Animation in DTC Promotion

Data to Support Drug Product Communications as Used by the FDA

FDA Animation_Cog Int_Attachment C_Informed Consent

Animation in DTC Promotion

OMB: 0910-0695

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Attachment C:
Animation in DTC Advertising
Consent Form for Cognitive Interviews
Introduction and Purpose:
Thank you for agreeing to participate in this research study. The purpose of the study is to test survey
questions to make sure that they are easy to understand.
RTI International, a non-profit research organization in North Carolina, is conducting the study. You are
one of approximately 18 people in the Washington, DC area being asked to participate in this phase of
the study.
You are eligible to participate in this study because you have been diagnosed with [chronic dry
eye/psoriasis].
Procedures:
If you agree to participate, you will watch an ad and then the interviewer will ask you a series of
questions about your reactions to, preferences for, and understanding of the ad. Finally, we will ask you
to answer some survey questions. The viewing and interview will last approximately 60 minutes.
Benefits:
There is no direct benefit to you for participating. However, you may find the discussion informative and
may learn how other people discuss health issues.
Risks:
There are no known risks to participating in this study. While the questions we ask are not meant to be
sensitive, there is always a chance that you may feel uncomfortable with some of the questions. You do
not have to answer any question that you don’t want to answer.
Confidentiality:
We will try to keep the information you share in this interview confidential. The study team will not
disclose your name or any of your comments, and your personal information (name, address, phone
number) will not be linked to any of your responses.
With your permission, we will audio-record the discussion to supplement our notes. Recordings will not
include full names and will be stored on password protected computers that only project staff can
access. At the end of the project, we will destroy the recordings. All paper forms will be kept in a locked
file cabinet that only project staff can access.
Observation:
Some project staff may observe the discussion behind a one way mirror. They will not record your name
and will keep all of your comments confidential.
Reimbursement:
In appreciation for your time and travel, we will reimburse you $100 at the end of the interview.

Right to Refuse or Withdraw:
Your participation in this study is voluntary. You can choose not to talk about any topic, and you can end
the interview for any reason at any time without penalty.
Persons to Contact:
If you have questions about the study, you can call the project director, Dr. Bridget Kelly, at 1-800-3348571, ext. 22098 or the associate project director, Dr. Sarah Parvanta, at 1-800-334-8571, ext. 26045.
They 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.
Your Consent:
I have read this consent form. I had a chance to ask questions, and my questions were answered. I was
given a copy of this consent form. I agree to participate in the study.

_________________________________

_________________

Signature of Participant

Date

_________________________________

_________________

Signature of Person Obtaining Consent

Date


File Typeapplication/pdf
File TitleMicrosoft Word - FDA Animation_Cognitive Interview OMB Memo_Appendix C.doc
Authorrpaquin
File Modified2016-03-04
File Created2016-03-03

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