Clinical Research Past and Present
Clinical Research Past and Present
Tina Ross-Cruz
Abstract Research disasters have been noted for years. In the early years, the reasons for these disasters was that there were no regulations governing the protection of human beings; and there were no guidelines for safety and efficacy of a new medication or treatment prior to the use in humans. Now regulations and guidelines are in effect for the protection of human subjects. These guidelines and regulations also protect the researchers. These regulations have enabled the researchers to further scientific knowledge of diseases and the etiology, along with the bioavailability, toxicology, and pharmacology of the new medication or treatment. Even with all of these regulations and guidelines, still researchers perform unethical research on human subjects. This could be attributed to several factors: One is the financial gain; second, is the need to be the best; and third, the professional and academic pressure put on the researchers. Although there are these pressures, the research subject should still be aware of the research at hand and the qualifications of the researchers.
Clinical Research Past and Present
Imagine living in the early twentieth century and suffering from chronic headaches. A physician suggests trying something different, a medication not approved by the Food and Drug Administration (FDA) for chronic headaches. The medication is taken at the physician 's request and the result is death. This kind of pre-clinical research actually did happen and still does today. There are regulations today that govern clinical research in humans because of this type of disregard for human life. These regulations enable healthcare providers to enhance scientific development and to minimize risks involved with participation in a clinical research trial.
The need for current and accurate information concerning the proper conduct of clinical research has never been greater than it is today.
Tina Ross-Cruz
Abstract Research disasters have been noted for years. In the early years, the reasons for these disasters was that there were no regulations governing the protection of human beings; and there were no guidelines for safety and efficacy of a new medication or treatment prior to the use in humans. Now regulations and guidelines are in effect for the protection of human subjects. These guidelines and regulations also protect the researchers. These regulations have enabled the researchers to further scientific knowledge of diseases and the etiology, along with the bioavailability, toxicology, and pharmacology of the new medication or treatment. Even with all of these regulations and guidelines, still researchers perform unethical research on human subjects. This could be attributed to several factors: One is the financial gain; second, is the need to be the best; and third, the professional and academic pressure put on the researchers. Although there are these pressures, the research subject should still be aware of the research at hand and the qualifications of the researchers.
Clinical Research Past and Present
Imagine living in the early twentieth century and suffering from chronic headaches. A physician suggests trying something different, a medication not approved by the Food and Drug Administration (FDA) for chronic headaches. The medication is taken at the physician 's request and the result is death. This kind of pre-clinical research actually did happen and still does today. There are regulations today that govern clinical research in humans because of this type of disregard for human life. These regulations enable healthcare providers to enhance scientific development and to minimize risks involved with participation in a clinical research trial.
The need for current and accurate information concerning the proper conduct of clinical research has never been greater than it is today.
References: Byar, M.D., David P., et al "Randomized Clinical Trials." The New England Journal of Medicine. Vol 295 No.2 (1976): p 74-80 Code of Federal Regulations Helms, Robert. "No Charges Filed: The Manslaughter of Jesse Gilsinger" March 2000. Retrieved November 10, 2000, from http://www.geocities.com Jones, J Parasandola Ph.D., Mark. "The History of Medical Research in the United States" Journal of Clinical Research Practice 1:1 (1999): 7-20 Parascandola, Ph.D., Mark Passamini, M.D., Eugene. "Clinical Trials are they Ethical? The New England Journal of Medicine. Vol 324 No. 22 (1991) : 1589-1592 Scott, Stephen Shyrock, R.: American Medical Research Past and Present. NY: The Common Wealth Fund, 1947 World Medical Association "The Declaration of Helsinki" June 1964, Retrieved December 14, 2006, from http://www.wma.net