Compliance In Focus

Since the suicide death of Dan Markingson in May of 2004, there has been a lot of debate as to whether or not the 26 year old psychiatric patient should have been approached to consent to participate in a clinical research trial for the comparison of three atypical antipsychotic drugs. Recently, there has been an article published in the Minnesota Daily about a petition signed by over 3,000 ethicists, researchers and scholars asking the University of Minnesota’s President to review the case to prevent future tragedies at the institution. Such a petition was created due to several errors in processes related to human subject protection.

Informed consent is arguably the most important aspect of patient protection in clinical research. The informed consent process is intended to protect the rights and welfare of subjects by educating them about their potential participation in a clinical trial. Unfortunately, informed consent remains an issue today. In fact, the FDA has sent out many warning letters regarding informed consent over the last few years.