Jan 19, 2022, 16:59 PM
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
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.
THE FIVE SECTIONS OF THE EVALUATION INSTRUMENT
This section provides an explanation of how to interpret the Element.
2) Regulatory and Guidance References
Listed here are regulatory and guidance citations from the U.S. federal agencies that oversee research with human participants. These citations were updated on September 22, 2016. Also, listed here are the guidance citations from the International Committee on Harmonisation - Good Clinical Practice (E6) guideline.
Organizations that must follow a certain set of regulations (e.g., DHHS or FDA) must meet the regulatory requirements. Organizations that are not bound to follow a particular set of regulations are not required to meet them, but they should describe and provide equivalent protections, when applicable.
3) Required Written Materials
This section contains the requirements for written materials an organization must have to meet the Element.
AAHRPP uses the generic term “policies and procedures” to refer to all types of written materials. Policies and procedures include any written materials that the organization uses to define and communicate its practices, such as standard operating procedures, policy statements, procedure descriptions, checklists, guidelines, educational materials, job descriptions, memoranda, forms, templates, strategic plans, Web sites, charters, by-laws, mission statements, or other forms, that are used to administer the Human Research Protection Program. Policies and procedures are not limited to IRB or EC policies and procedures; other organizational procedures are likely to be relevant, such as some policies related to human resources, budgeting, pharmacy, contracting, student orientation, corporate compliance, or corporate ethics.
A policy is generally defined as a strategy, goal, or objective. It defines an expectation regarding a behavior or course of action. A procedure is a method by which a policy can be accomplished. Procedures should describe the operational steps that are followed to meet regulatory requirements. A restatement of the regulations or guidance is generally insufficient to provide the necessary specificity. Procedures should include:
- An explanation of how key regulatory terms are interpreted,
- The actions that are taken,
- The title of the person, office, or entity responsible for taking the action, and 4) The timing of actions.
No single format is required for policies and procedures, and no specific wording is required to be used in policies and procedures. Organizations have used a range of models for writing policies and procedures. Procedures should provide enough detail to be understandable to individuals within the organization who use them. Procedures should reflect actual practice within the organization.
AAHRPP has provided a description of the content for many policies and procedures. U.S. regulatory requirements, such as the criteria for approval of research, elements of disclosure for the consent process, or types of disclosure for financial interests, are not listed. The organization must use the federal regulations to obtain these requirements.
4) Common Types of Materials That May Be Used to Meet the Element
These are examples of the types of materials organizations have provided to meet the Element. Sometimes, materials are listed under this section when there is requirement for written materials to meet the Element. AAHRPP has included this section under the Element to assist organizations in meeting the Element. Organizations that do not have the materials should not create them to meet the Element. The listing is intended only a facilitative tool.
In this section, “procedures” are not listed as an example of a written material that may be used to the meet the Element. In some cases, the combination of an application form and reviewer evaluation tool will be sufficient to meet the Element, and a written procedure in addition to the application form and reviewer evaluation tool is not needed. This must be judged uniquely for each Element and for each organization.
These are the practices that an organization should have in place.
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