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The Southern California Chapter of the Association of Clinical Research Professional met for a meeting on Wednesday, July 30th where they heard a very informative presentation by Michael R. Hamrell, Ph. D. of Moriah Consultants on the Ethical Considerations in Clinical Research.
Dr. Michael R. Hamrell, RAC is the President of MORIAH Consultants, a Regulatory Affairs and Clinical Research consulting firm located near Los Angeles, CA. Dr. Hamrell has a unique background with over 25 years’ experience in regulatory affairs, clinical research and drug development with academia, the FDA, NIH and in industry. He also worked for over 5 years at the FDA and 3 years at the NIH in the Division of AIDS, coordinating the development of drugs, biologics and vaccine products for AIDS, oncology and anti-infectives. Dr. Hamrell has dealt with Regulatory Authorities in over 40 countries and supervised all aspects of product development and approval.
Dr. Hamrell spent a number of years doing basic research, first as a Research Fellow at Duke University and later as an Assistant Professor of Pharmacology at the McGill University Cancer Center. He has a Ph.D. degree in Pharmacology from the University of Southern California and a B.S. in Biochemistry from the University of California, Los Angeles. Dr. Hamrell has received numerous awards for his research, teaching and professional work and is recognized in Who’s Who. He has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, computers and information systems.
Dr. Hamrell also serves on the Editorial Board of Regulatory Affairs FOCUS, Drug Information Journal, and Applied Clinical Trials.
At Dr. Hamrell’s presentation at ACRP – Southern California Chapter, he talked about the history of clinical trials and how they used to take place not too long ago, from the Nuremberg Code in 1947, through to the Common Rule in 1991.
The Declaration of Geneva, the Tuskegee Study, HeLa Cells, as well as other lapses of ethical consideration in clinical research that have taken place over time were discussed. Although great medical discoveries were made during these times, they were not made in the correct way. Dr. Hamrell went on to discuss the advancements the industry has made since then and how there has been more regulation put in place today.
There have been many positive aspects that have come out of clinical research that allow us to make medical advances with vaccinations, medicines, cures, as well as in many other areas within the medical field, however, at the same time, there is a delicate balance of at what cost. The general public remains weary of medical research and clinical trials but with more regulation and transparency, there is hope that this can be turned around, and more medical breakthroughs can be made. Dr. Hamrell makes once final point and that is to always remember that every single individual in these trials is someone’s family – a mother, father, sister or brother and if we always view them in this way, we are closer to having the correct balance in clinical trials.