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Evaluation Instrument for Accreditation
Jan 19, 2022, 16:59 PM
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INTERNATIONAL ADDENDA
Feb 20, 2023, 23:40 PM -
INTRODUCTION
Mar 20, 2022, 20:45 PM -
TABLES
Feb 17, 2022, 11:24 AM -
DOMAIN III: RESEARCHER AND RESEARCH STAFF
Feb 9, 2022, 14:15 PM -
DOMAIN II: INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE
Jan 20, 2022, 11:37 AM -
DOMAIN I: ORGANIZATION
Jan 19, 2022, 17:01 PM
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STANDARD III-2
Mar 19, 2022, 00:22 AM -
STANDARD III-1
Feb 9, 2022, 14:19 PM
Resources: For Accreditation - Evaluation Instrument
Table of Contents
INTRODUCTION
USE OF THE EVALUATION INSTRUMENT FOR ACCREDITATION
THE FIVE SECTIONS OF ELEMENTS AND STANDARDS
GLOSSARY OF TERMS
LIST OF STANDARDS AND ELEMENTS
SUMMARY OF REVISIONS
DOMAIN I: ORGANIZATION
STANDARD I-1
STANDARD I-3
STANDARD I-4
STANDARD I-5
STANDARD I-6
STANDARD I-7
STANDARD I-8
STANDARD I-9
DOMAIN 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-2
DOMAIN 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-1
TABLES
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.2.B.
ELEMENT III.2.B.: Researchers maintain appropriate oversight of each research study, as well as research staff and trainees, and appropriately delegate research responsibilities and functions.
Researchers are ultimately responsible for the conduct of research. Although researchers may delegate certain responsibilities and functions of the research, they must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility.
When researchers delegate responsibilities or functions, they should ensure that research staff are trained and able to perform the function and assume the responsibility for the delegated function.
Regulatory and guidance references
- DOJ: 28 CFR 512.11(a)(7)
- FDA: 21 CFR 312.53(c) (1), 21 CFR 312.60, 21 CFR 312.61, 21 CFR 312.62, 21 CFR 812.43(c) (4), 21 CFR 812.100, 21 CFR 812.140
- ICH-GCP(E6)(R3): II.1.5, III.2.3.
- VA: VHA Directive 1200.05, Section 5
- AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
Required written materials
- Essential requirements:
- Policies and procedures indicate that if the principal researcher or the local site researcher does not personally obtain consent, the researcher must formally and prospectively designate to another research team member in writing the protocol or the application for IRB approval the responsibility for obtaining consent, whether a waiver of documentation of the consent process has been approved by the IRB.
- If the researcher contracts with a firm to obtain consent, the firm must have its own IRB.
- Students and other trainees (including residents and fellows), including VA employees, from schools with an academic affiliation agreement consistent with current VHA policy, may serve as members of research teams, but not serve as principal researcher within a VA facility, or use data, or human biological specimens that have been collected within VA for clinical, administrative, or research purposes.
- A researcher sufficiently experienced in the area of the trainee’s research interest must serve as principal researcher or co-principal researcher and is responsible for oversight of the research and the trainee.
- When following DOJ requirements:
- Policies and procedures indicate that for research conducted within the Bureau of Prisons, the researcher must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.
- When following the ICH-GCP(E6)(R3) guideline:
- Policies and procedures describe responsibilities of researchers for supervising others, when relying on others to conduct the research:
- A qualified physician or, when appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) should have the overall responsibility for the trial-related medical care given to and medical decisions made on behalf of participants. Other appropriately qualified healthcare professionals may be involved in the medical care of trial participants, in line with their normal activities and in accordance with local regulatory requirements.
- The investigator may delegate trial-related activities to other persons or parties. The investigator may be supported by the sponsor in the identification of a suitable service provider(s); however, the investigator retains the final decision on whether the service provider intended to support the investigator is appropriate based on information provided by the sponsor.
- The investigator retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated to ensure the rights, safety and well-being of the trial participants and the reliability of data. The level of investigator oversight of the delegated activities should depend on the nature of the delegated activities and be proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability.
- The investigator should ensure that persons or parties to whom the investigator has delegated trial-related activities are appropriately qualified and are adequately informed about relevant aspects of the protocol, the investigational product(s) and their assigned trial activities (including activities conducted by staff provided by other parties in accordance with local regulatory requirements). Trial-related training to persons assisting in the trial should correspond to what is necessary to enable them to fulfil their delegated trial activities that go beyond their usual training and experience.
- The investigator should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities. Documentation of delegation should be proportionate to the significance of the trial-related activities. In situations where the activities are performed as part of clinical practice, delegation documentation may not be required.
- Policies and procedures describe responsibilities of researchers for supervising others, when relying on others to conduct the research:
- When following VA requirements:
- If the principal researcher or local site researcher does not personally obtain informed consent, the researcher must delegate this responsibility in writing (e.g., by use of a delegation letter) to research staff sufficiently knowledgeable about the protocol and related concerns to answer questions from prospective participants, and about the ethical basis of the informed consent process and protocol.
- If the researcher contracts with a firm (e.g., a survey research firm) to obtain consent from participants, collect private individually identifiable information from human participants, or be involved in activities that would institutionally engage the firm in human participants research, the firm must have its own IRB oversight of the activity.
- In addition, the Privacy Officer (PO) must determine that there is appropriate authority to allow the disclosure of individual names and other information to the contracted firm.
Common types of materials that may be used to meet the element
- Researcher manual
Outcomes
- Researchers are involved in the conduct of the research, including recruitment and obtaining consent, and maintain oversight of recruitment, consent, and protocol procedures.
- Researchers hire qualified staff.
- Research Staff indicate that the researcher delegates responsibility to them commensurate with their training and qualifications.
- Researchers are available to research staff when needed.
Proceed To:
ELEMENT III.2.C.