both undergraduate and graduate students who become involved in research using human subjects. However, given the wide range of student research that occurs - everything from course-related research exercises to Ph.D. dissertation studies - questions concerning the responsibility of the Administrative Panel on the Use of Human Subjects do arise. Must all student projects come before the Panel? If not, which activities do not require review? What are the Panel's concerns regarding student research activities?
Student work using human subjects generally falls into one of two categories:
- Research Practica (course-related research projects and/or directed studies), the goal of which is to provide research experience to the student;
- Faculty-Directed Research Projects (usually carried out as honors theses, graduate projects or theses, or group projects), the goal of which is to add to generalizable knowledge.
Generally, the first category of student research does not require human subjects clearance by the Panel, but the second category does. A brochure on the "Use of Human Subjects in Student Projects, Pilot Studies, and Oral Histories" is available in the Research Policy Handbook (http://rph.stanford.edu/7-3.html). Check with your supervising faculty member if you are not sure if you need human subjects clearance.
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Review of Animal Experimentation
"Animal" means any live or dead vertebrate animal used or intended for use in research, research training, experimentation, biological testing, or for related purposes.
Stanford's Assurance of Compliance with the Public Health Service's (PHS) Policy on the Humane Care and Use of Laboratory Animals emphasizes the humane care and treatment of animals, and a thorough review of all procedures for their proposed use.
Individual Principal Investigators are responsible for the experimental design (protocol) for all projects which utilize animals. However, the Administrative Panel on Laboratory Animal Care (A-PLAC) is charged with reviewing those projects to insure that animals are properly used, housed and cared for.
Stanford requires that a Protocol for Care and Use of Laboratory Animals form be filed for every activity involving animals. This document will provide the A-PLAC with the information needed to approve a protocol with or without modifications, or to withhold approval of all or any portion of a protocol. This mechanism also serves to authorize the purchase of animals.
No animals may be purchased or used without an approved animal protocol.
For further information about the Administrative Panel on Laboratory Animal Care, visit their website (http://labanimals.stanford.edu/).
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The Administrative Panel on Biosafety (APB)
Stanford's Administrative Panel on Biosafety:
- Reviews and approves all University research and teaching activities involving the use of biohazardous agents and recombinant DNA molecules, blood, bloodborne pathogens, or other potentially infectious materials.
- Advises the University and recommends policies to guide investigators and Environmental Health & Safety in carrying out Stanford's Biosafety Program in the acquisition, use, training, transfer, storage, disposal, and emergency response procedures for all biosafety activities.
- Reviews all biosafety protocols regardless of the source of funding for the project. The Panel may approve research protocols with or without modifications, or withhold approval for all or any portion of a protocol.
For general information and assistance related to biosafety, check the biosafety website (http://www.stanford.edu/dept/EHS/prod/researchlab/bio/) or contact the Stanford Biosafety Officer at 725-1473.
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The Administrative Panel on Radiological Safety (APRS)
Radiological hazards refer to electromagnetic and charged particle radiation that could cause harm to persons. Included are sources of ionizing radiation, e.g., X-ray machines, particle accelerators and radioactive materials. Also included are lasers, ultraviolet radiation sources, and microwave generators.
The Administrative Panel on Radiological Safety (APRS):
- Reviews and approves all Stanford research and teaching activities involving the use of ionizing, ultraviolet, laser and microwave radiation. All projects that involve radiation shall be reviewed by the Panel regardless of whether the project is sponsored or unsponsored.
- Ensures that faculty and staff projects comply with all Stanford and external regulations.
- Has oversight for the acquisition, use, storage, transfer, and disposal of radiological hazards and the relevant training of Stanford personnel.
Uses of ionizing radiation which may involve human subjects or laboratory animals in research are also subject to review and approval by the Administrative Panel on Human Subjects in Medical Research or the Administrative Panel on Laboratory Animal Care, respectively. For general information and assistance related to radiological hazards, select "Health Physics" from the Environmental Health and Safety website (http://www.stanford.edu/dept/EHS) or phone 723-3201.
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