General Guidance - Protocol Design
While not all potential harms or benefits can be definitively determined or even anticipated before a study is actually under way, researchers must take reasonable precautions when designing a study to minimize the risks to subjects. This may be achieved through such means as good study design, data and safety monitoring, and the selection of subjects least susceptible to harm. Investigators must also thoughtfully review the risks and benefits of conducting the research to determine if an acceptable risk-benefit relationship exits. This involves identifying the risks and potential benefits, quantifying these, and performing a risk analysis. IRB members must then review this analysis and decide if they concur.