Confidentiality
We must use information that shows your identity to do this research. Information already collected about you will remain in the study record even if you later withdraw. We will store your information in ways we think are secure. We will store paper files in locked filing cabinets. We will store electronic files in computer systems with password protection and encryption. However, we cannot guarantee complete confidentiality.
If you agree to be in the study and sign this form, we will share information and biological samples that may show your identity with the following groups of people:
People who do the research or help oversee the research, including safety monitoring.
People from Federal and state agencies who audit or review the research, as required by law. Such agencies may include the U.S. Department of Health and Human Services, the Food and Drug Administration, and the National Institutes of Health.
Any people who you give us separate permission to share your information.
We will share research data only after removing information that we think would show your identity. There still may be a small chance that someone could figure out that the information is about you. Such sharing includes:
· Publishing results in a professional book or journal.
· Adding results to a federal government database.
· Using research data in future studies conducted by us or by other scientists.
Subject’s Rights
By consenting to be in this study, you do not waive any of your legal rights. Consenting means that you have been given information about this study and that you agree to participate in the study. You will be given a copy of this form to keep.
If you do not agree to be in this study or if at any time you withdraw from this study, you will not suffer any penalty or lose any benefits to which you are entitled. Your participation is completely up to you.