BRIEF

Policy Summary

All Berkeley Lab research involving human participants must safeguard participants' welfare, privacy, and rights as specified under the guiding federal regulation, 45 CFR 46, known as the Common Rule.

Who Should Read This Policy

• Employees, affiliates (formerly known as "guests"), visitors, and subcontractors whenever they propose or conduct research that involves human participants (or human-derived data or biospecimens)
• The Institutional Official for Human Subjects Protection; members of the Institutional Review Board, known at Berkeley Lab as the Human Subjects Committee (HSC); and the staff of the Human and Animal Regulatory Committees (HARC) Office

To Read the Full Policy, Go To:

The POLICY tab on this wiki page

Contact Information

Human and Animal Regulatory Committees Office
Mailbox: B260097
HARC@lbl.gov
(510) 486-5399

POLICY

A. Purpose

All research at Lawrence Berkeley National Laboratory (Berkeley Lab) involving human participants must safeguard participants' welfare, privacy, and rights as specified under the guiding federal regulation, 45 CFR 46, known as the Common Rule.

B. Persons Affected

• Berkeley Lab employees, affiliates (formerly known as "guests"), visitors, and subcontractors whenever they propose or conduct research that involves human participants (or human-derived material, such as data or biospecimens)
• The Institutional Official for Human Subjects Protection; members of the Institutional Review Board, known at Berkeley Lab as the Human Subjects Committee (HSC); and the staff of the Human and Animal Regulatory Committees (HARC) Office, which supports the HSC as well as other regulatory committees

C. Exceptions

Not applicable

D. Policy Statement

Compliance with the Common Rule is a requirement at Berkeley Lab stemming from the Department of Energy (DOE) order 443.1C and Department of Health and Human Services policy (45 CFR 46). Ensuring that human research subjects are treated ethically, equitably, and respectfully is the core mission of Berkeley Lab's Human Subjects Committee (HSC) as a part of fulfilling these directives. Our commitment to these principles is established by our Federalwide Assurance (FWA) for the Protection of Human Subjects from the Office of Human Research Protections (OHRP). To ensure that these requirements are met:

1. All protocols for research involving human participants performed at or funded through Berkeley Lab must be submitted to and formally approved by the HSC prior to initiation, and
2. All work with human participants must follow the approved protocol.

The Laboratory can terminate research that is not conducted in accordance with HSC decisions, conditions, and requirements or that has been associated with unexpected serious harm to subjects.

E. Roles and Responsibilities

F. Definitions/Acronyms

G. Recordkeeping Requirements

None

H. Implementing Documents

I. Contact Information

Human and Animal Regulatory Committees Office
Mailbox: B260097
HARC@lbl.gov
(510) 486-5399

J. Revision History

DOCUMENT INFORMATION

Source Requirements Documents

Federal Policy for the Protection of Human Subjects ("Common Rule"), and subparts B, C, and D (45 CFR Part 46)
DOE O 443.1C, Protection of Human Research Subjects

Other Driving Requirements

The Belmont Report

Implementing Documents

Other References

• Training Policy
• Policies, Procedures, and Guidelines