iProtocol Guide

Data Sources

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.

Data Source Example A
Participants Teachers Students Parents
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
Teacher Survey
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.

Data Source Example B
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
or
Data Source 1: Survey A
Data Source 1: Survey A and B
or
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.

Data Source Example C
Participants Residents in a remote village
Study Activity Observations, short interviews,
lengthier interviews
Consent Form Oral consent process
Instrument Ethnographic notes
Data Sources Data Source 1: Observations, short interviews, lengthier interviews
Or
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.

Describe the data

Use this question to provide an overall description of the data in this “data source.” If you have a large data set and providing the data fields in this text box in untenable, you can upload it as an addendum in the “Instruments” section. Are the data already collected? For more information on what is considered “all ready collected” see Archival Data.

Recording devices

The Board needs to understand the tools that will be used to record participant data as a recording can add an extra layer of “identifiability.” For more information about using recording devices, see “Recording Devices.”

Participant Identity

The Board needs to understand what identifiers will be connected to the participant’s data (if any) and if there’s a point in which the identifiers are striped from the data or if the identifiers remain connected to the data (and why that is necessary). If there is more than one data source, you can also use the “Associate Data Source with Data Source” to describe how data are connected and identities are stripped (if applicable).

  1. Select the “create a new data source” link.
  2. Provide the source’s name in the text box. Select “Continue” to save data and return to the main protocol view.
  3. You will see a “Protocol was successfully updated” message. Click on the “return to protocol” link to continue adding content to the protocol.
  4. If you need to create additional data sources, go back to the “create a new data source” link. If there is one or more data source, you can “copy” the data source and use the content you already created as a template for a new data source. You can edit the text as needed once the new source is created.
Editing/deleting a Data Source
  1. Once a data source is created, find the new source in the “Data Source” list and select “goto” or simply scroll down the page to find it.
  2. Select “Edit all” or select individual questions to edit the content. When you are done with edits, select “Continue” to save data and return to the main protocol view.
  3. Data Sources can be deleted by clicking the “delete” box on the right side of the data source and confirming the deletion on the next page. Please note: if a data source is associated with another data source or participant group, the association is also deleted. You may need to revisit the association tools to make sure that they are correct.
  • The researcher addressed all the potential identifiers (direct or indirect) for this data tool.
  • The researcher provided a plan to obtain a Certificate of Confidentiality to protect data collection of identifiable illegal information or a Certificate of Confidentiality is not needed in this study.
  • The researcher plan to obtain a Certificate of Confidentiality to protect data collection of identifiable illegal information is appropriate or a Certificate of Confidentiality is not needed in this study.
  • This data tool is reasonable in relation to the proposed study and participant group (i.e. use of participant's time, relation to risk and benefit, participant group limitations).
  • This data tool will help to adequately answer the study question.