IRB Applications and Data Management Plans
Activity: Assess Data Management Plan language
Qualitative Data Repository sponsored a competition in 2021 to judge excellent Data Management Plans. Look through some of these examples of actual Data Management Plans, and review them in connection to the judges’ comments that declare why they have good data ethics.What, to you, was one particularly good example of ethical principles in regards to sharing and access section of one of these plans?
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Data Management Plans
Data Management Plans lay out to the funder at the beginning of the project your plan for how you will share the data (among other things). The funder will care a great deal about what protections you will incorporate if you have human subjects data. ICPSR, a social sciences data repository, provides a sample Data Management Plan (page 16-17 of linked PDF), such as if you are depositing in the ICPSR data repository. The Databrary repository provides some Data Management Plan template language for access and sharing as well.Please be aware that what you submit about data sharing in an IRB application and in a Data Management Plan is expected to be followed, unless you revise it for review.
IRB Applications
In order to begin any research project involving human subjects, you must submit and receive approval for an IRB application. The IRB office will examine the application to ensure the activities planned are ethical and compliant with federal regulations. It is going to care about the sensitivity of the data collected/used in your proposed project. Your university’s IT department should have data classification levels to express the sensitivity of (and security needed for) data. The picture below is Weill Cornell Medicine’s data classification levels (version 11.03 as of 11/19/2021).Though the IRB application review occurs far before data sharing occurs, there are questions about what type of data you have and what you will do with it (such as whether you’ll share it). The IRB office, in combination with the library, can be a source to consult in regards to how to share your data ethically.
Databrary, a video data repository for education research, provides some access and data sharing template phrasing to add into an IRB application.
NC State University’s Research Administration and Compliance office provides a great deal of guides and templates for the IRB application, including informed consent form templates, and Broad Consent Addendum Templates. Broad Consent is a consent clause added to the Informed Consent form that allows the researcher to keep a participants’ information for future research studies beyond the current research study. There should be an opt-out option for broad consent, which means you would have to keep track of who agreed and who opted out of “broad consent.” You may choose to request directly identifiable data, a de-identified dataset that is reidentifiable only through a master list. Note that even if you secure broad consent, if you (or a different researcher wanting to reuse your data) want to reuse this data for another project, that new project would need to go through a new IRB application. You just wouldn’t need to resecure consent from the original participants.