"Innovative Treatment" vs Research: Which is It?

The following original article which I wrote and was published today at the bioethics.net website is reproduced here with permission.  I will put some additional comments as an Addendum at the end of the copy. ..Maurice.________________________February 19, 2013 12:30 pm“INNOVATIVE TREATMENT” VS RESEARCH: WHICH IS IT?Maurice Bernstein, M.D.When does a doctor’s treatment of a patient become medical or surgical research? If what the doctor does is a standard and accepted method of therapy using proven medications or surgical techniques and represents nothing novel then at first glance what is occurring cannot be designated as research or can it? Ah! But here is where the issue of “innovative treatment” versus “medical/surgical research” become clouded. The United States government has set a standard regarding what activities by physicians could be called research and what could not based upon the April 19,1979 Belmont Report summarizing a governmental commissions conclusions and set the ethical standards for the ethics of research. The standard of what is research is summarized in the IRB Handbook (1993)if there is a clear intent before treating the patient to use systematically collected data that would not ordinarily be collected in the course of clinical practice in reporting and publishing a case study. Treating with a research intent should be distinguished from the use of innovative treatment practices.The government considered this distinction...
Source: Bioethics Discussion Blog - Category: Health Medicine and Bioethics Commentators Source Type: blogs