IRB Resources

CITI Training: Protection of Human Subjects Training & Education

NSU has determined that all individuals involved in research with human subjects, including investigators (principal and co-) as well as members of the research team must complete the CITI: Course in the Protection of Human Subjects. CITI is comprised of certain modules. Each college/center at NSU selected the modules that their respective investigators would have to complete. Members of the research team who are not affiliated with another college/center at NSU must complete the modules within the same learner group as the principal investigator on the study.

Please visit the CITI program (http://www.citiprogram.org/) to register and complete the requisite modules. When you register you create your own login and password, but we ask that you be sure to provide as much contact information as possible in the profile section of the registration process. Please note that the CITI program must be completed prior to submitting to the IRB for initial review of a protocol, or for continuing review or revision of a previously approved protocol. Please be sure to register for the correct learner group that reflects the center/college you belong to.

Investigators are encouraged to consult with their Center Representative if they have any questions regarding CITI training.

• Creating a CITI Account
• Adding the required IRB Training Course in CITI
• Affiliate with NSU in CITI

Forms are available in Microsoft Word format, so they can be downloaded, completed, saved and printed as necessary.

• General IRB Information
• List of Required IRB documents

The Institutional Review Board has launched an electronic submission system, to access this system, click below:

• Login to IRBManager™
• Quick Guide for New Users: IRBManager™ Quick Guide

Students will complete the protocol submission form in IRBManager and then upload their proposal and CITI completion report in the IRB Progress section of ADRIANA. The IRB access button is near the top of the page.

Be sure that you have clicked the SUBMIT button after uploading all required documents on the File Submissions page. When the Upload Confirmation appears, follow the instructions and click the SUBMIT button. You will receive an automated email in your NSU account indicating that your IRB submission has been received.

The following information is only for students who are writing their dissertations in Spanish:

All IRB submissions will be paperless and submitted electronically on the ADRIANA student page. To submit the dissertation proposal for IRB approval, access the ADRIANA student page and log on using your NSU email username and password. The IRB access button is near the top of the page.

Be sure that you have clicked the SUBMIT button after uploading all required documents on the File Submissions page. When the Upload Confirmation appears, follow the instructions and click the SUBMIT button. You will receive an automated email in your NSU account indicating that your IRB submission has been received.

Document #1: Protocol Submission Forms

• IRB Manager
• IRB Manager Guide

Document #2: Informed Consent Guidance

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. These templates can be found at http://www.nova.edu/irb/manual/forms/index.html.

Social Behavioral Templates: If your study does not meet the above criteria, please use the Social Behavioral templates. These templates are used primarily by those conducting social, behavioral, or educational research. Most studies conducted at the Abraham S. Fischler College of Education will use the Social Behavioral templates.

 Guidance for Consent Forms:

• Informed Consent Process Types
• Informed Consent Requirements
• Readability Instructions

NOTE: Specific guidance and instructions for completing each type of consent form can be found on the first page of each template.

Social Behavioral Consent Document Templates

This template is used primarily by those conducting social, behavioral, or educational research.

• Social Behavioral General Consent Form
• Social Behavioral Parent/Guardian, LAR, & Adolescent (age 13-17) Consent Form
• Social Behavioral Waiver of Documentation of Informed Consent

Social Behavioral Consent Document Samples

• Social Behavioral General Consent Form SAMPLE
• Social Behavioral Parent/Guardian, LAR, & Adolescent (age 13-17) Consent Form SAMPLE
• Social Behavioral Parent/Guardian, LAR, & Adolescent (age 13-17) Consent Form SAMPLE2

Assent Form Template (for children ages 7-12)

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)

Assent Form Sample (for children ages 7-12)

• Child Assent Form SAMPLE (ages 7-12)

Participation Letter for Anonymous, One-time Surveys

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

• Template: Site Approval Letter
• Model: Site Approval Letter
• Tips for obtaining the administration letter
• NSU’s Policy on Survey Research (for surveys that involve a broad sampling or census of a population at NSU)

Other Required Documents

• CITI course completion report 
• Approved proposal 
• Data collection instruments 
• Recruitment materials (flyers, letters, etc.)

Unanticipated Problem and Adverse Event Reporting

• Unanticipated Problem and Adverse Event Report form

Proceso de IRB

• Instrucciones para someter sus documentos para revisión por el IRB
• Proceso para someter sus documentos para revisión por el IRB

Documentación requerida

1. Copia de la propuesta aprobada
2. Modelo de Solicitud de IRB
3. Consentimientos y asentimientos que procedan
4. Instrumentos de Recolección de data.
5. Anuncios para Reclutar Sujetos, Promover el estudio.
6. Carta de la Administración del Centro donde se Implementará la investigación
7. Copia del Certificado de CITI

Modelo de Solicitud Inicial

Consentimientos y Asentimientos

Los estudios pueden requerir uno o más de estos modelos, en dependencia de los sujetos involucrados en el estudio. Por ejemplo, si se incluyen maestros y padres/tutores en las mismas actividades se pude utilizar el mismo modelo de consentimiento. Pero si estarán involucrados en diferentes procedimientos o actividades entonces se deberá crear un modelo para cada grupo de sujetos. Para información mas detallada debe visitar el sitio web de CITI  www.citiprogramorg

Antes de contactar a los potenciales sujetos se debe obtener la autorización del IRB para implementar el estudio. Es decir que los procesos de reclutamiento, y de consentimiento o asentimiento solo deben iniciarse una vez que tenga la autorización del IRB.  Las iniciales que requieren los modelos de consentimiento y asentimiento son las del sujeto, y se debe añadir la fecha en que se firme el modelo.

NOTA: Existen regulaciones para involucrar/incluir a la población de NSU (incluyendo todas las categorias) en estudios de investigación. El co-investigador/tutor debe consultar con la Dra. Ashley Russom a través de russom@nova.edu antes de aprobar la propuesta de investigación. 

Plantilla: Consentimiento General de Adulto

En Puerto Rico la mayoria de edad para participar en un estudio es 21 o mas años de edad.  Los potenciales sujetos que no hayan cumplido los 21 años requieren del consentimiento de los padres o tutores.

Plantilla: Asentimiento de Menores 7-13 años

Se requiere el consentimiento firmado por los padres (al menos uno) o tutores, antes de contactar al menor.

Plantilla: Asentimiento de Adolescentes 13-17+ (hasta un dia antes de cumplir 18)

Se requiere el consentimiento firmado por los padres (al menos uno) o tutores, antes de contactar al menor.

Plantilla: Consentimiento del padre o tutor

Carta de Participación

Se utiliza solamente para determinar la voluntariedad de sujetos adultos (18 o mas años de edad except en Puerto Rico que son 21 o mas años de edad) para participar en la administracion de un cuestionario anónimo utilizando procedimientos que aseguren la no identificacion del sujeto.

Otros documentos

CITI Entrenamiento sobre la Protección de Personas que Participen como Sujetos de Estudios de Investigación

NSU determinó que todos los investigadores principales y co-investigadores/tutores de disertación (así como los miembros del equipo de investigación si los hubiere) que involucren individuos como sujetos de sus estudios deberán completar el curso CITI.

CITI está integrado por determinados módulos.  Debe visitar el sitio web del programa CITI: http://www.citiprogram.org para registrarse y completar los módulos requeridos. El curso puede tomarse totalmente en español. Busque el enlace adecuado en la parte superior de la pantalla principal. Al registrarse usted creará su propia identificación y contraseña. Asegúrese de inscribirse usando la institución NSU y como estudiante de Abraham S. Fischler College of Education para garantizar que está tomando los módulos requeridos.

Por favor tenga en cuenta que debe completar el curso CITI y tener una copia del certificado, antes de colocar los documentos de IRB para ser revisados por primera vez o si requiere cambios o extensión de tiempo de una investigación que está en proceso. El certificado debe tener vigencia durante todo el proceso de implementación de la investigación incluyendo el reporte final.

Muestra de Carta de Administración

If your New Protocol Submission xForm was completed in the new IRBManager electronic submission system:

1. Go to: https://nova.my.irbmanager.com/Login.aspx
2. Log into your IRBManager account.
3. Select "Home" located on the upper left-hand side of screen.
4. Under "My IRB Nos" click on the blue "IRB No." for the study you wish to file an amendment.
5. Find the "Event" you wish to amend, this will be either the initial submission or the most recent amendment.
6. Click on "xForms" located under the Actions column on the left-hand side of the screen.
7. Select the "Copy for Amendment" icon (a folder with a green plus sign). When your mouse hovers over the icon "Copy for Amendment" will appear. This will make a copy of your submission.
8. Follow instructions to complete the electronic Amendment xForm answering the amendment header questions where you will detail the proposed changes and justification for modifying your submission. You will then make the modifications you wish to make to the submission.

When you submit an amendment, you may be required to answer additional questions that were added to the New Protocol Submission xForm since your initial submission to comply with new Federal requirements.

PLEASE NOTE: If you originally completed your New Protocol Submission Form in the old paper format, you cannot use the IRBManager electronic submission system to file an amendment. You must complete the paper form found in our IRB Forms & Templates section and mail to the NSU IRB office.

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