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Evaluation Instrument for Accreditation
Jan 19, 2022, 21:59 PM
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INTRODUCTION
Mar 21, 2022, 00:45 AM -
TABLES
Feb 17, 2022, 16:24 PM -
DOMAIN III: RESEARCHER AND RESEARCH STAFF
Feb 9, 2022, 19:15 PM -
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
Jan 20, 2022, 16:37 PM -
DOMAIN I: ORGANIZATION
Jan 19, 2022, 22:01 PM
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STANDARD III-2
Mar 19, 2022, 04:22 AM -
STANDARD III-1
Feb 9, 2022, 19:19 PM
Resources: For Accreditation - Evaluation Instrument
Table of Contents
INTRODUCTION
USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATION
THE FIVE SECTIONS OF ELEMENTS AND STANDARDS
GLOSSARY OF TERMS
SUMMARY OF REVISIONS
DOMAIN I: ORGANIZATION
STANDARD I-1
STANDARD I-3
STANDARD I-4
STANDARD I-5
STANDARD I-6
STANDARD I-7
STANDARD I-8
STANDARD I-9
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
ELEMENT I.1.A
ELEMENT I.1.B
ELEMENT I.1.C.
ELEMENT I.1.D
ELEMENT I.1.E.
ELEMENT I.1.F.
ELEMENT I.1.G.
ELEMENT I.1.H.
STANDARD I-2
STANDARD II-1
STANDARD II-2
DOMAIN III: RESEARCHER AND RESEARCH STAFF
ELEMENT II.2.A.
ELEMENT II.2.B.
ELEMENT II.2.C.
Element II.2.D.
Element II.2.E.
Element II.2.F.
Element II.2.G.
Element II.2.H.
Element II.2.I.
STANDARD II-3
ELEMENT II.3.A.
ELEMENT II.3.B.
ELEMENT II.3.C.
ELEMENT II.3.D.
ELEMENT II.3.E.
ELEMENT II.3.F.
ELEMENT II.3.G.
STANDARD II-4
STANDARD II-5
STANDARD III-1
TABLES
ELEMENT III.1.A.
ELEMENT III.1.B.
ELEMENT III.1.C.
ELEMENT III.1.D.
ELEMENT III.1.E.
ELEMENT III.1.F.
ELEMENT III.1.G.
STANDARD III-2
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 Handbook 1200.05, 9
- AAHRPP Tip Sheet: Financial Conflict of Interest for Researchers and Research Staff
Required written materials
- Essential requirements:
- Policies and procedures pertaining to Element I.6.B. that address essential requirements.
- When following DHHS regulations:
- Policies and procedures pertaining to Element I.6.B. that address DHHS-specific requirements.
- When following FDA regulations:
- 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:
- 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.