Quick Start Guide
Chapter 22: Research with Human and Animal Subjects

NEW 07/10
URL: http://www.lbl.gov/ehs/pub3000/CH22.html
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

Why?

• 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:

1. Define work/protocols.


2. Analyze hazards. Perform risk assessment.


• Review applicable guidance (see above) and committee Web sites.


• Take required training:


• For human research, EH&S 740


• For animal welfare, see EH&S Division Protocols.


3. Develop controls.


• Write protocols for and obtain approval from appropriate organizations:


• For human research, the LBNL Human Subjects Committee (HSC). For more information, see Section 22.1 (Research with Human Subjects).


• For basic research involving human use of experimental radiocompounds, the LBNL Radioactive Drug Research Committee (RDRC). For more information, see Section 22.1 (Research with Human Subjects) and Section 22.2 (Research with Radioactive Drugs).


• For animal research, the Animal Welfare and Research Committee (AWRC). For more information, see Section 23.3.3.5 (Approval Procedures).


• 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:

• LBNL Health and Safety Manual (PUB-3000), Chapter 22 (Research with Human and Animal Subjects)


• The Human and Animal Regulatory Committees Office Web site

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.