Department of Population and Quantitative Health Sciences
University of Massachusetts Chan Medical School
368 Plantation Street
Albert Sherman Center, AS7.1075
Worcester, MA 01605 USA

 

Date November 14, 2022

Dear Parent/Guardian,

The University of Massachusetts Chan Medical School and the Massachusetts Department of Public Health (DPH), School Health Unit are collaborating on a project to study e-cigarette use (vaping) in high school students.

This letter is being sent to all parents/guardians of students in Grades 9-12 in your high school. The purpose of this letter is to give you the opportunity to keep your child out of the project if you do not want him or her to participate in the project for any reason.

All students at Shrewsbury High School will be made aware of the study and will be invited to participate. If your child meets eligibility criteria and wants to take part in the project, we will ask your child to give a one-hour interview about vaping and to receive either text messages or written materials about vaping and quitting over the course of six months. They may be asked to talk about vaping with peer coaches and give a saliva sample. Students who participate will receive two $25 gift cards for the of completion project activities. Your child will not be removed from their academic classes in order to participate in the project.

Please see the fact sheet included with this letter for more information on the research project.

Your child is under no obligation to participate in the project and he or she may decide not to participate at any time.

If you do NOT want your child to participate, email the project coordinator, Dante Simone, at Dante.Simone@umassmed.edu. Please include in the email: the student's full name and grade and school, your name and your relationship to the student. You do not need to return this form if it is okay for your child to participate.

If you have any questions please feel free to call the Shrewsbury High School nurse and/or the project team, Dante Simone, UMASS Chan Medical School, 508.856.8384

Thank you for your help.

Sincerely,

Rajani Sadasivam, PhD Professor, Division of Health Informatics and Implementation Science Department of Population and Quantitative Health Sciences

Lori Pbert, PhD Professor, Department of Population and Quantitative Health Sciences Associate Chief, Division of Preventive and Behavioral Medicine

 

UNIVERSITY OF MASSACHUSETTS CHAN MEDICAL SCHOOL

COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH FACT SHEET 

Title: Vaper to Vaper (V2V): A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping (H00021082)

Investigators: Rajani Sadasivam, PhD and Lori Pbert, PhD

Sponsor: National Institutes of Health (NIH)

Your child is being invited to take part in a research study. If your child is interested in being part of the research study, someone from our study team will explain this research to your child. This fact sheet helps to sum up their explanation.

A. We are inviting your child to participate in a research study.

B. Taking part in this research is voluntary and completely up to you and your child. If your child participates in the research study, your child is free to say no or to leave the research at any time. There will be no penalties or                       changes in the quality of the health care your child receives in the school health clinic and their grades will not be affected by whether or not they decide to participate. Your child will not lose any benefits to which they are                       otherwise entitled.

C. The purpose of this study is to develop a program to support adolescents to quit vaping (quit using e-cigarettes). 

D. If your child agrees to be in this study, they will be asked to: 

• Provide us with their home address, phone, cell phone, and phone numbers of three contacts and the best times/days to reach them;
• Complete a survey. The survey will ask your child to give information on their attitudes and behaviors towards e-cigarettes, marijuana, and tobacco. We will also ask your child about their use of e-cigarettes, marijuana, and tobacco. We will give your child a $25 gift card for completing this survey.
• Receive either written materials or text messages about vaping and quitting for six months. If they received the text messages, your child may also be asked during these six months to talk about vaping with peer coaches or to give a one-hour interview at six months. During this interview, we will ask your child how they felt about the text message content and how easy or hard it was to use the system.
• Complete a survey and give us a sample of saliva at six months. The survey will ask your child to give information on their attitudes and behaviors towards vaping, marijuana, and tobacco. We will also ask your child about their use of ecigarettes, marijuana, and tobacco. For the saliva sample, we will ask your child to hold a small sponge in their mouth for about 2 minutes. The saliva sample is used only to determine the amount of nicotine in their body. It will not be used for DNA retrieval or to determine if they have used any other type of drugs. We will give your child a $25 gift card for completing this survey and giving us a salvia sample.

E.  A risk of being in this study is that your child’s personal information could be lost or exposed. This is very unlikely to happen, and we will do everything to make sure that your child’s information is protected. To help protect your             child’s personal information, we will store their name separately from their research data and code their research data with a subject ID. We will keep paper documents under lock and key. We will keep electronic information on             secure computer networks. These computer networks have many levels of protection.

F.  We will keep study records and documents for a period of 3 years after the completion of the study. We will destroy the list that links your child’s identity to their data at the earliest possible time, once data collection is complete and       data accuracy are verified.

G. It is possible that we might use the research data in other future research. We may also share data with researchers and companies that are not part of UMMS. In these cases, we will not share your child’s name or other                       information that identifies your child directly, and we will not come back to you or your child to ask you for your consent.

H. At this time, we do not think that the research data (whether linked to your child or with identifiers removed) will lead to commercial profit. In the event it does, there are no plans to share any financial gain with you or your child.

I.  Your child’s participation may help us to gain knowledge about of vaping in their school. However, there is no direct benefit to you or your child.

J. It may be several years before the results of the research are available. If you would like us to try to reach you or your child at that time, please let us know. We will ask for your contact information.

K. We will try to limit access to your child’s personal information to people who have a need to review this information. We cannot promise complete privacy. The University of Massachusetts Chan Medical School, including the                  Institutional Review Board (IRB) and research, billing, and compliance offices, may see your child’s information. Information and records may also be shared with the research sponsor, people who work with the research sponsor,        and federal and state government agencies, such as NIH auditors.

L. The University of Massachusetts Chan Medical School does not provide funds for the treatment of research-related injury. If your child is injured as a result of their participation in this study, treatment will be provided. You or your          insurance carrier will be expected to pay the costs of this treatment. No additional financial compensation for injury or lost wages is available. You and your child do not give up any of your legal rights by participating in this research.

M. If you have any questions, concerns, or complaints, or think that the research has hurt your child, you can talk to the study team, Dante Simone (508)856.8384. This research has been reviewed and approved by an Institutional             Review Board. You can reach them at (508)856.4261 or irb@umassmed.edu if you would like to speak with someone not associated with the study or have questions about your child’s rights as a research subject.