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REQUIREMENTS AND POLICIES MANUAL

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Human Subjects Research

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    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:

    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
    [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

    Other References

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