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Research with Radioactive Drugs in Human Subjects

    Title:

    Research with Radioactive Drugs in Human Subjects

    Publication date:

    3/21/2014

    Effective date:

    3/21/2014

    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, the Common Rule. Research involving experimental radioactive drugs in humans must additionally follow the guiding regulations laid out at 21 CFR 361.1, Radioactive Drugs for Certain Research Uses.

    Who Should Read This Policy

    • Employees, affiliates(formerly known as "guests"), visitors, and subcontractors whenever they propose or conduct research that involves the use of applicable experimental radioactive drugs in human participants
    • The Institutional Official for human research, members of the Radioactive Drug Research Committee (RDRC), 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

    Radioactive Drug Research Committee
    Human and Animal Regulatory Committees Office
    HARC@lbl.gov
    (510) 486-5399

    Title:

    Research with Radioactive Drugs in Human Subjects

    Publication date:

    3/21/2014

    Effective date:

    3/21/2014

    POLICY

    A. Purpose

    All Lawrence Berkeley National Laboratory (Berkeley Lab) research involving human participants must safeguard participants' welfare, privacy, and rights as specified under the guiding federal regulation, 45 CFR 46, the Common Rule. Research involving experimental radioactive drugs in humans must additionally follow the guiding regulations laid out at 21 CFR 361.1, Radioactive Drugs for Certain Research Uses.

    B. Persons Affected

    • Employees, affiliates (formerly known as "guests"), visitors, and subcontractors whenever they propose or conduct research that involves the use of experimental radioactive drugs in human participants
    • The Institutional Official for human research, members of the Radioactive Drug Research Committee (RDRC), and the staff of the Human and Animal Regulatory Committees (HARC) Office, which supports the RDRC and the Human Subjects Protection Program as a whole

    C. Exceptions

    Research involving experimental radioactive drugs in human subjects where all the drugs used in the research are either approved by the Food and Drug Administration (FDA), or listed in the current United States Pharmacopeia, or are covered by an FDA-approved Investigational New Drug (IND) exemption

    D. Policy Statement

    All Berkeley Lab research involving human participants must safeguard participants' welfare, privacy, and rights as specified under the guiding federal regulation, 45 CFR 46, the Common Rule. Research including the administration to humans of experimental radioactive drugs not subject to the exception noted above in Section C, Exceptions, must additionally follow the guiding regulations laid out in 21 CFR 361.1. These requirements derive from a Department of Energy (DOE) order and Department of Health and Human Services regulations. 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 Human Subjects Committee (HSC) and, when applicable, the RDRC 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 and RDRC decisions, conditions, and requirements, or that has been associated with unexpected serious harm to subjects.

    E. Roles and Responsibilities

    Role

    Responsibility

    Human subjects researcher, including employees, affiliates (formerly known as "guests"), visitors, and subcontractors who propose or conduct research that includes the use of experimental radioactive drugs in human participants

    • Safeguards the welfare, privacy, and rights of human subjects who take part in the research experiment
    • Completes required training: EHS0740, Human Subjects Research Training
    • Develops protocols for and obtains HSC and RDRC approval
    • Ensures that staff working under the protocol(s) are trained
    • Follows approved protocols, files quarterly reports and renewals in a timely fashion, and promptly reports adverse/unexpected/reportable events to the HSC and RDRC

    Human Subjects Committee (HSC)

    • In addition to their responsibilities under the Human Subjects Research policy, verifies that RDRC approval has been obtained for studies involving the administration of radioactive drugs to human participants

    Institutional Official for Human Subjects Protection

    • Appoints members to the RDRC
    • Suspends or terminates research that is not conducted in accordance with RDRC decisions, conditions, and requirements, or that has been associated with unexpected serious harm to subjects
    • Approves changes in Laboratory policy relevant to research involving the use of experimental radioactive drugs in human participants
    • Ensures support to the RDRC and HARC Office sufficient to carry out their responsibilities

    Radioactive Drug Research Committee

    • Determines whether a given project falls within the purview of the RDRC
    • Reviews protocols for research with radioactive drugs in human participants
    • Ensures compliance with 21 CFR 361.1
    • Reviews the quarterly dose summaries for individual subject-studies
    • Reports annually and more often when needed to the Food and Drug Administration about activities carried out under the authority of 21 CFR 361.1

    RDRC Chair

    • Signs annual and special reports to the FDA on behalf of the RDRC

    Human and Animal Regulatory Committees (HARC) Staff

    • Facilitates and supports the RDRC, researchers, and the Institutional Official in carrying out their responsibilities
    • Oversees the Human/Animal Research Protocol Management System (HARP) database
    • Maintains physical files of RDRC records

    F. Definitions/Acronyms

    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 Human Subjects Committee (HSC) is the Berkeley Lab Institutional Review Board.

    Radioactive Drug Research Committee

    A board or committee authorized by the Food and Drug Administration responsible for the review and approval of research protocols involving the administration or use of radioactive drugs in human subjects

    Institutional Official for human subjects research

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

    Federal-wide 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 Berkeley Lab system housing online "smart" forms that lead researchers through protocol application, renewal, amendment, and adverse/unexpected event reporting processes

    Drug

    (1) Articles recognized in the United States Pharmacopoeia, Homoeopathic Pharmacopoeia of the United States, or the National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease 

    Radioactive drug or radiotracer

    Radioactive drugs or biological products labeled with a radionuclide

    Experimental radioactive drug

    A radioactive drug not listed in the United States Pharmacopoeia, Homoeopathic Pharmacopoeia of the United States, or the National Formulary, or any supplement to any of them

    Subject-study

    An instance of a radioactive drug being administered to a subject under an approved protocol

    G. Recordkeeping Requirements

    FDA Form 2914

    Radioactive Drug Research Committee Membership Summary: Prepared by the HARC staff and filed by the RDRC Chair annually (as part of the Annual Report) and whenever there is a membership change on the Committee

    FDA Form 2915

    Radioactive Drug Research Committee Report on the Research Use of Radioactive Drugs Study Summary: Filed quarterly by investigators with the RDRC to detail the actual subject-studies conducted during the previous quarter under each protocol approved for the use of experimental drugs. Filed by the RDRC with the FDA whenever the RDRC approves a research protocol meeting certain conditions established in 21 CFR 361.1.

    Annual Report

    An annual summary filed with the FDA by the RDRC Chair, containing a written summary of approved protocols, Form 2914, and Form(s) 2915 detailing the subject-studies conducted under each protocol approved for the use of experimental drugs at any time during the calendar year of the report

    H. Implementing Documents

    I. Contact Information

    Radioactive Drug Research Committee
    Human and Animal Regulatory Committee Office
    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

    3/21/2014

    1

    C. Byrne

    Full policy reformatted

    All

    Minor

     DOCUMENT INFORMATION

    Title:

    Research with Radioactive Drugs in Human Subjects

    Document number

    03.02.001.000

    Revision number

    1

    Publication date:

    3/21/2014

    Effective date:

    12/2001

    Next review date:

    3/21/2017

    Policy Area:

    Human and Animal Subjects Research

    RPM Section (home)

    Conduct of R&D

    RPM Section (cross-reference)

    None

    Functional Division

    Office of Institutional Assurance

    Prior reference information (optional)

    PUB 3000, Sec 22.1

    Source Requirements Documents

    • 21 CFR 361.1, Radioactive Drugs for Certain Research Uses
    • 45 CFR Part 46, Federal Policy for the Protection of Human Subjects (The Common Rule)

    Other Driving Requirements

    None

    Implementing Documents

    Document Number

    Other Reference Number

    Title

    Document Type


    03.02.002.001

    PUB-3000 Chapter 22

    Research with Human and Animal Subjects

    Program


    n/a

     

    Human Subjects Committee (HSC) Guidelines
    Reviewing Protocols Involving the Use of Ionizing Radiation

    Procedure


    n/a

     

    Human and Animal Research Protocol (HARP) system online "smart" protocol form

    Website

    FDA Form 2914

     

    Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs — Membership Summary

    Form

    FDA Form 2915

     

    Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs — Study Summary

    Form

    Other References

     

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