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IRB Forms & Templates

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.

Consent Guidance & Templates

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.

The child participant (ages 7-12) must be assented using this form and a Parent/Guardian must provide their consent by signing the appropriate Parent/Guardian Consent Form. Children ages 13-17, do not use this Child Assent Form and should sign the bottom of the Parent/Guardian Consent Form.

This template is intended for studies that meet ALL of the following criteria:

  1. Investigators will seek IRB Waiver of the requirement that participants must sign the consent form.
  2. The research involves a one-time anonymous survey (either in person or online).

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:

  1. The study is considered a biomedical research study, which is defined as a research 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.
  2. The majority of participants that will be enrolled in the study are English speakers, but there may be potential participants who will not be able to understand consent form in English.

For further information regarding the use of a Short Form and the template itself, please click on the document listed below.

Miscellaneous Forms/Letters

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:

Institutional Review Board
Nova Southeastern University
3301 College Ave
Fort Lauderdale, FL 33314

HIPAA Forms

UP/AE/SAE Reporting

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

Guidance Documents on Unanticipated Problem and Adverse Event Reporting

  1. 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.
  2. For FDA governed research, please note that the criteria of an Unanticipated Problem is slightly different.
    • Unexpected
    • Serious
    • 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).
  3. Serious Adverse Events are defined as follows:
    • Death
    • 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:

Questions?

Please refer to our Frequently Asked Questions section for common questions regarding the IRB process.
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