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Protecting Participants of Research Trials

            I have allowed my children to be part of research trials in the past and I never knew so much work was involved in protecting the subjects. My eighteen year old daughter has colitis and her doctor has requested that she take part in a few studies over the years. He was always very thorough and went over the paperwork in great detail. I remember countless times saying to him, I trust you, I will sign, for him to say no I have to go over every part of this with you. I now understand why he was always so thorough and why he went over every single part. .
             The informed consent part for me was a given. You need to tell the risks involved and make sure they are understood. Even though my daughter was already having a procedure done and having biopsies, the doctor made sure he explained the risk of adding on the extra biopsies needed for the research study.A few times the studies only involved a blood sample and still we were given the risks involved. I am grateful that the research on human subjects is held to such a high esteem today. When we go back and watch videos made in the 1930's involving babies in particular it makes my skin crawl and saddens me to my core. .
             The Belmont report requires that all research done on humans follow three key principles, first is the respect for persons, making sure that the person is able to give informed consent. Second, is beneficence,following a do no harm rule. If the risk outweighs the possible benefit to a person then the person should not be part of the study. Third, is Justice, which spells out who should benefit from the research and who should bear the burdens. .
             The IRB was set up to oversee researchers and make sure that human subjects are treated in the appropriate manner. There are three different types of review, exempt, expedited and full board. Exempt is for the research studies that have minimal risk involving humans. Expedited, no more than minimal risk, the IRB can determine that it can be done through expedited review.


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