Resources

• • Each day that you are wearing AutoSense, you will place a chest belt and electrodes on your chest and a smartwatch on each of your wrists.

• • You will remove the AutoSense chest belt, electrodes, and smartwatches at night while you are sleeping.

• • You should wear the AutoSense chest belt, electrodes, and smartwatches at all times while you are awake, except when you shower, bathe, or swim. The sensors are water-resistant, but are not completely waterproof. Please don’t let the sensors get wet.

• • You should carry the study smartphone with you at all times while wearing the sensors

• • You should always charge the study smartphone and study sensors at night while you are sleeping.

• • The smartphone will gather information about your heart rate, breathing, and activity from the sensors that you will be wearing. This information can be used by the research team to understand when you are feeling stressed, are craving [e.g., drugs, smoking], smoke cigarettes, use certain drugs, or engage in other activities.

• • The smartphone has an internal GPS (GPS stands for Global Positioning System). The GPS will keep track of your location. Your GPS location will only be seen by the researchers who are authorized to look at your data. The purpose of the GPS is not to keep an eye on you, but to help identify locations that are important for the research [examples may be provided].

• • The information collected by the smartphone, including the location ata, will be transferred automatically from your study smartphone to secure data storage [the institution/location of any back-end computational hardware may be listed].

• • At the end of the [study duration] that you wear the sensors, we will ask you to fill out a questionnaire about your experiences wearing the sensors and talk to the researchers about your experience.

IRBs and participants must be informed of how participant data will be managed and shared as a matter of confidentiality. Sample language for several tiers of data sharing (from more restrictive to more permissive) based on the sensitivity of data are presented. Additionally, language describing retention may be flexible, but should also be reasonable and justifiable to the nature of the project and contribution to science. An example of language related to retention of sensor data is provided as well.

• • Study participants will be informed that this research is conducted as a part of the MD2K Center of Excellence. Study participants will be informed that data that may identify them (specifically, GPS) may be shared with other researchers at other institutions who are a part of the MD2K Center of Excellence, if those researchers have a legitimate, IRB-approved question regarding these data. These investigators must provide documentation of their own Institutional Review Board approval or authorization agreement with the [IRB of record] and must agree to maintain the confidentiality of participants’ data before data from this study will be shared with them. Participants will also be informed that their research data that does not include GPS or other (direct or indirect) identifiers may be shared with other (non-MD2K) researchers who have a legitimate research question for which secondary analyses are requested regarding these data.

• • Participants of this research study will be informed of the collaborative nature of the MD2K Center, which includes the following procedures: (1) the secure transmission of study data to the MD2K Center computational cluster at the University of Memphis, (2) that, with approval from their own IRBs and the MD2K Executive Committee, human subjects data may be shared from the computational cluster with other mHealth researchers amongst the 13 institutions that comprise the MD2K Center, and (3) that all investigators must agree to maintain the confidentiality of participants’ data. A listing of the MD2K Center institutions is maintained online at https://www.md2k.org.

• • Raw data, including video and identifiable geolocation (GPS) data, will be available to the study team. We intend to collect video to annotate certain health events, and GPS information to determine whether participants’ geolocation is associated with the presence or absence of certain health behaviors. Raw geolocation data is identifiable, as it can be traced to the exact locations of participants. As such, we will use the GPS data to code for points of interest (POI; i.e., location clusters) that categorically denote the location of participants at a given time (e.g., home, work, school, car, etc.). After the study has been completed, a copy of the dataset will be made that does not contain the video, raw GPS data, or participant codes, yielding a de-identified dataset. Participants will be informed that their de-identified data may be retained and shared with other researchers who are not a part of the research team if those interested researchers submit a research plan to the lead investigator of this study and agree not to share the data with others without the express permission of the lead investigator. Participants will also be given the option to opt into the open sharing of the sensor data that could be downloaded by anyone. These data could be used for any purpose, but would principally be useful for the testing and training of computational models among the wider mHealth community. These data not contain codes or any other identifying elements that could trace back to the identity of the subjects.

• • Study participants will be informed that research data collected about them, including indirectly identifiable GPS (location) traces, will be stored at the [investigator’s institution] until they are no longer useful. It is estimated that the data will possibly be useful for 10 years, but that the data may be useful and may continue to be retained much longer than that.

The following language is an example of how to explain to participants how data may be shared. In this example, the data are to be either coded or de-identified before sharing with other researchers.

This research study is a part of a research collaboration that aims to develop new ways of improving health by using mobile sensor technology. Because of this, we want to save your research data and share it with other researchers who study mobile health. The rest of this section describes how we will use your data and share it with other researchers.

Data security & confidentiality: We will use best practices to prevent unauthorized access to your information. For example, we will make sure that all paper study records are kept in locked areas not accessible to the general public. All electronic study records and data (including video data and GPS) will be kept on computers that are secured with appropriate technical safeguards such as password protection and encryption. This means it will be very difficult for someone to access your information if they do not have permission. We will protect your identity to the extent required by law. However, we cannot guarantee complete secrecy. For example, we are required by law to report evidence of child abuse or neglect. All of your records will be open to inspection by the research study staff, the IRB, other representatives of this institution, and the sponsor of this study: the U.S. Department of Health and Human Services, National Institutes of Health.

How we will use your data: We will link your contact information and your research data (the data collected by all of the questionnaires, study sensors, and the phone) with a code number. A master key that links your name, your contact information, and your code number will be maintained in a separate and secure location from your research data. We will only use your contact information for the purposes of contacting you about this research study, and future research studies if you choose. We will use your research data for scientific progress and for publication of study results. Information that we make public will only be in the form of summaries that make it impossible to tell who the individual participants were.

How we will share your data: The research data that we collect about you in this study may also be shared with other researchers. Some of these researchers may be at other universities/institutions. We will only share information that can’t be used to identify you. GPS data will contain all of the places you have visited during the study. Because of this, GPS data could be used to identify you. We will not share any data that includes your raw location data (GPS) with other researchers. We will use your GPS data to make a code for certain points of interest (POI, also called “clusters”). These POI might say “home,” work,” “school,” “car,” or some other generic code for where you have been at a given time. We will use this code in datasets that we share with other researchers, so that they couldn’t know your exact location while you were in the study.

We will share your research data with these other researchers only after:

1. They describe, in writing, how they will use the data.
2. They agree that they will keep your research data secure. They will agree that only people working on their study will be able to see your research data.

After we finish this study, we will also make a copy of the data that will be stripped of all information that could identify you (including raw location data/GPS and your code). This dataset will not have the code that identifies you. We may share this dataset with any researcher who has a use for it.

If you agree, we will also make a dataset that only has the non-identifiable sensor data from the devices. This dataset will have no identifiable information and no codes that could link back to you. This dataset can help the wider research community, and we would share it with anyone who could find it useful. This is completely optional. You can agree to take part in the study but not include your data in this open data project.

How long we will keep your data: We expect to complete this study after 3 years. After the study is over, we will we will make a copy of the data that will be stripped of all information that could identify you (including raw location data/GPS, your video, and your code). We will save this copy of your research data as long as we think it is still useful. We expect that the data will be useful for 10 years after the study is over, but we may keep it much longer.

Canceling your permission: If you change your mind later and you don’t want your research data shared with other researchers, you can cancel your permission. To cancel your permission, you have to write a letter to Santosh Kumar. When you write us a letter and cancel your permission, we will delete your information from the database. No new researchers will be able to get a copy of the data. We will not be able to take back the research data from researchers who already have the data.

After we finish this study, we will also make a copy of the data that will be stripped of all information that could identify you (including raw location data/GPS and your code). This dataset will not have the code that identifies you. If you decide to cancel your permission to share your data with other researchers after we finish this study, we will not be able to find or delete your individual research data from this copy of the dataset.

Open data set opt-in section:

If you agree, we will also make a dataset that only has sensor data from the devices that cannot identify you as an individual. This dataset will have no identifiable information and no codes that could link back to you. This dataset can help the wider mobile health (mHealth) community to learn how mobile sensor data can improve health. We would post this dataset on a publicly accessible website for anyone to download. This is completely optional. You can agree to take part in the study but not include your data in this open data project. By signing next to “Yes,” you agree that we can keep and share the de-identified sensor signals that we collect from you on a publicly accessible website.

Will you allow us to share the sensor data we collect for this study on a publicly accessible website?

YES ________________________
Signature of Participant

NO _________________________
Signature of Participant

Name of [authorized] person obtaining informed consent & Date

__________________________________________________________