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Columbia University Human Research Protection Program

Education & Training

Required Training:

Human Subjects Protection

Columbia Human Subjects Protection Training Program

Human Subjects Protection Training Update: Requirement for Continuing Education

CITI Requirement

Program Overview

Before a protocol will be approved by a CU IRB, the PI must review the Human Subjects Protection Training course and receive a passing score of 80 or greater on the relevant exams.  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. 

Effective October 20, 2010, there is a requirement for refresher training to be completed every 3 years.  In addition, all research personnel who have previously completed the CUMC Good Clinical Practices Courses or the Morningside Human Subjects Training Course must complete the CITI Human Subjects Protection Training Program no later than March 31, 2011. 

For more information on the Human Subjects Protection training requirements, please see our FAQs

https://www.rascal.columbia.edu/login/tc0087/

 

FDA Regulated Research

The FDA-regulated research module required for researchers involved in a study that involves a drug, device, biologic, or other biomedical intervention in a study of its potential therapeutic use, or a diagnostic test or procedure to study its potential clinical utility.  This module is accessible within the CITI Human Subjects Protection Training Program, and should be accessed through the RASCAL Training Center.

 

HIPAA Privacy Training

Key personnel must also complete the CUMC online HIPAA (Health Insurance Portability and Accountability Act) training course prior to participation in the research.

https://www.rascal.columbia.edu/login/tc0019/

 

Research with Minors

If the study population includes children, completion of the CITI Biomedical Research with Minors module is required.  This module is accessible within the CITI Human Subjects Protection Training Program, and should be accessed through the RASCAL Training Center.

 

Clinical Research Coordinator Training

All Clinical Research Coordinators (CRCs) must complete the Mandatory Training Program.  For the policy, click here.   

If you have any questions, please e-mail ctoinformation@columbia.edu or call (212)342-2763.

Training requirements:

Completion of the RASCAL Training Course TC0098 with 80% of the questions answered correctly.

https://www.rascal.columbia.edu/login/tc0098/

 

Additional Training Opportunities:

 

Monthly Investigator Meetings (MIM)

Introduced in 2003, the Monthly 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.

 

IRB 101

A quarterly informational session for our human subjects research community.  This session provides:

  • 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 Power point Presentations and Handouts

 

RASCAL Submission Workshops

These sessions are intended to focus on both the technical aspects and required content for different types of RASCAL submissions ranging from the creation of consent forms to the submission of specific types of events.  These workshops will be hands on, held in a computer lab, and researchers are encouraged to bring their own current submissions to work on during the session.  Workshop topics will be rotated every two weeks, focusing on the Consent Form Builder or Protocol Submissions.  Space is limited because of the nature of these workshops. 

 

 

Annual IRB Conferences

 

Columbia University Homepage Slideshow

 

8th Annual Institutional Review Board Conference

 

May 12, 2014

 

 

 

 

Registration

 

Agenda & Presentations

 

Payment Information

Faculty

Conference Supporters & Exhibitors

 

 

 

 

The 2014 IRB Educational Conference will be held on May 12, 2014 on Columbia's Morningside (main) campus, pictured above. 

Our annual conference is designed to provide advanced educational training on the challenges faced by IRBs and investigators. This year’s program will focus on the protection of human subjects in research involving emerging technologies, covering such topics as personalized medicine, repositories and honest broker systems, and data security. We are again pleased to host nationally recognized researchers, ethicists, and IRB professionals on the conference faculty to provide increased awareness of, and practical solutions to, challenges in these areas.

We are pleased to announce that Continuing Medical Education (CME) credits are available.  Also, the Society for Clinical Research Associates (SoCRA), the Association of Clinical Research Professionals (ACRP), and the Council for Certified IRB Professionals (CCIP) have recognized this conference as eligible for continuing education and training credits.     

       

For those traveling from out of town, hotel accommodations are available to facilitate your travel plans.

 

Check back soon for updates as more conference details become available!

 

 

 

Conference Planning Committee

 

Continuing Education Credits

 

Hotel Accommodations

 

Special Needs

 

 

Directions to

The Roone Arledge Auditorium

Conference Evaluation

 

 

 

 

7th Annual Institutional Review Board Conference

 

May 7 & May 8, 2012

 

 

 

 

 

Registration

 

Agenda & Presentations

 

Payment Information

Faculty

Conference Supporters & Exhibitors

 

 

 

 

The 2012 IRB Educational Conference will be held on May 7 and 8, 2012 on Columbia's Morningside (main) campus, pictured above. 

Our annual conference is designed to provide advanced educational training on the challenges faced by IRBs and investigators. The conference will again focus on how the protection of human subjects will need to evolve over the next decade, due to multiple factors such as expanding public health concerns, increasing demands and diminishing resources, the explosion of social media, and potentially a changing regulatory environment, only to name a few. We are again pleased to host nationally recognized researchers, ethicists, and IRB professionals on the conference faculty to provide increased awareness of, and practical solutions to, challenges in these areas.

We are pleased to announce that Continuing Medical Education (CME) credits are available.  Also, the Society for Clinical Research Associates (SoCRA), the Association of Clinical Research Professionals (ACRP), and the Council for Certified IRB Professionals (CCIP) have recognized this conference as eligible for continuing education and training credits.     

       

For those traveling from out of town, hotel accommodations are available to facilitate your travel plans.

 

Check back soon for updates as more conference details become available!

 

 

 

Conference Planning Committee

 

Continuing Education Credits

 

Hotel Accommodations

 

Special Needs

 

 

Directions to

The Roone Arledge Auditorium

Conference Evaluation

 

 

 

 

 

6th Annual Institutional Review Board Conference

 

 

March 31 & April 1, 2011

 

 

 

 

 

Registration

 

Agenda & Presentations

 

Payment Information

Faculty

Conference Supporters & Exhibitors

 

 

 

 

The 2011 IRB Educational Conference will be held on March 31 and April 1, 2011 on Columbia's Morningside (main) campus, pictured above. 

Our annual conference is designed to address challenges faced by IRBs and investigators. This year, the conference will focus on how the protection of human subjects will need to evolve over the next decade, due to innovative interventions, rapidly evolving technology, and the relative ease of worldwide interactions.  Particular areas to be addressed are: incidental findings, genetics, deception research, international research.  With the help of nationally recognized researchers, ethicists, and IRB professionals, we hope to provide increased awareness of, and practical solutions to, challenges in these areas.

We are pleased to announce that Continuing Medical Education (CME) credits are available.  Also, the Society for Clinical Research Associates (SoCRA) and the Council for Certified IRB Professionals (CCIP) have recognized this conference as eligible for continuing education and training credits.     

       

For those traveling from out of town, hotel accommodations are available to facilitate your travel plans.

 

Check back soon for updates as more conference details become available!

 

 

 

Conference Planning Committee

 

Continuing Education Credits

 

Hotel Accommodations

 

Special Needs

 

 

Directions to

The Faculty House

Conference Evaluation

 

 

 

 

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5th Annual Institutional Review Board Conference

 

April 20, 2010

 

 

Registration

 

Agenda & Presentations

 

Payment Information

Faculty

 

Conference Planning Committee

 

Continuing Education Credits

 

Hotel Accommodations

 

Special Needs

 

Campus Map

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Evaluation

 

The 2010 IRB Educational Conference will be held on April 20, 2010 on Columbia's Morningside (main) campus, pictured above. 

This conference will highlight some common challenges in the conduct and review of behavioral and biomedical human subjects research.  Speakers and panels will focus on the challenges of reviewing and conducting human subjects research and offer insights for the development of practical solutions.  We are honored once again that the conference faculty includes nationally and internationally recognized leaders.  One such leader, Professor Jeffrey Sachs, will provide the keynote address. 

The Conference Committee designed the program to provide advanced human subjects research training, although those new to the field will also gain valuable insights. The program will provide insights for researchers (investigators and staff), research administrators, research sponsors, compliance officers, legal counsel, and IRB Chairs, IRB members, and IRB staff.


In the morning, this year’s conference will focus on international and genetic research.  In the afternoon, there will be a number of sessions addressing concerns regarding the collection of and privacy protections for sensitive data, recruitment, subject advocacy, and informed consent, particularly in vulnerable populations.  An additional session will address the regulatory challenges of clinical research with investigational devices, and a session providing insights on certification as an IRB professional will also be offered.

We are pleased to announce that Continuing Medical Education (CME) credits are available.  Also, the Society for Clinical Research Associates (SoCRA) and the Council for Certified IRB Professionals have recognized this conference as eligible for continuing education and training credits.     

       

For those traveling from out of town, hotel accommodations are available to facilitate your travel plans.

 

 

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              2009 Institutional Review Board Annual Educational Conference - March 17, 2009

                    2009 Educational Conference Agenda

 

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

 

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 TRAINING:

  • TC0018 - Rascal Training: How to use Consent Form Builder
  • TC0017 - Rascal Training: How to do Human Subjects Protocols

 

 
     


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