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Human Subject Research Policies and Procedures

IRB Transmittal Form (Revised - April 2013)

 

IRB Sample Research Consent Form (Revised April 2013)

 

 

New Human Subjects Research Training Requirement - CITI Program

As of January 01, 2011, all Key Research Personnel (see definition below) engaged in humans subject research must complete the online Collaborative Institutional Training Initiative (CITI) Training Program prior to IRB approval of a new or continuing review application.  The prior NIH training certification will not be accepted after December 31, 2010 for any new Principal Investigators of a study who have not had a protocol approved previously. The prior NIH training certificate will continue to be valid for any previously approved applications.   Please click here for additional guidance.

Key Personnel are defined as the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved with handling private information (example: patient's medical records and charts) related to study participants during the course of a research project. Key Personnel also include faculty sponsors who provide direct oversight of research with study participants or research using study participant's private information.

IRB Deadline Calendar

Next Deadline for Full Board Review:  Protocols are due to the local school IRB representative by April 24, 2013.   Final protocols are electronically due in the IRB office by noon on May 8, 2013, for the full board meeting on Wednesday, May 22, 2013.   There are no deadlines to apply for Expedited or Exempt Review.

Institutional Review Board

All research conducted at or sponsored by Duquesne University that involves human subjects must be approved by the IRB before research begins and, when necessary, reviewed periodically during the course of the project. Information is available from the office of the Chair of the IRB, Dr. Joseph Kush, Room 301A Administration Bldg. Ext: 6326.

IRB Committee Members

To determine where your IRB protocol will be reviewed locally, please view the IRB Committee member chart for school assignments.

The Belmont Report

The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years.

IRB Documents

Instructions for Researchers

IRB Transmittal Form Revised - April 2013

IRB Amendment Form

IRB Policies and Procedures

Duquesne University Human Subjects Policy - TAP #41

D.H.H.S. Policy - Office for Human Research Protections (OHRP)

IRB Guidelines for Protocol Review

Institutional Review Board Guidebook

IRB Frequently Asked Questions

IRB Consent Form Instructions

IRB Sample Research Consent Form (On Duquesne University Letterhead) - revised April 2013

IRB Annual Renewal Form

 

HIPAA Documents

Instructions for Researchers

Understanding the HIPAA Privacy Rule

Form #1 - Authorization Form & HIPAA Policy

Form #2 - Authorization to Release Health Information

Form #3 - HIPAA Permission Form

Form #4 - Accounting of Disclosures

Form #5 - Limited Data Set

 

Chair: Dr. Joseph Kush
Room 301A Administration Bldg.; Ext: 6326

kush@duq.edu