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Privacy Policy

AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION

Both federal and state laws regarding privacy require the protection of information that pertains to your identity and your health.

During your participation in a clinical research study, the physician and staff will collect personal health information about you. This will include your medical history and the results of any tests, examinations or any other procedures performed while you are in the study. It may be necessary to request a copy of your medical history from your health care providers. The information will be recorded on official study forms. This personal health information will be maintained in your study-related medical records.

Your records may also 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. Therefore, you will not be able to participate in a study unless you give your permission to use and disclose your PHI by signing an authorization form. In so doing, you are agreeing to allow the research physician and staff to use your PHI to conduct a study, to monitor your health status, and possibly to help to develop new tests, procedures and medical products that could benefit patients with particular health conditions.

In signing the authorization form, you are also 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. You will not ordinarily be identified in the records sent to the sponsor. The sponsor, however, may look at your complete study records, which would identify you. The sponsor may also visit the study site to oversee the way the study is being conducted and may review your PHI during this visit to ascertain that the information is correct.
     
  • The Institutional Review Board (“IRB”) may have access to your PHI in relation to its responsibilities as such an entity.

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. By signing the authorization form, however, you are agreeing not to view or copy your PHI until the sponsor has completed all work related to the study. At that time, you can request to see your records.

The authorization will never expire unless and until you cancel or withdraw it. You have a right to revoke it at any time. If you do so, your PHI will no longer be used for the study, except to the extent that 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 choose to revoke the authorization, you will not be allowed to continue your participation in the study.

We are required by law to provide a copy of the privacy policy to you when you visit our office. You will also receive a form to sign that acknowledges your receipt of this document and a form that agrees to authorization for use and disclosure of your protected health information.

If you have questions regarding the privacy of your health and study-related information, please be sure to ask them when you call or visit our office.

Additional information regarding clinical research trials or privacy protection laws can be found on the U.S. Food and Drug Administration (FDA) website www.fda.gov.  The details of the Texas legislation regarding privacy can be found at http://www.legis.state.tx.us/billlookup/text.aspx?LegSess=81R&Bill=HB300

To view our Notice of Privacy Practices and our Conditional Consent for Use and Disclosure of Protected Health Information please click here.
 

 

10260 North Central Expressway, Suite 100N    Dallas, Texas 75231     Phone: 214-265-2137  Fax: 214-265-2164    e-mail: research@researchdallas.com      Privacy Policy

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