Thursday, March 14, 2013

Embracing Your IRB

Today's post comes from Dorey Rutland of MidLands IRB (MLIRB). She has worked in the field of research ethics and subject protections for over six years and am experienced in applying international, federal, state, and local policies and regulations to both Biomedical and Social and Behavioral protocols.  MidLnds IRB will be an exhibitor at the 2013 Partnerships in Clinical Trials Event. As a reader of this blog, when you register to join us and mention code XP1800BLOG, you'll save 15% off the standard rate!

When it comes to the IRB review process, Investigators and Project Managers can relate to the annoyance of what is generally viewed as just another hurdle before the scientific discoveries can begin. And why wouldn’t it be? You’ve now spent weeks prepping your submission materials and are on your 78th review of the Informed Consent document for fear you may have accidentally used a coercive exclamation point somewhere in the now 27- page document. Let’s be honest, if you find yourself a good IRB, its members and staff should eliminate many of the unnecessary, time-consuming burdens that don’t provide meaningful protections for subjects. However, in most cases, those “annoyances” are what will ensure participants are treated with the three most fundamental ethical principals; respect for persons, beneficence, and justice.

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.




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