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
HARC@lbl.gov
(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:

  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

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
HARC@lbl.gov
(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

Other References

ADDITIONAL 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

Author name/contact info

C. Byrne



Revision 0 publication date

1/2/2012

Retirement date

none

Prior reference information (optional)

PUB-3000, Section 22.1



Inputs from more than one Functional Area?

No

List additional Functional Areas & contacts




Inputs from more than one Policy Area?

No

List additional Policy Areas & contacts




30-day notification needed?

No

30-day start date


30-day end date




LDAP protected?

No



Need TABL reminders?

No

Frequency


Brief reminder text:


Key labels/tags:

  • (Policy Area 1), (Policy Area 2), (Section)

New terms that need to be added to Glossary/Acronym list:

  • (list items not found and context (Policy Area name) – full definition would be included in Policy)

Implementing Documents restricted to department/functional use

(optional – these will be used for tracing between requirements and associated documents)

Document number

Title





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