Consent

Audience Research on Self-Management Education

Attachment 4 to the HMTS Expedited Review Form

Contents

Attachment 4a: Informed Consent Form 1

Attachment 4b: Informed Consent Form: Participant Copy 2

Attachment 4a: Informed Consent Form

Audience Research on Self-Management Education

Attachment 4a to the HMTS Expedited Review Form

May 16, 2013

Informed Consent Form

Identification of Project	Audience Research on Self-Management Education
Purpose	The Centers for Disease Control and Prevention (CDC) is the sponsor of this research project. FHI 360 is helping with this project. The purpose of this project is to gather feedback regarding messages related to programs designed to help people manage their ongoing health problems. It will help inform how CDC and its partners can better communicate health-related information to audiences with ongoing health conditions.
Procedures	We have asked you to join a focus group (a group discussion). The discussion will take place in a professional research facility. During the discussion, you will be asked about your opinions regarding ideas related to health and to the work of CDC and its partners. The group will have up to seven other people. All participants live in communities near the research facility and have at least one ongoing health problem. The group will last no more than 90 minutes. A trained person will lead the discussion group.
Information Security	We will make audio recordings of the group. In addition, some people who work on the project may listen to the recordings and may also listen during the discussion group. They will write a report based on their notes and the recordings. However, no one outside of this project will listen to the recordings. We will keep what you say secure to the extent permitted by law. Please note, although we are asking group members not to discuss what was said during this discussion with anyone outside the group, we cannot guarantee confidentiality. 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 2016.
Risks	The risks of your participation are expected to be minimal. This means that the risks are not expected to be greater than the risks persons may normally find in their daily life.
Benefits, Freedom to Withdraw, & Ability to Ask Questions	This project is not designed to help you personally. It is intended to help CDC understand how to best communicate certain health-related information to different audiences. You do not have to answer questions that you do not want to answer. You may stop at any time. You will receive $50 to show appreciation for your completed participation.
Contact Information	If you have any questions, please contact the Tom Lehman from FHI 360 at [email protected] or the Institutional Review Board Office at Protection of Human Subjects Committee, PO Box 13950, Research Triangle Park, NC 27709, USA, (phone number: 1-919-405-1445, e-mail: [email protected]).

My signature confirms that I have read the information on this page. I am at least 18 years of age, and I understand my rights as a participant. I agree to take part in this discussion group. I agree to have audio recordings made of the discussion. I realize that only the people working on this project will listen to the recordings and that they may also listen during the discussion groups. I understand that my name will NOT be used in the report or any other products. No other information that could identify me will be used either.

Signature: ________________________________________________________

Name (Please print): ________________________________________________

Date: ___________________________

Attachment 4b: Informed Consent Form: Participant Copy

Audience Research on Self-Management Education

Attachment 4b to the HMTS Expedited Review Form

May 16, 2013

Informed Consent Form

(Please keep this copy)

Identification of Project	Audience Research on Self-Management Education
Purpose	The Centers for Disease Control and Prevention (CDC) is the sponsor of this research project. FHI 360 is helping with this project. The purpose of this project is to gather feedback regarding messages related to programs designed to help people manage their ongoing health problems. It will help inform how CDC and its partners can better communicate health-related information to audiences with ongoing health conditions.
Procedures	We have asked you to join a focus group (a group discussion). The discussion will take place in a professional research facility. During the discussion, you will be asked about your opinions regarding ideas related to health and to the work of CDC and its partners. The group will have up to seven other people. All participants live in communities near the research facility and have at least one ongoing health problem. The group will last no more than 90 minutes. A trained person will lead the discussion group.
Information Security	We will make audio recordings of the group. In addition, some people who work on the project may listen to the recordings and may also listen during the discussion group. They will write a report based on their notes and the recordings. However, no one outside of this project will listen to the recordings. We will keep what you say secure to the extent permitted by law. Please note, although we are asking group members not to discuss what was said during this discussion with anyone outside the group, we cannot guarantee confidentiality. 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 2016.
Risks	The risks of your participation are expected to be minimal. This means that the risks are not expected to be greater than the risks persons may normally find in their daily life.
Benefits, Freedom to Withdraw, & Ability to Ask Questions	This project is not designed to help you personally. It is intended to help CDC understand how to best communicate certain health-related information to different audiences. You do not have to answer questions that you do not want to answer. You may stop at any time. You will receive $50 to show appreciation for your completed participation.
Contact Information	If you have any questions, please contact the Tom Lehman from FHI 360 at [email protected] or the Institutional Review Board Office at Protection of Human Subjects Committee, PO Box 13950, Research Triangle Park, NC 27709, USA, (phone number: 1-919-405-1445, e-mail: [email protected]).