IRB Meeting
Invesitigator's Handbook  

SCOPE AND PURPOSE OF THE IRB

IRB MEMBERSHIP
INSTITUTIONAL REVIEW BOARD OFFICE
WHAT NEEDS IRB REVIEW
WHO NEEDS IRB REVIEW
TYPES OF IRB REVIEW
RESEARCH ETHICS EDUCATION POLICY
SUBMISSION DEADLINES AND APPROVAL PROCEDURES
PREPARING AN APPLICATION FOR IRB REVIEW
INFORMED CONSENT
RECRUITMENT AND SELECTION OF SUBJECTS
FOOD AND DRUG ADMINISTRATION REGULATIONS
RESPONSIBILITIES OF THE PI FOR RESEARCH IN PROGRESS
EMERGENCY USE OF EXPERIMENTAL DRUGS OR DEVICES
HUMAN SUBJECT RESEARCH WITHOUT PRIOR IRB REVIEW

Research Ethics Training Policy and Procedure

All investigators and research staff conducting human research at institutions using the UTHSCSA Institutional Review Board (IRB) must complete research ethics training provided by the University of Miami, Collaborative IRB Training Initiative (CITI). (www.citiprogram.org)

Two categories of learners:

VA researchers: Individuals conducting research at STVHCS and/or the General Clinical Research Center/GCRC

Must complete the VA training annually on the CITI website
Not required to take UTHSCSA training. (Attachment 1)

UTHSCSA researchers: Individuals conducting research at UTHSCSA and other IRB-affiliated institutions

Must complete UTHSCSA training on the CITI website every three years.

Not required to complete the VA training. (Attachment 2)

 
All new studies submitted to the UTHSCSA IRB and studies reviewed at continuing review must comply with this policy.
Individuals who completed the previously approved research ethics programs (e.g., UTHSCSA - "Protecting Study Volunteers in Research" Dunn & Chadwick; or VA - “Overview of Good Clinical Practice and Human Subjects Protection” EES): may receive credit for completing the course; and must still meet the continuing education requirements.
Overview
Investigators are responsible for completing the online training or supplying the OIRB with proof of other previously approved or subsequently authorized training.
Office of the IRB (OIRB) staff are responsible for confirming training dates for new studies / continuing review.
IRB Director is responsible for determining if alternate programs are comparable to IRB approved training.
University of Miami, Collaborative Institutional Training Initiative (CITI) is responsible for providing Research Ethics Education under contract, including a UTHSCSA specific module with information/policies that must be agreed to in order to complete the training, (Attachment 3)

Attachment 1 - FAQ – VA & GCRC Researchers

Attachment 2 - FAQ – UTHSCSA IRB Affiliated Researchers

Attachment 3 - UTHSCSA Specific Module

Attachment 4 - Instructions “How to Register with CITI”

 
 

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