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However, the compound became widely available for routine use in the treatment of B12 deficiency in the early 1950s (8)
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As part of the informed consent process, this information must be given to each potential research subject before enrolling in a clinical trial: A statement explaining that the study involves research An explanation of the purposes of the research The expected length of time for participation A description of all the procedures that will be completed during enrollment on the clinical trial Information about all experimental procedures that will be completed during the clinical trial A description of any predictable risks Any possible discomforts (e.g., injections, frequency of blood test etc.) that could occur as a result of the research Any possible benefits that may be expected from the research Information about any alternative procedures or treatment (if any) that might benefit the research subject A statement describing: The confidentiality of information collected during the clinical trial How records that identify the subject will be kept The possibility that the FDA may inspect the records For research involving more than minimal risk, information including an explanation as to whether any compensation or medical treatments are available if injury occurs, what they consist of, or where more information may be found Research subject participation is voluntary Research subjects have the right to refuse treatment and will not lose any benefits for which they are entitled Research subjects may choose to stop participation in the clinical trial at any time without losing benefits for which they are entitled For people considering participation in a clinical trial, it is extremely important to learn as much as possible about the clinical trial, the risks and benefits to the participants, the responsibilities of participants, the care expected, and the team that will be conducting the trial
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