SOP 008: IRB Determinations

Purpose

This SOP describes the different determinations the IRB may make concerning all non-exempt human subjects research protocol applications.

Overview

1. It is the responsibility of the convened IRB or expedited IRB reviewer to make a determination within the scope of this SOP for all non-exempt human subjects research protocol applications.
2. It is the responsibility of all researchers, investigators, and persons under the auspices of WVU IRB to respect these IRB determinations.
   
3. Except for research waived under 45 CFR 46.101(i) or exempted under 45 CFR 46.104, the following actions will be taken by a vote of a majority of the regular and alternate members present at a convened meeting (See SOP 019: Full Board Protocols). Alternately, the IRB Chair, Vice Chair, or experienced reviewer designated by the IRB Chair may approve the research (See SOP 018: Expedited Protocols). When an application is reviewed using expedited procedures, the IRB Chair or designee may take any of the following actions except to defer for substantive issues or disapprove a study.
   
4. The IRB Chair or designee is responsible for ensuring the appropriateness of all IRB decisions and actions. The IRB Chair or designee may confer with the OHRP staff to verify that all IRB decisions and actions are based on institutional and regulatory requirements.
   
5. IRB decisions and actions voted on by the convened IRB are documented by using reviewer checklists and are included in the official minutes of the convened meeting approved by the IRB.
   

Procedures

1. The IRB may take one of the following actions as a result of its review of research submitted for initial review or continuing review, including review of amendments. Actions are recorded in the minutes when reviewed by a full convened board. When an IRB Chair or designee takes one of the following actions as a result of his/her expedited review of research, it is recorded in the WVU electronic IRB system.
1. Approval: If the IRB approves an application as submitted, approval commences on that day. The application and accompanying documents are approved as submitted. The PI must receive an approval letter by WVU OHRP staff before any research activity can begin.
2. Board Modification (Specific Minor Revisions): The IRB may stipulate specific minor revisions to the protocol application and/or the informed consent form. The minor revisions can include wording changes, with replacement language provided. For protocol applications reviewed at a convened meeting, the required revisions are agreed upon at the meeting. For protocol applications reviewed under expedited review, the required revisions are designated by the reviewer(s). None of the required revisions may be related to the regulatory criteria for approval. The revisions are presented to the PI for incorporation by simple concurrence. The revisions must be made exactly as designated by the IRB or the reviewer(s).

   To receive approval for a protocol deferred for non-substantive issues:

   • Full Board Review: the PI’s response, the revised protocol application, and the previously submitted protocol application are provided to the IRB Chair, Vice Chair, or a subcommittee of the IRB for review. The reviewer(s) may approve the protocol application upon receipt and approval of the revisions without further action by the IRB.
   • Expedited Review: the PI’s response, the revised protocol application, and the previously submitted protocol application are provided to the same reviewer (whenever possible) or to a subcommittee of the IRB for review. The reviewer(s) may approve the protocol application upon receipt and approve the revisions without further action by the IRB.

   Approval of the protocol application will not be granted until all deficiencies, if any, are corrected to the satisfaction of the IRB or IRB reviewer(s). The date of approval for expedited protocol applications is the date conditions were determined to be met. This is considered the final date of initial approval. The date of approval for full board protocol applications is calculated based on the date of the last convened IRB meeting and not on the final date of initial approval.

3. Deferred for Substantive Issues: If the convened IRB requests substantive clarifications or modifications regarding the protocol application or the informed consent documents that are directly relevant to the determinations required by the IRB according to the regulations (See SOP 006: IRB Criteria for Approval), the protocol application is deferred pending subsequent review by the convened IRB that reviewed the protocol originally.

   To receive approval for a protocol deferred for substantive issues:

   • Full Board Review: the PI’s response must be submitted for review at a subsequent, convened meeting of the same IRB (whenever possible). The WVU OHRP provides the IRB with the PI’s response, the revised protocol application, and the previously submitted application. The PI’s responsive material is placed on the agenda for re-review at the next available convened meeting.
   • Expedited Review: the PI’s response, the revised protocol application, and the previously submitted application are placed on the agenda for review by the full board at the next available convened meeting.

   Approval of the protocol application will not be granted until all deficiencies, if any, are corrected to the satisfaction of the IRB or IRB reviewer(s). The date of approval for expedited protocol applications is the date the conditions were determined to be met. This is considered the final date of initial approval. The date of approval for full board review for the protocol application is calculated based on the date of the last convened IRB meeting, and not on the final date of initial approval.

   Failure to submit a response to IRB-stipulated changes or inquiries related to deferred protocol applications within 75 days of the IRB date of determination will result in the administrative closure of the IRB file. The PI will receive notification of the closure of the protocol application, including an explanation for this action. An extension beyond 75 days may be granted by the IRB if sufficient cause is provided by the PI.

4. Disapproved: If the protocol application fails to meet one or more IRB approval criteria, the IRB may disapprove the application. Disapproval cannot be given through the expedited review procedure. A protocol application may only be disapproved by a majority vote at a convened meeting of the IRB. If a designated expedited reviewer believes a protocol application should be disapproved, the reviewer documents the recommendation in the expedited reviewer feedback materials in the WVU electronic protocol system and contacts the OHRP staff. The OHRP staff then forward the protocol application to the next available agenda for discussion by the full IRB at a convened meeting.

   Criteria for disapproval may include but is not limited to the following:

   • The protocol application violates any laws or regulations of the United States, the state of West Virginia, or West Virginia University.
   • Risks to participants outweigh the benefits to them or society.
   • Unnecessary risks are created
   • Selection of participants is inequitable.
   • Procedures for obtaining and documenting informed consent are inadequate
   • Payment or other offered inducements are likely to influence participants’ judgment
   • The protocol is poorly or improperly designed such that meaningful conclusions cannot be derived.
   • The protocol is promotional (seeding), and not scientific in nature

References

WVU Policies:

• SOP 018: Expedited Protocols
• SOP 019: Full Board Protocols

Federal Regulations:

• 45 CFR 46.118

AAHRPP:

• Element II.5.B