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Ethical Issues Concerning Human Research Subjects

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Ethical Issues Concerning Human Research Subjects in Phase I Cancer related Clinical trials

Personal History

What are clinical trials and how are they brought about?

Personal History

On Mothers Day, May 9, 1999, my mother, Deborah Ann Hall was diagnosed with pancreatic cancer. I spent the majority of my day in a church, hoping and praying for some new and improved drug to come about for my mother. I thought, “anything is possible, anything could happen and that she could survive. New drugs and treatments are developed all the time. There is surely something for her.” My father and I began our research on-line that night and all my hope began to fade. There was little known about pancreatic cancer at the time. Researchers and oncologists could not put their fingers on any successful treatment for this type of cancer. My mother was given a year to live.

After a couple months of the regular, commonly used dosage treatments for pancreatic cancer, there were no results indicating her tumors were shrinking or even that they had stopped growing. They still grew, but basically at a slower rate. It was at this point that my mother’s doctor suggested applying for a clinical trial.

The “clinical trial family meeting” was at my dinner table at my family home in Simi Valley, California. We sat my withered, lifeless, 44 year old mother down. My older brother sat at one end, my father at the other, I, across from her. We asked her and explained to her all of the possibilities involved with clinical trials. She was of course already aware of the many symptoms involved with chemotherapy, however we had to make it clear to her that there was a high possibility she would receive treatments that provide little or no treatment. Additionally she might receive treatments that her body cannot handle and there may be side effects previously unknown.

It was at this point my mind cleared. I looked up at my mother, a woman who knew her time on earth was coming to an end and thought, “Who really holds the decision making here? Would she choose to receive this treatment if we were not here, begging her to stay alive? Is it worth the pain and torture?
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