Columbia University Human Research Protection Program

Education & Training

Required Training:

Human Subjects / GCP and HIPAA

Before a protocol will be approved by a CU IRB, the PI must review the most pertinent Good Clinical Practice (GCP or Human Subjects Research course offered by Columbia and receive a passing score of 80 or greater on the relevant exam.  Research personnel other than the PI who have contact with subjects, contact with confidential study data, or are otherwise engaged in the research, (i.e., key personnel) must also complete training in the protection of human subjects prior to participation in the research.  Key personnel on the CUMC campus must also complete the CUMC online HIPAA (Health Insurance Portability and Accountability Act) training course prior to participation in the research.

click here for GCP/Human Subjects and HIPAA instructions

CITI Training

If the study population includes children, completion of the CITI Research with Minors module is required.

click here for CITI Training information and instructions

Additional Training Opportunities:

IRB-Investigator Meetings

The IRB-Investigator Meetings provide regular educational opportunities that address current human subjects protection topics.

The objectives of these meetings are:

1. To help ensure that all human subjects research is conducted in accordance with the federal regulations, in an ethical manner, and with high standards of excellence;
2. To improve the quality of submissions to the IRB; and
3. To form a network among researchers, the IRB, and the Office of Clinical Trials for the purposes of facilitating human research.

Featured Speakers have included:

• Director of the Office of Human Resource Protections (OHRP)
• Associate Director for Regulatory Affairs, FDA

Click here for a list of past sessions, Powerpoint Presentations & Handouts

IRB 101

A series of three two-hour informational sessions for our human subjects research community.  These sessions, which are held on a bi-monthly basis, provide:

• A history of human subjects protection and the ethical principles that guide human subjects research;
• An overview of the federal regulations for the protection of human subjects in research;
• Criteria for IRB review;
• Tips for submitting complete and understandable new protocols, modifications, renewals, and adverse event reports;
• An overview of the RASCAL system and process;
• Special considerations for vulnerable populations; and
• The IRB Review process, continuing review and oversight monitoring at CU.

Who should attend?

• New research personnel
• Research Personnel new to Columbia
• Researcher personnel who have not yet attended Part I of the IRB 101 series in the past
• All those who wish to gain a historical perspective and learn the ethical and regulatory guidelines for Human Subjects Research

Watch for dates in "News & Announcements"

Click here for IRB 101 Powerpoint Presentations and Handout

Annual Educational Conferences

The 2007 Institutional Review Board Annual Educational Conference - April 24, 2007

The 2007 IRB Educational Conference was held on April 24th at the historic Low Library on Columbia's Morningside (main) campus, pictured above. 

Our annual conference is designed to address challenges faced by the IRBs and investigators at Columbia University. Nationally recognized speakers provide practical knowledge and solutions to many of these issues. Columbia IRB Chairs, Board Members, IRB staff, investigators and research staff attend.  This year we were again pleased to offer registration to individuals from other institutions, as we believe that IRBs nationwide face similar challenges. 

Please click on the following link for additional information about the 2007 IRB Educational Conference:

2007 Educational Conference Agenda with Links to Powerpoint Presentations

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2006 Institutional Review Board Annual Educational Conference - April 18, 2006

2006 Agenda with Links to Powerpoint Presentations

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2005 Institutional Review Board Annual Educational Conference - April 14, 2005

2005 Conference Overview

2005 Agenda with links to Powerpoint Presentations

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Other Web-based Training

Online Educational sessions are available anytime to all personnel on the RASCAL website.

Go to the Rascal home page at https://www.rascal.columbia.edu.

Select 'Testing Center' under 'Compliance'.

Log in with your UNI and password.

Click on "Course Listing" and select from the following courses:

RASCAL:

TC0018 - Rascal Training: How to use Consent Form Builder

TC0017 - Rascal Training: How to do Human Subjects Protocols