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Human Subject Research Policies and Procedures

 

New Human Subjects Research Training Requirement 

 

CITI Program

Please note that as of March 15, 2014, all key personnel engaged in human subject research must complete the NEW online CITI training program prior to IRB approval of a new or continuing review application. The new CITI training has been streamlined for your convenience and also includes a module and quiz specific to research conducted at Duquesne University.

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.

The prior NIH training certification will not be accepted after March 15, 2014 for any personnel conducting human subject research.

Please following the link below for guidance on first time registration in the CITI program.

http://citiprogram.desk.com/customer/portal/articles/163300-how-do-i-enroll-in-a-citi-course-for-the-first-time-

 IRB Deadline Calendar

Next Deadline for Full Board Review via Mentor: 

Full Board Protocols are to be uploaded to Mentor by January 8, 2014 for review by the local School/College Primary Reviewer.  If revisions are necessary, the final protocol must be in Mentor no later than January 22, 2014 to be placed on the agenda for the following full board meeting on February 5, 2014.  

There are no deadlines to apply for Expedited or Exempt Review and can be uploaded at any time after January 6, 2014.

 

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. Linda Goodfellow, Room 312 Fisher Hall, Ext 6548 or from Marianne Volk, IRB Coordinator, 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

Mentor - I.R.B.  User Guidelines

Protocol Summary Form

Consent Form Template

Amendment Submission Form

HIPAA Documents

HIPAA Forms

Instructions for Researchers

Understanding the HIPAA Privacy Rule

Duquesne University I.R.B. Policies and Procedures

Duquesne University Human Subjects Policy - TAP #41

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

O.H.R.P. Institutional Review Board Guidebook

 

Chair: Dr. Linda Goodfellow

Room 312 Fisher Hall.; Ext: 6548

goodfellow@duq.edu