BROWN UNIVERSITY

CONSENT FOR RESEARCH PARTICIPATION

A Comparison of Electronic Cigarettes and Combination Nicotine Replacement Therapy among Individuals with Obesity who Smoke

[Screening consent, Version 1, December 29, 2023]

You are invited to take part in an eligibility screening for a Brown University research study. Your participation is voluntary.

• RESEARCHER: Cara Murphy, Ph.D.

• PURPOSE: The study is about the potential effects of providing electronic cigarettes or nicotine replacement therapy products such as nicotine patches and lozenges to people who smoke cigarettes.

• PROCEDURES: You will provide information about yourself to see if you qualify for the next step of study enrollment. You can complete the screening questions online or call us and we can ask you the questions. You will be asked questions about smoking, weight, pregnancy, and health. Information about eligibility will be kept for study records.

• TIME INVOLVED: This screening will take about 5 minutes.

• COMPENSATION: You will not be paid for answering these eligibility questions.

• RISKS: Some of the questions may make you feel uncomfortable. You can skip any questions you prefer not to answer. You can end the screening at any time.

• BENEFITS: There are no direct benefits to you for completing this screening. 

• CONFIDENTIALITY: To protect your information, we will assign a code number to all of your responses. Any information you provide that identifies you, like your name, will be stored separately. It will be carefully protected on a secure computer server that is available only to the research staff on this project.

Brown University staff sometimes review studies like this one to make sure they are being done safely and correctly. If a review of this study takes place, your records may be examined. The reviewers will protect your confidentiality. After the study has ended, data that identifies you will be destroyed.

Certification of Confidentiality: To help us protect your privacy, we have a Certificate of Confidentiality from the National Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.

The Certificate cannot be used to resist a demand for information from personnel of the United States federal or state government agency sponsoring the project and that will be used for auditing or program evaluation of agency funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, medical care provider, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information.

The Certificate of Confidentiality will not be used to prevent disclosure to state or local authorities of such as child abuse and neglect, or harm to self or others.

• VOLUNTARY: You do not have to screened for eligibility if you do not want to be. Even if you decide to be screened, you can change your mind and stop at any time.

• CONTACT INFORMATION: If you have any questions about this screening, you can call Cara Murphy at 401-863-6519.

• YOUR RIGHTS: If you have questions about your rights as a research participant, you can contact Brown University’s Human Research Protection Program at 401-863-3050 or email them at IRB@Brown.edu.

• CONSENT TO PARTICIPATE: Do you agree and understand the information that has been provided to you? Do you agree to volunteer to be screened for eligibility to participate in this study?