Unethical research stems all the way back to the mid 1800’s with James Marion Sim’s crude experimentation on enslaved African American women and it continues to this very day. Over 100 years after Sim’s research, studies are still receiving extreme media scrutiny and public backlash. Very recently, Secretary of State, Hilary Clinton and Health and Human Services Secretary, Kathleen Sebelius gave a very public apology to the Guatemalan Government and the subjects involved in the study after it was discovered that U.S. funded Investigators were infecting mental patients, prisoners, and soldiers with Syphilis in order to test the effectiveness of Penicillin.
Although a majority of Investigators and Sponsors have good intentions, it’s like elementary school recess; you lose 5 minutes every time the class clowns act out. Each time an Investigator or Sponsor puts their subjects at an increased risk without benefit, the regulations will become more stringent and good, ethical research suffers.
The intention of this article is to not merely summarize historic cases of unethical research or to wish those who conduct unethical research a lifetime of sleepless nights. The intent is to emphasize the importance of a positive relationship between those who conduct research and their IRB. In other words, throw out the caffeine and Tylenol you planned to use as a chaser after your IRB submission and, instead, tackle the regulatory burdens throughout the review process together. Your IRB should not drown you with endless questions asked five different ways or require its investigators to practice additional unnecessary subject protections that, in fact, don’t provide protections at all. Your IRB should be there to support the scientific advancement of your research, and protect you by ensuring the highest level of protections for the very people who made your incredible discoveries possible, the RESEARCH PARTICIPANTS.