Attachment E - Informed Consent

Attachment E - Informed Consent.docx

National Children's Study Formative Generic Clearance

Attachment E - Informed Consent

OMB: 0925-0590

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About This Project


We have asked you to [take part in an interview/join a focus group]. [The group will have up to eight other people]. We will discuss information about health care issues. We will also ask you to look at printed educational materials. The [interview/group] will last about [60/90] minutes. A trained person will lead it.


We will make audio recordings of the discussion. Additionally, some team members may take notes while observing the [groups/interview] from behind a one way mirror and review the recordings to produce a report. The recordings will also help us to make more effective educational materials. However, no one outside of this project will listen to the recordings.


We will keep what you say private. This is required by law. We will NOT put your name in the report or on the recordings. We will keep the recordings in a locked cabinet. The recordings will be destroyed by February 2013.


There will be no risk to you. You do not have to answer questions that you don’t want to. You may stop at any time. You will receive $[Amount] as reimbursement for any expenses you may incur.


The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Development is the sponsor of this project. The Academy for Educational Development is helping with the project.


If you have any questions, please call Elyse Levine at (202) 884-8913. You may ask her about your rights as a project participant. If no one answers, leave a message and someone will call you back soon. If you feel you have been harmed by taking part in this research or if you have questions about your rights as a study volunteer, please contact the National Institutes of Health Human Research Protection Office at 1-800-XXX-XXXX. Let them know you are calling about study number XXX.


Thank you for your time!

Participant Consent


My signature confirms that I have read the “About This Project” page. I understand my rights as a participant. I agree to take part in today’s discussion. I understand that the group will discuss information about health care issues. I agree to have the discussion recorded and to be observed by team members from behind a one way mirror/or by telephone. I realize that only the people working on this project will listen to the recordings.


I understand that my name or other identifying information will NOT be used in the report or any other products.


Signature: ________________________________________________________


Name (Please print): ________________________________________________


Date: ___________________________




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