Title:

Human Subjects Research

Publication date:

6/10/2021

Effective date:

6/10/2021

Role

Responsibility

Human subjects researcher, 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, tissues, or fluids

• Safeguards the welfare, privacy, and rights of human subjects who take part in the research experiment
• Completes required training: EHS0740; note that PI on a protocol must have completed the appropriate CITI ethical use of human subjects training as indicated on the HSC website
• Develops protocols for and obtains HSC approval
• Ensures that staff working under the protocol(s) are trained
• Follows approved protocols, files renewals in a timely fashion, and promptly reports adverse/unexpected/reportable events to the HSC

Human Subjects Committee (HSC)

• Establishes and maintains a Federalwide Assurance of Compliance
• 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 adverse events to the Institutional Official and Laboratory Director
• Recommends changes in Laboratory policy relevant to human subjects research to the Institutional Official
• Certifies to funding agencies, the Office of Sponsored Partnerships & Industry Partnerships, and/or 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 Federalwide Assurance of Compliance 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
• Oversees the HARP database

Term

Definition

Human subject

A living person about whom a researcher obtains (1) data through intervention or interaction or (2) identifiable private information

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

Institutional Review Board

A board or committee authorized by a federal assurance to review research with human participants. The HSC is the Berkeley Lab Institutional Review Board.

Institutional Official for human subjects research

The Berkeley Lab official who signs the Federalwide Assurance of Compliance committing the institution to following the regulations laid out at in 45 CFR 46 (known as the Common Rule) and Subparts B, C, and D

Federalwide Assurance of Compliance

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

Document Number

Other Reference Number

Document Title

Type

n/a

Human/Animal Research Protocol (HARP)

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

Human Subjects Protection Program, Federalwide Assurance of Compliance

Compliance document

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

Title:

Human Subjects Research

Document number

03.02.002.000

Revision number

1.1

Publication date:

6/10/2021

Effective date:

6/10/2021

Next review date:

6/10/2026

Policy Area:

Human and Animal Subjects Research

RPM Section (home)

Conduct of R&D

RPM Section (cross-reference)

None

Functional Division

Prior reference information (optional)

PUB-3000, Section 22.1

Document Number

Other Reference Number

Document Title

Type

n/a

Human/Animal Research Protocol (HARP)

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

Human Subjects Protection Program, Federalwide Assurance of Compliance

Compliance document