Steps to submit a scientific study to the IRB
Protocol Identification Number
IRB Fee Services
Information to be included in protocols
Information to be included in a final report
Informed Consent Minimal Requirements Basic and Additional Elements
IRB Application Form Rev. May 2019
Continue Report Form
IRB Recommendations for the protection during the COVID-19 pandemic
REVISED COMMON RULES, EFFECTIVE JANUARY 21, 2019
UCC- 2018 FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS (45 CFR 46)- RULES AND REGULATIONS 2018
RESUMEN – 2018 FEDERAL POLICY FOR THE PROTECTION OF HUMANS SUBJECTS- 45 CFR 46 – RULES AND REGULATIONS 2018
IRB Comunicado
IRB Guide for the Creation of HIPAA Documentation
HIPAA Form for Investigations
Human Research Protections
Human Subject Regulations Decision Charts
Food and Drug Administration
Federal Policy for the Protection of Human Subjects
“WHO NEEDS: TRAINING ON THE NIH´S CHANGES TO CLINICAL TRIALS POLICIES- GOOD CLINICAL PRACTICE (GCP) TRAINING”. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html, https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm
Web Certificate – Link to get Web Certificates go to https://about.citiprogram.org/en/homepage/ Certificados de Human Subjects Research (HSR), Information Privacy & Security (IPS) & Good Clinical Practice (GCP)
Orientacion Comité del IRB-20220825_183314-Meeting Recording.mp4
