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.
- Instructions on how to create a new CITI account
Note: Forms are available in Microsoft Word format, so they can be downloaded, completed, saved and printed as necessary.
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 (http://apps.fischlerschool.nova.edu/ADRIANA/student/Login.aspx) and log on using your NSU email username and password. The IRB access button is near the top of the page.
Nota: Los modelos están en formato Microsoft Word para que pueda bajarlos, completarlos, salvarlos en su computadora e imprimirlos según requiera.
Document #2: Consent and Assent Forms
Note: Studies may need to use only one or several of these forms, depending on the groups involved in the research. For example, if different procedures are used for teachers and parents, use two different consent forms.
Informed Consent Instructions
Note: Signatures on consent form(s) should not be obtained until after you have received IRB approval. The IRB must review and approve your study prior to any participant solicitation.
Consent and Assent Form Templates
- Consent Form Checklist
- Adult Consent Form Templates
- Child Assent Form Template
- Adolescent Assent Form Template
- Parent/Guardian Consent Form Templates
Consent and Assent Form Models/Samples
- Adult Consent Form Models/Samples
- Child Assent Form Model/Sample
- Adolescent Assent Form Model/Sample
- Parent/Guardian Consent Form Models/Samples
Participation Letter
Note: To be used for anonymous surveying of Adults only.
Document #3: Administration Letters
Other Required Documents
- CITI course completion report
- Approved proposal
- Data collection instruments
- Recruitment materials (flyers, letters, etc.)
Unanticipated Problem and Adverse Event Reporting
Documento #1: Protocolo de Investigación
Nota: El IRB debe revisar y aprobar es estudio antes de que se contacten los potenciales sujetos.
- Modelo de Protocolo de Investigación - Solicitud Inicial (este documento es requerido cuando se inicia la solicitud del IRB)
Documento #2: Modelos de Consentimiento y Asentimiento
Nota: Los estudios pueden requerir el uso de uno o varios de estos modelos en dependencia de los grupos de sujetos involucrados en la investigación. El lenguaje utilizado debe estar acorde con el nivel medio de instrucción de la población involucrada. El IRB debe revisar y aprobar el estudio antes de que se contacten los potenciales sujetos. La firma de los modelos de consentimiento y asentimiento por parte de los sujetos se gestionará después de que el estudio sea aprobado por el IRB.
- Modelo de Consentimiento de Adulto
- Modelo de Asentimiento del Menor
- Modelo de Asentimiento del Adolescente
- Modelo de Consentimiento del Padre o Tutor
- Carta de Participación
Nota: Utilizada solamente para administrar cuestionarios anónimos a sujetos adultos
Documento #3: Carta de la Administración
- Carta de la Administración autorizando la implementación del estudio
For information regarding the use and disclosure of protected health information in research please review Nova Southeastern University's Institutional Review Board website at
http://www.nova.edu/irb/manual/forms.html