researchindex

Disclaimer
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Privacy Policy

AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION

During your participation in a research study, the study doctor and study staff will collect or create personal health information about you ( for example, medical histories and results of any tests, examinations or any procedure performed while you are in the study) and record it on study forms. The study doctor will keep this personal health information in your study- related medical records (“your records”). In addition, the study doctor may obtain and include in your records information regarding your past, present and/or future physical or mental health condition, such as medical records from your primary care physician. Your records may include other personal information which could be used to identify you (such as social security number, medical record numbers, date of birth, etc.). Health information that could identify you is called “Protected Health Information” (“PHI”).

Under federal law (the “Privacy Rule”), your PHI that is created or obtained during a research study cannot be “used” to conduct the research or “disclosed” for research purposes without your permission. This permission is called an “Authorization”. Therefore, you may not participate in a study unless you give your permission to use and disclose your PHI by signing an Authorization. By signing, you are agreeing to allow the study doctor and staff to use your PHI to conduct a study; to monitor your health status; possibly to develop new tests, procedures and commercial products.

You also are agreeing to allow the study doctor to disclose PHI as described below:

•Your PHI may be disclosed to the sponsor of the study and any agents, representatives or consultants working on behalf of the sponsor to conduct the study. The sponsor will analyze and evaluate the PHI and may disclose it to the United States Food and Drug Administration (“FDA”) or similar regulatory agency in the United States and/or foreign countries. The study staff will assign a code number and/or letters to your records which mean that you will not ordinarily be identified in the records sent to the sponsor; however, the sponsor may look at your complete study records, which would identify you. In addition, the sponsor may visit the study site to oversee the way the study is being conducted and may review your PHI during such visit to ensure the information is correct.

·• The Institutional Review Board (“IRB”) may have access to your PHI in relation to its responsibilities as an Institutional Review Board.

These disclosures also help ensure that the information related to the research is available to all parties who may need it for research purposes. Your identity will remain confidential and, except for the disclosures described above, will not be shared with others unless such disclosure is required by law. If your PHI is given to the parties listed above or to others who are not required to comply with the federal law, your PHI will no longer be protected by this law and could possibly be used or disclosed in ways other than those listed here.

You have a right to see and make copies of your PHI. You are agreeing, however, by signing the form, not to see or copy your PHI until the sponsor has completed all work related to the study. At that time, you may ask to see your records.

The Authorization will never expire unless and until you revoke (cancel or withdraw) it.
You have a right to revoke it at any time. If you revoke the authorization, your PHI will no longer be used for the study, except to the extent the parties to the research have already taken action based upon your Authorization or need the information to complete analysis and reports for the research. To revoke your Authorization, you must send a written notice to the study doctor’s office, stating that you are revoking your Authorization to Use or Disclose Protected Health Information. If you revoke the authorization, you will not be allowed to continue your participation in the study.

Studies
Your participation in any of the studies will provide you with study related care, such as physical exams, lab tests, and study medication at no cost. You will be compensated for time and travel if you qualify for the study.

For additional information regarding clinical trial participation, please visit the FDA web site.