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Protocol and informed consent

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According to GCP-ICH, every single step in an interventional trial has to adhere to a prospectively formulated protocol. (A noninterventional trial is one where the assignment of a patient to a therapeutic strategy is not influenced by the study and where no additional procedures are undertaken in that patient's treatment due to the study.)

Informed consent is the process of presenting enough information to a volunteer to allow them to intelligently decide whether or not to participate as a research subject. Ideally, the informed consent form describes the overall experience and explains the research activity, paying particular attention to any new drugs, extra tests, separate research records or nonstandard means of management, such as flipping a coin for random assignment, and any other design issues. Human subjects must be informed verbally and in writing about the foreseeable harms, discomforts, inconveniences and risks that may be associated with the research activity. Likewise, the benefits that subjects may reasonably expect to encounter should be reported, though they should be made aware that helping the public at large is the goal of the study. If payment is given to defray the incurred expense for participation, it must not be coercive in amount or method of distribution. The informed consent form should also describe any alternatives to participating in the research project. For example, in drug studies the medication(s) may be available through a family doctor or clinic without the need to volunteer for research activity.

Informed consent is a fundamental mechanism for ensuring respect for persons. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. Therefore, informed consent language, especially in explanation of the study's purpose, duration, experimental procedures, alternatives, risks and benefits, must be lay language. An example glossary of lay terms that may be used in preparing informed consent forms is provided at http://humansubjects.stanford. edu/medical/glossary.html.

Terms such as 'randomisation' are frequently used but are not commonly understandable to potential participants. Randomisation assigns research participants by chance, rather than by choice, to either the investigational group or the control group of a clinical trial. Each study participant has a fair and equal chance of receiving either the new intervention being studied or the existing or control intervention. This procedure must be clearly explained to volunteers. A randomised, controlled trial is considered the most reliable and impartial method of determining which medical interventions work the best. However, this approach also potentially withholds effective treatment from those allocated to the control group; a limitation that appears unavoidable in strengthening evidence in research.

If research-related injury (i.e. physical, psychological, social, financial or otherwise) that is more than 'minimal' risk is possible, an explanation must be given of whatever compensation and/or treatment will be provided. It is worth noting that a risk is considered 'minimal' when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. The regulations do not limit injury to 'physical injury', which is a common misinterpretation. It is important not to overlook the need to point out that no penalty or loss of benefits will be incurred by subjects as a result of either not participating or withdrawing at any time. It is equally important to alert potential subjects to any foreseeable consequences to them should they unilaterally withdraw while dependent on some intervention to maintain normal function.

With few exceptions only, informed consent should be documented by the use of a written consent form approved by the IRB/IEC and signed by the subject or the subject's legally authorised representative. A signed informed consent form should thereby document that the voluntary subject has fully understood the purpose, the aim, the scope as well as the risks of their participation in the trial. The process of obtaining a patient's properly informed consent to take part in a clinical trial should not be seen as an exercise in bureaucratic form filling but as an essential part of the trial, requiring time, insight and communication skills. When patients refuse to give their consent, this is not a sign that the investigator has failed but rather an indication that the investigator was conscientious enough to ensure the patients were properly informed and made a free decision. If large proportions of patients refuse to enter a study, however, this may signify a problem with the study design.