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.
The purpose of informed consent is to ensure that a potential research participant receives enough information to decide whether or not to participate in a research study. If a participant is unable to read and understand the consent document then they cannot properly consent to enroll into a research study.
Review the NSU IRB Readability Level of Consent Documents guidance sheet for more information.
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 the study will be conducted in languages other than English, translated documents must be submitted via the Amendment xForm after the investigator has received final approval of their New Protocol Submission xForm. The Translation Verification Form, listed below, must be attached to your Amendment xForm in order to submit translated documents to the IRB for review.
The IRB permits investigators, who have native or professional level fluency in reading and writing the target language, to translate consent materials and instruments themselves. They must sign the Translation Verification Form listed above and provide details regarding their qualifications to conduct the translations.
All documents that are to be translated must be translated by a certified translator unless this requirement is waived by the convened IRB. The certified translator must provide documentation of the certified translation.
ATTENTION: Electronic translator applications (such as Google Translate) are not appropriate for generating translated documents and will not be accepted by the NSU IRB.
Documentation of permission to conduct your study at a non-NSU site must be attached to your New Protocol Submission xForm. A study site can grant conditional approval pending final approval from the NSU IRB. This language is included in the template provided below. Researchers may provide this template to study sites to assist them with drafting an approval letter.
Model Site Approval Letter
Template Site Approval Letter
The privacy of the research subjects may be protected through the issuance of Certificates of Confidentiality. These Certificates of Confidentiality provide protection against compelled disclosure of identifying information about subjects enrolled in sensitive biomedical, behavioral, clinical, or other research. This protection is not limited to federally supported research.
Learn more about Certificates of Confidentiality.
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: