In this section you will provide the Board with a description of the data in the study. Like the “Participant Groups,” you can create more than one “Data Source” to describe the various aspects of data in the study. Data sources can include data that are already collected (archival data) and data that will be collected during the study. Data Sources can be used to describe different data collection methods and/or tools. For many studies, creating one “data source” will be sufficient for describing the data in the study; there are no rules or specific requirements regarding how this section should be completed but rather it is a tool to help you describe your study. A “Data Source” can be “copied;” if you have similar data sources but want to describe them individually, using the copy feature can make it easy to do so. If you have more than one data source, you can use the “Associate Data Source with Data Source” tool to describe how the data sources are connected. The “Associate Data Source with Participant Groups” can be used to describe which participant groups use what data sources. Please note that you will be able to upload study “instruments” in the “Instruments” section.
The Board reviewers will need to understand the scope of the data and how it is connected to the participants. The process for accessing already collected data and/or collecting data can significantly impact on the level of risk to participants in the study.
|Study Activity||Interview and survey||Survey and classroom materials||Survey|
|Consent Form||Consent form for “Teachers”||Student Assent Form
Parent Consent Form
|Parent Consent Form
(as study participants)
|Instrument||Teacher interview protocol
|Student Survey||Parent Survey|
|Data Sources||Data Source 1: Teacher Interview (uses video tape)
Data Source 2: Teacher Survey
|Data Source 3: Student Survey||Data Source 4: Parent Survey|
Data Source Example A is a complicated study with multiple participant groups and methods for collecting data. The principal investigator opted to create a data source for each of the instruments that she is using. The benefit of creating the different data sources helps the principal investigator to demonstrate the different levels in which identifying information is collected. Participants in the “teachers” group will participate in videotaped interview and online survey; the “teachers” identifiers will be connected to their data and justifiably retained. However, the student survey and parent survey are collected online; participants are provided with a code so that their surveys can be linked but no identifying information is collected. The principal investigator is able to demonstrate in the protocol that the students and parents can qualify for a consent form waiver (consent form doesn’t need to be signed) but the teachers will need a signed consent form.
|Participants||“Normal” Adult Group 1||“Normal” Adult Group 2|
|Study Activity||Anonymous Online Survey||Anonymous Online Survey|
|Consent Form||Online notification||Online notification|
|Instrument||Online Survey A||Online Survey B|
|Data Sources||Data Source 1: Survey A and B
Data Source 1: Survey A
|Data Source 1: Survey A and B
Data Source 2: Survey B
Data Source Example B also involves multiple participant groups but they are all participating in an online survey. While the surveys are different, the overall method for collecting data is essentially the same. In this case the principal investigator may decide to only create one data source; if he wants to distinguish between the two surveys and create two different data sources, that option is certainly available as well. In this case, using the “copy” feature when creating a new data source can save the PI from rewriting similar content; instead he can edit the text in the “copied” version to fit the second survey.
|Participants||Residents in a remote village|
|Study Activity||Observations, short interviews,
|Consent Form||Oral consent process|
|Data Sources||Data Source 1: Observations, short interviews, lengthier interviews
Data Source 1: Observations and short interviews
Data Source 2: Lengthier interviews
Data Source Example C is an ethnographic study where the researcher will spend time with a community, documenting their culture and experiences. Studies like this one can be fluid at times in regards to the data collection process. While there is the potential to interact with a variety of individuals and collect data in different ways, it may not make sense to create multiple “data sources.” In this example the principal investigator could create only one data source to describe the interaction with the community. However, he knows that while he will probably observe and conduct short interviews with most of the community, a select group will participate in the lengthier interviews. It may be to his advantage to create two data sources to distinguish between the different data, particularly if he created two “participant groups” to distinguish between the two. He could use the questions in the data sources section to distinguish when he will use a video recording for the lengthier interview or just take notes for the observations and short interviews.
Once you create multiple participant groups, data sources, etc, the “associate tools” will help to create tables that connect the correct participant groups with consent forms and data tools, so having clearly defined participants groups is a good first step towards using these tools appropriately.