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Medical research is the most common term used to describe studies and experimentations done on live test subjects in the areas of biomedical research or experimental medicine. Simply put, it is the process by which medical companies can test their products in a medically controlled environment on test subjects who are either volunteers or paid to be part of the research group. During this procedure, the doctors hope to produce a new cure or treatments that are more effective and safe than previous incarnations of a drug or procedure. Most of these researches are performed by biomedical scientists or molecular biologists. Such clinical trials are condicted within a hospital or clinic either on a localized or international basis via a multicenter trial in order to determine the efficacy of the drug or procedure on a large body of people who all suffer from the same illness. Although a clinical research has the best of intentions, there is a question regarding the ethics of how to implement the study due to the possiblity of abuse and lack of supervision at certain points during the trial that could lead to the death or inconclusive results.
The main ethical consideration that has to be dealt with is the process of informed consent. Even though research participants are informed about the procedures they will be undergoing during the research, and they are asked to sign an informed consent form after the objective of the research has been explained to them, and they have been approved for participation in the study, there is still a great concern that due to the technicality of the procedures, the participants do not actually understand the full extent and scope of their participation and possible outcomes of the study. Additionally, due to the international scope of the researchers, owing to the huge financing theat pharmaceautical companies put behind the project, there is a concern over the uniformity of the procedures and strict compliance to the rules governing the study. More importantly, there is a growing support for the creation of an international ethical standard for the implementation of these studies. For example, countries whose economic ranking show that such a procedure, once approved by the proper oversight committees, will not be affordable to those who need the procedure, should not be included in the research group as it will not serve its healing purpose in that particular area of the world.
There is also the localized problem of supervising clinical trials and reasearch studies within the United States. The Office for Good Clinical Practice was established in 2001 in order to regulate researches done by over 50,000 clinical investigators, 1,000 commercial sponsors of research, and 2,500 IRB’s, there are still too many problems that fall through the cracks when it comes to the implementation of research guidelines. Even the Office for Human Research Protections, established in 2001 cannot successfully supervise and protect the patients within the study. 5 years between on site visits at research facilities does not allow the office to properly supervise these clinical trials. If anything, yearly visits should be the mandatory on site visiting rule in order to keep the researchers on their feet and constantly in compliance with the guidlines.
There have been 2 research study deaths between the year 2000 and 2001. Both patients were healthy participants who should not have died if all regulations and protective procedures were in place for them. These deaths were all caused by negligence on the part of the researchers and because the Office for Human Research Priotection does not seem to have enough manpower to properly investigate such research related deaths, these incidents become forgotten parts of the process. Something totally unacceptable because these people joined the research in the hopes of helping others get well. Their death, left to be concluded on a piece of paper makes all of the work they did for the research a death in vain.
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