Human Subjects Research - VA Pittsburgh Healthcare System
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Human Subjects Research

IRB Office Information

Rachel Samuels
IRB Administrator
Phone: 412-360-2384

Research and Development Office
Research Office Building
Mail Code 151
University Drive
Pittsburgh, PA 15240

Fax: 412-360-2377

Questions about ProSPECT?

Please contact the IRB Office staff or email the ProSPECT Support Team.

Research Office Contact Information

VAPHS Staff Training Requirements

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Human Subjects Research is defined as:

Research involving the collection of data through intervention or interaction with living individuals or the collection of identifiable private information (or specimens) from such persons.

With the exception of animal research proposals, all new submissions are initially reviewed by the VAPHS Institutional Review Board (IRB) to determine whether or not the proposal meets the definition of human subjects research or if a "Not Human Subjects Determination" is appropriate.

The IRB also reviews Quality Improvement/Quality Assurance (QA/QI) projects and requests for Reviews Preparatory to Research.

If you are unsure if your project requires review by the IRB, please contact the IRB Office for assistance.

IRB Submission Information

New Submissions

All new research protocols involving human subjects (including Full Board, Expedited and Exempt studies) and those which do not include animal subjects must be submitted using ProSPECT (Protocol Submission Portal and Electronic Communication Tracker), the online submission system at VAPHS. Any project deemed Human Subjects will be reviewed by the IRB. Any project that is deemed not human subjects, will be forwarded on to the proper review committee(s).

  • Access ProSPECT
    [Note: You must be a registered user. ProSPECT can only be accessed from behind the VA firewall.]

Other Activities Reviewed by the IRB

Quality Assurance/Quality Improvement (QA/QI) Projects

These types of projects are generally undertaken by a service line or department to evaluate the quality of a particular procedure or process. QA/QI projects are not considered research, however, there are times at which the lines between QA/QI may become blurred.

Therefore it is suggested that you review the QA/QI Policy as well as the VAPHS MCM LD-077 to help you determine whether your project is research or not. If you have any doubt as to the status of a project, you should submit a copy of the Operations Activity Worksheet, along with the materials requested on the form to the IRB for a formal determination.

Reviews Preparatory to Research

Reviews preparatory to research are generally small reviews (NOT PILOT PROJECTS) conducted in preparation for a research project in which access to personally identifiable information is needed in order to design a research study or assess the feasibility of conducting a study. Individuals interested in conducting a review preparatory to research should follow the Guidance on Reviews Preparatory to Research.

Honest Broker Certification and Associated Processes

Individuals interested in serving as Certified Honest Brokers must submit an application for review and approval by the VAPHS IRB. Investigators interested in using an Honest Broker should consult the Honest Broker Policy for additional information. Forms related to the Honest Broker Process can be accessed in ProSPECT.