Current status of research on the federal guidelines for performing research using an exception from informed consent.
In order to set the stage for the later discussion of future directions, this Consensus Conference began by reviewing some of the existing research on conducting resuscitation studies using an exception from informed consent. That research is described in this article. The authors conclude that, based on the experiences reported by researchers and institutional review boards, resuscitation research may be ethically and legally conducted under the current regulations, but such research requires substantial effort, financial resources, and personnel. Federal regulations have set the bar appropriately high, and this may pose significant difficulties for small sponsors and individual investigators. However, further study of the experiences of subjects, researchers, and the regulatory process is warranted.
Schmidt
Terri A
TA
Department of Emergency Medicine, Center for Ethics in Health Care, Oregon Health & Science University, Portland, OR 97239, USA. schmidtt@ohsu.edu
Lewis
Roger J
RJ
Richardson
Lynne D
LD
D001291:Attitude of Health Personnel; D001294:Attitude to Health; D003159:Community-Institutional Relations; D028744:Ethics Committees, Research; D035082:Federal Government; D019983:Guideline Adherence / Q000941:ethics* / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000592:standards*; D018579:Patient Selection / Q000941:ethics*; D014481:United States