Contents
Overview
All data collection activities must be approved by the FIU IRB. There are two key components of the approval process: preparing the informed consent/assent form(s) and drafting the protocol for IRB approval. Any subsequent changes to the study, such as modifying questionnaires, onboarding new study staff, or adopting new technological tools (data collection, data storage) must be explicitly approved by the FIU IRB in an amendment to the original protocol. Before any protocol change can be made to a study, the researcher must confirm that the change has been approved by the IRB. They should do so by checking the most up-to-date IRB-approved protocol and subsequently confirming with the NDCLab Manager. The NDCLab Manager tracks all lab IRBs and must be involved in any IRB-related procedures.
Informed Consent/Assent
The FIU IRB templates for informed consent/assent, available here, must be used as the basis for all informed consents submitted to the FIU IRB. The NDCLab typically uses:
- for adult-only studies: “online” consent, where the participant simply checks an “I consent” button on REDCap
- for studies involving children/adolescents: “written” consent, where the participant/parent signs their name on the REDCap survey
Contact the lab manager for assistance with drafting an informed consent/assent for a new study, as it is often easier, for a new IRB submission, to update an existing consent/assent from a previously approved study than to draft a new consent/assent from scratch.
Witness Signatures
If the required template includes a witness signature, the NDCLab member serving as witness can ‘pre-sign’ the REDCap form after the participant arrives for the study session.
Translations
For studies involving children/adolescents, the NDCLab actively seeks to ensure that consent forms for parents are available in both English and Spanish. When submitting a Spanish-language consent to the IRB, it is required to submit an English back translation and a form signed by both the Spanish translator and the English back translator. The back translator cannot be a named associate on the IRB protocol for which they sign the translation form (there is no such restriction placed on the Spanish translator). The NDCLab Manager coordinates all consent translation activities.
REDCap Instrument
The NDCLab Manager provides a REDCap .zip for all IRB-approved consent/assent forms. This .zip should be loaded into REDCap without modification.
Protocol Approval
The NDCLab Manager assists with planning and submitting all original IRB protocols and any future amendments. Be aware that drafting a new protocol can take several weeks, and at least one month is usually required for IRB review, revision, and final approval.
Onboarding New Staff
Before any new staff member can help with a project, they must be approved by the IRB for that project. If any new staff members are onboarded after the original IRB submission, they must be added to the IRB in an amendment and they must not begin helping with the project until that amendment is approved. To ensure that a staff member is approved by the IRB, please check the most recent approved IRB submission, this Google sheet, and the ‘Secondary RA’ Google Calendar. Finally, you must confirm with the lab manager that the staff member is IRB-approved before they begin helping with any projects.