New Requirement for IRB submissions starting January 1, 2011

For Investigators and Key Personnel to Meet IRB Training Requirement

Training in the protection of the rights and welfare of human subjects in research is a requirement.  The Office for Human Research Protections (OHRP) and the Samuel Merritt University IRB (SMUIRB) require that all investigators, study coordinators, and other research team members involved in human subject research or who handle subject identifiable research information have basic certification in human subject protection.  This basic certification may be obtained from one of the sites listed below.  Once you complete the modules, you should print and keep a copy of the certificate for yourself, the SMUIRB, and your sponsors (if applicable).  It is also strongly suggested that you save your User ID and Password so that you can access your training information at any time if someone (such as a new study sponsor) asks you for proof of training.

Please note that this requirement applies to ALL research team members (principal investigators, sub-investigators, study coordinators and other research team members).

Once you have participated in one of the educational opportunities listed below, note the date you completed the training.  Make sure that you print your certificate and submit to the SMUIRB (or NIH if needed).

There are two ways you can satisfy this requirement:  NIH Office of Extramural Research Training or CITI Research Training.


Course Information

NIH Office of Extramural Research Training 

Go to:

Click on "New to PHRP Course".  Follow the directions to register for the course.  In order to satisfy the training requirement, one must complete all modules and print out a certificate of completion.

Completion Time: This course contains a total of 7 modules, 4 of which are followed by quizzes. The entire course will take approximately 3 hours to complete.


Sutter Health Central - CITI Research Training

Go to:

Select "New Users - Register Here."

At "Participating Users" drop down box, select "Sutter Health Central Area Institutional Review Committee."

You will be directed from there.

Description: This is a full human subjects research educational program.  There are modules grouped for focus on biomedical research and social/behavioral research, as well as for IRB members, for records research, quality control (data) and/or specimen research.  Each individual module covers a different aspect of human subjects research.  Each module, developed by worldwide experts in the IRB community, has an associated quiz.  The software is maintained at the University of Miami, who compile the quiz scores.  When the user completes the required materials, they can print/download a completion report that details the learner's accomplishments.  The course is hosted on a secure server, and all records are kept in strict confidence.  There is also CME available to those interested in research-specific CME.  (Go to the bottom of the web site page and click the CME link for further instructions on applying for your certificate.)

In order to satisfy the training requirement, one must complete all modules for their particular group and print out a certificate of completion.

Completion Time: To complete all modules takes 4-6 hours, depending on current knowledge and experience level.

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