An Investigation of Allergy to Cosmetics in the United States

Appendix B

OMB Control Number: 0910-0497 Expiration Date: 10/31/2020

Consent to Participate in RTI Research

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 0910-0497 and the expiration date is 10/31/2020. The time required to complete this information collection document is estimated to average 15 minutes or 0.25 hours per response.

Introduction

You are being asked to participate in a research study. Before you decide if you want to take part in this study, you need to read this Informed Consent form so that you understand what the study is about and what you will be asked to do. This form also tells you who can be in the study, the risks and benefits of the study, how we will protect your information, and who you can call if you have questions. Please ask the researcher to explain anything you don’t understand before you make your decision.

Purpose

This research study is being conducted by RTI International, with funding from a government agency. We will reveal the study sponsor during tonight’s discussions. The purpose of study is to learn how consumers purchase and use specific consumer products at home. You are one of approximately 64 adults who will participate in this study.

Procedures

If you agree to participate, you will be asked to participate in a focus group discussion. In the discussion, we will talk about how you purchase and use specific consumer products at home.

Tonight’s discussion will be digitally recorded to collect your thoughts and opinions. The audio-recordings will be transcribed. The transcriptions and the video recordings will be used to prepare a summary of each group’s discussion. During the discussion, you will be addressed by your first name only. It is possible that your first name will be connected to your responses in the transcripts, but your name will not be used in any reports. At the completion of this study, RTI will destroy all audio recordings; however, the transcripts and the video-recordings will be sent to the client as part of a final report. Additionally, project team members may be viewing tonight’s discussion.

Study Duration

Your participation in this study will take no more than 120 minutes, which includes 15 minutes to review and complete this consent document and 105 minutes to complete the actual focus group study.

Possible Risks or Discomforts

There are minimal psychological, social, or legal risks to participating in this study. You will be asked to share your thoughts and opinions in a group setting; however, tonight’s topic is not sensitive in nature. Your participation is voluntary, and you can choose not to answer any questions.

Benefits

There are no direct benefits to you from participating in this study. Your opinions will help us understand how consumer purchase and use certain products at home.

Token of Appreciation for Participation

You will receive $75 as a token of our appreciation for your participation.

Privacy

During the focus group discussion, you will be addressed by your first name only. It is possible that your first name will be connected to the answers you provide in the transcripts; however, your name will not be used in any reports. If you voluntarily share personal identifiable information during the discussion, this information will be redacted from the transcripts.

The Institutional Review Board (IRB) at RTI International has reviewed this research. An IRB is a group of people who are responsible for assuring that the rights of participants in research are protected. The IRB may review the records of your participation in this research to assure that proper procedures were followed. A representative of the IRB may contact you for information about your experience with this research. This representative will be given your name, but will not be given any of your private study data. If you wish, you may refuse to answer any questions this person may ask.

Future Contacts

We will not contact you in the future.

Your Rights

Your decision to take part in this research study is completely voluntary. You can stop participating at any time and/or refuse to answer any question. If you decide to participate and later change your mind, you will not be contacted again or asked for further information.

Your Questions

If you have any questions about the study, you may call Katherine Kosa of RTI at 1‑800‑334‑8571, extension 23901. If you have any questions about your rights as a study participant, you may call RTI’s Office of Research Protection at 1-866-214-2043.

YOU WILL BE GIVEN A COPY OF THIS CONSENT FORM TO KEEP.

Your signature below indicates that you have read the information provided above, have received answers to any questions you may have, and have freely decided to participate in this research. By agreeing to participate in this research, you are not giving up any of your legal rights.

______________ ___________________________________ _ Date Signature of Participant

____________________________________ __

Printed Name of Participant

I certify that the nature and purpose, the potential benefits, and possible risks associated with participating in this research have been explained to the above-named individual.

______________ ___________________________________ _ Date Signature of Person Obtaining Consent

____________________________________ __

Printed Name of Person Obtaining Consent

Consent Version: page 2 of 2

RTI IRB ID:

RTI IRB Approval Date: XX/X/XX