BRIEF

Policy Summary

All protocol applications for research involving human subjects must be submitted to and approved by the Berkeley Lab Human Subjects Committee (HSC), which is the Berkeley Lab Institutional Review Board. All protocol applications must include disclosure of any financial or other personal considerations that may compromise, or have the appearance of compromising, the researchers' professional judgment in conducting or reporting research so as to adversely affect the rights and welfare of subjects.

Who Should Read This Policy

• Employees, affiliates (formerly known as "guests"), visitors, and subcontractors whenever they propose or conduct research that involves human participants, including the Protocol Lead Investigator(s) and any individuals having direct contact with human subjects
• 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
Research and Institutional Integrity Office [email protected]
End Brief

POLICY

A. Purpose

All protocol applications for research involving human participants at Lawrence Berkeley National Laboratory (Berkeley Lab) must include disclosure of any financial or other personal considerations that may compromise, or have the appearance of compromising, the researchers' professional judgment in conducting or reporting research so as to adversely affect the rights and welfare of subjects.

B. Persons Affected

• Employees, affiliates (formerly known as "guests"), visitors, and subcontractors whenever they propose or conduct research that involves human participants, including the Protocol Lead Investigator(s) and any individuals having direct contact with human subjects.
• 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

C. Exceptions

Not applicable

D. Policy Statement

1. General
   1. In the protection of human subjects at Berkeley Lab, "conflict of interest in research" refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, a researcher's professional judgment in conducting or reporting research so as to adversely affect the rights and welfare of subjects. Additionally, a conflict of interest in research depends on the situation, and not on the actions or character of an individual investigator.
   2. The U.S. Department of Health and Human Services, from which Berkeley Lab holds its approval to conduct research involving human subjects, has issued Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection, which can be found at: http://www.hhs.gov/ohrp/policy/fguid.pdf.
2. Human Subjects Research. At Berkeley Lab, all protocol applications for research involving human subjects must be submitted to and approved by the Berkeley Lab Human Subjects Committee (HSC), which is the Berkeley Lab Institutional Review Board. The Human and Animal Regulatory Committees (HARC) Office provides support for HSC.

E. Roles and Responsibilities

F. Definitions/Acronyms

G. Recordkeeping Requirements

None

H. Implementing Documents

I. Contact Information

Human and Animal Regulatory Committees Office [email protected]
Research and Institutional Integrity Office [email protected]

J. Revision History

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DOCUMENT INFORMATION

Source Requirements Documents

• The U.S. Department of Health and Human Services, Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection

Implementing Documents

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ADDITIONAL INFORMATION

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• (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)

Side bars:
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