This section contains guidance, forms, and consent templates necessary for investigators to complete their IRB protocol submissions.
NOTE: Additional paper submission forms for investigators who filed their Initial Submission Form via the old paper format can be found under the Miscellaneous Forms/Letters section.
There are two sets of consent forms, Social Behavioral and Biomedical. Please use the type relevant to your research study.
Biomedical Templates: A biomedical research study is a study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Social Behavioral Templates: If your study does not meet the above criteria, please use the Social Behavioral templates. This template is used primarily by those conducting social, behavioral, or educational research.
Guidance for Consent Forms:
NOTE: Specific guidance and instructions for completing each type of consent form can be found on the first page of each template.
A biomedical research study is a study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
This template is used primarily by those conducting social, behavioral, or educational research that does not meet the criteria to use the biomedical template.
This template is intended for studies that meet ALL of the following criteria:
If a study meets criteria #1 but does not meet criteria #2, the researcher will need to use the appropriate Waiver of Documentation of Informed Consent Template.
This form is intended for studies that meet ALL of the following criteria:
For further information regarding the use of a Short Form and the template itself, please click on the document listed below.
Recruitment materials must include ALL required elements.
*If your Recruitment Flyer does not include all the required elements, it will be sent back to you for revision.
The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects. Individuals in these groups may be considered potentially vulnerable because they may not be able to make informed decisions for themselves, they may be in situations in which they can easily be manipulated, or they may be a convenient and readily available study population. Click the link below to view descriptions of different populations that NSU IRB policy provides special protections.
If you completed your Initial Submission Form via the old paper format, please use the forms below and mail a signed hardcopy to our office at:
Model Site Approval Letter
Template Site Approval Letter
Unanticipated Problems, Adverse Events (AE) and Serious Adverse Events (SAE) must be reported to the IRB in a prompt manner by investigators. The IRB has established definitions, a reporting process, and policy related to unanticipated problems and adverse events that is available on the policies page.
Unanticipated Problems and Adverse Events must be reported to the IRB Office within 5 working days. Serious adverse events must be reported to the IRB Office within 24 hours.
Unanticipated Problems, Adverse Events, and Serious Adverse Events are to be reported using the following form: