IRB/EC Approval Process
United States
In addition to regulatory approval, approval from the IRB/EC must also be obtained for each clinical trial. An IRB, like an EC, is an independent group of professionals who review and approve/reject clinical trial protocols based upon their assessment of benefit to risk. In the U.S., IRBs must be registered with the National Institute of Health (NIH) and have a current Federal Wide Assurance Number (FWA#). A sponsor must ensure that each clinical trial investigator obtains IRB approval for the protocol, informed consent form, etc. related to the trial to be conducted at its specific study site. In the U.S., it is the investigator who submits the study protocol and other required documents to his/her local IRB. The IRB meets, reviews the clinical trial documentation, and provides the investigator with a written decision. At the conclusion of their review, the IRB will provide a formal letter to the investigator. A copy of this letter is sent to the sponsor by the investigator(s). A sponsor can only send clinical trial investigational medication to an investigator who has received written IRB approval. There is no timeline for completion of the local IRB’s review and approval process. In my experience, the timeline can be as little as two months or as much as a year or more. So, the interactions with the local IRB are through the investigator and not the sponsor.
European Union
According to the EU Regulation, a sponsor must obtain approval from the central EC of each MS where the trial is to be conducted. Each MS has at least one central EC, which is approved by the CA of that country. Unlike the U.S., interactions with central EC are with the sponsor, not the investigator. The composition and responsibilities of the EC are similar to those of the IRB.
The timeline for the central EC review and approval/rejection is 60 days or less for standard products and up to 90 days for gene therapy studies. Should the EC need clarification from the sponsor during its review, it “stops the clock” until an answer is provided by the sponsor. In the event that the sponsor’s response is inadequate, the EC can reject the submission and the sponsor must start over. Central EC approval is documented by checking the “APPROVED” section of the CTA EC review box