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

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

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

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.

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.”

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.
5. Please note that you will be able to upload any related Data Source documents (copies of the study instruments for example) in the “Data Source Upload” section.
6. If you will be using Qualtrics to issue a survey, please upload the survey document (Word or PDF) and the link to the project in Qualtrics so that the reviewer may compare the survey document to the survey questions within Qualtrics.

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.