Contents

  1. Overview
  2. Creating the Draft Protocol
  3. Piloting
  4. Debriefing Participants

Overview

The experimental protocol serves as both an indispensable tool to ensure consistency of the study experience from one participant to the next, as well as a formal record of the study procedures. It cannot be too detailed! Reminder that any change to the study protocol must be approved by the FIU IRB before it is implemented. Check with the NDCLab Manager before implementing any study protocol change.

Creating the Draft Protocol

It is highly recommended that you review past study protocols within the lab during the process of writing your own.

Various considerations:

  • Participants should be reminded that they can withdraw consent at any time. They should also be reminded (assuming that the IRB protocol for the study includes this), that they can request that their contact information be deleted at any time so that they are not contacted for future studies. However, the researcher should not offer the deletion of any existing data collected except when a study involves deception and the deception is revealed at the end of the study.
  • Participants should never enter their name (for example, as a participant ID in PsychoPy/Pavlovia). The only occurrence of their name should be in the REDCap eligibility and demographics questionnaires.

Piloting

Protocol variations used during piloting should be carefully logged in the study notebook. This will help you track ideas and their outcomes.

Debriefing Participants

Each protocol should include a debrief for the study. To begin a debrief, always tell participants “the study session is complete.” It is important to communicate clearly to the participant that the study session has come to a definitive end and they are no longer being tested.

  1. Ask participants “Did you have questions or concerns that I can answer for you?” If a participant is not satisfied with the RA’s answers or if they have further concerns, they should be given George’s e-mail so they can reach out to him as the PI.
  2. Tell participants about the purpose of the study, using language from the IRB.
  3. Ask participants to “please not share the details of the study with others.” Explain that we want to make sure that other people who do the study in the future are not already aware of its purpose.
  4. Special care is required in planning debriefing protocols for multi-session/longitudinal studies that involve more than one study visit, as well as studies using deception, which have special ethical and IRB considerations.