IRB Considerations

 Wondering how to get started?

In general, most research studies require approval by an Internal Review Board (IRB), and to obtain that approval, you will need to write an IRB protocol, which will include an Informed Consent statement.

While these will be tailored to each individual study and for each institution, we’ve provided samples of both documents:

A note about informed consent in Terracotta:

If you select “Students will be invited to consent” from among the participation options, Terracotta will create an informed consent assignment, which will ask students whether or not they choose to participate in your experiment.

IRBs generally expect that, in routine experimental research, if someone wants to participate, they provide affirmative consent. And if they don't, then they just walk away. In most situations, it would be weird to ask a research participant to register that they do not provide consent, because then you'd be keeping identifiable records about people who did not agree to participate.

This context is more complicated, though, as both a research and education setting. Here’s why a decline-to-consent option is important here:

  • The decline to consent button enables a student to withdraw consent after having provided consent. In education settings, a student can't simply stop participating, because they would become noncompliant with course requirements.  In Terracotta, a student can withdraw consent by resubmitting the consent assignment and selecting "I do not agree to participate."

  • Terracotta is designed to administer consent in a Canvas assignment, as this is the only way for a tool to receive student input in an LMS. Terracotta collects responses, and then assigns consenting students to a condition, or registers non-consenting students as such and ceases collecting their data. Instructors never know who has and who has not consented.

  • By default, Terracotta assigns 1 point to the Informed Consent assignment as completion credit. Regardless of the response, students receive credit for having completed the assignment. Without an "I do not agree to participate" option, only students who provide consent could get the points, and their consent decisions would become visible to the teacher in the gradebook (because they got the points). This non-consenting option allows students' decisions to remain private.

  • Similarly, outside Terracotta, Canvas assumes that students should submit their assignments, and shows students a to-do list of unsubmitted assignments. Canvas Analytics registers missed assignments, and missed assignments are flagged in the teacher and student views of the gradebook.  For these reasons, students may reasonably want to respond to the consent assignment, so that they are compliant with their course assignments. By providing an "I do not agree to participate" option we are effectively providing students an opportunity to complete the assignment without providing consent, thus remaining compliant with their assignments. Without this option, students would be faced with an unethical choice: either consent or appear to be missing an assignment.

  • Finally, even though we provide the "I do not agree to participate" option, students don't need to click it in order to opt out. Terracotta does not collect data from students who do not provide affirmative consent, and that includes students who don’t respond.

 

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