Columbia University Human Research Protection Program
Education & Training
Human Subjects Protection
Columbia Human Subjects Protection Training Program
Human Subjects Protection Training Update: Requirement for Continuing Education
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 requirement, click see our FAQs.
HIPAA Privacy Training
Key personnel who will be conducting research involving Protected Health Information (PHI) must also complete the online HIPAA (Health Insurance Portability and Accountability Act) training course prior to participation in the research.
Research with Minors
If the study population includes children, completion of the CITI Biomedical Research with Minors module is required.
Additional Training Opportunities:
The IRB-Investigator Meetings provide regular educational opportunities that address current human subjects protection topics.
The objectives of these meetings are:
- 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;
- To improve the quality of submissions to the IRB; and
- 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
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
2011 Institutional Review Board Annual Educational Conference - March 31, 2011
The 2010 Institutional Review Board Annual Educational Conference -
April 20, 2010
Conference Planning Committee
Continuing Education Credits
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.
2009 Institutional Review Board Annual Educational Conference - March 17, 2009
2009 Educational Conference Agenda
2007 Institutional Review Board Annual Educational Conference - April 24, 2007
2007 Educational Conference Agenda with Links to Powerpoint Presentations
2006 Institutional Review Board Annual Educational Conference - April 18, 2006
2005 Institutional Review Board Annual Educational Conference - April 14, 2005
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:
TC0018 - Rascal Training: How to use Consent Form Builder
TC0017 - Rascal Training: How to do Human Subjects Protocols