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Resources: For Accreditation - Evaluation Instrument
Table of Contents
USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATIONTHE FIVE SECTIONS OF ELEMENTS AND STANDARDSGLOSSARY OF TERMSSUMMARY OF REVISIONSDOMAIN I: ORGANIZATION
STANDARD I-1STANDARD I-3STANDARD I-4 STANDARD I-5 STANDARD I-6 STANDARD I-7 STANDARD I-8 STANDARD I-9DOMAIN 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-2DOMAIN 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-1TABLES INTERNATIONAL ADDENDA
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
USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATION
use of the evaluation instrument for accreditation: The Evaluation Instrument for Accreditation is intended for use by organizations seeking accreditation and by site visitors who evaluate organizations. To achieve accreditation, an organization must meet all the accreditation Standards and Elements. If an organization meets the Elements for a particular Standard, it meets the Standard. This Evaluation Instrument provides the information necessary to meet each Element.
AAHRPP has defined Domains of responsibility: Organization, Institutional Review Board (IRB) or Ethics Committee (EC), and Researchers and Research Staff. Within each Domain are Standards, and for each Standard there are Elements that provide more specificity for the Standard. Each Element contains four parts: Commentary, Regulatory and Guidance References, Required Written Materials, and Outcomes.
For some Elements, Common Types of Materials That May Be Used to Meet the Element are included. Listed under this heading are examples of written materials that organizations have used to meet the Element. They are not required, and organizations may use other types of written materials to meet the Element. If an Element refers to written policies and procedures it generally means that a written procedure (e.g., standard operating procedure) is required to meet the Element. In some cases, an application form or reviewer checklist can serve the same purpose as a written procedure. AAHRPP has attempted to identify those Elements.
By designating certain types of written materials that may be used to meet an Element, AAHRPP does not desire to reduce the flexibility of the accreditation or limit creativity. The listing of Common Types of Materials That May Be Used to Meet an Element is intended to be helpful by providing guidance on the types of materials that can meet an Element.
This Evaluation Instrument is designed to be used by organizations in the United States as well as organizations in other countries that are obligated to follow U.S. federal regulations and those that are not so obligated. The Evaluation Instrument separately designates regulations and guidance from various U.S. federal agencies as well as the International Committee on Harmonisation – Good Clinical Practice Guideline (ICH-GCP) (E6). This includes regulations and guidance from the Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA), as well as other departments or agencies that have additional requirements, such as the Department of Defense (DoD), the Department of Education (ED), the Department of Energy (DOE), the Department of Justice (DOJ), the Department of Veteran Affairs (VA), and the Environmental Protection Agency (EPA).
For each Element, there are essential requirements that all organizations must follow. These essential requirements meet many U.S. and international government requirements for protection of human research participants. For some Elements, additional requirements are listed for specific U.S. federal agencies and the ICH-GCP (E6) Guideline.
Each Element (or Standard without Elements) begins on a separate page. This gives the appearance that the Evaluation Instrument is longer than it actually is. Separating each Element provides discrete documents to print and consider.
Proceed To: THE FIVE SECTIONS OF ELEMENTS AND STANDARDS