Attachment I CDSME consent form

YOUR PROGRAM NAME

Participant Consent Form

Welcome to the [PROGRAM NAME] workshop!

This workshop is made possible through a grant from the U.S. Administration on Aging (AoA). AoA has asked us to give you a short Survey. The survey is voluntary: you do not need to complete it to take this workshop. Before we can share your Survey answers, you must read and sign this Consent Form that explains how the information you provide will be used. Please read the information below (or have someone read it to you). Ask any questions you have before signing this Consent Form.

What is the purpose of the Survey and how will my information be used?

The survey provides information about the people who attend these workshops. This information is very valuable to us. We use it to:

• Help us improve our services.

• Help AoA show they are spending their money wisely. AoA needs to know how many and what types of people are taking this program all across the country.

• Tell AoA how many people who come to at least 4 of the 6 classes. To track how many times you come to class, we ask for your name or a nickname or number to put on a class Attendance List. We do not share your name with AoA or anyone else.

If you have Medicare and you agree, we would also like to use your information to help AoA with a Medicare study.

• AoA would like to share your birthday, zip code, and gender with the Centers for Medicare & Medicaid (CMS) or a company that is hired to do the study (called a “contractor”).

• CMS or the contractor would use this information to look up your Medicare claims records. These records could include your medical conditions and how often you have gone to the hospital or used other health care services.

• The Medicare study will help show if the people who go to the workshops have lower health care costs.

What are you asking me to do?

We are asking you to do two things:

1. Read the Consent Form. If you understand and are comfortable with the information provided on the Consent Form, please sign it. By signing the Consent Form, you are agreeing to let us share your information with AoA and CMS, who may match it to your Medicare claims records. We will not share your information without your consent.

2. Complete the Participant Information Survey.

Are there any risks to you by taking this workshop or filling out the Survey?

The [Program Name] has been tested in large studies in the United States, Canada and other countries with thousands of people. No one has reported any harm.

• If you agree to the Medicare study, where your survey information may be matched to your Medicare claims records, there is a very small risk that your claims information might not stay private. If that happens, it might make it harder for you to get other insurance.

• However, we will follow very strict rules to protect your information and to keep it private:

  • The people who handle your information are trained to protect personal data.

  • All Survey forms are stored in secure, locked offices. After your information is entered into a secure computer, we will destroy your Survey form.

  • CMS has very strict rules about keeping information private. We will use these to make sure your information stays private.

Will I receive any benefits?

You will not receive any benefits for completing the Survey or signing the Consent Form. However, people who have taken the workshop before have told us that it helped them feel better. The information you give us might make it easier for others to attend these workshops and maybe improve their health.

Do I have to complete the Survey?

• No, you do not. Completing the Survey is entirely voluntary. You can still take the workshop even if you decide not to complete the Survey or sign the Consent Form.

• You may skip any questions that you do not want to answer.

• You can agree to complete the Survey, but not agree to let us share your information for the Medicare study.

• If you sign the Consent Form, you can change your mind at any time and tell us not to give your information to CMS.

What if I have questions?

Please ask your group leader if you have any questions about the Consent Form or Survey. If you have any questions about how AoA will use your Survey answers, you can email the national program manager, Ms. Michele Boutaugh at [email protected].

For information about your rights as a person involved in a research study, please contact Dr. Susan Chibnall, Deputy Chairperson of the Manila Institutional Review Board at 571-218-0599. She is not a part of the study team and will answer all of your questions.

Please go to the Statement of Consent on the next page

Statement of Consent

Please show us that you understand the information on the Participant Consent Form and how your survey information will be used. Check each box you agree to and sign below. Print your name and today’s date.

• I have read the information on this form or it has been read to me. I understand the information and have received answers to any questions I asked. I understand that I do not have to complete the survey and if I do not, it will not affect the services I receive.

• I agree to allow [host agency name] to share my survey information with AoA and its contractors.

• I agree to allow my gender, zip code and date of birth to be shared with CMS or its contractors to match with my Medicare claims information.

Signature

____________________________________________

Printed Name

__________________________________________

Date

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