What does risk/benefit analysis involve in IRB reviews?

Risk/benefit analysis in IRB reviews is fundamentally about weighing potential risks against the anticipated benefits of a research study. This process is essential to ensure that the potential benefits to participants and society justify any risks or harms that may arise from the research.

The IRB evaluates whether the risks are reasonable in relation to the expected benefits, considering both the likelihood of the risks occurring and the severity of their impact. This analysis helps ensure ethical standards are upheld, protecting participants from undue harm while allowing valuable research to progress if the benefits are likely to outweigh the risks.

In the context of research, the goal is to maximize positives, such as advancements in knowledge or improvements in treatment strategies, while minimizing negatives, such as physical harm, psychological distress, or other adverse effects. This holistic view of both sides is crucial in the ethical oversight of research involving human subjects.