From: No title defined [SPONSOREDRESEARCH@CUVMC.AIS.COLUMBIA.EDU] on behalf of David Hirsh [davidhirsh-evpresearch@COLUMBIA.EDU]

Sent: Tuesday, October 26, 2010 4:34 PM

To: SPONSOREDRESEARCH@CUVMC.AIS.COLUMBIA.EDU

Subject: New Human Subjects Protection Training Requirement

To:             Columbia human subjects research community 

Subject:       New Human Subjects Protection Training Requirement

Date:          Oct. 26, 2010

Columbia University is committed to the highest ethical and compliance standards when it comes to the protection of human subjects who participate in Columbia research.  In keeping with best practices, we are launching a new mandatory refresher training requirement in the protection of human research subjects for all human subjects researchers.

Many of our peer institutions have implemented refresher training requirements in the protection of human subjects for all human subjects researchers. Columbia similarly will be implementing a refresher training requirement to be in full effect by March 31, 2011.

As you may know, in Spring 2009, the University switched its Human Subjects Protection (HSP) training requirement to the web-based Collaborative Institutional Training Initiative (CITI) for new human subjects researchers.  Since then, more than 4,000 CU researchers have completed CITI training.

Now, all Columbia researchers who have not already completed the CITI training course must do so as refresher training, even if they took a Columbia HSP (GCP) training previously.  The CITI course includes seven modules and takes 3-4 hours to complete.  It does not need to be completed in one sitting and can be completed at your convenience.  If appropriate, you have the option to select modules that are specific to social and behavioral research.

As of March 31, 2011, the IRB may not approve an initial human subjects research protocol, or a modification or renewal of an existing protocol unless all researchers listed on the Data Sheet have completed CITI training. 

Once the 7-module CITI training has been completed, an abbreviated CITI refresher training will be required every three years.  Those researchers who have already completed CITI training will be notified when the time for refresher training approaches.

The CITI Human Subjects Protection course can be accessed through the Rascal Training Center: Course TC0087: Human Subjects Protection Training.  A list of frequently asked questions about Human Subjects Protection training can be found on the IRB website.  If you have questions about the new requirements, please contact the IRB at askirb@columbia.edu or the Office of Research Compliance and Training at research-compliance@columbia.edu.

Finally, there are a small number of Morningside researchers who are involved in clinical research.  The University has launched a required training for all clinical research coordinators, including any on the Morningside campus.  More information about the Clinical Research Coordinator Training is available here.

Thank you for your attention to this important matter.

Sincerely,

David Hirsh

Executive Vice President for Research

Claude Steele

Provost