301 IRB Approval and Operations for Clinical Studies

Purpose

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Procedures

The Principal Investigator (PI) or designated personnel must adhere to the following procedures before and after implementing a study protocol:

1. Initial Submission:

• The PI or designated personnel must submit an initial clinical study application to the IRB for approval. This submission should include the protocol, advertisements, amendments, informed consent forms, case report forms (CRFs), and the Investigator's Brochure (IB), if applicable. Approval from the IRB is required before the study can commence at the PI site.

2. IRB Response:

• The PI or designated personnel will receive written notification from the IRB regarding its decision to approve, disapprove, or require modifications to the protocol. If disapproved, the IRB will provide the reasons for its decision and offer the PI an opportunity to respond.

3. Expedited Review:

• The PI may request an expedited review of the study protocol by the IRB Chairperson, or one or more experienced reviewers designated by the Chairperson from among the IRB members under the following conditions:
  • The research category is listed in the Federal Register and involves no more than minimal risk.
  • The protocol includes minor changes to previously approved research during the period of one year or less for which approval is authorized.
• These reviewers have the authority to approve the research but cannot disapprove it.

4. Multicenter Protocols:

• For multicenter protocols, reviews by multiple IRBs or a central qualified IRB may be used to comply with regulations, subject to consultation and approval by the Ohio University IRB.

5. Annual Review:

• The PI or designated personnel must submit an annual review form detailing the study’s progress to the IRB before the study approval expires. The IRB will conduct a continuing review of the protocol at intervals appropriate to the degree of risk, but at least once per year.

6. Documentation:

• The PI or designated personnel must obtain and retain copies of IRB approvals for the protocol, advertisements, amendments, informed consent forms, relevant correspondence, and other approved materials in the study regulatory file.

7. Ongoing Reporting:

• During the study, the PI is responsible for notifying the IRB of any changes to the research conduct, including:
  • Serious adverse reactions;
  • Unanticipated or anticipated problems;
  • Progress reports from the sponsor, especially those involving adverse events or new information on the drug/device.

8. Renewal or IRB Approval:

• The PI must obtain IRB approval renewal at intervals specified by the IRB, but at least once per year.

9. Final Report:

• Upon study completion, the PI or designated personnel must prepare a final report for the IRB and the sponsor, if applicable. The report should include:
  • A listing of serious adverse events that occurred during the study;
  • Comments on the study conduct;
  • A statement that the study is completed, including the number of subjects who entered and completed the study;
  • Any conclusions drawn by the PI regarding the study.

References: None

Attachments: None

Appendices: None

Approver: Director, CTRU and Clinical Partnerships