Below are the paper format of the submission forms needed for the IRB process along with model/template/checklist documents to assist researchers in developing informed consent materials. Researchers are encouraged to review the Frequently Asked Questions, as it provides answers that may facilitate the IRB process as well as discusses some of the duties of primary investigators who have received IRB approval for their studies.
The IRB Office is no longer accepting paper initial submission forms at this time. Please refer to our IRBManager Electronic Submission System section of our website for information regarding submitting the Initial Submission Form using IRBManager.
If your research has concluded, please complete a Closing Report Form. This form must be submitted within 30 days of the conclusion of research activities (intervention/interaction with human subjects AND data analysis have ended).
Note: For adult and parent consent forms the IRB is providing two versions for each form. You may select which version you would like to use. The bold title containing a version number at the top of each model and template is intended to provide information as to the nature of the form. The actual form you create should NOT contain the bolded title and should begin with either "Consent Form for Participation. . ." or "Assent Form for Participation." Letterhead: Principal investigators should contact their College Representative to receive letterhead for the consent and assent forms. A list of College Representatives is available on our website at http://www.nova.edu/irb/membership.html.
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 Problem and Adverse Event Reporting Flowcharts
Unanticipated Problems (non FDA research) are considered to include any incident, experience, or outcome that meets all of the following criteria:
Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related outcomes, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research; and
Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
For FDA governed research, please note that the criteria of an Unanticipated Problem is slightly different.
Would have implications for the conduct of the study (e.g., requiring a significant, and usually safety-related, change in the protocol such as revising inclusion/exclusion criteria or including a new monitoring requirement, informed consent, or investigator’s brochure).
Serious Adverse Events are defined as follows:
Congenital Anomaly/Birth Defect
Hospitalization Required or Prolongation of a Hospitalization
Life Threatening Event
Significant or Persistent Disability/Incapacity
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: