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Deck of Cards
idConflict of Interest in Research – Human Subjects
Card
defaulttrue
labelBrief
titleBrief

Title:

Conflict of Interest in Research – Human Subjects

Publication date:

5/31/2013

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]

...

Card
labelPolicy
titlePolicy

Title:

Conflict of Interest in Research – Human Subjects

Publication date:

5/31/2013

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

  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. Anchor
    human
    human
    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
  • 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/Animal Research Protocol (HARP) system (online "smart" protocol form)

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

Human and Animal Regulatory Committees Office
[email protected]
(510) 486-5399

Research and Institutional Integrity Office
[email protected]

J. Revision History

Date

Revision

By whom

Revision Description

Section(s) affected

Change Type

1/2/2013

0

Stoufer

Rewrite for wiki (brief)

All

Minor

5/31/2013

1

C. Byrne

Full policy reformatted

All

Minor

...

Card
labelDocument Information
titleDocument Information

DOCUMENT INFORMATION

Title:

Conflict of Interest in Research – Human Subjects

Document number

05.02.004.000

Revision number

1

Publication date:

5/31/2013

Effective date:

12/16/2010

Next review date:

5/31/2016

Policy Area:

COI in Research

RPM Section (home)

Conflict of Interest

RPM Section (cross-reference)

10.09

Functional Division

Research and Institutional Integrity Office

Prior reference information (optional)

RPM Section 10.09

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

Document Number

Document Title

Type

N/A

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

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

...

Builder show
grouprpm2-admins
Card
labelAdditional Information
titleAdditional Information

ADDITIONAL INFORMATION

Title:

Conflict of Interest in Research – Human Subjects

Document number

05.02.004.000

Revision number

1

Publication date:

5/31/2013

Effective date:

12/16/2010

Next review date:

5/31/2016

Policy Area:

COI in Research

RPM Section (home)

Conflict of Interest

RPM Section (cross-reference)

10.09

Functional Division

Research and Institutional Integrity Office

Author name/contact info

M. Stoufer

 

 

Revision 0 publication date

1/2/2012

Retirement date

n/a

Prior reference information (optional)

RPM Section 10.09

 

 

Inputs from more than one Functional Area?

No

List additional Functional Areas & contacts

 

 

 

Inputs from more than one Policy Area?

No

List additional Policy Areas & contacts

 

 

 

30-day notification needed?

No

30-day start date

n/a

30-day end date

n/a

 

 

LDAP protected?

No

 

 

Need TABL reminders?

No

Frequency

n/a

Brief reminder text:

n/a

 

 

Approval Sheet for this revision received (date)
[Note: author is responsible}

 

Key labels/tags:

  • (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)

Document number

Title

 

 

 

 

Side bars:
Side bar 1 location (cite by Policy Section # - for example: Section D.2.a)
Sidebar 1 text:
Sidebar 2 location
Sidebar 2 text:
Sidebar 3 location
Sidebar 3 text:

...