You can start a new study by clicking on the
Create Study button from the left panel:
This will open the
Start a New Study page which includes the steps to design a study in Ethica. Below, we will walk you through the necessary steps to set up your study.
The first step is to provide a
Name for your study and enter the content of the
Consent Form. The name should be short and concise. It will be used both on the Ethica website and in the app to refer to this study.
Consent Form allows you to enter the content of the participant consent form for your study, approved by your institution's review board. This content is shown to participants during the registration which they have to read and accept prior to joining the study. In particular, you need to ensure your consent form covers the following:
- What is the purpose of the study?
- What are the potentials risks or benefits to the participant?
- How data will be handled and who will have access to the data?
- How can participants contact a member of the research team?
- What is the withdrawal process?
If you are already planning to meet with each participant in person and ask them to sign a paper form, then the content written here will be more informatory. In this case, you can just add the information you want to be easily accessible to participants.
On the other hand, if you don't plan to get a signed paper copy of the consent form from each participant, you can put the consent form materials in this field, and inform participants that their registration in the study will indicate their implicit consent.
Institution field will contain the name of the organization leading this research. By default, it will be set to the name of the institution you are associated with. But if this study is being conducted by another organization, you can change the name here.
In the second step, you specify the enrollment timeline, how many participants you expect to enroll, and who can join your study. Study Period defines when the study is expected to start, and when it should end. Participants can join a study prior to the start date, but their participation will not begin, and no data will be collected from them, nor any survey is presented to them, until the start date you have selected here. Also, no participant can join the study after the end date.
Participation Duration specifies how many days each participant should be part of the study.
For example, assume you are planning to start a study where all participants are expected to start their participation on the same date. Depending on how many participants you want to enroll and how much time is needed for the enrollment, you can plan when the enrollment is expected to end. Then you can set the start date of the
Study Period to the date when the enrollment is expected to be finished. Participants can join any time prior to the start date, though Ethica will not start the data collection until the start date is reached. This guarantees that the data collection for everyone starts exactly at the same time.
If a participant joins after the start date, their start time is set to the time they joined. Their last date is set to the number of days specified in
Participation Duration after the start date, or the end date of the study, whichever is the earliest. This guarantees that no data collection happens after the end date of the study.
Another example involves conducting rolling enrollments. For such studies, you probably don't have a fixed end date, so you can set the end date as Open-Ended. Therefore, participants can join the study anytime they are recruited. Ethica will mark their start time as the time they joined, and their end time as "Participation Duration" days after the start time.
Another example involves longitudinal or surveillance studies where participants are expected to remain enrolled for an indefinite amount of time. In such cases, you can set Study Period as Open-Ended and set the Participation Duration as Same as the study. In this case, both the Study Period and Participation Duration will be open-ended, and Ethica continues the operations indefinitely.
The next question in this section asks about the number of participants you plan to enroll. If this is not known in advance, you can leave it at zero and set it later. Ethica will use this number in the dashboard to provide you with reports on enrollment progress.
In the last part, you should specify the
Enrollment Type for the study, i.e. who can join the study. If the Enrollment Type is set to Public, anyone with the study's registration code can join the study. If the Enrollment Type is set to Invitation-based, only those participants whom you have invited can join the study. If the Enrollment Type is set to Closed, Ethica does not allow anyone to join the study. You can read more about different Enrollment Types here.
In the next step, you should select the types of data you need to collect from participants during the study. You can add data sources one by one by clicking on the
Add a New Data Source button as shown below:
Add a New Data Source dialog where you can select a new source of data:
When you select a data source from the list, you can read a short description of what that data source is and what type of data it collects. For more details on the available data sources, please refer to the Data Sources section.
For each data source, you also can choose whether it's Mandatory or not (i.e. optional). If a data source is defined as optional, Ethica app allows participants to opt out from providing that type of data, if they choose too. On the other hand, for mandatory data sources, participants are required to provide the data.
Not all data sources are available in both Android and iPhone. Depending on technical restrictions, some data sources are provided only on Android, and at times, only on certain Android devices. You can refer to the Data Sources section for details on what data sources are available on which platform. If a participant joins a study via a smartphone which is not capable of providing the data requested by the study, the Ethica app simply skips that data source and provides data for remaining available data sources.
Some data sources are not available in the Ethica primary app and are offered as a separate plug-in to the Ethica app. Therefore, if you choose to include these data sources in your study when a participant joins your study, she will be asked to install the required plug-in as part of their study participation. Examples are app-usage statistics, or SMS and phone call logs data source.
Survey Responses is a special type of data source, as adding it to a study does not initiate any data collection automatically, unless you define one or more surveys for your study as well. If you intend to include any surveys in your study, you can add Survey Responses data source here, and define the specific surveys later on. You can read more about adding surveys in the Surveys section.
In the last step, you can specify a few more configurations for your study. The
Automatic Data Upload Reminder instructs Ethica to monitor the incoming data from each participant, and if they don't upload data for longer than a certain period, send them a reminder notification. This setting offers you three options, as explained below:
- Do not send automatic data upload reminder: This option disables the reminders for your study.
- Send reminders after X days of inactivity: This option instructs Ethica to send the reminder if the participant does not upload any data for longer than X days. In this case, a participant receives a notification if they don't upload any sensor data or survey responses for X days in a row.
- Send a reminder after not uploading X surveys: This option instructs Ethica to send a reminder if the participant does not upload their responses to X surveys in a row. Note that this only applies to time-triggered surveys, where the server knows ahead of time when the participant is expected to respond to a survey.
Upload via Wi-Fi Only option instructs Ethica that by default, it only should upload non-survey data via Wi-Fi only. This way, if the participant is connected to the Internet but is not on Wi-Fi, Ethica does not upload any data other than survey responses. The survey responses are considered as an exception here because they are small in size but they are important and have to be transferred to the servers as early as possible. Note that only survey responses are the exception in this case, and any media captured as part of the response will respect this setting.
Also, note that this setting defines the default value of this option for participants. Each participant can override this default value in their app, and decide whether they want the data to be uploaded via Wi-Fi only or not. In this case, their choice will have precedence over this setting.
Study Background option allows you to customize the look and feel of the Ethica app for your study. The image you select here will be used by the Ethica app as the background and theme of your study. The following images show how a study with a custom background looks like on the smartphone:
After configuring the options in the last step, you can click on the
Create Study button to create a study based on the specified settings. This might take a few seconds, and during this time, Ethica will set up a database for your study, and configure it based on the type of data you have chosen.
By default, you are the only person who has permission to access the study as a researcher, though you can invite other colleagues as well to join your study, as explained here.
At this stage, you will be taken to the study's home page in your Researcher Dashboard. If you have chosen Survey Responses data source, you will be presented with the following dialog where you can choose to go to the Surveys page and start adding the surveys right away.