The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research
*Version for investigator who is in an institution that is covered by HIPAA but is not the covered entity that has the protected health information (PHI) of interest.
Consent Form and Permission To Use and Share Your Protected Health Information
We are asking you to be in a research study.
You do not have to be in the study.
If you say yes, you can quit the study at any time.
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?
Sign this document if you want to:
- Be in this study.
- 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].
- Let the researchers use and share your health information for this study.
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:
- Ask about [describe survey items, e.g., your health, what you eat, and if you exercise, smoke, or drink alcohol, and what medicines you take].
- Give you a form with questions for you to answer.
- Read the questions out loud and fill out the form with you, if you want.
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:
- Send this permission form to your health care providers at [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 my 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?
If you say no:
- We will not get your information.
- No one will treat you differently. You will not be penalized.
- The care you get from your doctor will not change.
- [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.]
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.] The care you get from your doctor will not change.
You can stop letting your health care providers share information with us. You can also 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 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:
- The questions could make you sad or upset.
- Someone could find out that you were in the study and learn something about you that you did not want others to know.
- You could have a legal problem if you told us about a crime such as child abuse [list other mandatory reporting required in your state] that we have to report.
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 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. After the study is done, your health care provider at [insert name of institution or organization] will no longer share your information with us and we will no longer use or share your information. [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:
- Any questions about the study.
- Questions about your rights.
- Concerns that you have been injured in any way by being in this study.
- Questions about how we will use this information.
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:
- You agree to be in the study.
- You are letting your health care provider share your health information with us.
- You are letting us use and share your health information for this study.
- [Add other uses and disclosures referenced above. For example: You are giving permission to contact you about being in other research studies.]
- We talked with you about the information in this document and answered all your questions.
You know that:
- You can skip questions you do not want to answer.
- You can stop answering our questions at any time and nothing will happen to you.
- You can call the office in charge of research at [insert phone#] if you have any questions about the study or about your rights.
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.