Please take as much time as you need to make your choice.
Your medical care will not change in any way if you say no.
Why sign this document?
To be in this study and let researchers from [insert name of institution or organization] use and share your health information for this study, sign this document.
Why are you doing this research study?
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 happens if I say yes, I want to be in the study?
If you say yes, we will:
There are no right or wrong answers to these questions. You can skip any question you do not want to answer.
How long will the study take?
The study will take about [insert time] of your time.
What information will you use and share for the study?
If you say yes, we will also:
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 my information?
What happens if I say no?
What happens if I say yes, but change my mind later?
You can stop being in the study at any time. You will not be penalized. [For studies with prospect of benefit, add: While you will not get the benefit of being in this study, you will not lose any other benefits.] [For studies with no prospect of benefit, add: You will not lose any benefits.]
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 also 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 any questions, contact [insert name and phone # and e-mail].
If you stop, the care you get from your doctor will not change.
Who will see my answers?
The only people allowed to see your answers will be the people who work on the study and people who make sure we run our study the right way. [If there is a study sponsor that will have access to the data, name sponsor here.]
Your survey answers, health information, and a copy of this document will be locked in our files. We will not put your answers into your medical record.
When we share the results of the study [insert details here, e.g., in medical journals] we will not include your name. We will do our best to make sure no one outside the study will know you are a part of the study.
Will it cost me anything to be in the study?
Will being in this study help me in any way?
Being in the study will not help you, but may help people with [insert condition] in the future.
Will I be paid for my time?
Yes. We will give you [insert amount]. This is to pay you for your time. You will get this money [insert detail, e.g., at the end of the survey today] even if you decide to skip some of the questions.
Is there any way being in this study could be bad for me?
Yes. There is a chance that:
We will do our best to protect your privacy.
[Note to researcher: Insert details on additional risks if relevant to the study, such as: You could have a legal problem if someone outside the study found out that you did something illegal.]
[Provide details regarding accommodation or referrals (e.g., for counseling) if relevant to the study.]
How long will my health information be used?
We expect our study to take [insert number] years. We will not 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:
You can also call the office in charge of research at [insert phone#] to ask questions about this study.
Do I have to sign this document?
No. You only sign this document if you want to be in the study.
What should I do if I want to be in the study?
You sign this document. We will give you a copy.
By signing the document you are saying:
| ____________________________________________________________ Your name (please print) | |
| ____________________________________________________________ Your signature If an interpreter was used: | __________________ Date |
| ___________________________________________________________ Name of interpreter (please print) | |
| ___________________________________________________________ Signature of interpreter If someone is signing this form for the subject, explain why: | __________________ Date |
| ___________________________________________________________ ___________________________________________________________ Name of legally responsible person (please print) ___________________________________________________________ |