Confidentiality
We will not record your name or any information that shows your identity. You will not be signing this form. We will store survey answers in ways we believe 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 by participating in the survey, we will share survey answers 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.
We will share research data where we have removed anything 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 book or journal.
· Adding results to a Federal government database.
· Using research data in future studies, done by us or by other scientists.
Potential Conflict of Interest:None.
Subject’s RightsBy participating 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. 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. Your decision will not affect your ability to get health care or payment for your health care. It will not affect your enrollment in any health plan or benefits you can get.
QuestionsThe investigator or a member of the research team will try to answer all of your questions. If you have questions or concerns at any time, contact Dr. Rachael Arabian at 703-717-2146.
You may also call 760-410-5279 or email mganesan@usa.edu. You will be talking to Mohan Ganesan, the university-wide IRB chair at the University of St. Augustine for Health Sciences. The IRB is a group that helps monitor research. You should call or email the IRB if you want to find out about your rights as a research subject. You should also call or email if you want to talk to someone who is not part of the study about your questions, concerns, or problems.
THIS PROJECT HAS BEEN REVIEWED BY THE UNIVERSITY OF ST. AUGUSTINE FOR HEALTH SCIENCES INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS. IF YOU HAVE QUESTIONS OR CONCERNS, PLEASE CONTACT THE INSTITUTION-WIDE IRB CHAIR, DR. MOHAN GANESAN, EMAIL: MGANESAN@USA.EDU, PHONE: 760-410-5279.