Despite the safeguards imposed by the IRB and the consent process, the prospective researcher still may have problems with ethical considerations. There are many motives for performing clinical research, which run the gamut from patient-care concerns, such as inadequate standard therapy, to those less pure, such as reimbursement and academic standing. It is imperative that the rights and welfare of study populations be observed and guarded strictly. This means that all studies must be reviewed by an appropriate IRB before initiation of the study. Failure to do so not only may compromise the ethical integrity of the study but also may prevent the investigator from publishing their findings. Although emergency research may present challenges, recently published guidelines give direction for emergency research requiring waiver of informed consent. Knowledge of the guidelines and federal regulations will assist the researcher to know the expectations necessary to prepare for an IRB review. Ongoing dialog with an IRB representative is helpful to explain and clarify the study and assure that questions are answered before IRB submission.
ASJC Scopus subject areas
- Emergency Medicine