FAQ which may be answered and may also be available on our
website.
Details on this study are available on our website at https://roseresearchcenter.com/current-studies/
The main purpose of this Study is to better understand how adult smokers use the Study Product and how they feel about it. The Study Product has been developed by Juul Labs, Inc. (“the Sponsor”), to provide adult smokers with an alternative to cigarette smoking.
Your participation in this study will last about four weeks and will include 3 visits to the study center.
This first visit will include screening procedures and will take about 1-2 hours. The other study visits will last about 30-45 minutes.
You will be compensated for your time and inconvenience related to your participation in this study. If you do not complete the study, for any reason, you will be paid for the study visits you do complete according to the following schedule:
The maximum compensation you may receive without unscheduled visits is $470
● You will receive $50 for completing screening procedures at your first visit.
● During the four-week product use period you will receive $50 for completing each weekly survey within three days (total $200).
● You will receive a payment of $50 for attending study visit 2 and $70 for attending study visit 3 (total $120).
● If you complete the entire study and return all study products you will receive an additional payment of $100.
You will receive compensation via the Greenphire ClinCard, a prepaid MasterCard debit card.
Greenphire will collect your name, address, date of birth, and social security number to activate your debit card. The payment amounts will be loaded onto the card within 48 hours of completing the activity (visit or weekly surveys).
Payment received as compensation for participation in research is considered taxable income. You are responsible for paying any state, federal or Social Security taxes on the money you receive. If your total payment from Rose Research Center exceeds $600 in any one calendar year, we are required to report this information to the Internal Revenue Service (IRS). You will be required to provide your Social Security number or tax identification number for payment.
Your records will be kept as private as possible under law. Your Information will be stored in limited-access databases. The study staff will have access to these databases. Each of these individuals will be obligated to protect the confidentiality of your Information and to use and disclose it only as described in this document.
Rose Research Center, the Study Sponsor, the FDA, other health authorities, and the IRB may inspect your hard-copy and electronically stored research records which may include your name, address and other personal information that identifies you. If necessary, some of these records may be copied during these inspections.
The results of this research study may be presented at meetings or in publications. However, you will not be personally identified in any presentations or publications.
As part of the Study, you may also provide app usage data which may be analyzed for various scientific
and regulatory purposes.
The study is being funded by Juul Labs, Inc.
The informed consent process provides you with the information required to ensure you make an informed decision about participation in the clinical research study. This process will:
Before participating, we will take you through a written Informed Consent Form (ICF) that outlines important information to consider before joining the study. The study staff will go through this document with you and answer any questions you may have. This document provides details of the study, such as study expectations, duration, and what you will need to do. All known possible risks and potential benefits are also explained in the ICF. After you have read and discussed all the information about the study, you can decide whether or not to sign the consent form. This consent form is not a contract, and you are always free to leave the study at any time and for any reason, with no penalty to you. Additionally, during your participation, the study staff will let you know in a timely manner of any information that may change your mind about participating.
If you have any other questions, please call us at (866) 984-7673.