Protection of Human Subjects and Lab Animals
Research conducted by SJSU faculty, staff, or students that involves the use of human subjects or laboratory animals requires additional review and approvals by specialized review boards established by the university president.
Institutional Review Board (IRB)
The Institutional Review Board (IRB) reviews research proposals that are submitted by SJSU faculty, staff, and students that involve the use of human subjects and oversees human research activities. This committee ensures that the proposed research is in compliance with university and federal policies and regulations regarding the safety of human participants in research and the ethical and responsible conduct of investigators.
Research that includes the involvement of human participants either through direct interaction (interviews, surveys, experimental interventions, etc.) or through the use of private records about individuals require IRB approval. The protocol must be approved by the IRB before the research begins. For IRB procedures, forms, and other detailed information about requirements for research involving the participation of human subjects, please visit the Research and Innovation Human Subjects Institutional Review Board web page.
Institutional Animal Care and Use Committee (IACUC)
The university complies with federal, state, university, and other regulatory requirements related to the acquisition, care, use, and treatment of animals in the performance of instruction and research. Established by the SJSU president, the Institutional Animal Care and Use Committee (IACUC), is responsible for the oversight and review of all issues related to animal care, facilities, and procedures.
The IACUC is charged with:
- reviewing and approving animal care and use protocols;
- monitoring all approved animal activities and facilities;
- ensuring human and animal welfare associated with approved activities;
- making recommendations to the Institutional Official regarding any aspect of animal care and use standards, facilities and personnel training; and
- investigating reported concerns of animal care and use at SJSU.
For standard protocol, training, forms, and other detailed information about research involving the use of laboratory animals, visit the Research and Innovation Institutional Animal Care and Use Committee web page.
Institutional Biosafety Committee
The Institutional Biosafety Committee (IBC) oversees biological safety at SJSU. The committee ensures safe and responsible use of research facilities and adherence to requirements for handling of biological agents as specified in National Institutes of Health (NIH) Guidelines and applicable university policies. The overall objective of the IBC is to ensure that activities meet the standards of good biological safety practice emphasizing protection of personnel, the public, and the environment.
Biological Use Authorization
All SJSU faculty, staff, and lecturers who use any of the biological agents in research or teaching activities must submit a request for a biological use authorization (BUA) when research activities involve any of the following:
- Biological agents above biosafety level 1(BSL-1)
- Recombinant or synthetic nucleic acid molecules
- Unfixed materials derived from humans and nonhuman primates
- Collection of plant and animal or cultivation of exotic or noxious plants
- Biological toxins with an LD50 of less than 100 micrograms per kilogram of body weight in vertebrates;
- Select agents and toxins subject to 42 CFR Part 73, 9 CFR Part 121, or 7 CFR Part 331;
- Agents of Dual Use Research Concern
Violations or Accidents
Violations of NIH Guidelines, any problems, research-related accidents or illnesses must be immediately reported to the Institutional Biosafety Committee (firstname.lastname@example.org) for review. Incidents specified in the NIH Guidelines must be reported to the NIH Office of Science Policy.