You can start a new study by clicking on Create Study from the left panel:
This will open the Start New Study page which includes the steps to design a study in Ethica. In this document, we will walk you through the necessary steps to setup 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 field allows you to enter the content of the study's consent form, 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 how will have access to the data?
- How can participants contact a member of the research team?
- What is the withdrawal process?
Institution is the name of the organization leading this research.
In this 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. Ethica does not allow any new participant to join after the end date. While participants can join a study prior to the start date, their participation will not begin until the selected start 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 Study Period's start date at the end of the enrollment. 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 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 study's Enrollment Type, i.e. who can join the study. If the Enrollment Type is set to Public, anyone with the registration code can join the study. If the Enrollment Type is set to Invitation-based, only those participants who 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 as part of your study. You can add data sources one by one by clicking on Add New Data Source as shown below:
This opens 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 on what that data source is and what type of data it collects. For more details on the available data sources, please refer to Data Sources section.
For each data source you also can choose whether it's Mandatory or 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. You can read further on how participants can opt out from the optional parts of a study, or temporarily pause their study participation.
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 Data Sources section for details on what data sources is 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 custom data sources are offered as a separate plugin to Ethica app. Therefore, if you choose to include these data sources in your study, participants will be asked to install the required plugin as part of their study participation. Data sources related to wearable devices all fall in this category. Such data sources are currently only supported by Android, and participants using an iOS device will not be able to provide such data.
Survey Responses is a special data source. Adding it to a study does not initiate any data collection unless specific surveys are also defined for the study. 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 Surveys section.
In the last step, you need to specify two more attributes of the study. The Study Dropout option allows you to decide whether participants should be offered a way to drop out of the study through the app or not:
Selecting this option adds a section to the app which participations can use to leave the study. Note that participants always have the option of leaving the study by simply uninstalling Ethica from their device. Providing them with this option enables you to track who many participants have dropped the study. Ethica will show dropped participants as follow throughout the dashboard:
Moreover, if you enable this option and participants choose to select this over uninstalling the app to drop out of the study, you can capture reasons behind their decision using Exit Surveys. When you define an Exit Surveys for a given study, Ethica will ask the survey right after the participant chooses to leave the study. You can read more about Exit Surveys in Surveys section.
Study Background allows you to customize the look and feel of the Ethica app for your study. The image you select here will be loaded in the app and used as the background. The following images show how a study with a custom background looks like on the smartphone:
The image will also be used as the background for study's homepage in Ethica. The following image shows the website for a given study loaded on an Android phone:
One important decision in each study is defining who has access to the data collected during the study and can modify the study design if required. By default, you are the only one with full access to the studies you have created. You can also invite more researchers to have access to your study. This can be done in Study's Design page after the study is created. You can read more about how to modify access permissions in Access Permissions section