Research and Human Subject Protections
Consent is the First Step
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You (or your representative) must give permission to participate
in a research study. You may not be in a study without your knowledge
and consent. A consent form may appear complex because it is important
that you have all the information needed to make a decision. A consent
form must contain the following:
- an invitation to be a part of the research project
- an explanation of why the study is being done
- a statement about the company or agency that is funding the
study, if there is one
- detailed information about any risks of he treatment as well
as any benefits of participating in the study
- information about other treatments that might be available if
you choose not to be a part of the study
- identify who will have access to your personal health information
and who will be able to use the information obtained by the study
- identify whom you may ask for more information about the study
or about your rights as a participant in the study
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