*Version for investigator who is in the same covered entity as the protected health information (PHI) of interest.
Permission To Use and Share Your Protected Health Information
We are asking you to let us use and share your health information in a research study.
Your medical care will not change in any way if you say no.
Why sign this document?
To let the researchers from [insert name of institution or organization] use and share your health information for this study, sign this document. We will give you a copy.
Why are you asking for my information?
We want to learn more about how to help people who have [insert condition]. This study will help us learn more about [insert specifics]. We are asking people like you who have [insert condition] to help us.
What information will you use and share for the study?
If you say yes, we will:
- Use and share information from [insert name of institution or organization].
- Use and share [describe in detail the information to be used, e.g., entire medical record, information from your record, such as how often you visited the doctor and the reason for your visits, what medicines you take, the results of lab tests, and your medical record number, sex, and date of birth].
The information we are asking to use and share is called "Protected Health Information." It is protected by a federal law called the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). In general, we cannot use or share your health information for research without your permission.
If you want, we can give you more information about the Privacy Rule. Also, if you have any questions about the Privacy Rule you can speak to our Privacy Officer at [insert phone #].
How will you use and share this information?
- We will use your information only for the study described in this document.
- We may share your information with [list anyone other than the researchers who will receive identifiable information. For example, if there is a study sponsor that will have access to the data, name sponsor here].
- [Note to researcher: If the information is being shared for any reason other than this research study that also requires a HIPAA authorization, this purpose needs to be described. For example: We may share your name with other people doing research on [insert condition] so they can contact you about being in other research studies.]
- We will do our best to make sure your information stays private. But, if we share information with people who do not have to follow the Privacy Rule, your information will no longer be protected by the Privacy Rule. Let us know if you have questions about this.
What happens if I say no?
We will not use or share your information for this study. The care you get from your doctor will not change.
What happens if I say yes, but change my mind later?
At any time, you can tell us to stop using and sharing health information that can be traced to you. We will stop, except in very limited cases if needed to comply with law, protect your safety, or make sure the research was done properly. If you have any questions about this, please ask. [Note to researcher: After permission is revoked, researchers are permitted to use and disclose health information in very limited circumstances that relate to protecting the integrity of the research. For example, such use and disclosure is permitted to account for a subject's withdrawal from the research study, to conduct investigations of scientific misconduct, or to report adverse events.]
If you want us to stop, you have to tell us in writing. Write or e-mail [insert name and address and e-mail]. If you have questions, contact [insert name and phone # and e-mail].
If you stop, the care you get from your doctor will not change.
How long will my health information be used?
We expect our study to take at least [insert number] years. We will not use or share your information after the study is done [Note to researcher: If the information is being shared for any reason other than this research, that also requires a HIPAA authorization (e.g., sharing a person's contact information for recruiting to other research projects), include the expiration date for the authorized activity, if different from this expiration date.]
What if I have questions?
If you have any questions about the study, call the head of the study, [insert name and phone #]. Please call if you have:
- Questions about your rights.
- Questions about how we will use and share your information.
You can also call the office in charge of research at [insert phone#] to ask questions about this study.
By signing the document you are letting us use and share your health information for this study. [Add other uses and disclosures referenced above. For example: By signing the document you are giving us permission to contact you about being in other research studies.]
Your name (please print)
If an interpreter was used:
Name of interpreter (please print)
Signature of interpreter
If someone is signing this form for the subject, explain why:
Name of legally responsible person (please print)
|Signature of person signing for the subject|
Relationship to you: _________________________________________
Name of person conducting the consent discussion (please print)
Signature of person conducting the consent discussion
* This form is designed for minimal risk, noninterventional research only.