Conflict of Interest in Research – Human Subjects

Title:	Conflict of Interest in Research – Human Subjects
Publication date:	6/11/2021
Effective date:	12/16/2010

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]

Title:	Conflict of Interest in Research – Human Subjects
Publication date:	6/11/2021
Effective date:	12/16/2010

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

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.
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

Role	Responsibility
Institutional Official for Human Subjects Protection	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
Protocol Lead Investigator	Identifies in all Human/Animal Research Protocol Management System (HARP) applications for human subjects research those personnel responsible for the design, conduct, and or the reporting of the study Discusses with personnel whether or not they have reportable financial interest(s) Completes the HARP application IRB Conflict of Interest page Uploads financial disclosure documents into HARP as needed Responds promptly to requests for additional information from the Research and Institutional Integrity Office (RIIO)
Responsible Personnel	Disclose financial interests to the Protocol Lead Investigator Complete financial disclosure documents as needed Respond promptly to requests for additional information from the Research and Institutional Integrity Office (RIIO)
Human Subjects Committee (HSC)	Reviews positive disclosures to the Research and Institutional Integrity Office (RIIO) Determines appropriate representation of the relationship in the protocol and consent forms
Research and Institutional Integrity Office (RIIO)	Reviews disclosures, and routes to review as appropriate Reviews financial interests related to research, and facilitates conflict of interest reviews Contacts the individuals filing the disclosure for additional information as needed Informs the HARC Office, the individual filing the disclosure, and the Protocol Lead Investigator of the outcome of the conflict of interest review

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
Institutional Review Board	A board or committee authorized by a federal assurance to review research with human participants. The Human Subjects Committee is the Berkeley Lab Institutional Review Board.
IO	Institutional Official for Human Subjects Protection
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
RIIO	Research and Institutional Integrity Office

G. Recordkeeping Requirements

None

H. Implementing Documents

Document Number	Document Title	Type
N/A	Human Subjects Committee (information on human subjects protection at LBNL and link to the Human/Animal Research Protocol (HARP) system)	Web site
N/A	Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection	Web site
Form DFI-3	LBNL Positive Disclosure of Financial Interests	Form

I. Contact Information