Quick Start Guide
Chapter 22: Research with Human and Animal Subjects
Revision Record: http://www.lbl.gov/ehs/pub3000/Pub3000Changes.html
Who needs to know about these requirements?
The requirements of Research with Human and Animal Subjects apply to:
- Berkeley Lab employees, participating guests, visitors, and subcontractors
Whenever they are
- Conducting research that involves human participants (or their data, tissues, fluids, or other human-derived material) or vertebrate animal subjects
- In accordance with Department of Energy and Department of Health and Human Services regulations, research involving human participants must safeguard their welfare, privacy, and rights as specified under the guiding federal regulation, the Common Rule.
- Research involving experimental radioactive drugs in humans must additionally follow the guiding regulations laid out at 21 CFR 361.1.
- Research involving animals must be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the Animal Welfare Act (see the Public Health Service’s Guide for the Care and Use of Laboratory Animals).
What you need to do before performing work:
- Define work/protocols.
- Analyze hazards. Perform risk assessment.
- Write protocols for and obtain approval from appropriate organizations:
- Ensure that staff working under the protocols are trained.
- Follow approved protocols, and report adverse/unexpected events promptly to the relevant committee.
Where to find out more:
Whom to contact for help:
- For assistance with research with human and animal subjects, call the LBNL Human and Animal Regulatory Committees Office at (510) 486-5399.