Ethics approval requirement for CJEM research publications: a step forward for Canadian emergency medicine.

Every emergency medicine researcher has, on occasion, cursed a Research Ethics Board (REB). The ethics approval process is both complicated and timeconsuming. REBs frequently request seemingly arbitrary changes to protocols that took months and sometimes years to develop. Research in the emergency department (ED) or in pre-hospital settings pose unique ethical challenges, and REBs are frequently unfamiliar with these environments. This can lead to delays in obtaining ethics approval, as researchers educate their REB and negotiate acceptable approaches. In light of these concerns, it may seem surprising that CJEM recently formalized a policy that all research published in the Journal must be approved by an REB (see CJEM Instructions for Authors online at http: //www.caep.ca/). While the ethics approval process can be inconvenient and frustrating, history has shown that it is crucial for the protection of research subjects and that it is necessary to avoid the harm that ill-conceived or poorly executed research can produce. The ethics approval process provides a counter-balance to powerful and pervasive forces that push research forward at any cost; it fosters a trusting relationship between researchers and subjects. The history of medical research is littered with stories of research gone wrong, and research subjects who have suffered as a result. The unconscionable experiments of Nazi physicians came to light in the mid 1940s during the Nuremberg trials. The Nuremberg Code was subsequently developed in 1947 to articulate the principles of ethical research. Other codes and declarations followed; however, unethical research still occurred all too frequently. One particularly egregious example was the Tuskegee Syphilis Study. In 1932, the US Department of Public Health initiated a project designed to determine the natural history of syphilis. Because there was no effective treatment for syphilis, it was considered acceptable to withhold treatment from a group of infected subjects and follow them over time. Four hundred poor and minimally educated African-American men were recruited into the study. Few understood that they were part of a research project, and deceptive means were used to ensure compliance with invasive data collection procedures. In the 1940s, when it was discovered that penicillin was an effective treatment for syphilis, the investigators actively prevented their subjects from receiving antibiotics. The study continued for decades and published results in peer-reviewed journals until 1972, when a series of New York Times articles led to public outrage, particularly among minority communities. It is tempting to view the Nazi experiments and the Tuskegee events as a result of bad men living in a different time. Unfortunately, there are more recent examples of the same phenomenon. In 1988, the Cartwright Inquiry examined the case of a prominent New Zealand gynecologist and researcher who withheld treatment from women with cervical dysplasia in an effort to “prove” that it did not lead to cervical cancer. This took place between 1966 and 1987 and resulted in the deaths of many participants. In 1999, 19-year-old Jesse Gelsinger died after participating in gene