Before participating in a biomedical research study (a clinical trial), you should make an effort to know as much about the trial as possible. You could use the following questions as a guide when you are discussing your participation with the research staff and/or your family/friends.
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Who is responsible for conducting this research? Who are the responsible investigators?
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Who is the sponsor of the research?
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What is the official title of the research project?
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What is the purpose of the research?
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How much previous research has been done on this topic/drug/device?
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How do I know if I am eligible to participate in this research?
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How do I know if I should not participate in this research?
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Are there any known drug interaction concerns?
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What will happen if I decide to quit the study?
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What is being done as part of the research?
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What is being done as part of my standard treatment?
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Is my standard treatment being withheld as part of this research?
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What are the potential risks and inconveniences of this study?
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Should I and my sexual partner use birth control while participating in this research?
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Is there any danger to my unborn or breast-fed child?
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Can I participate in more than one research project at a time?
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Will my participation in this research be confidential?
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Will my name be in the research records?
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Will someone going over the research records be able to recognize who I am?
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Who has access to the research records?
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If I am injured as a result of my participation, what will be done?
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How will the risks of the research be minimized?
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What are the benefits of this study?
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Would I benefit directly from volunteering to participate?
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Will I receive any kind of compensation as a result of participating in the research?
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Are there benefits to other people in the future as a result of this research?
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Will I need to cover any of the costs of the research myself?
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Will my insurance company need to cover any of the costs of the research?
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Will information or results from the research be used for commercial gain?
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Who can I contact if I have questions about the research?
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Who can I contact if I have questions about my rights?
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Has an Institutional Review Board (IRB) approved this research?
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Is there a written consent document for this study? If so, how do I get a copy of the consent document?
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Will the results of this research be shared with me?
