Orlando Clinical Research Center (OCRC)
5055 S. Orange Avenue Orlando, Florida 32809
Notice of Privacy Practices for Protected Health Information
Effective Date: April 14, 2003
THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION.
PLEASE REVIEW IT CAREFULLY.
This Notice of Privacy Practices describes how we may use and disclose your protected health information to carry out research-related procedures and for other purposes that are permitted or required by law. It also describes your rights to access and control your protected health information. “Protected health information” is information about you, including demographic information (e.g., age, gender), that may identify you and that relates to your past, present or future physical or mental health condition and related health care services.
We are required to abide by the terms of this Notice of Privacy Practices. We may change the terms of our notice, at any time. The new notice will be effective for all protected health information that we maintain at that time. You are entitled to receive a revised copy of the Notice by calling the office and requesting that a revised copy be sent to you in the mail, by picking up a copy at our office, or by accessing our website at www.ocrc.net.
WHO WILL FOLLOW THIS NOTICE
The following individuals share OCRC’s commitment to protect your privacy and will comply with this Notice:
• All employees, research staff and other research personnel at OCRC.
• All volunteers and/or students who are completing all or part of school curriculum requirements.
HOW WE MAY USE AND DISCLOSE MEDICAL INFORMATION ABOUT YOU
Unless you object we may use or disclose your protected health information to notify, or assist in notifying a family member, personal representative, or other person responsible for your care, about your location, and about your general condition.
Information about you and your health, that might identify you, may be given to others to carry out a research study. We may also use and disclose medical information to contact you with appointment reminders or information pertaining to research studies that you may be interested in.
The following categories describe different ways that we use and disclose medical information. For each category of uses or disclosures we will explain what we mean and try to give some examples. Not every use or disclosure in a category will be listed. However, all of the ways we are permitted to use and disclose information will fall within one of the categories.
Research – In the course of conducting research, the Investigator (study doctor) and research staff may obtain, create, use, and/or disclose individually identifiable health information. They may give this information to others during and after the study.
Who may see this information?
The study sponsor also may see your health information and know your identity. “Sponsor” includes any people or companies working for or with the sponsor or owned by the sponsor. They all have the right to see information about your during and after the study. The following people, agencies and businesses may get information from us that shows who you are:
• 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)
• Government agencies in other countries
• Government agencies that must receive report about certain diseases
• The Institutional Review Board (IRB). The IRB is a committee established for the purpose of protecting the rights of volunteers in a research study.
Business Associates – There are some services provided in our organization through contacts with business associates. Examples include physician services, diagnostic services, certain laboratory tests, and contract personnel. When these services are contracted we may disclose your health information to our business associate so that they can perform the job we’ve asked them to do. So that your health information is protected, however, we require the business associate to appropriately safeguard your information.
As Required By Law – We will disclose medical information about you when required to do so by federal, state or local law.
To Avert A Serious Threat To Health Or Safety – We may use and disclose medical information about you when necessary to prevent a serious threat to your health and safety or the health and safety of the public. Any disclosure, however, would only be to someone able to help prevent the threat.
Military and Veterans. If you are a member of the armed forces, we may release medical information about you as required by military command authorities.
Public Health Risks. We may disclose medical information about you for public health activities. These activities generally include the following:
• to prevent or control disease, injury or disability
• to report reactions to medications or problems with products
• to notify a person who may have been exposed to a disease or may be at risk for contracting or spreading a disease or condition
Lawsuits and Disputes. If you are involved in a lawsuit or a dispute, we may disclose medical information about you in response to a court or administrative order.
Law Enforcement. We may release medical information if asked to do so by a law enforcement official (e.g., In response to a court order, subpoena, warrant, summons or similar process.)
National Security and Intelligence Activities. We may release medical information about you to authorized federal officials for intelligence, counterintelligence, and other national security activities authorized by law.
Protective Services for the President and Others. We may disclose medical information about you to authorized federal officials so they may provide protection to the President, other authorized persons or foreign heads of state or conduct special investigations.
Coroners, Medical Examiners and Funeral Directors. We may release medical information to a coroner or medical examiner as necessary to identify a deceased person or carrying out their duties as required by law. We may also release medical information about research subjects to funeral directors as necessary to carry out their duties.
YOUR HEALTH INFORMATION RIGHTS
The medical and research study information we maintain are the physical property of Orlando Clinical Research Center. You have the following rights with respect to your Protected Health Information:
Right to Inspect and Copy – Right to inspect and copy your health information. If you request a copy of the information (must complete “Authorization to Release Information Form”), we may charge a fee for the costs of copying, mailing or other supplies associated with your request. You will not have the right to review your records while the research is in progress. However, you will be able to review your records after the research has been completed, as long as the study doctor has this information in his possession.
We may deny your request to inspect and copy in certain very limited circumstances. If you are denied access to medical information, you may request that the denial be reviewed.
Right to Amend – Right to request that your health information be amended to correct incomplete or incorrect information by delivering a written request to our office. In addition, you must provide a reason that supports your request.
We may deny your request for an amendment if it is not in writing or does not include a reason to support the request. In addition we may deny your request if you ask us to amend information that:
• Was not created by us, unless the person or entity that created the information is no longer available to make the amendment;
• Is not part of the medical information kept by or for the research site;
• Is not part of the information which you would be permitted to inspect and copy; or
• Is accurate and complete
Right to an Accounting of Disclosures – Right to receive and accounting of disclosures of your health information as required to be maintained by law by delivering a written request to our office. An accounting will not include internal uses of information for treatment, payment, or operations, disclosures made to you or made at your request, disclosures to correctional institutions and law enforcement, or disclosures made to family members or friends in the course of providing care. An accounting is not required if you have provided authorization for the disclosure of protected health information when participating in a clinical research study.
Your request must state a time period that may not be longer than six years and may not include dates before April 14, 2003. The first list you request within a 12-month period will be free. For additional lists, we may charge you for the costs of providing the list. We will notify you of the cost involved and you may choose to withdraw or modify your request at that time before any costs are incurred.
Right to Request Restrictions – Right to request a restriction or limitation on the medical information we use or disclose about you to someone who is involved in your care, like a family member or friend. For example, you could ask that we not use or disclose information about the kind of research study you had participated or is currently participating in.
We are not required to agree to your request. If we do agree, we will comply with your request unless the information is needed to provide you emergency treatment.
To request restrictions, you must make your request in writing to Thomas Marbury, MD. In your request, you must tell us (1) what information you want to limit; (2) whether you want to limit our use, disclosure or both; and (3) to whom you want the limits to apply, for example, disclosures to your spouse.
Right to Request Confidential Communications – Right to request that we communicate with you about medical matters in a certain way or at a certain location. For example, you can ask that we only contact you at work or by mail.
To request confidential communications, you must make your request in writing to Thomas C. Marbury, M.D., Orlando Clinic Research Center, 5055 S. Orange Avenue, Orlando, FL. 32809. We will not ask you the reason for your request. We will accommodate all reasonable requests. Your request must specify how or where you wish to be contacted.
Right to a Paper Copy of This Notice – You have a right to a paper copy of this notice. You may ask us to give you a copy of this notice at any time.
TO REQUEST INFORMATION OR FILE A COMPLAINT
If you believe your privacy rights have been violated, you may file a complaint with the Privacy Official at our facility or with the Secretary of the Department of Health and Human Services. To file a complaint with the Secretary of the Department of Health and Human Services, write to 200 Independent Avenue S. W., Washington, DC. The DHHS toll-free telephone number is 1-877-696-6775. All complaints must be submitted in writing.
You will not be penalized for filing a complaint.
OTHER USES OF MEDICAL INFORMATION
Other uses and disclosures of medical information not covered by this notice or the laws that apply to us will be made only with your written permission. If you provide us permission to use or disclose medical information about you, you may revoke that permission, in writing, at any time. If you revoke your permission, we will no longer use or disclose medical information about you for the reasons covered by your written authorization. You understand that we are unable to take back any disclosures we have already made with your permission, and that we are required to retain our records pertaining to the research study you have participated in as well as records of the services we have provided you.
CHANGES TO THIS NOTICE
We reserve the right to change this notice. We reserve the right to make the revised or changed notice effective for medical information we already have about you as well as any information we receive in the future. We will post a copy of the current notice in the research site. The notice will contain, on the top of the first page, the effective date. In addition, each time you screen or enroll in a research study, we will offer you a copy of the current notice in effect.
If you have any questions about this Notice please contact a Privacy Officer at (407) 240-7878.