HCR 350: Intro Clinical Research - Participation Activity I
In this week’s reading, the topic that resonated most with me is the United States of America v. Paul H. Kornak, Criminal Action No. 03-CR-436 (FJS). I will first talk about the details of this case and then I will state why this case resonates with me. Paul H. Kornak, the research assistant at Stratton VA Medical Center in Albany, New York, falsified information stating that the subject qualified for the study. Because of this falsified information, the subject passed away. Fortunately, Paul H. Kornak was sentenced to 71 months in prison with a $639,000 fine in restitution with a lifetime debarment from all federally funded research projects.
I will now insert a quote from our book in this week’s reading: “’ Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record…’ (42 CFR Pt. 93.103)” (Health Care Compliance Association. 2019. Research Compliance Professional’s Handbook, Third Edition.). This quote is important to understand falsification and fabrication from a compliance research standpoint. This quote is specifically from the website: https://www.ecfr.gov/current/title-42/chapter-I/subchapter-H/part-93/subpart-A/section-93.103 from the Code of Federal Regulations and this was last amended on 01/04/2023. Fabrication and falsifying data is a federal crime but also it is very dangerous for all subjects as you can see from Kornak’s crime. A subject must qualify for a research project for not only research accuracy but also safety.
I will now talk about why this reading resonated with me. I looked into the HHS website on this case for more extensive information on what happened during the time of the crime. Mr. Kornak was conducting Oncology research for TAX 325 and Tax 327: Bladder Cancer Study which was also known as the Iron (Fe) and Atherosclerosis Study (FeAST). This involved blood tests to determine subject qualifications for the study, which, as we can see were falsified. I work in an oncology center (I work for a lab that has me stationed there as – In-Office-Phlebotomist) and for example of my experiences there, if an HGB is let’s say 9.0 then they would need a shot to help bring it up. However, let’s say I didn’t mix the vial well and the HGB comes out as 6.7 then the patient would need a blood transfusion. This could result in very bad reactions or even worse, death. Therefore, this case resonates with me in this week’s reading. I understand blood lab results and how extremely dangerous this is to falsify blood lab results.
Resources
· Health Care Compliance Association. 2019. Research Compliance Professional’s Handbook, Third Edition.)
· Office of the Secretary, Department of Health and Human Resources. N.d. Case Summary: Kornak, Pau H. Retrieved from https://ori.hhs.gov/case-summary-kornak-paul-h
