Consent Form

Medical Device Decision Analysis: A Risk-Tolerance Pilot Study

Introduction Screen and Consent Screens

Consent Form

OMB: 0910-0722

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Introduction Screen and Consent Screens

Obesity Survey
Thank you for your interest in this health survey. In this survey, we will ask you about
weight management and what you think about devices that can be used to help people
lose weight. Please answer the following questions to confirm that you are eligible to
participate in this survey.
[Screening Questions]

S1. Are you 18 years of age or older?
YES [Continue]
NO [Ineligible, end survey]

S2. About how tall are you?
____ feet and ____ inches

S3. About how much do you weigh?
____ pounds

Eligible if answer yes to S1 and combination of S2 and S3 results in Body Mass
Index (BMI) of 30 or above. 150 subjects with BMI between 30-35, 150 with BMI
between 35-40, and 150 with BMI above 40.

[Ineligible, end survey]

Study Purpose
You are one of about 450 people in the United States who are being asked to take this
survey to help us understand preferences for attributes of devices that can help people
lose weight.

Study Duration
The survey will take about 25 minutes to complete.

Study Details
Research Triangle Institute (RTI) is doing this study for the U.S. Food and Drug
Administration’s Center for Devices and Radiological Health (FDA-CDRH). RTI is a nonprofit research organization in Research Triangle Park, North Carolina. RTI has
contracted with Knowledge Networks (KN) to collect data. If you have questions about
this survey, please contact Panel Relations at 1-800-782-6899 (a toll-free number) and
someone will direct your questions to a researcher at RTI.

Possible Risks or Discomforts
If any questions make you uncomfortable, you do not need to answer them.
KN will protect your responses under its Privacy Policy. RTI and the FDA-CDRH will
receive your survey responses without any personal identifiers. RTI will also make every
effort to protect your responses. There is a potential risk of disclosure of the survey
data, but the data could not be directly tied to you.
If you have any concerns about this survey, you may call the RTI Office of Research
Protection at 1-866-214-2043 (a toll-free number).

Benefits
There are no direct benefits to you for participating in this study. Benefits of this survey
apply to the broader population of people with obesity such that it will generate a better
understanding of their preferences and potentially lead to a wider choice of treatments.

Confidentiality
Many steps have been taken to protect your information. KN will report only your
responses to RTI, not your name or other contact information. If the results of this study
are presented at scientific meetings or published in scientific journals, no information will
be included that could identify you or your responses personally.
The Institutional Review Board (IRB) at RTI has reviewed this research. An IRB is a
group of people who make sure that the rights of participants in research are protected.
The IRB may check records of your activity in this research to see if proper procedures
were followed.

Your Rights
Your decision to take part in this research study is completely voluntary. Your decision
to participate in this study will not affect your usual medical care. You can refuse to
answer any question or stop at any point after you begin the survey and still receive
your KN points for participating in the survey.

If you have read the previous screens and agree to participate, please click the Yes
button, if not, click the No button.
Yes, I agree to participate. [continue with next section]
No, I do not agree to participate. [go on to next question]

Are you sure you don't want to participate? Your opinions are important to us. Please
select the Yes button to continue this survey; if not, select the No button to exit.
Yes, I agree to participate. [continue with next section]
No, I do not agree to participate [end survey].

[If they do not agree to participate]

Thank you for your consideration. You have exited the survey.


File Typeapplication/pdf
File TitleMicrosoft Word - Introduction Screen and Consent Screens_6-18-12.doc
Authorjgonzalez
File Modified2012-06-18
File Created2012-06-18

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