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.8.A.: The organization has a written agreement with the sponsor that addresses medical care for research participants with a research-related injury, when appropriate.
When appropriate, arrangements for medical care for research-related injury should be defined before the research starts and communicated to prospective participants. (See Element II.3.F.) This Element does not require any particular party, among the organization, sponsor or its agents, or participant to be responsible for such care; it requires that it be made clear to participants who will provide medical care and who will be responsible to pay for it.
This Element primarily applies only to the organization that conducts clinical research. If an organization conducts other types of research in addition to clinical research, this Element is generally not applicable, although there might be instances where research-related injury requiring medical care could occur. The organization should evaluate the risk of injury in the research conducted under its auspices and should make determinations whether medical care for research-related injury might be needed.
Regulatory and guidance references
- DHHS: 45 CFR 46.116(a)(6), 45 CFR 46.116(a)(7)
- FDA: 21 CFR 50.25(a)(6), 21 CFR 50.25(a)(7)
- AAHRPP Tip Sheet: Provisions in Contracts and Funding Agreements
Required written materials
- Essential requirements:
- Policies and procedures have contracts or other funding agreements indicate who will provide care and who is responsible to pay for it.
- For independent IRBs:
- If the organization contracts with sponsors or clinical research organizations, contracts or other funding agreements state that sponsors are required to indicate who will provide care and who is responsible to pay for it.
- Policies and procedures include the process used to ensure that contracts with the researcher indicate who will provide care and who is responsible to pay for it, such as an attestation or other written statement from the researcher or clinical research organization, for examples master service agreement or work order.
Common types of materials that may be used to meet the element
- Contract template
- Reviewer checklist for contract language
- When appropriate, arrangements for medical care for research-related injury are defined before the research starts.
- For independent IRBs attestations or other written statements or agreements describe who will provide care and who is responsible to pay for it.
Proceed To: ELEMENT I.8.B.