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 III-2Mar 19, 2022, 00:22 AM
STANDARD III-1Feb 9, 2022, 14:19 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 III.1.D.: Researchers determine that the resources necessary to protect participants are present before conducting each research study.
Researchers should have the resources required to conduct research in a way that will protect the rights and welfare of participants and ensure the integrity of the research. These resources might include personnel, time, and access to a study population. Researchers should not commence a research study without adequate resources to protect participants and should stop a research study if resources become unavailable.
Regulatory and guidance references
- ICH-GCP: 4.2.1, 4.2.2, 4.2.4, 4.3.2
- VA: VHA Handbook 1200.05, 9
- AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
Required written materials
- Essential requirements:
- Policies and procedures pertaining to Element II.3.A. that address essential elements.
- The policies and procedures pertaining to Element II.3.A 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 II.3.A, but are in support of Element III.1.D., include them here.
- Researchers are responsible to:
- Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
- Ensure that research staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials and, when relevant, privileges) to perform procedures assigned to them during the study.
Common types of materials that may be used to meet the element
- Researcher manual
- When conducting a research study, researchers have the resources necessary to protect human participants, including:
- Adequate time for the researchers to conduct and complete the research.
- Adequate number of qualified staff.
- Adequate facilities.
- Access to a population that will allow recruitment of the necessary number of participants.
- Availability of medical or psychosocial resources that participants may need as a consequence of
- the research.
- A process to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions.
Proceed To: ELEMENT III.1.E.