Clinical trials in an emergency setting: implications from the fifth version of the Declaration of Helsinki.

ABSTRACT

Everybody agrees that research is crucial to improve the quality of emergency care. Consent of human subjects for participation in research requires that they fully understand their role and risk, not be coerced, and be allowed to withdraw at any time without penalty. In an emergency situation, informed consent is not always possible but the need for good research data is very high. Here is the ethical difficulty, and a real conflict of values a population that might ultimately benefit from research cannot consent to the research and are thus excluded from the potential therapeutical advances. Patients at high risk of morbidity or death, with cardiac arrest, shock, head injury, or altered mental status, are evidently incapable of providing an adequate consent, but nevertheless are often in the greatest need of innovative therapy and might be willing to assume some risk for potential benefit. In an attempt to resolve this dilemma, the new version of the Declaration of Helsinki presents updated requirements for the waiver of informed consent and the protection of human subjects in emergency research.