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Located Inside: Research Policy Handbook

Summary:

Outlines membership and responsibilities of Stanford University's five Administrative Panels for Research Compliance:

• Administrative Panel on Human Subjects in Non-Medical Research
• Administrative Panel on Human Subjects in Medical Research
• Administrative Panel on Radiological Safety
• Administrative Panel on Biosafety
• Administrative Panel on Laboratory Animal Care.

Related Research Policy Handbook Documents:

6.7    Radiological Hazards [EH&S document]
6.9    Biohazardous Agents and Recombinant DNA [EH&S document]
7.1    Federalwide Assurance of Protection for Human Subjects
8.1    Animal Welfare Assurance: Core Contents
10.1  Preparation, Review and Submission of
          Sponsored Project Proposals

SEE ALSO:  Research Compliance Office Home Page
          Environmental Health & Safety Office Home Page

Authority:

Vice Provost and Dean of Research

Contact Person:

Research Compliance Director

Stanford University's five Administrative Panels on research compliance are appointed by the University President and report to him through the Office of the Vice Provost and Dean of Research. The Panels assure the institution's compliance with federal, state and local regulation of research and teaching activities by reviewing those activities which involve the use of human subjects, laboratory animals, biohazardous agents, recombinant DNA or radiological hazards. In addition, the Administrative Panels are responsible for assessing current research policy and helping formulate new policy governing the conduct of research and training at Stanford with respect to the subjects or agents under the jurisdiction of each panel.

Although in most cases external regulations typically apply to government-funded research projects, Stanford policy is to apply such regulations to all relevant activities, whether they are externally funded or not. In cases of dispute with respect to procedures or decisions of the Administrative Panels, faculty may appeal to the Vice Provost and Dean of Research for adjudication. However, external regulations prohibit approval of research activities governed by the Panel if they have not been approved by the Panel.

Each Administrative Panel is required to submit an annual report to the President summarizing the Panel's activities and recommendations for the previous year. Administrative Panel activities are subject to Stanford's guidelines on Confidentiality of Administrative Panel Proceedings (see Research Policy Handbook document 1.5 on this subject).

Copies of the Charges to Stanford's Administrative Panels are available from the Office of the Vice Provost and Dean of Research. Questions regarding compliance with research policy and procedure should be directed to the Research Compliance Administrator (723-4697), who represents the University to external funding agencies to certify the review and approval of University research projects.

REPRESENTATION ON THE PANELS

The term of tenure for members of the Panel is for the twelve-month period following the beginning of each academic year. Student representatives on the Administrative Panels are nominated by the ASSU Committee on Nominations. A representative of the Vice Provost and Dean of Research, a representative of the Dean of the School of Medicine, or a representative of the General Counsel may serve, where appropriate, as an ex-officio member of the University's Administrative Panels. Further details on criteria for appointment to the University's Administrative Panels appear below.

Questions regarding University policy intended to protect subjects, the environment or the public at large with respect to the conduct of research at Stanford should be directed to the Research Compliance Administrator or to the Dean of Research.

Below is a summary of the charge, role and composition of each of Stanford's Administrative Panels for research compliance.

ADMINISTRATIVE PANELS ON HUMAN SUBJECTS

If any proposed research involves the use of human subjects, the proposal must comply with the University's agreement on file with the U.S. Department of Health and Human Services (DHHS). This agreement requires prior review and approval of research proposals involving the use of human subjects in research. Stanford has two Human Subject Panels, one dealing with research in social sciences and behavioral issues, the other dealing with medical research such as experimental diagnostic mechanisms, drugs, prosthetic devices or other experimental treatments of human physical disorders.

1. ADMINISTRATIVE PANEL ON HUMAN SUBJECTS IN NON-MEDICAL RESEARCH
   
   

   The Human Subjects (Non-Medical) Panel has oversight responsibility for the review of all University projects which involve human subjects in non-medical research to ensure that the rights and welfare of the subjects are adequately protected. In most cases, Panel reviews involve approval of a clearly-worded consent form which assures that the subject is fully informed of the risks inherent in participation and of the benefits which might be reasonably expected.

   The Panel consists of at least five members, including the following: faculty and staff chosen by the President, one Stanford student, and at least one member from the community who is otherwise not affiliated with the University. The Panel meets as necessary to conduct its business, but no less than bi-monthly.

   Questions pertaining to the use of human subjects in research should be directed to the Research Compliance Administrator (723-4697).

2. ADMINISTRATIVE PANEL ON HUMAN SUBJECTS IN MEDICAL RESEARCH
   
   

   The Administrative Panel on Human Subjects in Medical Research has oversight responsibility for the review of all University projects which involve human subjects in medical research to ensure that the rights and welfare of the subjects are adequately protected. In most cases, Panel reviews involve approval of a clearly-worded consent form which assures that the subject is fully informed of the risks inherent in participation and of the benefits which might be reasonably expected.

   The Panel's jurisdiction is limited to research projects which involve either the participation of Stanford personnel including members of the Academic Council, University employees, students, and Hospital employees, or use of facilities of Stanford University, Stanford University Hospital, Palo Alto Veterans Administration Medical Center, or Children's Hospital at Stanford. The Panel will not review projects conducted by Voluntary Clinical Faculty (VCF) except in projects as described above in this paragraph.

   The Panel consists of at least five members, including the following: faculty and staff chosen by the President, one Stanford student, and at least one member from the community who is otherwise not affiliated with the University. The Panel meets as necessary to conduct its business, but no less than twelve times during the year.

   Questions pertaining to the use of human subjects in medical research should be directed to the Research Compliance Administrator (723-4697).

ADMINISTRATIVE PANEL ON RADIOLOGICAL SAFETY

The Administrative Panel on Radiological Safety is charged with the responsibility to advise the University on problems relating to radiological hazards. In addition, it is responsible for exercising the authority delegated to it by the President under the University's broad-form licenses from the State of California, the Nuclear Regulatory Commission and other regulations. The Panel's objective is to ensure the safety of personnel and the general public and to make sure that those persons using ionizing, ultra-violet, laser and microwave radiation comply with laws, regulations and standards of good practice.

The specific responsibilities of the Panel include providing guidelines for and review of Local Control Committees for radiological hazards, providing a continuing review of the University's Health Physics Program, and providing the review and enforcement of the University radiation safety policy.

Members of the Panel are selected for their expertise in radiation science, including but not limited to the following: one representative from each Local Control Committee, a liaison appointed by the Director of the Stanford Linear Accelerator Center, and a Stanford University graduate student.

The Panel's jurisdiction extends to all programs and activities of Stanford University involving radiation except for the Stanford Linear Accelerator Center (SLAC), which maintains its own procedures in accordance with Department of Energy (DOE) regulations. The Panel meets as necessary to conduct its business, but no less than three times during the twelve months of the year.

Investigators who plan to undertake experiments or instructional programs involving the use of materials or devices which pose radiation hazards (e.g., isotopes, radiation-producing machines), should consult the Director of Health Physics (725-1413) and the appropriate Local Control Committee while the proposal is being prepared, i.e., prior to delivery of materials to campus and commencement of the work. For projects to be undertaken at SLAC, the SLAC Health Physics Office should be consulted.

ADMINISTRATIVE PANEL ON BIOSAFETY

The Administrative Panel on Biosafety is responsible for the review of the University's teaching projects, research activities and facilities involving the acquisition, use, storage and disposal of biohazardous agents. For this purpose, biohazardous agents are defined as infectious/pathogenic agents classified in the following categories:

1. Class 2,3,4 and 5 bacterial, fungal, parasitic, viral, rickettsial or chlamydial agents,
2. other infectious agents that have the potential for causing disease in healthy individuals, animals or plants.
   
   

The Panel provides the University's assurance of compliance with applicable institutional policies, NIH Guidelines, and state regulations regarding the use of infectious agents and toxin-producing agents that have the potential for causing disease in healthy individuals, animals or plants.

The Panel advises the University and recommends policies to guide investigators and the Department of Environmental Health and Safety in carrying out the University's Biosafety program in research involving recombinant DNA and infectious agents (see Stanford's Policy on Biohazardous Agents and Recombinant DNA).

Panel membership is comprised of at least five members who have experience and expertise in general issues of laboratory biosafety and in recombinant DNA technology, two members from the community who are not otherwise affiliated with Stanford, and a Stanford student. The Panel meets as necessary to conduct its business throughout the calendar year.

Questions pertaining to the use of biohazardous agents should be directed to the Biosafety Officer, 725-1473.

ADMINISTRATIVE PANEL ON LABORATORY ANIMAL CARE

The Administrative Panel on Laboratory Animal Care (A-PLAC) is charged with the responsibility to determine that all vertebrate animals used in research or teaching within the University are treated humanely and with proper care, and that the University is in compliance with all relevant government laws, regulations and policies.

The Administrative Panel on Laboratory Animal Care is comprised of at least ten members as follows: five faculty members who use animals in research at Stanford, two faculty members who are not involved in the use of animals in teaching or research, the Director of the Veterinary Services Center (VSC), a Stanford student (an upperclassman with previous animal experience in laboratory settings), and at least one member who is otherwise not affiliated with the University. Alternate members are also appointed each year. The Panel meets as necessary to conduct its business, but no less than bi-monthly.

If laboratory animals are to be used in the conduct of a research or teaching project, a protocol must be submitted to the A-PLAC for review and approval prior to the commencement of the project and prior to the University's acceptance of an award. Investigators must comply with University regulations established by the Panel, federal standards relating to animal care, and the terms of the University's Assurance filed with the Department of Health and Human Services (DHHS).

Approval of a protocol may be granted for a one year period only after review at a convened meeting of a quorum of the Panel. At least twice per year, the Panel must inspect all facilities in which experimental animals are housed. It shall also conduct periodic inspections of facilities in which research or teaching procedures are performed involving animals. The Veterinary Services Center is responsible to periodically review the ongoing care and use of animals to ensure its compliance with the terms outlined in the research protocol.

Questions pertaining to the use of laboratory animals should be directed to the Research Compliance Administrator (723-4697).