The controversy over emergency research. A review of the issues and suggestions for a resolution.
Emergency research that occurs upon critically ill subjects in circumstances that do not allow the subjects or their legally authorized representatives to grant an informed consent is currently the subject of great controversy. This Clinical Commentary reviews three issues that dominate the debate: research risk assessment, the concept of a particular kind of risk called minimal risk, and the regulations governing research on human subjects. The theses of this article are that Institutional Review Boards (IRBs) are not violating Office of Protection from Research Risks (OPRR) regulations, that Food and Drug Administration (FDA) regulations do not adequately address research design, and that emergency research fits within the ethical standards of justice, respect for autonomy, and beneficence. To defend these claims, the following points are argued: risk assessment is a moral or transscientific exercise, minimal risk refers to the increment of risk that the subject of the research faces, and that when equipoise exists between experimental and standard therapies, this state of uncertainty contributes to a study's justifications. In order to resolve the emergency research controversy, certain regulations will need to be rewritten and others reinterpreted, and a national board created to review a proposed study's clinical relevance and whether the current state of knowledge justifies a trial.
Karlawish
J H
JH
MacLean Center for Clinical Medical Ethics, University of Chicago, Pritzker School of Medicine, Illinois, USA.
Hall
J B
JB
D016638:Critical Illness / Q000628:therapy*; D004630:Emergencies; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D010344:Patient Advocacy / Q000331:legislation & jurisprudence; D012106:Research / Q000331:legislation & jurisprudence*; D018570:Risk Assessment; D014481:United States; D014483:United States Dept. of Health and Human Services / Q000331:legislation & jurisprudence; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*