Effect of the final rule on the conduct of emergency clinical research.
The development of life-saving techniques in medical emergencies often requires enrollment of patients into clinical trials without the opportunity for informed consent. The Food and Drug Administration had designated such exemptions from informed consent for the purpose of emergency research as "the Final Rule." In the decade following the Final Rule for emergency research, little progress has been made in the study of therapies for acute, life-threatening conditions with high mortality rates. The potential for significant change in accepting research without consent begins with a level of public knowledge, trust, and credibility in the healthcare delivery system. This review seeks to address the Final Rule and its ramifications and issues that undermine the provisions of emergency research. In understanding the complexities of emergency research and its potential, there are opportunities for improvement for the scientific community to develop a greater understanding of the general public's attitudes and perceptions concerning research without consent.
Department of Surgery, Conemaugh Memorial Medical Center, Johnstown, Pennsylvania, USA.
Stephanie K
SK
Gonzalez
Thomas S
TS
Helling
D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D002985:Clinical Protocols / Q000592:standards*; D004635:Emergency Medicine; D005260:Female; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008297:Male; D011050:Policy Making; D019724:Presumed Consent / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration