RPM

Skip to end of metadata

Title:	Human Subjects Research
Publication date:	10/28/2021
Effective date:	10/28/2021

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
[email protected]
(510) 486-5399

Title:	Human Subjects Research
Publication date:	10/28/2021
Effective date:	10/28/2021

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:

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
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

Role	Responsibility
Human subjects researchers, including employees, affiliates (formerly known as "guests"), visitors, and subcontractors who propose or conduct research that involves human participants or human-derived material such as data or biospecimens	Safeguard the welfare, privacy, and rights of human subjects who take part in the research experiment. Complete required Collaborative Institutional Training Initiative (CITI) training: See Training Policy. Develop protocols for and obtain HSC approval. Ensure that staff working under the protocol(s) are trained. Follow approved protocols, file renewals in a timely fashion, and promptly report adverse/unexpected/reportable events to the HSC.
Human Subjects Committee (HSC)	Establishes and maintains the FWA. Under the direction of the Chair, determines whether a given project constitutes human subjects research. Reviews research proposals to ensure the protection of human subjects. Monitors ongoing human subjects research for participant safety and fair treatment. Educates Berkeley Lab human subjects researchers as needed. Reports unanticipated problems and/or adverse events to the Institutional Official, Laboratory Director, and DOE HSP Program Manager. Recommends changes in Laboratory policy relevant to human subjects research to the Institutional Official. Certifies to funding agencies, the Strategic Partnerships Office, and/or the DOE that research has been reviewed and approved by the Institutional Review Board. Provides a contact for subjects of approved studies to answer their questions and address their concerns.
Institutional Official for Human Subjects Protection	Signs the FWA on behalf of the Laboratory. Appoints members to the HSC. Suspends or terminates research that is not conducted in accordance with HSC decisions, conditions, and requirements or that has been associated with unexpected serious harm to subjects. Approves changes in Laboratory policy relevant to human subjects research. Ensures support to the HSC and HARC Office sufficient to carry out their responsibilities.
Human and Animal Regulatory Committees (HARC) Staff	Facilitate and support the HSC, researchers, and the Institutional Official in carrying out their responsibilities. Oversee the HARP database.

F. Definitions/Acronyms

Term	Definition
Common Rule	45 CFR 46, the section of the Code of Federal Regulations that lays out the federal policy for the protection of human subjects
Federalwide Assurance (FWA) for the Protection of Human Subjects	The written, binding agreement submitted to the Department of Health and Human Services in which the institution commits to complying with regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved
Human/Animal Research Protocol Management System (HARP)	The system housing online "smart" forms that lead researchers through protocol application, renewal, amendment, and adverse/unexpected event reporting processes
Human subject	A living individual about whom an investigator (whether professional or student) conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Institutional Official for Human Subjects Protection	The Berkeley Lab official who signs the FWA committing the institution to following the regulations laid out in 45 CFR 46 (known as the Common Rule) and Subparts B, C, and D
Institutional Review Board	A board or committee authorized by a federalwide assurance to review research with human participants. The HSC is the Berkeley Lab Institutional Review Board.

G. Recordkeeping Requirements

None

H. Implementing Documents

Document Number	Other Reference Number	Document Title	Type
n/a		Human Subjects Committee	Web site
03.02.002.001	PUB-3000 Chapter 22	Research with Human and Animal Subjects	Program
n/a		Human Subjects Committee Charter	Charter
n/a		Federalwide Assurance for Protection of Human Subjects	Compliance document

I. Contact Information

Human and Animal Regulatory Committees Office
Mailbox: B260097
[email protected]
(510) 486-5399

J. Revision History

Date	Revision	By Whom	Revision Description	Section(s) Affected	Change Type
1/2/2012	0	C. Byrne	Brief for wiki	All	Minor
1/23/2013	1	C. Byrne	Full policy reformatted	All	Minor
6/10/2021	1.1	D. Bolt	Periodic review. Contact information and links updates. Added CITI training note.	Contact info; E	Editorial
9/29/2021	2	K. Miller	Updates on language, training, documents.	B, D, E, F, H	Minor

DOCUMENT INFORMATION

Title:	Human Subjects Research
Document number	03.02.002.000
Revision number	2
Publication date:	10/28/2021
Effective date:	10/28/2021
Next review date:	10/28/2026
Policy Area:	Human and Animal Subjects Research
RPM Section (home)	Conduct of R&D
RPM Section (cross-reference)	None
Functional Division	EH&S
Prior reference information (optional)	PUB-3000, Section 22.1

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

Document Number	Other Reference Number	Document Title	Type
n/a		Human Subjects Committee	Web site
03.02.002.001	PUB-3000 Chapter 22	Research with Human and Animal Subjects	Program
n/a		Human Subjects Committee Charter	Charter
n/a		Federalwide Assurance for Protection of Human Subjects	Compliance document

RPM

REQUIREMENTS AND POLICIES MANUAL

Human Subjects Research