A. Brown Bag Sessions

A. New Investigator Training

B. Training for Research Involving Children

C. Human Subjects Protections Training

The Office of Research Services offers seasonal presentations on topics of specific interest to the research community as well as periodic talks on updates to current policies, procedures, or forms. This presentations are not required, but rather are meant to provide overview information to PIs and research staff. Please contact James Lynch at 4-1613 for information on upcoming training sessions.

A. Brown Bag Sessions

The IRB instituted bi-monthly “Brown Bag” training sessions beginning in March 2007. Training sessions occur during the lunch hour; attendees are encouraged to bring their lunch. All sessions will be one hour in length and are designed to provide researchers with guidance on IRB processes, provide an opportunity to have questions answered, as well as help develop a stronger interactive relationship between the IRB staff and researchers. 


Past Sessions:

° 1st training session on Friday, March 9th, 2007
 topic and presenter were:
“Certification of Grants by the IRB: What, When, and How to Submit Grants that Involve Human Subject Research,”
presented by Millie Maleckar, Director of Regulatory Compliance for Human Subjects

° 2nd training session on Friday, May 25th, 2007
 topic and presenter were:
“The IRB Review Process: From Submission to Approval,”
presented by James Lynch, Assistant Director of IRB Education and Quality Assurance

° 3rd training session on Friday, October 12th, 2007
 topic and presenter were:
“AE Reporting Workshop: What, When, and How to Submit,”
presented by James Lynch, Assistant Director of IRB Education and Quality Assurance

Information about upcoming presentations will be posted in this space as it becomes available. We hope you will join us for future presentations.

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In order to ensure that human subjects are adequately protected from research risk, both the Universtity of Chicago and certain funding agencies set requirements for the training of investigators and their research staff. This training generally involves education on some combination of aspects of federal regulations, ethical principles, and university-specific policies. Training is usually required for investigators both upon beginning work in research at this institution and on an ongoing basis as new guidance, regulations, and areas of concern in research emerge.

The training recommended or required by the IRB for persons involved in human subjects research at the University of Chicago is outlined below. Note that funding agencies or your department or section may require other training not described here prior to your assumption of a role on a research study.

Questions regarding training should be directed to James Lynch at 4-1613 or jlynch@bsd.uchicago.edu.


A. Required Training for New Investigators

The Office of Clinical Research (OCR) conducts a required training program for new principal investigators. Please contact Linda DeSouza in the OCR at 5-7421 or ldesouza@delphi.bsd.uchicago.edu for more information. The IRB will verify training with the OCR at the time of new protocol submission by a new investigator. If you as an investigator currently have a study approved with the IRB, you will have either completed the training or been exempted from this requirement. Proposals from first-time investigators will not be reviewed by the IRB unless training has been completed.

New investigators who plan to enroll children in research are also required to complete the training on research involving children (see below).



B. Required Training for Investigators and Research Staff Involved in Research with Children
 
The University and the IRB have also determined that training is necessary for all investigators who conduct research with pediatric populations.  In July 2005, we asked Dr. Lainie Ross, Associate Professor, Department of Pediatrics and an expert in research involving children, to conduct two training sessions for faculty on this topic.  Dr. Ross’s training is now available on videotape and DVD so that if you did not attend a live session, a taped version is available in the IRB offices.  

Effective September 1, 2005, all faculty listed on protocols that include pediatric populations must have completed the pediatric research training. 

New faculty should complete the pediatric training prior to the approval of any research protocols involving children.We also strongly recommend that all staff involved in research protocols that enroll children receive training on this topic.

Please feel free to contact the IRB staff for further information.



C. Recommended Human Subjects Protections Training
(required by the NIH)

The IRB suggests that all new researchers complete training in “Human Subjects Protections,” either by checking out the videotape from the IRB or attending a training session. The BSD/UCH IRB training videotape is available in the IRB office (contact James Lynch at 4-1613). The IRB presents live training sessions periodically throughout the year; notification regarding upcoming training sessions will be posted on this website, via emails to faculty, and on flyers within the hospital.

This training is not mandatory for IRB submission. However, please note that human subject protection training is mandatory for research staff on any NIH-funded project. The NIH provides an on-line training program to fulfill this requirement (http://phrp.nihtraining.com/users/login.php), or you can check out the videotape from the IRB office.