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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
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 II.1.E.: The IRB or EC has and follows written policies and procedures requiring research protocols or plans to be reviewed by individuals with appropriate scientific or scholarly expertise and other expertise or knowledge as required to review the research protocol or plan.
The IRB or EC should have the competence and knowledge to review research so that it can protect the rights and welfare of research participants.
To review research, the IRB or EC should have or acquire the scientific or scholarly expertise and other expertise or knowledge to understand the protocol. Policies and procedures should describe the steps to follow so that each protocol undergoes an in-depth review by individuals with relevant expertise and knowledge.
Policies and procedures should describe the steps the IRB or EC uses to assess the scientific or scholarly expertise or other expertise or knowledge required for each protocol submitted for review so that one or more IRB or EC members or consultants with appropriate expertise perform an in-depth review. In the case of an organization with multiple IRBs, this might involve directing the protocol to the IRB or EC with relevant expertise. In the case of an organization that uses a primary reviewer system, this might involve directing the protocol to one or more primary reviewers with relevant expertise. In the case of an organization with multiple IRBs and primary reviewer systems, this might involve both strategies.
If there is not at least one person on the IRB or EC with appropriate scientific or scholarly expertise to conduct an in-depth review of the protocol, the IRB or EC should defer review until such expertise can be obtained through
membership or consultation.
When additional expertise is needed, policies and procedures should describe the steps followed to obtain consultation and communicate the results of the consultation to the IRB or EC.
IRB or EC members may obtain consultations by directly contacting colleagues for information. Such consultations are acceptable provided they are described in policies and procedures and the information is documented.
Regulatory and guidance references
- DHHS: 45 CFR 46.107
- ED: 34 CFR 356.3
- FDA: 21 CFR 56.107
- ICH-GCP: 3.2.6
- AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
Required written materials
- Essential requirements:
- Policies and procedures describe the process so that at least one person with appropriate scientific or scholarly expertise conducts an in-depth review of the protocol.
- Policies and procedures describe the process to determine whether other types of expertise or knowledge are required in order to conduct an in-depth review of the protocol.
- Policies and procedures have the IRB or EC defer to another meeting, IRB or EC, or obtain consultation if there is not at least one person on the IRB or EC with appropriate scientific or scholarly expertise or other expertise or knowledge to conduct an in-depth review of the protocol.
- Policies and procedures describe who evaluates each protocol to determine whether a consultant is needed.
- Policies and procedures describe the process to obtain consultants.
- Policies and procedures indicate consultants do not vote with IRB or EC members.
- Policies and procedures describe the ways in which information provided by consultants is documented.
- At least one IRB or EC member or consultant with
- appropriate scientific or scholarly expertise reviews each protocol in depth.
- When required by the circumstances of the research, at least one IRB or EC member or consultant with appropriate expertise or knowledge other than scientific or scholarly expertise reviews the protocol in depth.
- When the IRB or EC needs additional expertise, the IRB or EC obtains consultation.
- When a consultant is obtained, the IRB or EC is made aware of the information provided by the consultant.
Proceed To: STANDARD II-2