Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical research as we advance forward.

Dexmedetomidine (DMT), a highly selective α2-adrenoceptor agonist, has been used safely as a sedative in patients under regional anesthesia. The purpose of this study was to determine the 50% effective dose (ED50) of single-dose DMT to induce adequate light sedation in elderly patients in comparison with younger patients undergoing transurethral resection of the prostate (TURP) with spinal anesthesia.

Kim WO, et al. Korean J Anesthesiol. 2011 Nov;61(5):405-412. http://dx.doi.org/10.4097/kjae.2011.61.5.405

To justify the use of the lidocaine/tetracaine medicated patch or peel as a preventive treatment for reducing pain and discomfort in adults and children. We reviewed randomized controlled trials (RCTs) to evaluate the efficacy and safety of the lidocaine/tetracaine medicated patch or peel compared with placebo. Ten RCTs (574 patients) were included in this systemic review. Relevant studies were identified through searches of MEDLINE, SCOPUS and the Cochrane database library. The outcome was the adequacy of cutaneous anesthesia reflected in the patient's assessment of pain intensity during minor dermatologic procedures and adverse effects after application of the lidocaine/tetracaine medicated patch or peel versus placebo. The efficacy of the lidocaine/tetracaine patch or peel was consistently very significantly beneficial 30 or 60 minutes after the application compared to placebo (Relative risk, RR: 2.5; Number needed to treat, NNT: 2.2). We did not identify any difference in the effectiveness of adequate analgesia between the lidocaine/tetracaine patch and peel (the number needed to treat or to harm, NNT 2.4 vs. 2.0). No serious side effects or adverse events were observed with the lidocaine/tetracaine medicated patch or peel and placebo. Minor skin reactions were transient and resolved without treatment (Odd ratio, OR: 1.4 and 95% confidence interval, CI: 0.9-2.1; NNT: 14.9). The lidocaine/tetracaine medicated patch or peel is a well accepted, effective and safe method for minor dermatologic procedures based on pooled data of trials in terms of adequacy of cutaneous anesthesia and adverse effects.