The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology
FAQ

How long does it take to get an IRB study approved?

April 14, 2022

Institutional Review Boards (IRBs) can be classified into two groups; private and hospital/clinic based groups. The private institutions typically review cases in a short period of time, based on client requests to determine the safety concerns to classify studies as low/medium or high risk. 

A low risk study means that the surgeon or physician has alternatives and mitigation options to the studied device and can override any unsafe conditions to prevent adverse events. High risk studies have the potential to harm a patient, and will require extensive testing and risk mitigations to potentially be approved for a study. These cases may potentially never be approved depending on the center rules and guidelines and may require controlled clinical study protocols to proceed instead, which is referred to as Investigational New Device (IND) or Investigational Device Exemption (IDE) filings with the FDA. This process can take 1 to 2 years to clear depending on the complexity of the device and competence of the design and regulatory teams.

Given those designations, for private IRBs,  low risk studies can be reviewed and approved in a matter of weeks, and high risk items can take much longer periods, in the form of quarters based on needs for enrollment, safety, etc. 

Conversely, hospital based IRBs can take a longer period of time due to the structure of the group. Typical hospital IRB only meets monthly to discuss the items on deck. This means that depending on the scheduling, the study can wait for up to 2 months before a full review. 

Typically, there are many questions that are asked from the initiator which will then be reviewed again in the next meeting. A low risk study will take at least 3 months to review before approval, and a high risk study may never be approved due to the perceived risk to the hospital and the patients.

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