IRB Forms & Templates

The IRB Office has developed the following Research Protocol Template for use by the NSU research community. Under certain circumstances, it is recommended that researchers use a research protocol template in preparation for submitting their study via the New Protocol Submission xForm in IRBManager. Refer to the document below for further details regarding when it is recommended and what options are available.

• NSU IRB Research Protocol Template

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:

• Informed Consent Process Types
• Informed Consent Requirements

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.

To verify the reading level of a document, use the following website: https://readabilityformulas.com/free-readability-formula-tests.php and use the The Flesch-Kincaid Grade Level output.

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.

• Biomedical General Consent Form (v2023-08-31)
• Biomedical Parent/Guardian, LAR, & Adolescent (age 13-17) Consent Form (v2023-08-31)
• Biomedical Signed Consent Form Waived (Process Not Waived) Form (v2023-08-31)

This template is used primarily by those conducting social, behavioral, or educational research that does not meet the criteria to use the biomedical template.

• Social Behavioral General Consent Form (v2023-08-31)
• Social Behavioral Parent/Guardian, LAR, & Adolescent (age 13-17) Consent Form (v2023-08-31)
• Social Behavioral Signed Consent Form Waived (Process Not Waived) Form (v2023-08-31)

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.

• Child Assent Form (ages 7-12) (v2023-08-31)

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.

• Participant Letter for Anonymous Surveys (Signed Consent Form Waived, Not Consent Process)(v2023-08-31)

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 contact the IRB Office at IRB@nova.edu

Recruitment materials must include ALL required elements.

Required Elements*:

• All flyers must have 3” by 3” blank/light colored space in the top right-hand corner to allow for electronic approval stamping.
• Study title.
• The word "research." Make it clear that this is a research study.
• “Nova Southeastern University"
• The PI's name.
• A contact name with either a phone number or e-mail address.
• Eligibility criteria, if applicable, should be noted briefly. Especially if payment depends on meeting these criteria. For example, "English speaking only," "Women only," etc.
• State whether participants will be paid for their time and effort. The amount of payment may be included, but should not be the most prominent element on the page and should not seem excessive considering the nature of the project.

Recommended Elements:

• Purpose of the study.
• What is expected of the participant.
• The time commitment.
• The location where the research will take place.

  *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.

• Vulnerable Populations

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.

• Translation Verification Form

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 Problem and Adverse Event Reporting Flowcharts

• Adverse Event Reporting Flowchart
• Unanticipated Problem Reporting Flowchart
• FDA Adverse Event Reporting Flowchart

Guidance Documents on Unanticipated Problem and Adverse Event Reporting

• NSU Unanticipated Problems and Adverse Event Policy
• OHRP – Guidance
• FDA – Guidance

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:

• Unanticipated Problems and Adverse Event Report Form