Promotional Implications of Proprietary Prescription Drug Names

FDA Proprietary Names Appendix C – Consent Form

[CONSENT]

[Consent Screen 1]

OMB Control No. 0910-0695

Expiration date: 2/28/2021

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number.  The valid OMB control number for this information collection is 0910-0695 and the expiration date is 2/28/2021. The time required to complete this information collection is estimated to average 20 minutes per response, including the time for reviewing instructions and completing and reviewing the collection of information.

The U.S. Department of Health and Human Services (DHHS) is conducting this study to understand how people respond to product names. You are one of about 240 people in the United States who are being asked to participate in a survey about product names.  If you agree to take part in this research, you will be asked to review some product names and answer some questions about the names.  The study will take about 20 minutes. Participation is completely voluntary and you can withdraw from the study for any reason at any time without penalty.

[Consent Screen 2]

This survey is being conducted by RTI International (RTI), an independent nonprofit research organization. RTI is working with Lightspeed Health to conduct this survey but is not affiliated with Lightspeed Health in any way. If you have questions about this survey, please contact Lightspeed Health at http://www.lightspeed-health.com/contact-us/, and someone will direct your questions to the appropriate researchers at RTI.

Possible Risks or Discomforts

There are no known risks to participating in this study. We do not expect that any of the survey questions will make you uncomfortable or upset; however, if they do, you can refuse to answer any question or you may take a break at any time during the survey.

Benefits

There is no direct benefit to you for participating. Your responses are very important because they will help researchers understand how people make decisions about medications.

Incentive

As a token of appreciation, you will receive < IF GENERAL POPULATION: $”1.50 in of online points ”, IF HEALTH CARE PROVIDER: “an honorarium of $50”> for completing the survey.

Confidentiality

As with other surveys you receive from Lightspeed Health, your information is of the highest importance, and we are committed to maintaining a secure environment in which you can participate. All information collected in this survey will be kept secure to the extent provided by law. Your name and your e‑mail address will not be shared outside of Lightspeed Health, and they will not be associated with your answers or used in any report. The information obtained from all of the surveys will be combined into a summary report so that details of individual questionnaires cannot be linked to a specific participant.

Persons to Contact

If you have questions about the study, you can call the project director, Dr. Bridget Kelly, at 1-800-334-8571, ext. 22098. She can be reached between 9:00 AM and 5:00 PM Eastern Time Monday to Friday.

If you have questions about your rights as a participant, you can call RTI’s Office of Research Protection toll-free at 1-866-214-2043. Alternatively, you may contact Lightspeed Health at http://www.lightspeed-health.com/contact-us/and indicate that you would like to contact the RTI Office of Research Protection, and someone will provide you with the appropriate contact information.

[Consent Screen 3]

[radio]

[prompt if skip]

[Consent1.] If you have read the previous screens and agree to participate, please click the Yes button. If not, click the No button.

1. Yes, I agree to participate. [Continue with next section]

2. No, I do not agree to participate. [Go on to next question]

[radio]

[prompt if skip]

[if consent1=no or skip]

[Consent2.] Are you sure you don't want to participate? Your opinions are important to us. Please select the Yes button to continue this survey. Select the No button to exit.

1. Yes, I agree to participate. [Continue with next section]

2. No, I do not agree to participate. [End survey]

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