We have regulations to protect your private health information. By signing the consent form you provide your permission; your “authorization,” for the use and disclosure of information protected by the Privacy Law.
The research team working on the study will collect information about you in form of documents, media and statistical data. Collected information includes things learned from the procedures described in this consent form. They may also collect other information including your name, address, date of birth, and information from your medical records.
The research team will know your identity and that you are in the research study. Other people at our hospital, particularly your doctors, may also see or give out your information. We make this information available to your doctors for your safety. If you think this study might affect your clinical care, please inform your doctor.
People outside our hospital may need to see or receive your information for this study. Examples include government agencies (such as the Food and Drug Administration), safety monitors, and companies that sponsor the study. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include study sponsor, monitors, IRB/IEC, regulatory authorities/government agencies.
We cannot conduct this study on you without your authorization to use and give out your information. You are not required to give us this authorization. If you do not, then you may not join this study. We try to ensure that every person or entity needing access to your information, keeps it confidential.
The use and disclosure of your information has no time limit. You may cancel your permission to use and disclose your information at any time by notifying the Principal Investigator of this study by phone or in writing. If you contact the Principal Investigator by phone, you must follow-up with a written request that includes the study number and your contact information. The Principal Investigator can be reached by phone at or by sending a letter to institute address. If you do cancel your authorization to use and disclose your information, your part in this study will end and no further information about you will be collected. Your revocation (cancellation) would not affect information already collected in the study, or information we disclosed before you wrote to the Principal Investigator to cancel your authorization.
You should know that a Confidentiality Certificate does not prevent you or a member of your family from voluntarily releasing information about you or your involvement in this research. If an insurer or employer learns about your participation and obtains your consent to receive research information, then we may not use the Certificate of Confidentiality to withhold this information. This means that you and your family must also actively protect your privacy.
You should also understand that your doctor and the group conducting this study may take steps, including reporting to authorities, to prevent you from seriously harming yourself or others.