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:
- They describe, in writing, how they will use the data.
- 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?
Signature of Participant
Signature of Participant
Name of [authorized] person obtaining informed consent & Date