Wednesday, September 8, 2010

Human Subjects Protection

Howard Brown is committed to the protection of the rights of all research participants. Upon hire, all individuals involved in research at Howard Brown must take the Collaborative IRB Training Initiative (CITI) Course in The Protection of Human Research Subjects. The CITI course is a comprehensive Web-based education program used by reputable universities and medical centers across the country.

All studies conducted at Howard Brown are Institutional Review Board (IRB) approved. Behavioral studies are reviewed by the Howard Brown Health Center IRB; clinical research studies, such as drug trials, are reviewed by central IRBs. Training requirements are extended to IRB members to make certain our board is current in matters concerning the protection of our human subjects.

If you have any questions about our human subjects protection program, please contact David Fingerhut, Manager of Research Compliance, Department of Research at davidf@howardbrown.org or 773-388-8669.


IRB Submission Materials

All study materials – including recruitment flyers and other advertisements – are required to be reviewed by Howard Brown Health Center's IRB. Any materials posted on the Howard Brown Research Board located in the medical clinic waiting room must be HBHC IRB approved. For outside studies that wish to post their recruitment materials (e.g., pull-tab flyers or advertisement flyers) at Howard Brown Health Center or affiliated agencies, a full IRB review of all study materials (protocol, all study instruments, all outside IRB approval letters, and other materials that participants will see) is required.

The Howard Brown Institutional Review Board meets the third Thursday of the month to review research submissions. The deadline for submissions is the first Monday of the month. Please complete the relevant forms from the list below. Completed forms should be submitted to David Fingerhut, Manager of Research Compliance, Department of Research at davidf@howardbrown.org.

HBHC IRB Helpful Hints

IRB Application Procedures

2010  Request for IRB Review

2010 Financial Conflict of Interest Disclosure Form 

2010 Modification to Approved Protocol

2010 Continuing Review Application

2010 Protocol Violation Report

2010 Adverse Event Report

2010 Serious Adverse Event Report