What are the risks I might experience if I take part in the C’RILLOS or the Disinformation project?

Breach of confidentiality is a risk of harm but a data security plan is in place to minimize such a risk. Also, some questions may make you feel uncomfortable. If that happens, you can skip those questions or withdraw from the study altogether. While all possible precautions will be taken, there is a potential risk of loss of privacy or confidentiality. The primary risks associated with this study come from potential distress in response to questions and disclosure of responses. However, we have taken several steps to reduce this risk. To reduce the risk of potential discomfort, we have chosen validated survey questions when possible.

Is there a benefit to participating in the C’RILLOS or the Disinformation project?

There are no direct benefits to you for taking part in this research. You will be contributing to knowledge about flavored LCC advertisements and about the ban on menthol cigarettes and flavored cigars that may help the study team, our sponsor, the National Institutes of Health, National Institute of Drug Abuse understand your thoughts about flavored LCC packaging and the upcoming flavor ban.

How will information about me be kept private or confidential?

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.

There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state or local laws require, such as laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.

Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.

What will happen if I do not want to take part or decide later not to stay in the study?

Your participation is voluntary. If you choose to take part now, you may change your mind and withdraw later. In addition, you can choose to skip questions that you do not wish to answer. If you do not click on the ‘submit’ button after completing the form, your responses will not be recorded. You may also withdraw your consent for use of data you submit, but you must do this in writing to the PI Kymberle Sterling.

Who can I call if I have questions?

If you have questions about taking part in this study, you can contact the Principal Investigator: Kymberle L. Sterling, DrPH, MPH, Department of Health Behavior, Society and Policy, email: Kymberle.L.Sterling@cts.rutgers.edu

If you have questions, concerns, problems, information or input about the research or would like to know your rights as a research subject, you can contact the Rutgers IRB or the Rutgers Human Subjects Protection Program via phone at (973) 972-3608 or (732) 235-2866 or (732) 235-9806 OR via email irboffice@research.rutgers.edu, or you can write us at 335 George Street, Liberty Plaza Suite 3200, New Brunswick, NJ 08901.