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.

We have had this discussion numerous times over the years.  Many believe that the informed consent form is documentation enough.  On the other hand, others would like to see all consent processes documented with a progress note, in addition to the consent document.

The informed consent process is arguably one of the most important parts of a clinical research study. From the Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research.  The regulations, CFR part 50 also cover the importance, rules and process of informed consent.