NOTICE OF PRIVACY PRACTICES
This notice describes how information about you may be used and disclosed and how you can get access to this Information. Please review it carefully.
If you have any questions about this notice, please contact the Chief Privacy Officer, Metroplex Clinical Research Center at 214-879-6737 or in writing at 8144 Walnut Hill Ln, Suite 810, Dallas, TX 75231.
WHO WILL FOLLOW THESE PRACTICES
The practices described in this notice will be followed by anyone who represents Metroplex Clinical Research Center.
YOUR PROTECTED INFORMATION
This notice applies to the protected information and records we have about you, such as your name, address, telephone number, social security number, health information, health status, and the health care and clinical trial services you receive at this office.
We are required by law to give you this notice. It explains how we may use and disclose information about you. It also describes your rights and our obligations regarding the use and disclosure of that information.
HOW WE MAY USE AND DISCLOSEINFORMATION ABOUT YOU
We must have your written, signed authorization to use and disclose information about you. We may use and disclose information about you for any of the following reasons:
• Participation in Research Studies
We may use information about you to provide you with medical treatment or services as part of the research studies we conduct. We may disclose information about you to doctors, nurses, technicians, coordinators, office staff or other personnel who help conduct our studies.
Our staff may need to know if you have health problems that could complicate your participation in or include/exclude you from participation in a research study. In addition, our staff may use your medical history to decide which research study is best for you. The study doctor may tell another doctor about your condition to help determine the most appropriate care for you and to make recommendations regarding your research study participation.
We may use information about you to provide you with medical treatment or services that are not a part of a research study. For example, personnel in our office may phone prescriptions to your pharmacy, schedule lab work, order x-rays, etc.
• Stipend Payment
We may use and disclose information about you so that you may receive a stipend for your research study participation.
• Office Operations
We may use information about you to evaluate the performance of our staff in caring for you, to help us decide what additional research studies we should offer, to learn how we can become more efficient, and to determine whether certain new treatments are effective.
• Research Purposes
We may use and disclose information about you to organizations that sponsor our research, organizations that monitor our research, ethical review boards, and to the FDA upon request.
• In Order to Contact You
We may contact you to remind you that you have an appointment at our office; to inform you about test results; to clarify information you have provided; or to tell you about research studies, products or services that might interest you.
Please notify us if you do not wish to be contacted for appointment reminders or if you do not wish to receive communications about research studies or health-related products and services. If you advise us in writing (at the address listed at the top of this notice) that you do not wish to receive such communications, we will not use or disclose your information for these purposes.
You may revoke your authorization at any time by giving us written notice. Your revocation will be effective when we receive it, but it will not apply to any uses and disclosures that occurred before that time.
If you revoke your authorization, we will not be permitted to use or disclose information for purposes of treatment, payment, or office operations, and we may therefore choose to discontinue your participation in our research studies and any related health care treatments and services.
We may use or disclose health information about you without your permission for the following purposes, subject to applicable legal requirements and limitations:
• Health or Safety Threats
We may use and disclose health information about you when necessary to prevent a serious threat to your health and safety or the health and safety of others.
We may disclose health information about you for public health reasons in order to prevent or control disease, injury or disability; or report births, deaths, suspected abuse or neglect, non-accidental physical injuries, reactions to medications or problems with products.
• Required By Law
We will disclose health information about you when required to do so by federal, state or local law.
If you are or were a member of the armed forces or part of the national security or intelligence communities, we may be required by military command or other government authorities to release health Information about you. We may also release information about foreign military personnel to the appropriate foreign military authority.
If you are involved in a lawsuit or a dispute, we may disclose health information about you in response to a court or administrative order.
We may release health information if asked to do so by a law enforcement official in response to a court order, subpoena, warrant, summons or similar process, subject to applicable legal requirements.
We may use and disclose health information about you for our research projects that are subject to a special approval process. We will ask for your permission if the researcher will be involved in your care at the office or will have access to your name, address or other information that reveals who you are.
• Health Oversight Activities
We may disclose health information to a health oversight agency such as the FDA for audits, investigations, inspections or licensing purposes. These disclosures may be necessary to enable state and federal agencies to monitor the health care system and government programs and to ensure compliance with civil rights laws.
• Coroners, Medical Examiners and Funeral Directors
We may release health information to a coroner or medical examiner. This may be necessary, for example, to identify a deceased person or determine the cause of death.
• Information Not Personally Identifiable
We may use or disclose health information about you in a way that does not personally identify you or reveal who you are.
• Family and Friends
We may disclose health information (except information regarding HIV status, mental disorders, and substance abuse information) about you to your family members or friends if we obtain your verbal agreement to do so or if we give you an opportunity to object to such a disclosure and you do not raise an objection. We may also disclose health information to your family or friends if we can infer from the circumstances, based on our professional judgment, that you would not object. For example, we may assume you agree to our disclosure of your personal health information to your spouse when you bring your spouse with you into the exam room during a clinic visit.
For situations in which you are not capable of giving consent (because you are not present or due to incapacity or medical emergency), we may, using our professional judgment, determine that disclosure to a family member or friend is in your best interest. We will disclose only health information relevant to the person's involvement in your care. For example, we may inform the person who accompanied you to the emergency room that you fainted during a blood draw and provide updates on your progress and prognosis. We may also use our professional judgment and experience to make reasonable inferences that it is in your best interest to allow another person to act on your behalf, for example to pick up filled prescriptions, medical supplies, or X-rays.
OTHER USES AND DISCLOSURES OF HEALTH INFORMATION
We will not use or disclose your information for any purpose other than those identified in the previous sections without your specific, written authorization. We must obtain your authorization separately or as part of a general or specific consenting process. If you give us authorization to use or disclose information about you, you may revoke that authorization in writing at any time. If you revoke your authorization, we will no longer use or disclose information about you, but we cannot take back any uses or disclosures already made during the time we had your permission.
If we have HIV or substance abuse information about you, we cannot release that information without a special signed, written authorization from you (different from the authorization mentioned above) that complies with the law governing HIV or substance abuse records.
YOUR RIGHTS REGARDING HEALTHINFORMATION ABOUT YOU
You have the following rights regarding health information we keep about you:
• Right to Inspect and Copy
You have the right to Inspect and copy your health information, such as our participant study files, that we use to make decisions about your care and/or your participation in research studies. You must submit a written request to the Chief Privacy Officer in order to inspect and/or copy your health information. If you request a copy of the information, we may charge a fee for the costs of retrieving, copying and mailing. We may deny your request to inspect and/or copy if the trial you participated in is still in progress. If you are denied access to your health information, you may ask that the denial be reviewed. If such a review is required by law, we will select a licensed health care professional to review your request and our denial. The person conducting the review will not be the person who denied your request, and we will comply with the outcome of the review.
• Right to Amend
If you believe health information we have about you is incorrect or incomplete, you may ask us to amend the information.
To request an amendment, complete and submit a Medical Record Amendment Correction Form to the Chief Privacy Officer. 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:
- we did not create, unless the person or entity that created the information is no longer available to make the amendment,
-is not part of the health information that we keep,
-you would not be permitted to inspect and copy, or
-is accurate and complete.
Right to an Accounting of Disclosures
You have the right to request an "accounting of disclosures." This is a list of the disclosures we have made of medical information about you for purposes other than research study eligibility and/or participation, payment and office operations. To obtain this list, you must submit your request in writing to the Chief Privacy Officer. It must state a time period which may not be longer than six years and may not include dates before April 14,2003. Your request should indicate in what form you want the list (e.g., on paper, electronically, etc.). 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
You have the right to request a restriction or limitation on the health information we use or disclose about you.
For example, you could ask that we not use or disclose information about a surgery you had. To request restrictions, complete and submit the Restriction Request form to the Chief Privacy Officer.
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. If we do not approve your request, you may be ineligible to join a research study.
To request restrictions, you may complete and submit the Request For Restriction On Use/Disclosure Of Medical Information to the Chief Privacy Officer.
- Right to Request Confidential Communications
You have the right to request that we communicate with you about medical matters by a certain means or a certain location. For example, you can ask that we only contact you at work or by mail.
To request confidential communications, send your written request to the Chief Privacy Officer. 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 the right to a paper copy of this notice. You will be given a copy of this notice the first time you come to our clinic for an appointment. You may ask us to give you a copy of this notice at any time. Even if you have agreed to receive it electronically, you are still entitled to a paper copy. To obtain a paper copy, ask your local site representative or contact the Chief Privacy Officer.
CHANGES TO THIS NOTICE
We reserve the right to change this notice and 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 summary of the current notice in the office with its effective date in the top right hand corner. You are entitled to a copy of the notice currently in effect.
If you believe your privacy rights have been violated, you may file a complaint with our office or with the Secretary of the Department of Health and Human Services. To file a complaint with our office, contact the Chief Privacy Officer at 214-879-6737 or in writing at 8144 Walnut Hill Ln, Suite 810, Dallas, TX 75231. You will not be penalized for filing a complaint.
Authorization for Use and Disclosure of Protected Health Information
Use and Disclosure of Protected Health Information
During and after your participation in this research project, Metroplex Clinical Research Center and the study doctor may need to release identifiable information about you and/or your health to Metroplex Clinical Research Center staff, the entity that monitors the research project, the sponsor of the study, the FDA, and possibly other agencies of the federal government.
Metroplex Clinical Research Center will release only the minimally necessary information. This information, contained in your Metroplex Clinical Research Center data file and/or study chart(s), may include your name, address, emergency contact person, date of birth, telephone and fax numbers, e-mail address, social security number, study record number, photos (if applicable) or other number, code or characteristics, date of service, type of service provided.
The purpose of releasing this information is to conduct clinical research trials for the development of pharmaceutical agents, vaccines, biological agents and/or medical devices. Information will be released as required to comply with reporting requirements of the study sponsor and government agencies. This protected health information may be used to diagnose a condition, to provide treatment to you, to carry out health care operations (such as assessing quality and reviewing the competence of healthcare professionals of Metroplex Clinical Research Center), as a basis for planning your care and treatment, as a means of communication among health professionals who contribute to your care and to analyze research findings.
You may inspect or copy your health information that is to be released as permitted under federal law (or state law to the extent the state law provides greater access rights). Further details can be found by reviewing the Metroplex Clinical Research Center, Notice of Privacy Practices.
With this authorization, Metroplex Clinical Research Center may call or mail your home, or other designated location, and leave a message about things such as appointment reminders, information pertaining to your clinical care (such as laboratory results), and other information as needed for conducting research studies.
I understand that this authorization does not expire unless state law mandates expiration, in which case this authorization will expire 40 years from the date of my signature. Otherwise, this authorization shall remain in effect unless revoked in writing by me. To revoke this authorization, I must send a letter to the Chief Privacy Officer, Metroplex Clinical Research Center, 8144 Walnut Hill Ln, Suite 810, Dallas, TX 75231. I understand that such a revocation will only apply to future releases of information. It does not apply to information already obtained or previously released.
I understand I have the right to request a restriction on how my health information is used or disclosed. Metroplex Clinical Research Center is not required to agree to the restrictions that I may request. I understand that I may be ineligible to join a research study if my request is not approved. However, if Metroplex Clinical Research Center agrees to a restriction that I request, Metroplex Clinical Research Center will follow the restriction.
I understand that information used or disclosed before this authorization may have been re disclosed to a third party and may no longer be protected by federal or state law.
I have been made aware of the Metroplex Clinical Research Center "Notice of Privacy Practices" and have received a copy. I understand I am not required to sign this authorization.
|Signature of Subject or Personal Representative||Date|
|Name of Subject or Personal Representative||Description of Personal Rep's Authorization|