Title: |
Human Subjects Research |
Publication date: |
1/23/2013 |
Effective date: |
12/2001 |
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, tissues, fluids, or other materials)
- The Institutional Official for human research; 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
[email protected]
(510) 486-5399
Title: |
Human Subjects Research |
Publication date: |
1/23/2013 |
Effective date: |
12/2001 |
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, tissues, or fluids)
- The Institutional Official for human research; 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 and the Human Subjects Protection Program as a whole
C. Exceptions
Not applicable
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, known as the Common Rule, including, where applicable, Subparts B, C, and/or D. This requirement derives from a Department of Energy (DOE) order and Department of Health and Human Services policy. To ensure that this requirement is met:
- 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
- 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 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 |
|
Human Subjects Committee (HSC) |
|
Institutional Official for Human Subjects Protection |
|
Human and Animal Regulatory Committees (HARC) Staff |
|
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 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 |
G. Recordkeeping Requirements
None
H. Implementing Documents
Document Number |
Other Reference Number |
Document Title |
Type |
n/a |
|
Web site |
|
03.02.002.001 |
PUB-3000 Chapter 22 |
Program |
|
n/a |
|
Charter |
|
n/a |
|
Human Subjects Protection Program, Federalwide Assurance of Compliance |
Compliance document |
I. Contact Information
Human and Animal Regulatory Committees Office
[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 |
DOCUMENT INFORMATION
Title: |
Human Subjects Research |
Document number |
03.02.002.000 |
Revision number |
1 |
Publication date: |
1/23/2013 |
Effective date: |
12/2001 |
Next review date: |
1/23/2016 |
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, 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)
Other Driving Requirements
Implementing Documents
Document Number |
Other Reference Number |
Document Title |
Type |
n/a |
|
Web site |
|
03.02.002.001 |
PUB-3000 Chapter 22 |
Program |
|
n/a |
|
Charter |
|
n/a |
|
Human Subjects Protection Program, Federalwide Assurance of Compliance |
Compliance document |