Select appropriate Study sites – delete others

The University of Texas Southwestern Medical Center

Parkland Health & Hospital System

Children’s Health

Retina Foundation of the Southwest

Texas Scottish Rite Hospital for Children

Texas Health Resources

Authorization for Use and Disclosure of

Health Information for Research Purposes

NAME OF RESEARCH PARTICIPANT: _______________________________________________

What is the purpose of this form?

This authorization describes how information about you and your health will be used and shared by the researcher(s) when you participate in the research study of [Brief description, e.g., comparative study of two treatments for recurrent breast cancer, (“Research Project”). Health information is considered “protected health information” when it may directly identify you as an individual. By signing this form you are agreeing to permit the researchers and other others (described in detail below) to have access to and share this information. If you have questions, please ask a member of the research team.

Who will be able to use or share my health information?

[Name of Institution(s)/Covered Entity(ies)] may use or share your health information with [Name of Principal Investigator] and his or her staff at UT Southwestern Medical Center (“Researchers”) for the purpose of this research study.

Will my protected health information be shared with someone other than the Researchers?

Yes, the Researchers may share your health information with others who may be working with the Researchers on the Research Project (“Recipients”) for purposes directly related to the conduct of this research study or as required by law. These other people or entities include:

[Name(s) of Sponsor(s)] Delete if not applicable]. The sponsor includes any people, entities, groups or companies working for or with the sponsor or owned by the sponsor. The sponsor will receive written reports about your participation in the research. The sponsor may look at your health information to assure the quality of the information used in the research.

[Name(s) of Collaborating Institution(s)] Delete if not applicable]. These are other research facilities that are working with UT Southwestern on the Research Project.

[Name(s) of company(ies) to supply study drug, device or resources] Delete if not applicable] These companies are supplying the [insert drug/device/resource] for this study. The Researchers may share your health information with these companies.

[Name(s) of any and all outside organization(s) assisting in the research — e.g., Contract Research Organization(s), Reference Laboratories, Data Safety Monitoring Boards] Delete if not applicable]. These organizations need access to your health information to assist the Researchers in the Research Project.

The UT Southwestern Institutional Review Board (IRB). This is a group of people who are responsible for assuring that the rights of participants in research are respected. Members and staff of the IRB at UT Southwestern may review the records of your participation in this research. A representative of the IRB may contact you for information about your experience with this research. If you do not want to answer their questions, you may refuse to do so.

Representatives of the Food and Drug Administration (FDA) [Delete if not applicable]. The FDA may oversee the Research Project to confirm compliance with laws and regulations. The FDA may photocopy your health information to verify information submitted to the FDA by the Sponsor.

Representatives of domestic and foreign governmental and regulatory agencies may be granted direct access to your health information for oversight, compliance activities, and determination of approval for new medicines, devices, or procedures.

If applicable (for example, any tests or procedures ordered and resulted in the EPIC system): Medical information collected during this study and the results of any test or procedure that may affect your medical care may be included in your medical record. The information included in your medical record will be available to health care providers and authorized persons including your insurance company.

How will my health information be protected?

Whenever possible your health information will be kept confidential as required by law. Federal privacy laws may not apply to other institutions, companies or agencies collaborating with UT Southwestern on this research project. There is a risk that the Recipients could share your information with others without your permission. UT Southwestern cannot guarantee the confidentiality of your health information after it has been shared with the Recipients.

Why is my personal contact being used?

Your personal contact information is important for the UT Southwestern Medical Center research team to contact you during the study. However, your personal contact information will not be released without your permission.

What health information will be collected, used and shared (disclosed)?

The Researchers will collect List types of health information that will be collected, used, and disclosed in a way that will be meaningful to the patient. For example, type of test results, prior treatments, physical and mental history, and information collected as part of the research. Include any “sensitive” information, such as HIV status, illegal drug use, pregnancy testing, genetic testing, mental health information NOTE - Do not list any demographic or subject contact information unless this information will be disclosed to the Recipients.

Will my health information be used in a research report?

Yes, the research team may fill out a research report. (This is sometimes called “a case report”.) The research report will not include your name, address, or telephone or social security number. The research report may include your date of birth, initials, dates you received medical care and a tracking code. The research report will also include information the research team collects for the study.

Will my health information be used for other purposes?

Yes, the Researchers and Recipients may use your health information to create research data that does not identify you. Research data that does not identify you may be used and shared by the Researchers and Recipients in a publication about the results of the Research Project or for other research purposes not related to the Research Project.

Do I have to sign this authorization?

No, this authorization is voluntary. Your health care providers will continue to provide you with health care services even if you choose not to sign this authorization. However, if you choose not to sign this authorization, you cannot take part in this Research Project.

How long will my permission last?

This authorization has no expiration date. You may cancel this authorization at any time. If you decide to cancel this authorization, you will no longer be able to take part in the Research Project. The Researchers may still use and share the health information that they have already collected before you canceled the authorization. To cancel this authorization, you must make this request in writing to: [Principal Investigator or Designee, address, and phone number].

Will I receive a copy of this authorization?

Yes, a copy of this authorization will be provided to you.

Signatures:

By signing this document you are permitting UT Southwestern Medical Center to use and disclose health information about you for research purposes as described above.

Signature of Research Participant	Date	Time: AM/PM

For Legal Representatives of Research Participants (if applicable):

Printed Name of Legal Representative:

Relationship to Research Participant: _________________________

I certify that I have the legal authority under applicable law to make this Authorization on behalf of the Research Participant identified above. The basis for this legal authority is: ________________________________________________________________________________.

(e.g. parent, legal guardian, person with legal power of attorney, etc.)

Signature of Legal Representative	Date Time: AM/PM