ELEMENT III.1.B.

ELEMENT III.1.B.: Researchers and research staff identify and disclose financial interests according to organizational policies and regulatory requirements and, with the organization, manage, minimize, or eliminate financial conflicts of interest.

Researchers and research staff should understand the organization’s financial conflict of interest policy in order to follow it. For example, researchers and research staff should know which interests the organization requires to be disclosed. Researchers and research staff should know how, when, and to whom to disclose financial interests.

Researchers and research staff should understand how financial conflicts of interest can influence the protection of research participants. Researchers and research staff should also work collaboratively with the organization in the management of financial conflicts of interest.

Independent researchers and research staff who work with independent IRBs should understand legal and regulatory requirements for disclosing, managing, minimizing, or eliminating financial conflicts of interest. Such researchers and research staff should know how, when, and to whom to disclose financial interests and work collaboratively with independent IRBs in the management of financial conflicts of interest.

Regulatory and guidance references

DHHS: 42 CFR 50.603, 42 CFR 50.606(a), 45
CFR 690
FDA: 21 CFR 54.1, 21 CFR 54.2, 21 CFR 54.4, 21 CFR 312.64(d), 21 CFR 812.110(d)
VA: VHA Directive1200.05(3), 5
AAHRPP Tip Sheet: Financial Conflict of Interest for Researchers and Research Staff

Required written materials

Essential requirements:
1. Policies and procedures pertaining to Element I.6.B. that address essential requirements.
When following DHHS regulations:
1. Policies and procedures pertaining to Element I.6.B. that address DHHS-specific requirements.
When following FDA regulations:
1. Policies and procedures pertaining to Element I.6.B. that address FDA-specific requirements.
When following DHHS and FDA regulations:

Policies and procedures pertaining to Element I.6.B. must also address the written material requirements for this Element. If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element. If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Element I.6.A., but are in support of Element III.1.B., include them here.

When following VA requirements:
1. Researchers must disclose conflicts of interest. This means disclosing to the IRB any potential, actual, or perceived conflict of interest of a financial, professional, or personal nature that may affect any aspect of the research, and complying with all applicable VA and other federal requirements regarding conflict of interest.

Common types of materials that may be used to meet the element

Researcher manual

Outcomes

Researchers and research staff understand the concept of conflict of interest.
Researchers and research staff disclose required financial interests.
Researchers and research staff work collaboratively with the organization or independent IRB to manage financial conflicts of interest.

Proceed To: ELEMENT III.1.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT III.1.B.