Informed Consent

Attachment D_Informed Consent.docx

CDC and ATSDR Health Message Testing System

Informed Consent

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ATTACHMENT D: INFORMED CONSENTS

Verbal Consent Reminder Script for Focus Group Moderator (Adults)

ICF International (ICF) is conducting small group discussions to hear your input on CDC’s HEADS UP concussion prevention campaign. We value your feedback and thank you for taking the time to speak with us.

This discussion is authorized under Section 301 of the Public Health Service Act, (42 U.SC.241) authorized on December 31, 2004.

Procedures

  • This telephone discussion will last up to 90 minutes.

  • You will be asked questions about concussion and your perceptions of the HEADS UP concussion prevention materials.

  • This discussion will observed by ICF and CDC staff and will be recorded.



Privacy

  • ICF and CDC staff will be present during the discussion, and only ICF and CDC will have access to the recording and notes taken during the discussion.

  • Your name will not be used in any reports.



Voluntary Participation

  • You can choose not to answer any question and you can leave the discussion at any time, for any reason.

  • Your participation in this discussion group will help CDC to develop more effective messages and materials for a range of audiences about concussion. There are no known risks to participants for participating in this discussion.



Do you agree to participate in this discussion?



Recontact

  • We will be using the information we gathered today to develop messages and resources to improve the HEADS UP campaign materials. Within the next year, would you be willing to talk with us again to provide feedback on the revised materials? Your willingness to be recontacted will not affect your participation today.

  • [If yes] Thank you. I will reconfirm your willingness to be recontact at the end of the discussion.







Written Consent Form for Focus Group (Adults)



ICF International (ICF) is conducting small group discussions on behalf of the Centers for Disease Control and Prevention (CDC) to hear your input on CDC’s HEADS UP concussion education campaign. We value your feedback and thank you for taking the time to speak with us.



You have been invited to participate in a 90-minute discussion with other participants like yourself. A report of the results from the discussions will be prepared by ICF for CDC. Before you agree to join in this discussion, please review and consider the conditions listed below:



  • Participation in this group discussion is completely voluntary.

  • Any questions you have about this discussion group will be answered before the group discussion begins.

  • The discussion will be audio recorded.

  • The discussion may be observed by CDC staff.

  • ICF and CDC staff will be present during the discussion, and only ICF and CDC will have access to the recordings and notes taken during the discussion.

  • Your name, your organizations’ name, and/or any other personally identifiable information will not be used in any reports.

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

  • You may choose to leave the group at any time for any reason.

  • You will receive a stipend of $30 to compensate you for your time.

  • Your participation in this discussion group will help CDC to develop more effective messages and materials for a range of audiences about concussion. There are no known risks to participants for participating in this discussion.



This discussion is authorized under Section 301 of the Public Health Service Act, 42 U.SC.241) authorized on December 31, 2004.



Your signature below indicates that you understand the conditions stated above and agree to participate in this group.





Signature _______________________________________



Date _______________________________________

The following consent form will be emailed to parents on eligible youth athlete participants for them to sign in advance of their athlete participating in the triad.

Informed Consent for Focus Group (Parental)

Thank you for considering the participation of your child in this research project. ICF International (ICF) is conducting small group discussions on behalf of the Centers for Disease Control and Prevention (CDC) to hear feedback from young athletes about the CDC’s HEADS UP concussion prevention campaign.

Allowing your child to participate in this study will add to the knowledge of how CDC can improve educational messages and resources for young athletes about concussion. Being involved in this project may also give you or your child useful information concussion. There are no known risks to participants for participating in this discussion.


If you decide to allow your child to participate in this discussion group, I will ask you to sign this consent form granting permission for your child to participate in a small group discussion with other young athletes about concussion and the HEADS UP campaign.

The telephone discussion will last 90-minutes. Taking part in this discussion group is completely voluntary. Your child is free to refuse to answer any questions or to leave the discussion at any time and will still receive $20 compensation for their time.


A report of the results from the discussions will be prepared by ICF for CDC. The discussion will be audio recorded and observed by ICF and CDC staff. ICF and CDC staff will be present during the discussion, and only ICF and CDC will have access to the recordings and notes taken during the discussion. Your name, your child’s name, and any other personally identifiable information will not be used in any reports.


This discussion is authorized under Section 301 of the Public Health Service Act, 42 U.SC.241) authorized on December 31, 2004.


Any questions you have about this discussion group will be answered before the discussion begins. If you have any questions or concerns about the study, please contact me by phone or e-mail (Rosanne Hoffman, Rosanne.hoffman@icfi.com, 301-407-6596).



___________________________

Child’s Name



___________________________

Parent’s Signature

Written Assent Form for Focus Group (Young Athletes)


ICF International is doing a research study on behalf of the Centers for Disease Control and Prevention (CDC) to learn what you think about concussion and the CDC HEADS UP concussion education program. If you decide that you want to be part of this study, you will be asked to join a 90-minute small group discussion with other young athletes.


There are some things about this discussion group you should know. 

  • Participation in this group is completely voluntary.

  • Any questions you have about this discussion group will be answered before the discussion begins.

  • The discussion will be audio recorded.

  • CDC staff may listen to the conversation.

  • ICF and CDC staff will be present during the discussion, and only ICF and CDC will have access to the recordings and notes taken during the interview.

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

  • You may choose to leave the group at any time for any reason.

  • You will receive a stipend of $20 to compensate you for your time.


When we are finished with this study we will write a report about what was learned.  This report will not include your name or that you were in the discussion group.

You do not have to be in this discussion group if you do not want to be.  If you decide to stop after we begin, that’s okay too.  Your parents know about the study too. Your participation in this discussion group will help CDC to develop better materials about concussion.

This discussion is authorized under Section 301 of the Public Health Service Act, 42 U.SC.241) authorized on December 31, 2004.

If you decide you want to be in this study, please sign your name.

I, _________________________________, want to be in this research study.

___________________________________              ______
               (Sign your name here)                                   (Date)

Verbal Assent Reminder Script for Focus Group Moderator (Young Athletes)



ICF International (ICF) is conducting small group discussions on behalf of the Centers for Disease Control and Prevention (CDC) to hear what you think about concussion and CDC’s HEADS UP concussion prevention campaign. Thank you for taking the time to speak with us.



Procedures

  • This telephone discussion will last up to 90 minutes.

  • You will be asked questions about concussion and what you think about HEADS UP concussion prevention materials.

  • This discussion will observed by ICF and CDC staff and will be audio recorded.



This discussion is authorized under Section 301 of the Public Health Service Act, 42 U.SC.241) authorized on December 31, 2004.



Privacy

  • ICF and CDC staff will be present during the discussion, and only ICF and CDC will have access to the recording and notes taken during the discussion.

  • Your name will not be used in any reports.



Voluntary Participation

  • You can choose not to answer any question and you can leave the discussion at any time, for any reason.

  • Your participation in this discussion group will help CDC to develop better materials about concussion



Do you agree to participate in this discussion?



Recontact

  • We will be using the information we gathered today to develop messages and resources to improve the HEADS UP campaign materials. Within the next year, would you be willing to talk with us again to provide feedback on the revised materials? Your willingness to be recontacted will not affect your participation today.

  • [If yes] Thank you. I will reconfirm your willingness to be recontact at the end of the discussion.



Verbal Consent Script for Follow-Up Focus Group Moderator (Adults)



ICF International (ICF) is conducting small group discussions on behalf of the Centers for Disease Control and Prevention (CDC) to hear your input on CDC’s HEADS UP concussion prevention education campaign. We value your feedback and thank you for taking the time to speak with us.

This discussion is authorized under Section 301 of the Public Health Service Act, (42 U.SC.241) authorized on December 31, 2004.

Procedures

  • This small group discussion will last up to 60 minutes.

  • You will be asked questions about concussion and your perceptions of the HEADS UP concussion prevention materials.

  • This discussion will observed by ICF and CDC staff and will be recorded.



Privacy

  • ICF and CDC staff will be present during the discussion, and will have access to the recording and notes taken during the discussion.

  • Your name will not be used in any reports.



Voluntary Participation

  • You can choose not to answer any question and you can leave the discussion at any time, for any reason.

  • Your participation in this discussion group will help CDC to develop more effective messages and materials for a range of audiences about concussion. There are no known risks to participants for participating in this discussion.



Do you agree to participate in this discussion?







Written Consent Form for Follow-Up Focus Groups (Adults)



ICF International (ICF) is conducting small group discussions on behalf of the Centers for Disease Control and Prevention (CDC) to hear your input on CDC’s HEADS UP concussion education campaign. We value your feedback and thank you for taking the time to speak with us.



You have been invited to participate in a 60-minute discussion with other participants like yourself. A report of the results from the discussions will be prepared by ICF for CDC. Before you agree to join in this discussion, please review and consider the conditions listed below:



  • Participation in this group discussion is completely voluntary.

  • Any questions you have about this discussion group will be answered before the discussion begins.

  • The discussion will be audio recorded.

  • CDC staff may listen to the conversation.

  • ICF and CDC staff will be present during the interview, and only ICF and CDC will have access to the recordings and notes taken during the interview.

  • Your name, your organizations’ name, and/or any other personally identifiable information will not be used in any reports.

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

  • You may choose to leave the group at any time for any reason.

  • You will receive a stipend of $20 to compensate you for your time.

  • Your participation in this discussion group will help CDC to develop more effective messages and materials for a range of audiences about concussion. There are no known risks to participants for participating in this discussion.



This discussion is authorized under Section 301 of the Public Health Service Act, (42 U.SC.241) authorized on December 31, 2004.



Your signature below indicates that you understand the conditions stated above and agree to participate in this group.





Signature _______________________________________



Date _______________________________________

Informed Consent Follow-Up Focus Groups (Parental)

Thank you for considering the participation of your child in this research project. ICF International (ICF) is conducting small group discussions on behalf of the Centers for Disease Control and Prevention (CDC) to hear feedback from young athletes about the CDC’s HEADS UP concussion prevention campaign.

This research is authorized under Section 301 of the Public Health Service Act, (42 U.SC.241) authorized on December 31, 2004.

Allowing your child to participate in this study will add to the knowledge of how CDC can improve educational messages and resources for young athletes about concussion. Being involved in this project may also give your child useful information concussion. Participation in this discussion group will help CDC to develop more effective messages and materials for a range of audiences about concussion. There are no known risks to participants for participating in this discussion.


If you decide to allow your child to participate in this discussion group, please sign this consent form granting permission for your child to participate in a small group discussion with other young athletes about concussion and the HEADS UP campaign.

The telephone discussion will last 60-minutes. Taking part in this discussion group is completely voluntary. Your child is free to refuse to answer any questions or to leave the discussion at any time and will still receive $15 compensation for their time.


A report of the results from the discussions will be prepared by ICF for CDC. The discussion will be audio recorded and observed by ICF and CDC staff. ICF and CDC staff will be present during the discussion, and only ICF and CDC will have access to the recordings and notes taken during the discussion. Your name, your child’s name, and any other personally identifiable information will not be used in any reports.


Any questions you have about this discussion group will be answered before the discussion begins. If you have any questions or concerns about the study, please contact me by phone or e-mail (Rosanne Hoffman, Rosanne.hoffman@icfi.com, 301-407-6596).



___________________________

Child’s Name



___________________________

Parent’s Signature



Written Assent Form for Follow-Up Focus Groups (Young Athletes)


ICF International is doing a research study on behalf of the Centers for Disease Control and Prevention (CDC) to learn what you think about concussion and the CDC HEADS UP concussion education program. If you decide that you want to be part of this study, you will be asked to join a 60-minute small group discussion with other young athletes.


This discussion is authorized under Section 301 of the Public Health Service Act, (42 U.SC.241) authorized on December 31, 2004.

There are some things about this discussion group you should know. 

  • Participation in this group discussion is completely voluntary.

  • Any questions you have about this discussion group will be answered before the group discussion begins.

  • The discussion will be audio recorded.

  • CDC staff may listen to the conversation.

  • ICF and CDC staff will be present during the discussion, and only ICF and CDC will have access to the recordings and notes taken during the interview.

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

  • You may choose to leave the group at any time for any reason.

  • You will receive a stipend of $15 to compensate you for your time.

  • Your participation in this discussion group will help CDC to develop better materials about concussion.


When we are finished with this study we will write a report about what was learned.  This report will not include your name or that you were in the discussion group.

You do not have to be in this discussion group if you do not want to be.  If you decide to stop after we begin, that’s okay too.  Your parents know about the study too.

If you decide you want to be in this study, please sign your name.

I, _________________________________, want to be in this research study.

___________________________________              ______
               (Sign your name here)                                   (Date)

Verbal Assent Moderator Reminder Script for Follow-Up Focus Groups (Young Athletes)



ICF International (ICF) is conducting small group discussions on behalf of the Centers for Disease Control and Prevention (CDC) to hear what you think about concussion and CDC’s HEADS UP concussion prevention campaign. Thank you for taking the time to speak with us.

This discussion is authorized under Section 301 of the Public Health Service Act, (42 U.SC.241) authorized on December 31, 2004.

Procedures

  • This telephone discussion will last up to 60 minutes.

  • You will be asked questions about concussion and what you think about HEADS UP concussion prevention materials.

  • This discussion will observed by ICF and CDC staff and will be audio recorded.



Privacy

  • ICF and CDC staff will be present during the discussion, and only ICF and CDC will have access to the recording and notes taken during the discussion.

  • Your name will not be used in any reports.



Voluntary Participation

  • You can choose not to answer any question and you can leave the discussion at any time, for any reason.

  • Your participation in this discussion group will help CDC to develop better materials about concussion.

  • Your parents know about this study too.



Do you agree to participate in this discussion?



Recontact

  • We will be using the information we gathered today to develop messages and resources to improve the HEADS UP campaign materials. Within the next year, would you be willing to talk with us again to provide feedback on the revised materials? Your willingness to be recontacted will not affect your participation today.

  • [If yes] Thank you. I will reconfirm your willingness to be recontact at the end of the discussion.







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