Evaluation Instrument for AccreditationJan 19, 2022, 16:59 PM
INTERNATIONAL ADDENDAFeb 20, 2023, 23:40 PM
INTRODUCTIONMar 20, 2022, 20:45 PM
TABLESFeb 17, 2022, 11:24 AM
DOMAIN III: RESEARCHER AND RESEARCH STAFFFeb 9, 2022, 14:15 PM
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEEJan 20, 2022, 11:37 AM
DOMAIN I: ORGANIZATIONJan 19, 2022, 17:01 PM
STANDARD I-9Jan 27, 2022, 15:15 PM
STANDARD I-8Jan 27, 2022, 14:26 PM
STANDARD I-7Jan 27, 2022, 13:17 PM
STANDARD I-6Jan 27, 2022, 12:59 PM
STANDARD I-5Jan 21, 2022, 18:03 PM
STANDARD I-4Jan 19, 2022, 17:22 PM
STANDARD I-3Jan 19, 2022, 17:21 PM
STANDARD I-2Jan 19, 2022, 17:20 PM
STANDARD I-1Jan 19, 2022, 17:02 PM
Resources: For Accreditation - Evaluation Instrument
Evaluation Instrument for AccreditationDownload as PDF
Latest Update: May 15, 2022
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
ELEMENT I.4.B.: The organization conducts activities designed to enhance understanding of human research by participants, prospective participants, or their communities, when appropriate. These activities are evaluated on a regular basis for improvement.
To enhance the public’s understanding of research, organizations should perform outreach activities. The scope of the outreach activities should be proportional to the size and complexity of the research program. There is no requirement that a single activity will result in measurable changes in community understanding.
Regulatory and guidance references
Required written materials
- Essential requirements:
- Policies and procedures describe the plan and methods for enhancing the understanding of participants, prospective participants, and communities.
- Policies and procedures describe the periodic evaluation of outreach activities.
Common types of materials that may be used to meet the element
- Pamphlet or brochure
- Web site
- Research Day
- Mini-medical school
- Speaker bureau
- Evaluation reports
- Quality improvement plans
- The organization provides information designed to enhance the understanding of research involving participants and their community.
- IRB or EC members and researchers can describe the characteristics and culture of the communities in which they oversee or conduct research, respectively.
- The organization makes improvements to its outreach activities as needed, based upon a periodic assessment.
Proceed To: ELEMENT I.4.C.