The Privacy Rule Authorization Form and Clinical Research: What You Should Know

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The Privacy Rule Authorization Form and Clinical Research: What You Should Know

Medical research helps us learn new information about health, illness, and disease and how we can improve health for everyone. You have been asked to join a clinical research study. If you agree to be in this study after learning about it, the research team will ask you to sign certain important forms. One of these may be an authorization form. This form may ask you to let your doctors or other health care providers give your personal health information to the research team. The authorization form could also ask you to let the research team use or share your personal health information with others for the research study. The research team might need to use and share different types of personal health information, such as:

  • Your name and address

  • Your health background

  • Your health care provider's name

  • Your birthday

  • Your Social Security number

Why am I being asked to sign an authorization form?

Many people have concerns about who can see and use information about them, particularly information about their health. The U.S. Government created a rule, called the Privacy Rule, under the Health Insurance Portability and Accountability Act (HIPAA) to help protect your personal health information from being used or shared when it shouldn't be.

Since 2003, most hospitals, doctors, and health plans that have your personal health information must follow the Privacy Rule. These hospitals, doctors, and health plans are called "covered entities."
People who work for "covered entities" also may have to follow the Privacy Rule. This usually means that research teams (such as scientists, nurses, and other hospital staff) that work for "covered entities" can use and share your personal health information for this study only after getting your okay. This also usually means that your doctor can't share your personal health information with the research team for this study unless you give your okay. You give your okay by signing the authorization form.
The research team may need information in your medical records for the research study. For example, they may need to know your medical diagnosis or know about allergies you may have. The research team may also need to collect health information about you from other health care providers because the information may be important to the study. For example, the research team may need to get your lab test results from your doctor.

What information will be in the authorization form?

The authorization form will tell you:

  • Who will use, share, and receive your personal health information. This could be your doctor, other doctors and nurses taking care of you, or the researchers and other members of the research team. This could also be other institutions or companies that pay for the research.

  • What personal health information is needed for the research study. This may include some or all of your medical records, information about the medicines you take, the results of blood tests or X-rays, and other health information.

  • Why your personal health information will be used or shared. This part will describe the research study. It also may tell you the title of the research study.

  • Your Right to change your mind and cancel your authorization at any time.

  • Information on what happens if you do not sign the authorization form, how to cancel your authorization, and how long your information will be used or shared.

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