Everything statisticians ever wanted to know about 50.24 studies but were afraid to ask.”
*Sara Goldkind , CDER FDA  

Keywords: Ethics Informed Consent

After a brief overview of some of the scientific requirements for an ethical study, generally, the presentation will focus more specifically on some of the required conditions necessary for the conduct of clinical investigations with the exception from informed consent for emergency research, under 21 CFR 50.24. Attention will be given to various permissible designs and endpoints for studies conducted under 21 CFR 50.24 as well as the context in which these studies occur. The discussion will also touch upon some of the unique additional protections required by 21 CFR 50.24, such as mandatory establishment of a data monitoring committee, public notification prior to and after completion of the study, and community consultation.