title: An ethical analysis of exception from informed consent regulations.
abstract: Federal regulations enacted in 1996 allow clinical research with an exception from informed consent in select emergency circumstances. Such research is only permitted when the therapy may directly benefit the research participant and it is not possible to conduct the research with informed consent. Among others, protective mechanisms include a process of community consultation and public disclosure and the establishment of a mandatory data safety monitoring board. Although the regulations do not preserve the right of self-determination of the research participant, the author argues that they do provide an ethical means to advance the science of resuscitation.
authors.affiliation: The Morgan Stanley Children's Hospital of New York-Presbyterian, New York, NY, USA. mcm2113@columbia.edu
authors.forename: Marilyn C
authors.initials: MC
authors.lastname: Morris
mesh_terms: D026686:Beneficence; D003159:Community-Institutional Relations; D030881:Disclosure / Q000941:ethics; D004635:Emergency Medicine / Q000941:ethics / Q000592:standards; D028744:Ethics Committees, Research; D005060:Europe; D019983:Guideline Adherence / Q000941:ethics* / Q000266:history / Q000592:standards*; D017408:Guidelines as Topic; D049673:History, 20th Century; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000266:history / Q000592:standards*; D018579:Patient Selection / Q000941:ethics*; D012935:Social Justice; D014481:United States; D014483:United States Dept. of Health and Human Services; D026712:Value of Life