The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research
*Version for investigator who is not in an institution that is covered by HIPAA to get protected health information (PHI) from a covered entity.
Permission To Get Your Protected Health Information
We are asking you to let your health care providers share your health information for a research study.
Your medical care will not change in any way if you say no.
Why sign this document?
To let your health care providers from [insert name of institution or organization] share your health information with the researchers from [insert name of institution or organization], 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 get from my health care providers?
If you say yes, we will:
- Send this permission form to your health care providers at [insert name of institution or organization].
- Get [describe in detail the information to be requested and 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 get 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, your health care provider cannot share your health information for research without your permission.
If you want, we can give you more information about the Privacy Rule. We will do our best to make sure your information stays private. But, once your information has been shared with us, it 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 get your information. 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 stop letting your health care providers share information with us. But, you have to tell your health care provider in writing. If you want us to tell your health care provider for you, let us know and we will do that. 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.
For how long will my health care provider be allowed to share my information?
We expect our study to take at least [insert number] years. After the study is done, your health care provider at [insert name of institution or organization] will no longer share your information with us. [Note to researcher: Edit this statement if authorization ends at an earlier time.
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 your health care providers will share your information with us.
By signing the document you are letting your health care provider share your health information with us.
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.