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Purpose of This Notice
We respect the privacy of personal information and understand the importance of keeping this information confidential and secure. This notice describes how medical information about you may be used as disclosed and how you can get access to this information.
Please review it carefully.
Authorization to Release Information for Research
If you volunteer to take part in a research study, you have the right to know that others may know your identity.
Study information may identify you in the following ways (name, address, telephone number, social security
number and other details about you).
Who may use and give out information about you?
The study sponsor may see your health information and know your identity. Sponsor includes any person or company working for or with the sponsor or owned by the sponsor. They all have rights to see information about you during and after the study. The following people, agencies and businesses may get information from us which show who you are:
Any physician or health care professional authorized to enter information into your medical chart.
All departments and units of our facility.
All employees, staff and other office personnel.
Doctors and healthcare professionals taking part in the study.
U.S Food and Drug Administration (FDA).
U.S Department of Health and Human Services (DHHS).
Governmental agencies in other countries.
Governmental agencies that must receive reports about certain disease.
The reviewing Institutional Review Board.
Information that may be used or shared
If you decide to be in this study, medical information that identifies you and relates to your participation in this study will be created. This may include the following types of information;
Blood and urine tests
Any other tests required by the study
Medical History and/or medical records you provide to us.
Why this information is used or shared?
Information about you and your health that might identify you may be given to others to carry out the research. The sponsor will collect, analyze and evaluate the results of the study and send this information to the FDA for drug approval. In addition, the sponsor and its consultants will be visiting the research site to monitor the study and they will be reviewing your information for this purpose.
Giving permission to use my health information
By signing the consent form, you are giving permission to use and give out the health information listed above for the purposes described above. If you refuse to give permission, you will not be able to participate in this research study.
Review or copy the information obtained from me or created about me
You have the right to review and copy your health information. However, if you decide to be in this study you will not be allowed to look at or copy your information until after the research is completed.
Withdraw or revoke my permission
You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending a written notice to the study doctor. If you withdraw your permission you will not be able to continue in the study. When you withdraw your permission, no new health information that might identify you will be gathered after that date. Information that has already been gathered may still be used and given to others. This would be done if it were necessary for the research to be reliable.
Protection of my health information after it has been given to others
If you sign the informed consent for a research study you are giving permission to give others your personal health information and therefore this information may no longer be protected. There is a risk that your health information will be released to others without your permission.
If you understand our policy and agree to the terms please print and sign below:
Subject/ Patient Name (Print)