INFORMED CONSENT FORM
FOR ADULTS AND PARENTS OF INFANT PARTICIPANTS
Sponsor / Study Title: The NANIT Insights Study: Impact of Smart Baby Monitor Technology on Infant Sleep and Parental Well-being in First-Time Parents – A Randomized Controlled Trial
Principal Investigator: Natalie Barnett, PhD
Telephone: 908-494-0676 (24-Hour)
Address: Nanit
244 5th Avenue
#2702
New York, NY 10040
ABOUT THIS RESEARCH
You are invited to take part in a research study. The purpose of this study is to examine if the use of the Nanit smart baby monitor is associated with parental and infant outcomes. This study is being conducted by Nanit researchers.
Participants will contribute to research that may benefit other new parents in the future. The study is voluntary, carries minimal risks, and allows withdrawal at any time without penalty.
On the other hand, some prospective participants may choose not to join due to concerns about data confidentiality, the time required to complete surveys over several months, or uncertainty about whether the study intervention will directly benefit them. Participation involves completing an initial survey during the last pregnancy trimester, being randomly (like the flip of a coin) assigned to a group with specific instructions, and then completing two follow-up surveys at 4 months and 6 months postpartum. While these tasks are relatively simple, the use of online survey platforms, random assignment to different conditions, and the potential for de-identified data to be used in future research may be unfamiliar aspects for some participants.
Participation in this study will not reduce access to standard medical treatments, but it may introduce new habits or strategies to support healthier sleep. Unlike treatment outside of the study, participants will have structured follow-up and access to resources specifically tested in this context. The novelty of this research lies in testing the benefits of smart baby monitors, which are widely used by many families, as a scalable channel for delivering personalized data and behavioral guidance directly to families in the home environment. About 200 primary caregivers and up to 200 secondary caregivers will participate in this study.
Investigators on this study has an ownership interest in Nanit, the company sponsoring this research study. As a result, the investigators may benefit financially from a successful study. Please speak with your study doctor if you have questions about this.
You are being asked to participate in a sleep research study. Scientists do research to answer questions and learn new information. Some research might help change or improve the way we do things in the future. This consent form will tell you more about the study to help you decide whether you want to participate. Please read this information before agreeing to be in the study.
WHAT WILL HAPPEN DURING THE STUDY?
Your participation in this study will last approximately 7 months and will include completion of 3 online surveys.
SCREENING
Before any study-related tests and procedures are performed, you will be asked to read and sign this consent document. The following screening tests and procedures will then be performed to determine if you qualify to take part in this study:
- Completion of a questionnaire about sociodemographic information and medical history
If you qualify to take part in this study and go on to participate, then the following will happen: You will be asked to complete an initial survey on your sociodemographic information, sleep, mental health and parent practices plans. If you have a partner, they will also be invited to complete the same initial survey. After completing the survey, you will randomly be assigned to one of two groups. Both groups will receive a Nanit Smartbaby Monitor, but the Intervention group will have access to the full Nanit feature set (analytics, longitudinal sleep reports, and behavioral guidance) while the control group will have a video-only experience for the first 6 months postpartum. You have an equal chance of being assigned to either group.
Both groups (primary participants and, if present, the partners) will be asked to complete a follow-up survey at 4 months, and again at 6 months postpartum. You will be asked to give consent to researchers to analyze Nanit sleep metrics for the duration of the study.
EXPECTATIONS
If you participate in this study, you will be expected to:
- Complete each survey
- Share Nanit infant sleep metrics
- Follow specific instructions during the study period
RISKS, SIDE EFFECTS, AND/OR DISCOMFORTS
To minimize potential risks in loss of confidentiality, the data you submit will be downloaded and securely saved to Nanit’s secure servers using Amazon Web Services (AWS). At Nanit, only senior research staff will have access to collected data, which is only viewed for research
purposes.
Through the Nanit device, there will be video recording so there is the risk that someone may recognize you. However, once the video recordings are collected, the video data will be analyzed and only the resulting analytics will then be stored. The analytics will be anonymized. The data will be saved on a password protected computer that is accessible only to experimenters who process the data.
There may be other risks that are unknown.
NEW FINDINGS
Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.
BENEFITS
This study might directly benefit you thanks to material offered to provide support during the postpartum period, however, any benefit cannot be guaranteed. In addition, we hope to learn things that will help health professionals in the future.
ALTERNATIVES
This study is for research purposes only. The only alternative is to not participate in this research study.
COSTS
There will be no charge to you for your participation in this study.
COMPENSATION FOR PARTICIPATION
All participants receive a Nanit camera at enrollment at no cost, regardless of group or study completion.
Intervention group: For primary caregivers, 4 months of active Nanit Milestone subscription access will be provided after the Pregnancy timepoint, 2 months after the Month 4 assessment and 3 months after the Month 6 assessment. Secondary caregivers in the intervention group will receive a $20 Amazon card at each completed survey timepoint (Pregnancy, Months 5, and 6 postpartum), plus an additional $10 Amazon gift card if they complete all surveys.
Waitlist control group: For primary caregivers, 3 months Nanit Milestone subscription for each completed survey timepoint will be granted after completion of the last survey at 6 months postpartum. Both primary and secondary caregivers in the control group will receive a $20 Amazon gift card at each completed survey timepoint (Pregnancy, Months 4, and 6 postpartum), plus an additional $10 Amazon gift card if they complete all surveys.
If a participant withdraws mid-study, they retain the camera and all compensation received for completed timepoints.
If you have any questions regarding your compensation for participation, please contact the
study staff.
CONFIDENTIALITY
Efforts will be made to keep your personal information confidential. That said, we cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. No information which could identify you will be shared in publications or archival databases. Organizations that may inspect or copy your research records for quality assurance and data analysis include groups such as the investigator and their research associates, and (as allowed by law) state or federal agencies, especially the Office for Human Research Protections (OHRP), who may need to access the research records.
By signing this information and consent form, you consent to the collection, access, use and disclosure of your information as described above.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Website will include a summary of the results. You can search this Website at any time.
WHOM TO CONTACT ABOUT THIS STUDY
During the study, if you have questions, concerns or complaints about the study such as:
- Payment or compensation for being in the study, if any;
- Your responsibilities as a research participant;
- Eligibility to participate in the study;
- The Investigator’s or study site’s decision to withdraw you from participation;
Please contact the Investigator at the telephone number listed on the first page of this consent document.
An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, contact:
- By mail: Study Subject Adviser
Advarra IRB
6100 Merriweather Dr., Suite 600
Columbia, MD 21044
- or call toll free: 877-992-4724
- or by email: adviser@advarra.com
Please reference the following number when contacting the Study Subject Adviser: Pro00094891.
VOLUNTARY PARTICIPATION / WITHDRAWAL
Your decision to participate in this study is voluntary. You may choose to not participate or you may withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care.
The Investigator or the sponsor can stop your participation at any time without your consent for the following reasons:
- If it appears to be medically harmful to you;
- If you fail to follow directions for participating in the study;
- If it is discovered that you do not meet the study requirements;
- If the study is canceled; or
- For administrative reasons.
CONSENT
I have read and understand the information in this informed consent document. I have had an opportunity to ask questions and all of my questions have been answered to my satisfaction. I voluntarily agree to allow study staff to collect, use, and share my and my infant’s health data as specified in this form. I voluntarily agree to participate in this study until I decide otherwise. I do not give up any of my legal rights by signing this consent document. I will receive a copy of this signed consent document.
Research Participant Data Privacy Acknowledgment
I agree to participate in the Study conducted by Nanit.
If you decide not to sign this form, you will not be able to take part in the study.