Blog | Navigating IRB Approvals: Key Insights

Navigating IRB Approvals

Key Insights

In the realm of clinical research, IRB approvals are pivotal. Here are some crucial points worth knowing:

Determinants of Approval

The IRB bases its approval on either “Societal Benefit” or “Scientific Benefit”. The aim of clinical research is to develop useful knowledge about human health and disease and ways of preventing, diagnosing, and treating disease. While participant benefits may occur, the primary objective is to advance knowledge that benefits society. The goal is not to benefit participants (although there are sometimes benefits) but the society at large because a relatively larger number of people could potentially benefit from the outcome of the research. A broader impact on public health is the ultimate goal.

Protocol Amendments and IRB

Sponsor directed amendments/modifications to a protocol need IRB review and approval. It is noteworthy that many IRBs only require ‘submission’ of minor editorial changes, not approval. It is advisable for each site to align with their specific IRB’s requirements.

Events That Should Be Reported 

IRBs should be informed of any event that pertains directly to a participant’s safety while on the trial. This includes:

    • Events unexpected in nature, severity, or frequency
    • Events that are related or possibly related to research participation
    • Events that suggest the research will put participants or others at greater risk of harm than previously known

The IRB’s responsibility is to protect the rights and welfare of human subjects enrolled in research.  If an event or action jeopardizes those rights or the subjects’ welfare, the IRB should be notified.By understanding these nuances, we ensure the ethical and efficient progression of our clinical research endeavors. This empowers us to contribute meaningfully to the broader landscape of human health and well-being.

Stay informed. Stay compliant. Elevate clinical research.