Research with Radioactive Drugs in Human Subjects

Title:	Research with Radioactive Drugs in Human Subjects
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, 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, 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 Subjects Protection, 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
HARC Office
Mailbox: B260097
[email protected]
(510) 486-5399

Title:	Research with Radioactive Drugs in Human Subjects
Publication date:	10/28/2021
Effective date:	10/28/2021

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, 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 Subjects Protection, 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 Committee (HSC)

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

In addition to the regulations discussed in the Human Subjects Research policy, research including the administration to humans of experimental radioactive drugs not subject to the exception noted above in Section C, must additionally follow the guiding regulations laid out by the FDA in 21 CFR 361.1. To ensure that these additional requirements are met, Berkeley Lab established the Radioactive Drug Research Committee (FDA#0038) to:

Review applicable studies prior to initiation; and
Provide oversight throughout the lifetime of those studies, ensuring that all reporting requirements to the FDA are met and the approved protocol is followed.

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 researchers, including employees, affiliates, visitors, and subcontractors who propose or conduct research that includes the use of experimental radioactive drugs in human participants	Safeguard the welfare, privacy, and rights of human subjects who take part in the research experiment Complete required Collaborative Institutional Training Initiative (CITI Program) training: see the Training Policy. Develop protocols for and obtain HSC and RDRC approval. Ensure that staff working under the protocol(s) are trained. Follow approved protocols, file quarterly reports and renewals in a timely fashion, and promptly report adverse/unexpected/reportable events to the HSC and RDRC.
Human Subjects Committee (HSC)	In addition to its responsibilities under the Human Subjects Research policy, identifies potential RDRC-covered studies and refers them for corresponding review. 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 (FDA) 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 all files of RDRC records.

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
Drug	(1) Articles recognized in the United States Pharmacopeia, Homoeopathic Pharmacopeia 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
Experimental radioactive drug	A radioactive drug not listed in the United States Pharmacopeia, Homoeopathic Pharmacopeia of the United States, or the National Formulary, or any supplement to any of them
Federal-wide Assurance for the Protection of Human Subjects (FWA)	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
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 Federal-wide Assurance for the Protection of Human Subjects (FWA) to review research with human participants. The Human Subjects Committee (HSC) is the Berkeley Lab Institutional Review Board.
Radioactive drug or radiotracer	Radioactive drugs or biological products labeled with a radionuclide
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
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
HARC Office
Mailbox: 260097
[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
3/21/2014	1	C. Byrne	Full policy reformatted	All	Minor
6/10/2021	1.1	D. Bolt	Periodic review. Updated contact information and links. Added CITI training note in E.	Contact info and E	Editorial
10/7/2021	2	K. Miller	Updated language, training, and document links.	B, D, E, F, H	Minor

DOCUMENT INFORMATION

Title:	Research with Radioactive Drugs in Human Subjects
Document number	03.02.001.000
Revision number	2.0
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, 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

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