ELEMENT I.1.C.

ELEMENT I.1.C.: The organization has and follows written policies and procedures that allow the Institutional Review Board or Ethics Committee to function independently of other organizational entities in protecting research participants.

To ensure that the IRB or EC functions independently of other organizational entities, the IRB or EC should be granted specific authorities to approve, require modifications to secure approval, disapprove research, to suspend or terminate IRB or EC approval of research, and to observe, or have a third party observe, the consent process or the research. The highest appropriate organizational person or entity should grant and recognize these authorities. Statements in the IRB or EC policies and procedures alone granting the IRB or EC such authorities are insufficient. The organization should have policies and procedures that respond to attempts to influence the IRB’s or EC’s independence or others responsible for the oversight of research.

Regulatory and guidance references

DHHS: 45 CFR 46.109(a), 45 CFR 46.109(e), 45 CFR 46.112, 45 CFR 46.113
FDA: 21 CFR 56.109(a), 21 CFR 56.109(e), 21 CFR 56.112, 21 CFR 56.113
VA: VHA Directive 1200.05(3) section 13; VHA Directive 1200.01 section 9

Required written materials

Essential requirements:
1. Policies and procedures grant the IRB or EC the authority:
  1. To approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organization.
  2. To suspend or terminate IRB or EC approval of research not being conducted in accordance with the IRB’s requirements or that had been associated with unexpected serious harm to participants.
  3. To observe, or have a third party observe, the consent process and the conduct of the research.
2. Policies and procedures describe the steps the organization takes to ensure that research involving human participants does not commence until the research has received all approvals required by the organization.
  1. Policies and procedures do not allow the organization to approve research that has not been approved by the IRB or EC.
3. Policies and procedures describe to whom IRB or EC members and staff report undue influence.
  1. Policies and procedures describe the organization’s response to attempts to unduly influence the IRB or EC.
When following VA requirements
1. For VA facilities:
  1. The facility director is responsible for ensuring that the IRB functions independently.
  2. An IRB-approved research activity may be disapproved by the facility director or the R&D Committee. If a research activity is disapproved by the IRB, or modifications to the research are required by the IRB, the disapproval or need for modification cannot be overruled by any other authority (e.g., facility Director or R&D Committee).
  3. The R&D Committee must provide the final approval before the research can be initiated. VA research cannot be initiated by the researchers until written notification is received from the Associate Chief of Staff/Research & Development (ACOS/R&D) that all required approvals have been obtained.

Outcomes

The organization does not allow officials of the organization to approve research that has not been approved by the IRB or EC.
Individuals responsible for the oversight of research know how to report undue influence.
The organization responds to attempts to unduly influence the individuals responsible for the oversight of research.
Individuals responsible for the oversight of research do not experience undue influence from the organizational official or others.
The IRB or EC functions independently.

Proceed To: ELEMENT I.1.D.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.1.C.