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Junta de Revisión Institucional (IRB)

The Comprehensive Cancer Center-University of Puerto Rico Institutional Review Board’s (IRB) primary responsibility is to ensure that the rights and welfare of human subjects in research are protected. The IRB must guarantee that the human subject research is conducted ethically, and in compliance with Federal regulations, the requirements of applicable local law, and institutional policies and procedures. The ethical conduct of research is a shared responsibility that requires cooperation, collaboration, and trust among the institution, the investigators and their research staff, the subjects who enroll in research, and the IRB.

An IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with the Common Rule and FDA regulations, the IRB has the responsibility of approving, requiring modification in to secure approval or disapproving research. The IRB also has the authority to suspend or terminate research for continued noncompliance with the Common Rule, FDA regulations, or its own findings, determinations, and initial and continuing review procedures.

IRB Basic Steps

All CCC employees (faculty/staff/administrators) and students conducting human subjects research, as defined by the Department of Health and Human Services (DHHS) and the Federal Drug Administration (FDA), need to submit required materials to the Office for Research Protections (ORP) for review before beginning any research activity

For Industry Sponsor Study

IRB Application Deadline

Nota Importante: Todo estudio/investigación que interese ser sometido al IRB de CCC debe ser enviado con al menos 2 semanas de antelación a la reunión del mes en el que va a ser evaluado. Debe incluir todos los formularios requeridos y la propuesta, 1 copias en papel y una digitalizada (electrónica). Una vez el sistema electrónico esté disponible las solicitudes serán enviadas a través de la aplicación de nuestra página web.

Todo investigador debe cumplir con:

IRB Standard Operating Procedures

IRB Charter
Glossary
IRB Policy 1
IRB Policy 2
SOP 3 – Initial and Continuing IRB Review Procedures
SOP 4 – Unanticipated Problems
SOP 5 – Managing Noncompliance
SOP 6 – Suspension Termination
SOP 7 – Reporting Unanticipated Problems
SOP 8 – Closure Of A Research Protocol
SOP 9 – Recruitment And Payment Of Human Participants
SOP 10 – Informed Consent
Exempt Review
SOP 12: Audits

IRB Educational Training

NIH Definition of Clinical Trial
NIH Definition of Clinical Trial Decission Tree
CITI Program
Department of Health & Human Services
The Belmont Report
Declaration of Helsinki
Federal Policy for the Protection of Human Subjects
IC for people with Dementia
A guide to responsible conduct in research
Steps to create an account for CITI Program
NIH Presentation Archives
NIH Library

IRB Forms / Templates

IRB Checklist
Excempt IRB Checklist
IRB Application
Excempt IRB Application
IRB Submission Log
Supplement A – Waiver of Content
Supplement B – International Research
Suplement C – Research Involving Children
Suplement D – Cognitively Impaired Subjects
Supplement E – Stored Data for Future Use
Supplement F – Research Involving Drugs / Biologics
Sample Broad Consent Español Ver Nov 2020
Sample Broad Consent English Ver Nov 2020
Informed Consent Template Instructions Oct 2020
Modelo de consentimiento informado
Personnel and Signature Log
Screening Log
Enrollment Log
Monitoring Log
Adverse Events Log
Adverse Event Report Form
Financial Conflicts of Interest
Translation Attestation Form
Unanticipated Problem / Serious Adverse Event Form
Non-affiliated Investigator Agreement
Continuing Review Form
IRB Study Closure Form

Para citas e información sobre los servicios del Hospital

o escriba a citas@cccupr.org

Para citas del Centro de Radioterapia

Ext. 8301, 8302