To support thorough risk assessment, the IRB is now asking study teams to upload any questionnaires or surveys (including validated surveys) used in studies under the Surveys, Questionnaires, Etc. section of the Documents & Attachments page in their IRB application. This helps the IRB evaluate the nature of questions participants are asked, especially when these questions may involve sensitive topics. It may be necessary for your study team to provide appropriate resources for participants in your ERICA application if something sensitive gets disclosed to the study team during the course of research. Sensitive questions may include (but are not limited to) topics like sexuality, abuse, suicide, immigration status, etc.
For now, we will request all surveys during the initial review of new studies submitted to the IRB. You may be asked to attach surveys at Continuing Review or Amendment that were not previously attached/reviewed.
Please refer to the Required Documents and Forms for IRB Applications Investigator Guidance Series for details on the documents the IRB reviews.
Thank you for your continued partnership in protecting research participants.