Human research

What is a human research subject?

The VA Pittsburgh Healthcare System defines human subjects research as follows:

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.

The VAPHS Institutional Review Board (IRB) reviews all new submissions (except animal research proposals) to determine whether a proposal meets the definition of human subjects research or whether it should receive a "not human subjects" determination.

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

If you are unsure whether your project needs IRB review, please contact the IRB Office for assistance.

Submitting your research for review

New research submissions

If your research protocol involves human subjects (and/or doesn't include animal subjects), you must submit it using ProSPECT (Protocol Submission Portal and Electronic Communication Tracker), VAPHS' online submission system; this requirement also applies to Full Board, Expedited, and Exempt studies. 

Any project that includes human subjects will be reviewed by the IRB. Any project that does not include human subjects will be forwarded to the proper review committee(s). 

To start your submission, access ProSPECT here.

Note: To make a submission, you must be a registered user. ProSPECT is only accessible behind the VA firewall.

Reviews preparatory to research

Reviews preparatory to research are small reviews completed in preparation for a project that requires use of personally identifiable information for study design or assessment of a study's feasibility. They are not pilot projects. If you're interested in conducting a review preparatory to research, please follow the link below.

If you're unsure whether your project is considered research (according to VA's definition), please review the QA/QI Policy (link below) and the VAPHS MCM LD-077 — these documents will help you make that determination. If you have any questions about the status of a project, submit a copy of the Operations Activity Worksheet (link below).

Quality assurance/quality improvement projects (QA/QI)

 

QA/QI 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. In some situations, QA can be difficult to distinguish from QI. 

 

Questions? Contact the IRB office

 

If you have questions about human research or the IRB review process, please contact the IRB office:

 

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

 

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

 

Other research safety information

 

General research

 

Find information on safety protocols and review processes for general research.

 

Animal research

 

Find information on special safety protocols and review processes for research with animal subjects.

 

Radiation safety

 

Find information on special safety protocols and review processes for research involving radiation.