Healthcare Professional Main Study

Disclosures in Professional and Consumer Prescription Drug Promotion

Appendix C - Informed Consent

Healthcare Professional Main Study

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Appendix C: Consent Forms


Consumer Survey Consent


You will be one of 1,500 adults in the United States to take part in this voluntary research study. In the survey, you will be shown advertisements for prescription medications and you will be asked questions about them. The survey will take approximately 20 minutes.


This research is being conducted by Fors Marsh Group (FMG) on behalf of the U.S. Department of Health and Human Services (DHHS). If you have questions about this survey, please contact Dr. Brian Griepentrog, Principal Investigator, by phone at 571-858-3757 or by email at pi@forsmarshgroup.com.


Possible Risks or Discomforts

We do not expect any of the survey questions will make you uncomfortable or upset; however, if they do, you can refuse to answer a question. If you skip a question, you can still continue with the rest of the survey.


Benefits

Your responses are very important because they will help researchers understand how people make decisions about medications they might take or encounter as a caregiver. There is no direct benefit to you for your participation.


Incentive

In appreciation for your time, you will receive $5 in e-Rewards currency for completing this survey.


Your Rights as a Participant

This study is voluntary. You can stop at any time. You also do not have to answer any questions that you do not want to. You will receive your points for your time when you complete the survey even if you choose not to answer some questions.


The Chesapeake Institutional Review Board (IRB) has reviewed this research on behalf of DHHS. An IRB is a group of people who are responsible for ensuring that the rights of participants in research are protected. If you have questions about your rights as a study participant or concerns about how you are treated in the study, you may contact Chesapeake at 1-866-992-4724 or cirbi@chesapeakeirb.com.


Privacy and Confidentiality

This survey will ask you for some general demographic information (for example, age, gender, race/ethnicity). However, no personal information, such as your name, will be collected. Your identity will not be linked to your responses. We will be very careful to only let people working on the study see your responses, which will not be linked back to any personal information that can be used to identify you. Your information will be kept private to the extent allowed by law.


If you have read the previous screen and agree to participate, please select Yes below. If not, select No.

Value

Value Label

01

Yes, I agree to participate. [Go to next section]

00

No, I do not agree to participate. [Terminate]

-99

Refused [Terminate]


Physician Survey Consent


We are asking about 5,800 health care providers in the United States to participate in this voluntary research study. In the survey, you will be shown advertisements for prescription medications and you will be asked questions about them. The survey will take approximately 20 minutes.


This research is being conducted by Fors Marsh Group (FMG) on behalf of the U.S. Department of Health and Human Services (DHHS). If you have questions about this survey, please contact Dr. Brian Griepentrog, Principal Investigator, by phone at 571-858-3757 or by email at pi@forsmarshgroup.com.


Possible Risks or Discomforts

We do not expect any of the survey questions will make you uncomfortable or upset; however, if they do, you can refuse to answer a question. If you skip a question, you can still continue with the rest of the survey.


Benefits

Your responses are very important because they will help researchers understand how health care providers make decisions about medications they might prescribe to patients. There is no direct benefit to you for your participation.


Incentive

In appreciation for your time, you will receive a $50 honorarium for completing this survey.


Your Rights as a Participant

This study is voluntary. You can stop at any time. You also do not have to answer any questions that you do not want to. You will receive your points for your time when you complete the survey even if you choose not to answer some questions.


The Chesapeake Institutional Review Board (IRB) has reviewed this research on behalf of DHHS. An IRB is a group of people who are responsible for ensuring that the rights of participants in research are protected. If you have questions about your rights as a study participant or concerns about how you are treated in the study, you may contact Chesapeake at 1-866-992-4724 or cirbi@chesapeakeirb.com.


Privacy and Confidentiality

This survey will ask you for some general demographic information (e.g., age, gender, race/ethnicity). However, no personal information, such as your name, will be collected. Your identity will not be linked to your responses. We will be very careful to only let people working on the study see your responses, which will not be linked back to any personal information that can be used to identify you. Your information will be kept private to the extent allowed by law.


If you have read the previous screen and agree to participate, please select Yes below. If not, select No.

Value

Value Label

01

Yes, I agree to participate. [Go to next section]

00

No, I do not agree to participate. [Terminate]

-99

Refused [Terminate]




Consumer Eye-Tracking Consent


You have been asked to participate in a research study about prescription drug advertising. This research is being conducted by Fors Marsh Group (FMG) on behalf of the U.S. Department of Health and Human Services (DHHS). This information sheet describes the purpose, procedures, benefits, risks, and precautions of the interview. It also describes your right to withdraw from the interview at any time. A member of the Fors Marsh Group (FMG) team is available to read this information sheet with you and discuss all the information, if you wish.


Why is this interview being conducted?

This interview is being conducted to examine the way prescription drug information is presented in print advertisements. The feedback from the interviews may ultimately affect the way pharmaceutical companies present prescription drug information to consumers.


What do I need to know about this interview?

We are interviewing individuals in the Washington, DC, metro area. Interviews will take place on [DATES]. Each interview will last 60 minutes and you will work one on one with a moderator. You will be shown some advertisements for prescription medications and will answer some questions about the ads using a computer. Your eye movements will be recorded using a state-of-the art eye tracker. The eye tracker uses harmless near-infrared light, similar to the light you would encounter naturally if you were outside on a sunny day. While completing the survey, you will be asked to discuss your thoughts and opinions with the moderator. Other staff might observe the interview remotely, and the interviews will be audio recorded. Your name will not be used in any description of findings.


What are the potential risks of participating in this interview?

There are no known risks associated with this interview. You will complete tasks on a computer. Upon completion, you will be asked questions about your experience and asked to give your opinion of the ads and survey. You do not have to answer any questions that you do not wish to answer. The information you provide will be anonymous and your name will not be associated with your answers. Your name will not be used in any reports, and quotes will not be associated with your identity.


Does participating in this interview provide any benefit?

There is no direct benefit to you from participating in this interview. However, you will be compensated $100 for your participation in the interview. We will use your feedback to improve our survey for future respondents.


Will it cost me anything to participate in this interview?

There are no costs for you to participate in the interview, other than possible transportation costs to and from the facility.


Do I have to participate in this interview?

Your participation is voluntary. There are no penalties associated with refusing to participate; however, your participation is encouraged to get a wider range of feedback.


Who will have access to the recordings from the interview and/or contact information?

Only the staff working on this project will have access to the audio recordings from the interview. Only the participant recruiters will have access to your contact information.


Who do I contact if I have questions about this interview?

If you have questions or concerns about the interview, you can contact Dr. Brian Griepentrog at Fors Marsh Group by email at pi@forsmarshgroup.com or by phone at 571-858-3757.



The Chesapeake Institutional Review Board (IRB) has reviewed this research on behalf of DHHS. An IRB is a group of people who are responsible for ensuring that the rights of participants in research are protected. If you have questions about your rights as a study participant or concerns about how you are treated in the study, you may contact Chesapeake at 1-866-992-4724 or cirbi@chesapeakeirb.com.


Your signature below indicates that you understand the conditions stated above and agree to participate in this interview. You may request a copy of this consent form to keep for your records.



Signature: _____________________________________ Date: ________________


Physician Eye-Tracking Consent


You have been asked to participate in a research study about prescription drug advertising. This research is being conducted by Fors Marsh Group (FMG) on behalf of the U.S. Department of Health and Human Services (DHHS). This information sheet describes the purpose, procedures, benefits, risks, and precautions of the interview. It also describes your right to withdraw from the interview at any time. A member of the Fors Marsh Group (FMG) team is available to read this information sheet with you and discuss all the information, if you wish.


Why is this interview being conducted?

This interview is being conducted to examine the way prescription drug information is presented in print advertisements. The feedback from the interviews may ultimately affect the way pharmaceutical companies present prescription drug information to health care providers.


What do I need to know about this interview?

We are interviewing individuals in the Washington, DC, metro area. Interviews will take place on [DATES]. Each interview will last 60 minutes and you will work one on one with a moderator. You will be shown some advertisements for prescription medications and will answer some questions about the ads using a computer. Your eye movements will be recorded using a state-of-the art eye tracker. The eye tracker uses harmless near-infrared light, similar to the light you would encounter naturally if you were outside on a sunny day. While completing the survey, you will be asked to discuss your thoughts and opinions with the moderator. Other staff might observe the interview remotely, and the interviews will be audio recorded. Your name will not be used in any description of findings.


What are the potential risks of participating in this interview?

There are no known risks associated with this interview. You will complete tasks on a computer. Upon completion, you will be asked questions about your experience and asked to give your opinion of the ads and survey. You do not have to answer any questions that you do not wish to answer. The information you provide will be anonymous and your name will not be associated with your answers. Your name will not be used in any reports, and quotes will not be associated with your identity.


Does participating in this interview provide any benefit?

There is no direct benefit to you from participating in this interview. However, you will be compensated $250 for your participation in the interview. We will use your feedback to improve our survey for future respondents.


Will it cost me anything to participate in this interview?

There are no costs for you to participate in the interview, other than possible transportation costs to and from the facility.


Do I have to participate in this interview?

Your participation is voluntary. There are no penalties associated with refusing to participate; however, your participation is encouraged to get a wider range of feedback.


Who will have access to the recordings from the interview and/or contact information?

Only the staff working on this project will have access to the audio recordings from the interview. Only the participant recruiters will have access to your contact information.


Who do I contact if I have questions about this interview?

If you have questions or concerns about the interview, you can contact Dr. Brian Griepentrog at Fors Marsh Group by email at pi@forsmarshgroup.com or by phone at 571-858-3757.


The Chesapeake Institutional Review Board (IRB) has reviewed this research on behalf of DHHS. An IRB is a group of people who are responsible for ensuring that the rights of participants in research are protected. If you have questions about your rights as a study participant or concerns about how you are treated in the study, you may contact Chesapeake at 1-866-992-4724 or cirbi@chesapeakeirb.com.


Your signature below indicates that you understand the conditions stated above and agree to participate in this interview. You may request a copy of this consent form to keep for your records.



Signature: _____________________________________ Date: ________________



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