Before initiating a clinical trial, how should foreseeable risks and inconveniences be weighed in relation to anticipated benefits for the subject and society?

• A. Risks and inconveniences should be weighed against anticipated benefits for the individual trial subject and society, and the trial should be initiated and continued only if the anticipated benefits justify the risks.
• B. Trials should be initiated regardless of risk if the investigational product shows promise.
• C. Risks must be eliminated entirely even if benefits are small.
• D. Inconveniences are acceptable as long as the subject signs a consent form.

Answer: (A)

The main idea here is that any clinical trial must be based on a favorable risk-benefit balance. Before starting, the foreseeable risks and burdens to participants must be weighed against the anticipated benefits to the individual subject and to society. A trial should be initiated and continued only if the expected benefits justify the risks, with efforts to minimize those risks and to monitor the situation so that the study can be stopped if risks become unacceptable. This protects participants while allowing valuable knowledge to be gained.

Even if the investigational product looks promising, ethical conduct requires that the risk to participants not be outweighed by potential benefits. Risks can’t be eliminated entirely, and obtaining consent does not justify exposing someone to unacceptable risk.