Informed Consent and Parent Permission Form for Participation in a Research Study
University of Massachusetts Amherst
Researcher(s): Christine W. St. Laurent, PhD
Study Title: B'town Moves Study: Assessing Physical Activity in Students and Schools
1. WHAT IS THIS FORM?
This form is called an informed consent and parent permission form. It will give you information about the study so you can make an informed decision about participation in this research. We encourage you to take some time to think this over and ask questions now and at any other time. If you decide to participate, you will be asked to sign this form and you will be given a copy for your records.
2. WHAT ARE SOME OF THE IMPORTANT ASPECTS OF THIS RESEARCH STUDY THAT I SHOULD BE AWARE OF?
- Consent is being sought for you and your child's participation in this study, but participation is voluntary. If you give permission for your child to participate, we will also seek their assent.
- We want to learn about your beliefs and perceptions of children's physical activity (in and out of school) and your child's physical activity behaviors, interests, and knowledge. This information will help us inform future school and community efforts to promote physical activity.
- Key to your role in this study are three components we ask you to consider:
- Complete an online questionnaire (20 to 30 minutes), to share your current beliefs, knowledge, and perceived barriers and facilitators of your child's physical activity
- Give consent for your child's school to share their questionnaire responses with our team, and/or
- Give permission for your child to wear an activity monitor (e.g., a Fitbit watch) for one week (and help them complete a daily log if they are under 13 years old).
- We anticipate the risk of participating in this study to be low, but there is always the potential risk of a breach of confidentiality and your child could experience some discomfort or skin irritation from the activity monitors.
- Although we do not expect any direct benefits, through participating in the assessments you and your child will have the opportunity to share your perceptions, needs, and goals regarding the district's wellness policy and physical activity promotion.
- Although there are no alternative procedures for this study, you and/or your child may opt out of any portion(s) of the study and may withdraw at any time.
3. WHY ARE WE DOING THIS RESEARCH STUDY?
This is a collaborative study between the UMass Department of Kinesiology and the Belchertown Public Schools (BPS) district. We aim to share resources and efforts to 1) develop a revised wellness policy proposal for BPS that is reflective of recent state curriculum framework updates and aligned with the BPS district's health promotion goals and values, and 2) initiate the first stages in the development of a Comprehensive School Physical Activity Program for the BPS district. The information gained from these assessments, along with assessments from BPS students and caregivers, and other informative planning steps will be used to determine the next steps and program goals.
4. WHO CAN PARTICIPATE IN THIS RESEARCH STUDY?
We are inviting primary caregivers (i.e., parents or guardians) of current BPS students (PK through grade 12) and current BPS students (K through grade 12) to participate in the components of the study described in this form.
All K to 12 students will be asked to complete a questionnaire for BPS purposes and final responses (not linked to student names or any identifying information) may be shared with the UMass research team. In other words, BPS will not share student names or any identifying information with UMass unless your child is enrolled in the study.
Students who have parent consent and permission, and give their own written or verbal assent, may participate in the study. They will be invited to wear an activity monitor for one week and have their shared questionnaire responses linked with their name.
5. WHERE WILL THIS RESEARCH STUDY TAKE PLACE AND HOW MANY PEOPLE WILL PARTICIPATE?
Your assessments may be completed online or in one of the BPS schools. Your child will complete the questionnaire activity at school and if they opt to, will be asked to wear the activity monitor daily for one week. We aim to hear from a representative voice through our assessments and hope to enroll at least 20% of BPS students and households (~400 participants).
6. WHAT WILL I BE ASKED TO DO AND HOW MUCH TIME WILL IT TAKE?
If you agree to take part in this study, you will be asked to complete a questionnaire. The questionnaire will be conducted online, or a paper copy can be made available. You may skip any question you feel uncomfortable answering. The questionnaire will take approximately 20 to 30 minutes to complete and you may complete it all at once, or break it up.
If you and your child agree to participate in this study, your child will be invited to wear a Fitbit activity monitor on their non-dominant wrist for one week to measure their activity and sleep. We will ask children (13+ years) or you (for children under 13 years) to complete a daily online log (about 40 minutes for the whole week). On the first day of the activity monitoring week, the online log will ask you or your child to share some basic demographic and daily routine information. This may take about 10 minutes. On the remaining six days, completing the log will take approximately 5 minutes. The log will ask you or your child to share information about their wake and sleep times, when the monitor is taken off, sport or movement activities they did that day (e.g., type, timing, and duration), their screen time (e.g., types and durations), and how they felt that day.
If your child is in grade 6 or above and participates in all activities, your total participation time could be up to 70 minutes (40 minutes for the daily log + 30 minutes for the caregiver survey).
If your child is over 13 years old and completes the daily log themselves, their total participation time (aside from wearing the monitor) could be up to 40 minutes.
If your child is in grade 5 or below and participates in all activities, your total participation time could be up to 45 minutes (15 minutes for the daily log + 30 minutes for the caregiver survey).
We will only contact you again regarding future research or assessments if you select that option when you complete this form.
7. WILL BEING IN THIS RESEARCH STUDY HELP ME IN ANY WAY?
You and your child may not directly benefit from this research; however, we hope that your participation in the study will provide the opportunity to have a voice and share your perceptions, needs, and goals.
8. WHAT ARE MY RISKS OF BEING IN THIS RESEARCH STUDY?
We believe there are minimal risks associated with this research study, but a risk of breach of confidentiality always exists. However, we have taken steps to minimize this risk as outlined in section 9 below. The Fitbit activity monitor may be slightly uncomfortable for your child and/or inconvenient to keep track of during their measurement week.
9. HOW WILL MY PERSONAL INFORMATION BE PROTECTED?
Your privacy and confidentiality are important to us. The information obtained from this project will be treated as privileged and confidential. We will not release your data unless we have your written consent. We will not release your child's personal information or data except upon a parent's written consent. However, there could be an expectation regarding confidentiality of personal information if you or your child express intent to harm yourself or someone else, or if there is a serious concern regarding a child or some other abuse. To protect the confidentiality of your information, all digital files will be maintained in encrypted, HIPAA-compliant Research Electronic Data Capture program (REDCap) or OneDrive servers with password protection. Personal information will be accessible via the REDCap only by study administrators through 3-tiered access restrictions and will be deleted 3 years after the close of the study. Additionally, you and your child will be assigned numerical ID numbers at the beginning of the study and all individual data will be identified by ID number only. The information linking you or your child to your questionnaire responses or their activity monitor data will only be accessible by the UMass primary investigator. Other computer files containing data will be password-protected and stripped of all identifiers. If you complete this form on paper, the consent document will be stored in a locked cabinet, in a locked office. The Fitbit watches being used in this study will only collect information regarding your child's movements (i.e., acceleration heart rate) and will not collect any personal information or location data (e.g., with GPS). After this study, the researchers may share and publish their findings. Information will be presented in summary format, and you will not be identified in any publications or presentations.
10. WILL I BE GIVEN ANY MONEY OR OTHER COMPENSATION FOR BEING IN THIS RESEARCH STUDY?
After completing your questionnaire, you can select to be entered into a raffle drawing. After the study, we will randomly select five parent/guardian participants to be each awarded a $50 Tango e-gift card (that can be redeemed for a variety of vendors).
If your child is in grade 5 or below and participates in the activity monitoring, they will receive a UMass Moove and Snooze Lab t-shirt. If your child is in grade 6 or higher and participates in the activity monitoring and daily log, they will be compensated with a $20 Tango e-gift card (that can be redeemed for a variety of vendors).
If you are compensated for your participation in this study, your personal information may be released to the accounting officials at the University of Massachusetts, Amherst. If payment to a research participant is $600 or more in any one calendar year, the University of Massachusetts, Amherst is required to report this information to the IRS as taxable income. This information will be kept confidential and will only be used to process payment.
11. WHO CAN I TALK TO IF I HAVE QUESTIONS?
Take as long as you like before you make a decision. We will be happy to answer any questions you have about this study. If you have further questions about this project or if you have a research-related problem, you may contact the lead UMass researcher, Christine St. Laurent (cstlaurent@umass.edu or 413-545-9436).
UMass Research Resource: If you have any questions concerning your rights as a research subject, you may contact the University of Massachusetts Amherst Human Research Protection Office (HRPO) at (413-545-3428 or humansubjects@ora.umass.edu).
Belchertown Public Schools Research Resource: If you have questions about your rights as a research subject, please contact the Testing, Research, and Evaluation Committee (TREC) at (413) 3232-0423 x118. The TREC is a group of people that reviews research studies and protects the rights of people involved in research.
If you have any questions that you would like to direct to BPS, you can contact Dr. Shawn Fortin who is serving as the lead community partner on this project (413-323-0423 or sfortin@belchertownps.org).
12. WHAT HAPPENS IF I SAY YES, BUT I CHANGE MY MIND LATER?
You and your child do not have to be in this study if you do not want to. If you or your child agree to be in the study, but later change your mind, you may drop out at any time. There are no penalties or consequences of any kind if you decide that you do not want to participate (now or later).
13. WHAT IF I AM INJURED?
The University of Massachusetts does not have a program for compensating subjects for injury or complications related to human subjects research. Although the risk of injury related to you or your child's role in this study is minimal, should you be injured, study personnel will assist you in getting treatment.
14. STATEMENT OF VOLUNTARY CONSENT AND PERMISSION
I have read this form and agree to my participation and my child's participation in the project described above. I have had a chance to read this consent form, and it was explained to me in a language that I use. I have had the opportunity to ask questions and have received satisfactory answers. I have been informed that I can withdraw at any time. I understand that I can withdraw my child at any time and my child may choose to withdraw as well. A copy of this signed Informed Consent and Parent Permission Form has been given to me.